Download WELLCARE/ `OHANA HEALTH PLAN

WELLCARE/ ‘OHANA HEALTH PLAN
2015
PRIOR AUTHORIZATION CRITERIA
(No Changes Made Since: 10/2015)
**To get updated information about the drugs covered by WellCare/’Ohana,
please visit our website (https://www.wellcare.com /
https://www.ohanahealthplan.com / https://fida.wellcareny.com)
or call Customer Service. Our phone number is available on our Contact Us
page.
PART B VERSUS PART D
Details
This drug may be covered under Medicare Part B or D depending upon the circumstances.
Information may need to be submitted describing the use and setting of the drug to make the
determination.
Products Affected
 Acetylcysteine Inhalation Solution 10 %,
20 %
 Acyclovir Sodium Intravenous Solution
50 MG/ML
 Adagen Intramuscular Solution 250
UNIT/ML
 Albuterol Sulfate Inhalation Nebulization
Solution (2.5 MG/3ML) 0.083%, (5
MG/ML) 0.5%, 0.63 MG/3ML, 1.25
MG/3ML
 Aldurazyme Intravenous* Solution 2.9
MG/5ML
 Alimta Intravenous Solution
Reconstituted 100 MG, 500 MG
 Amifostine Intravenous Solution
Reconstituted 500 MG
 Aminosyn II Intravenous Solution 10 %,
15 %, 7 %, 8.5 %
 Aminosyn II/Electrolytes Intravenous
Solution 8.5 %
 Aminosyn M Intravenous Solution 3.5 %
 Aminosyn/Electrolytes Intravenous
Solution 8.5 %
 Aminosyn-HBC Intravenous Solution 7
%
 Aminosyn-PF Intravenous Solution 10
%, 7 %
 Amphotericin B Injection Solution
Reconstituted 50 MG
Updated 10/2015
 Arzerra Intravenous Concentrate 100
MG/5ML
 Avastin Intravenous Solution 100
MG/4ML, 400 MG/16ML
 Azacitidine Injection Suspension
Reconstituted 100 MG
 Azathioprine Oral Tablet 50 MG
 Bleomycin Sulfate Injection Solution
Reconstituted 15 UNIT, 30 UNIT
 Blincyto Intravenous Solution
Reconstituted 35 MCG
 Buprenorphine HCl Injection Solution
0.3 MG/ML
 Chorionic Gonadotropin Intramuscular
Solution Reconstituted 10000 UNIT
 Clinimix/Dextrose (2.75/5) Intravenous
Solution 2.75 %
 Clinimix/Dextrose (4.25/10) Intravenous
Solution 4.25 %
 Clinimix/Dextrose (4.25/20) Intravenous
Solution 4.25 %
 Clinimix/Dextrose (4.25/25) Intravenous
Solution 4.25 %
 Clinimix/Dextrose (4.25/5) Intravenous
Solution 4.25 %
 Clinimix/Dextrose (5/15) Intravenous
Solution 5 %
 Clinimix/Dextrose (5/20) Intravenous
Solution 5 %
 Clinimix/Dextrose (5/25) Intravenous
Solution 5 %
 Clinisol SF Intravenous Solution 15 %
 Colistimethate Sodium Injection Solution
Reconstituted 150 MG
 Cromolyn Sodium Inhalation
Nebulization Solution 20 Mg/2ml
 Cyclophosphamide Injection Solution
Reconstituted 1 GM, 2 GM, 500 MG
 Cyclophosphamide Oral Capsule 25 MG,
50 MG
 Cyclophosphamide Oral Tablet 25 MG,
50 MG
 Cyclosporine Intravenous Solution 50
MG/ML
 Cyclosporine Modified Oral Capsule 100
MG, 25 MG, 50 MG
 Cyclosporine Modified Oral Solution 100
MG/ML
 Cyclosporine Oral Capsule 100 MG, 25
MG
 Elaprase Intravenous Solution 6
MG/3ML
 Elitek Intravenous Solution Reconstituted
1.5 MG, 7.5 MG
 Emend Oral Capsule 125 MG, 40 MG,
80 & 125 MG, 80 MG
 Engerix-B Injection Suspension 10
MCG/0.5ML, 20 MCG/ML
 Fabrazyme Intravenous Solution
Reconstituted 35 MG, 5 MG
 Faslodex Intramuscular Solution 250
MG/5ML
 Gengraf Oral Capsule 100 MG, 25 MG
 Gengraf Oral Solution 100 MG/ML
 Hecoria Oral Capsule 0.5 MG, 1 MG, 5
MG
 Hepatamine Intravenous Solution 8 %
Updated 10/2015
 Hepatasol Intravenous Solution 8 %
 Humulin R U-500 (Concentrated)
Subcutaneous Solution 500 UNIT/ML
 Imovax Rabies Intramuscular Injectable
2.5 UNIT/ML
 Intralipid Intravenous Emulsion 20 %, 30
%
 Ipratropium Bromide Inhalation Solution
0.02 %
 Ipratropium-Albuterol Inhalation
Solution 0.5-2.5 (3) MG/3ML
 Ixempra Kit Intravenous Solution
Reconstituted 15 MG, 45 MG
 Liposyn III Intravenous Emulsion 10 %,
20 %
 Lumizyme Intravenous Solution
Reconstituted 50 MG
 Methotrexate Sodium (PF) Injection
Solution 1 GM/40ML
 Methotrexate Sodium Injection Solution
Reconstituted 1 GM
 Mycophenolate Mofetil Oral Capsule 250
MG
 Mycophenolate Mofetil Oral Suspension
Reconstituted 200 MG/ML
 Mycophenolate Mofetil Oral Tablet 500
MG
 Mycophenolic Acid Oral Tablet Delayed
Release 180 MG, 360 MG
 Myozyme Intravenous Solution
Reconstituted 50 MG
 Naglazyme Intravenous Solution 1
MG/ML
 Nebupent Inhalation Solution
Reconstituted 300 MG
 Nephramine Intravenous Solution 5.4 %
 Novarel Intramuscular Solution
Reconstituted 10000 UNIT
 Nulojix Intravenous Solution
Reconstituted 250 MG
 Nutrilipid Intravenous Emulsion 20 %
 Pediarix Intramuscular Suspension
 Pentacel Intramuscular Suspension
Reconstituted
 Pregnyl Intramuscular Solution
Reconstituted 10000 UNIT
 Premasol Intravenous Solution 10 %, 6 %
 Procalamine Intravenous Solution 3 %
 Prograf Intravenous Solution 5 MG/ML
 Prolastin-C Intravenous Solution
Reconstituted 1000 MG
 Proleukin Intravenous Solution
Reconstituted 22000000 UNIT
 Prosol Intravenous Solution 20 %
 Pulmozyme Inhalation Solution 1
MG/ML
 RabAvert Intramuscular Suspension
Reconstituted
 Rapamune Oral Solution 1 MG/ML
 Recombivax HB Injection Suspension 10
MCG/ML, 40 MCG/ML, 5 MCG/0.5ML
 Sandimmune ORAL Solution 100
MG/ML
 Sirolimus Oral Tablet 0.5 MG, 1 MG, 2
MG
 Tacrolimus Oral Capsule 0.5 MG, 1 MG,
5 MG
 Tetanus Toxoid Adsorbed Intramuscular
Solution 5 LFU
 Travasol Intravenous Solution 10 %
 Treanda Intravenous Solution 180
MG/2ML, 45 MG/0.5ML
 Treanda Intravenous Solution
Reconstituted 100 MG, 25 MG
 Trelstar Intramuscular Suspension
Reconstituted 11.25 MG, 3.75 MG
Updated 10/2015
 Trelstar Mixject Intramuscular
Suspension Reconstituted 11.25 MG,
22.5 MG, 3.75 MG
 Trisenox Intravenous Solution 10
MG/10ML
 Trophamine Intravenous Solution 10 %,
6%
 Twinrix Intramuscular Suspension 72020
 Velcade Injection Solution Reconstituted
3.5 MG
 Virazole Inhalation Solution
Reconstituted 6 GM
 Zoledronic Acid Intravenous Solution 5
MG/100ML
 Zortress Oral Tablet 0.25 MG, 0.5 MG,
0.75 MG
ABIRATERONE
Products Affected
 Zytiga
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Stated diagnosis from oncologist of treatment for patients with metastatic
castration-resistant prostate cancer prescribed in combination with
prednisone.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ADALIMUMAB
Products Affected
 Humira
 Humira Pen
 Humira Pen-Crohns Starter
 Humira Pen-Psoriasis Starter
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Rheumatoid Arthritis: Monotherapy or as adjunct therapy for the
treatment of moderately to severely active RA when the patient has failed
an adequate trial (defined by the ACR) of 2 preferred disease modifying
anthrheumatic drugs (DMARDs).
Psoriatic Arthritis: Monotherapy or as adjunct therapy for the treatment
of active arthritis in patients with moderate to severe psoriatic arthritis
with documented trial and failure or contraindication to methotrexate and
at least 1 other preferred DMARD.
Plaque Psoriasis: Failure of two oral agents including methotrexate and a
steroid, OR PUVA treatment.
Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JIA):
For the treatment of moderately to severely active polyarticular juvenile
idiopathic arthritis when patient had inadequate response to methotrexate
alone for the appropriate treatment period OR methotrexate is
contraindicated AND 1 preferred DMARD.
Ankylosing Spondylitis: Monotherapy for reducing signs and symptoms
of active ankylosing spondylitis when patient hasn't responded to
maximum tolerated doses of at least two NSAIDS.
Preferred NSAIDs include sulindac, naproxen, and diclofenac.
Crohn's Disease: For inducing and maintaining clinical remission in
patients with moderately to severely active disease AND patient has failed
to respond to at least 1 steroidal therapy (budesonide, hydrocortisone,
prednisone, prednisolone, methylprednisolone).
Ulcerative Colitis: Moderate to severe UC and patient has failed
response to oral corticosteroids, azithropine, or 6-MP AND either
mesalamine or sulfasalazine.
Preferred DMARDs include: methotrexate, sulfasalazine,
hydroxychloroquine, cuprimine, azathioprine, leflunomide.
Age Restrictions
Updated 09/2014
18 years old and greater for uses other than juvenile idiopathic arthritis. 2
years and older for juvenile idiopathic arthritis
Prescriber
Restrictions
Rheumatologist for RA, JIA/JRA, Psoriatic Arthritis, Anklyosing
spondylitis. Dermatologist for Plaque Psoriasis. Gastroenterologist for
Crohn's, UC
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
AFATINIB
Products Affected
 Gilotrif
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use as the first-line treatment of
patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19 deletions
or exon 21 (L858R) substitution mutations as detected by an FDAapproved test. Members should obtain periodic liver testing during
treatment.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ALOSETRON
Products Affected
 Alosetron HCl
 Lotronex
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Males
Required
Medical
Information
Medical documentation of use for women with severe diarrheapredominant irritable bowel syndrome (IBS) with chronic IBS symptoms
(generally lasting 6 months or longer), have had anatomic or biochemical
abnormalities of the gastrointestinal tract excluded, and have not
responded adequately to conventional therapy.
Severe IBS includes diarrhea and 1 or more of the following:
1. frequent and severe abdominal pain/discomfort.
2. frequent bowel urgency or fecal incontinence.
3. disability or restriction of daily activities due to IBS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Prescribers who have enrolled in the Prometheus Prescribing Program for
LOTRONEX
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 08/2015
ALTRETAMINE
Products Affected
 Hexalen
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
For the palliative treatment of recurrent or persistent ovarian cancer
following first-line combination chemotherapy with cisplatin and/or
alkylating agent based combination (carboplatin, cyclophosphamide,
ifosfamide, lomustine).
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
AMBRISENTAN
Products Affected
 Letairis
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Statement of FDA approved diagnosis of pulmonary arterial hypertension
with WHO class II or III symptoms and stated trial and failure or
contraindication to preferred alternative sildenafil.
Treat women of child-bearing potential only after a negative pregnancy
test and treat only women who are using two reliable methods of
contraception OR
have had a tubal sterilization OR
a Copper T 380A IUD or LNg 20 IUD inserted.
Age Restrictions
18 years and older
Prescriber
Restrictions
Available only to those enrolled in the REMS program as needed
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
AMITRIPTYLINE
Products Affected
 Amitriptyline HCl Oral
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication including
physician indication for the continued use of the HRM (high risk
medication) with an explanation of the specific benefit established with
the medication, and how that benefit outweighs the potential risk. AND
the physician must document the ongoing monitoring plan for the agent.
AND
the physician must document that patient counseling has and will continue
to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
established indication.
Preferred alternatives include:
- For depression: paroxetine, sertraline, venlafaxine, duloxetine,
citalopram, escitalopram, fluoxetine, and trazodone.
-For migraine prophylaxis: propranolol, timolol, topiramate, valproic acid
and divalproex.
-For anxiety: paroxetine, venlafaxine, duloxetine, and buspirone.
-For postherpetic neuralgia: gabapentin.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
AMPHOTERICIN B LIPOSOMAL
Products Affected
 Ambisome
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement indicating FDA approved diagnosis of any of the following:
1. Empirical therapy for presumed fungal infection in febrile, neutropenic
patients.
2. Treatment of Cryptococcal Meningitis in HIV infected patients.
3. Treatment of patients with Aspergillus species, Candida species and/or
Cryptococcus species infections (see above for the treatment of
Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or
in patients where renal impairment or unacceptable toxicity precludes the
use of amphotericin B deoxycholate.
4. Treatment of visceral leishmaniasis. In immunocompromised patients
with visceral leishmaniasis treated with AmBisome, relapse rates were
high following initial clearance of parasites.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
30 days
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
AMPHOTERICIN B LIPOSOMAL ABELCET
Products Affected
 Abelcet
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement indicating FDA approved diagnosis of any of the following:
1. Empirical therapy for presumed fungal infection in febrile, neutropenic
patients.
2. Treatment of Cryptococcal Meningitis in HIV infected patients.
3. Treatment of patients with Aspergillus species, Candida species and/or
Cryptococcus species infections.
4. Treatment of visceral leishmaniasis. In immunocompromised patients
with visceral leishmaniasis treated with AmBisome, relapse rates were
high following initial clearance of parasites AND
refractory to or intolerant of conventional amphotericin B therapy.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
30 days
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
APOMORPHINE
Products Affected
 Apokyn
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patient that has not been previously treated with standard dopaminergic
therapy.
Required
Medical
Information
Advanced Parkinson's Disease:
1. Confirmed diagnosis of advanced Parkinson's disease AND
2. Unable to control "off" symptoms with adequate combinations of
conventional therapy (eg, entacapone, pramipexole, ropinirole,
carbidopa/levodopa, amantadine, tasmar, exelon patch, rivastigmine)
AND
3. Used in combination with a non-5-HT3 antagonist antiemetic for initial
therapy AND
4. Not used in combination with 5-HT3 antagonists as this is
contraindicated.
Apokyn will only be approved for intermittent subcutaneous injection.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
ARIPIPRAZOLE DISCMELT
Products Affected
 Abilify Discmelt Oral Tablet Dispersible
10 MG, 15 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medication documentation of FDA approved indication AND
statement of swallowing difficulty or intolerance to two preferred
alternatives.
Preferred alternatives include: risperidone ODT, risperidone oral solution,
and aripirazole oral solution.
Age Restrictions
18 years and older (Major Depressive Disorder, adjunctive treatment) 13
years and older (Schizophrenia) 10 years and older (Bipolar Disorder) 6 17 years (Autism)
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ARIPIPRAZOLE INJECTABLE
Products Affected
 Abilify Intramuscular
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicated for the acute treatment of agitation
associated with schizophrenia or bipolar I disorder (inj) and documented
failure or intolerable side effects with first generation short acting
injectable, haloperidol AND
atypical antipsychotic, olanzapine or ziprasidone.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ARIPIPRAZOLE MAINTENA
Products Affected
 Abilify Maintena
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis of schizophrenia and patient must
have documented treatment failure or intolerable side effects from
treatment with Invega Sustenna and Risperdal Consta is required. If
approved, requires concurrent treatment with a 14-day course of oral
Abilify or another oral antipsychotic.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ATOMOXETINE
Products Affected
 Strattera Oral Capsule 10 MG, 100 MG,
18 MG, 25 MG, 40 MG, 60 MG, 80 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Concomittant use within 2 weeks after discontinuing MAOI or other
drugs that affect brain monoamine concentrations. Narrow Angle
Glaucoma. Pheochromocytoma or history of pheochromocytoma.
Required
Medical
Information
Statement of FDA approved diagnosis of attention-deficit hyperactivity
disorder (ADHD) AND
For the treatment of ADHD must have documented failure or adverse
effect to one (1) amphetamine product and one (1) methylphenidate
product or have a history or family history of substance abuse.
Preferred alternatives including amphetamine salt combo,
dextroamphetamine, methylphenidate, dexmethylphenidate, metadate er,
or methylphenidate sr.
Age Restrictions
6 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
AXITINIB
Products Affected
 Inlyta
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of FDA approved diagnosis for the treatment of
advanced renal cell carcinoma and member must have tried and failed or
have a contraindication to preferred agent Sutent.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
BECAPLERMIN
Products Affected
 Regranex
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Known neoplasm(s) at the site of application.
Required
Medical
Information
Medical statement indicating patient has diabetic foot ulcer and is
undergoing debridement at least once weekly, and at least two of the
following are present and trial and failure or contraindication to preferred
alternative Santyl.
1) Stage III or IV wound
2) Wound at least 1 cm x 1 cm
3) Long-standing wound that does not heal with standard care
4) Patients at high risk for amputation (peripheral neuropathy, peripheral
vascular disease, skin or nail abnormalities, previous foot ulcer
amputation).
Age Restrictions
16 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Initial: 3 months. Reauth: maximum of 6 months
Other Criteria
Efficacy has not been established in the treatment of pressure ulcers and
venous stasis ulcers, nor exposed joints, tendons, ligaments, and bone (in
humans).
Updated 09/2014
BENZTROPINE
Products Affected
 Benztropine Mesylate Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
the physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
BEXAROTENE
Products Affected
 Bexarotene
 Targretin
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Medical statement of medically accepted diagnosis, manifestations of
cutaneous T-cell lymphoma in patients who are refractory to at least one
prior systemic therapy. Negative pregnancy test taken within 2 weeks of
request. Documented early stage disease treatment in patients who have
not tolerated other therapies or who have refractory or persistent disease.
Maximum Dose: 400 mg/m2/day.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 10/2015
BOCEPREVIR
Products Affected
 Victrelis
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of documented diagnosis of Hepatitis C Genotype 1 AND
use of ribavirin AND
peginterferon-alfa-2a or -2b with a 4 week lead-in period and triple
therapy to follow AND
Required laboratory documentation for initial approval: Baseline HCV
RNA (viral load).
Required laboratory documentation for reauthorization: HCV-RNA at
treatment weeks 8 and 12 and as clinically appropriate.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Initial approval for 12 weeks. Reapproval by 12 week extensions (Max 44
weeks of Victrelis therapy)
Other Criteria
Victrelis cannot be approved as monotherapy.
Updated 09/2014
BOSENTAN
Products Affected
 Tracleer
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy (category X)
Required
Medical
Information
Statement of FDA approved diagnosis of pulmonary arterial hypertension
WHO group I - III, with NYHA class II - IV symptoms, used to improve
exercise ability and decrease the rate of clinical worsening and stated trial
and failure or contraindication to preferred alternatives Letairis (for WHO
class II and III only) and sildenafil.
Age Restrictions
18 years and older
Prescriber
Restrictions
Available only to those enrolled in the Tracleer Access Program (T.A.P.)
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
BOSUTINIB
Products Affected
 Bosulif
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use for the treatment of chronic,
accelerated, or blast phase Philadelphia chromosome-positive (Ph+)
chronic myelogenous leukemia (CML) and trial and failure or
contraindication to preferred agents dasatinib AND imatinib.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at the time of enrollment will
not be required to meet prerequisites for authorization.
Updated 09/2014
BREXPIPRAZOLE
Products Affected
 Rexulti
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Schizophrenia: Documented treatment failure or intolerable side effects
from treatment with two formulary medications within the same class.
Formulary atypical antipsychotics include: risperidone, quetiapine,
olanzapine, ziprasidone, aripiprazole, Latuda, and Saphris.
Major Depressive Disorder -MDD- (augmenting treatment):
Documented continuous treatment with an antidepressant as monotherapy
AND documented treatment failure or intolerable side effects from
adjunctive treatment with two formulary medications within the same
class.
Formulary atypical antipsychotics include: quetiapine, olanzapine, and
aripiprazole.
Members not on an antidepressant require continuous trial with a
preferred antidepressant including fluoxetine, paroxetine, sertraline,
citalopram, bupropion, mirtazepine, venlafaxine, escitalopram, and
citalopram solution.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 10/2015
BROMOCRIPTINE
Products Affected
 Cycloset
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Type 1 diabetes and diabetic ketoacidosis
Required
Medical
Information
Statement of FDA approved diagnosis and trial and failure or
contraindication to two preferred agents for type 2 diabetes mellitus.
Preferred blood glucose regulators include: acarbose, Byetta, Bydureon,
glimepride, glipizide, nateglinide, pioglitazone, repaglinide, Januvia,
Onglyza, tolazamide, and tolbutamide.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
BUPRENORPHINE
Products Affected
 Buprenorphine HCl Sublingual
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Doses above 24mg/day. Concurrent use of a short acting or long acting
narcotic. Diagnosis of pain
Required
Medical
Information
1. Diagnosis of opioid dependence.
2. Dose
3. Current urine drug screen unless patient is new. If new patient,
documentation that patient is new to the program.
4. Documentation of ongoing psychosocial counseling with demonstration
of compliance along with submission of medical notes regarding
treatment plan, time frames for tapering, and psychosocial counseling
5. Taper schedule (if dose exceeds 16mg/day buprenorphine). For doses
greater than 16 mg/day, reauthorization after 1 month of continual therapy
will require a statement of taper trial including dose, duration, and
outcome. For doses less than or equal to 16mg/day, reauthorization after 3
months of continual therapy will require a statement of taper trial
including dose, duration, and outcome.
Age Restrictions
16 years and older
Prescriber
Restrictions
Licensed physician who qualifies for a waiver under the Drug Addiction
Treatment Act (DATA) and who has been assigned a DEA (X) number
Coverage
Duration
For doses greater than 16mg/day: 1 month. For doses less than 16mg/day:
3 months.
Other Criteria
N/A
Updated 09/2014
BUPRENORPHINE/NALOXONE
Products Affected
 Suboxone Sublingual Film
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Diagnosis of pain, concurrent use of a short or long acting narcotic, or
doses above 24 mg/day
Required
Medical
Information
Medical documentation including the following information are required
for approval:
1) Diagnosis of opioid dependence.
2) Daily dose
3) Current urine drug screen if established patient, if new patient,
documentation that patient is new to the program.
4) Documentation of ongoing psychosocial counseling with
demonstration of compliance along with submission of medical notes
regarding treatment plan and psychosocial counseling.
5) Taper schedule (if dose exceeds 16mg/day buprenorphine including
time frame for tapering).
Age Restrictions
16 years and older
Prescriber
Restrictions
Licensed physician who qualifies for a waiver under the Drug Addiction
Treatment Act (DATA) and who has been assigned a DEA (X) number
Coverage
Duration
3 months for doses less than or equal to 16 mg/day and 1 month for doses
greater than 16 mg/day
Other Criteria
N/A
Updated 09/2014
BUTALBITAL CONTAINING PRODUCTS
Products Affected
 Butalbital-APAP-Caffeine Oral Tablet
50-325-40 MG
 Butalbital-Acetaminophen
 Butalbital-Aspirin-Caffeine Oral Capsule
 Butalbital-APAP-Caff-Cod
 Butalbital-APAP-Caffeine Oral Capsule  Tencon Oral Tablet 50-325 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives.
Preferred alternatives include: NSAIDs such as ibuprofen and sumatriptan
or naratriptan.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 06/2015
C1 ESTERASE INHIBITOR
Products Affected
 Cinryze
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation for use of this C1 esterase inhibitor for routine
prophylaxis against angioedema attacks in adolescent and adult patients
with Hereditary Angioedema (HAE) AND trial and failure or
contraindiation to preferred agent danazol.
Age Restrictions
N/A
Prescriber
Restrictions
hematologist, immunologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
CABOZANTINIB
Products Affected
 Cometriq (100 mg Daily Dose)
 Cometriq (140 mg Daily Dose)
 Cometriq (60 mg Daily Dose)
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from oncologist for treatment of patients with
progressive, metastatic medullary thyroid cancer (MTC).
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
CALCITONIN
Products Affected
 Miacalcin Injection
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
1. For Postmenopausal Osteoporosis: trial and failure of one
bisphosphonate or selective estrogen-receptor modulator (SERM) AND
Failure of Calcitonin Nasal Spray AND
History of vertebral compression fractures, or fractures of the hip or distal
radius resulting from minimal trauma, or T score of -2.5 or less.
2. Paget's Disease: History of failure or intolerance to oral
bisphosphonates. Preferred bisphosphonate agents include: Alendronate,
Boniva.Preferred SERM is raloxifene.
3. For early treatment of hypercalcemic emergencies: along with other
appropriate agents, when a rapid decrease in serum calcium is required,
until more specific treatment of the underlying disease can be
accomplished. It may also be added to existing therapeutic regimens for
hypercalcemia such as intravenous fluids and furosemide, oral phosphate
or corticosteroids, or other agents.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
Hypercalcemic Emergencies, 4 - 7 days, All other indications, Through
the benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
CARBINOXAMINE
Products Affected
 Arbinoxa
 Carbinoxamine Maleate Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternatives.
The preferred alternative for pruritis, urticaria, seasonal or perennial
allergy is levocetirizine.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 03/2015
CASPOFUNGIN
Products Affected
 Cancidas
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis:
Empirical therapy for presumed fungal infections in febrile, neutropenic
patients.
Treatment of candidemia and the following Candida infections: intraabdominal abscesses, peritonitis and pleural space infections.
Treatment of esophageal candidiasis.
Treatment of invasive aspergillosis in patients who are refractory to or
intolerant of other therapies (amphotericin B, itraconazole).
Age Restrictions
3 months of age and older
Prescriber
Restrictions
Infectious Disease
Coverage
Duration
6 months
Other Criteria
N/A
Updated 09/2014
CEFTAROLINE FOSAMIL
Products Affected
 Teflaro
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation with notes and culture and sensitivity results from
within the last 30 days for use of this cephalosporin antibacterial as
indicated for the treatment of the following infections caused by
designated susceptible bacteria:
1. Acute bacterial skin and skin structure infections (ABSSSI) or
2. Community-acquired bacterial pneumonia (CABP) AND trail and
failure of two preferred agents:
Preferred agents include: trimethoprim/sulfamethoxazole, amoxicillin,
ampicillin, aztreonam, cephalosporins, piperacillin/tazobactam,
minocycline or doxycycline, and clindamycin.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
14 days
Other Criteria
N/A
Updated 09/2014
CERITINIB
Products Affected
 Zykadia
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy category D
Required
Medical
Information
Medical documentation stating diagnosis from an oncologist for patients
with anaplastic lymphoma kinase (ALK)-positive metastatic non-small
cell lung cancer (NSCLC) who have progressed on or are intolerant to
crizotinib.
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
CIALIS
Products Affected
 Cialis Oral Tablet 2.5 MG, 5 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Use in females. Diagnosis of Erectile Dysfunction only.
Required
Medical
Information
Statement of FDA approved indication used one daily for the treatment of
the signs and symptoms of benign prostatic hyperplasia (BPH).
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Cialis should not be used in combination with organic nitrates.
Updated 09/2014
CLEMASTINE
Products Affected
 Clemastine Fumarate Oral Tablet 2.68
MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternatives.
The preferred alternative for pruritis, urticaria, seasonal or perennial
allergy is levocetirizine.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
CLOMIPRAMINE
Products Affected
 Clomipramine HCl Oral
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication including
physician indication for the continued use of the HRM (high risk
medication) with an explanation of the specific benefit established with
the medication, and how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
established indication.
Preferred alternatives for obsessive-compulsive disorder are paroxetine,
sertraline, fluoxetine, and fluvoxamine.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
CLONIDINE ER
Products Affected
 Clonidine HCl ER
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis of attention deficit hyperactivity
disorder (ADHD) as monotherapy after having tried and failed or having a
contraindication to immediate release clonidine and immediate release
guanfacine or as adjunctive therapy to preferred stimulant medications
AND
must have documented failure or adverse effect to two preferred
alternatives including amphetamine salt combo, dextroamphetamine,
dextroamphetamine er, methylphenidate, dexmethylphenidate, metadate
er, or methylphenidate sr.
Age Restrictions
Ages 6 through 17 years
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
CLOZAPINE
Products Affected
 Clozapine Oral Tablet Dispersible 100
MG, 12.5 MG, 25 MG
 Versacloz
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with a history of clozapine-induced agranulocytosis or severe
granulocytopenia.
Required
Medical
Information
Refractory Schizophrenia/Schizoaffective Disorder: Clozapine orally
disintegrating tablet or oral suspension will be approved upon receipt of
physician statement that member requires the use of an atypical
antipsychotic for the treatment of refractory schizophrenia that has failed
to respond adequately to appropriate courses of standard formulary
antipsychotic agents or to reduce the risk of recurrent suicidal behavior in
patients with schizophrenia or schizoaffective disorder AND is intolerant
to oral solutions or unable to swallow other oral formulations.
Formulary antipsychotics: clozapine (tablet), risperidone (orally
disintegrating tablet, tablet, solution), quetiapine (tablet), olanzapine
(tablet), and ziprasidone (capsule).
Age Restrictions
18 years and older
Prescriber
Restrictions
Part of a clozapine registry
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at the time of enrollment will
not be required to meet prerequisites for authorization.
Updated 07/2015
CRIZOTINIB
Products Affected
 Xalkori
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis of late-stage (locally advanced or metastatic), non-small
cell lung cancers (NSCLC) with expression of the abnormal anaplastic
lymphoma kinase (ALK) gene as detected by an FDA approved test with
a maximum dose of 500 mg/day.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
CYPROHEPTADINE
Products Affected
 Cyproheptadine HCl Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternatives.
The preferred alternative for pruritus, urticaria, and seasonal or perennial
allergy is levocetirizine.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
CYSTEAMINE
Products Affected
 Cystagon
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Cysteamine is contraindicated in patients who have demonstrated
hypersensitivity to cysteamine or penicillamine hypersensitivity.
Required
Medical
Information
Statement of FDA approved diagnosis, Management of nephropathic
cystinosis in children and adults.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
DABRAFENIB
Products Affected
 Tafinlar
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with wild-type BRAF melanoma, in pregnancy, and when used in
combination with Zelboraf.
Required
Medical
Information
Medical documentation indicating use for the treatment of patients with
unresectable or metastatic melanoma with BRAF V600E or BRAF
V600K mutation as detected by an FDA-approved test. Test must confirm
the presence of BRAF V600E mutation before initiation of therapy as a
single agent or the presence of BRAF V600E or V600K mutation before
initiation of treatment with TAFINLAR in combination with trametinib.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
DALFAMPRIDINE
Products Affected
 Ampyra
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation supporting FDA approved diagnosis to improve
walking in patients with multiple sclerosis (MS) AND Timed 25-Foot
Walk (T25W) or other similar documentation dated within 30 days of
request showing baseline functional composite score.
Age Restrictions
N/A
Prescriber
Restrictions
Neurologist
Coverage
Duration
Through benefit year
Other Criteria
Max dose 10 mg twice daily
Updated 09/2014
DALFOPRISTIN/QUINUPRISTIN
Products Affected
 Synercid
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation with notes and culture and sensitivity results from
within the last 30 days for use for complicated skin and skin structure
infections caused by Staphylococcus aureus (methicillin susceptible) or
Streptococcus pyogenes after trail and failure of two preferred agents.
Preferred agents include trimethoprim/sulfamethoxazole, amoxicillin,
ampicillin, aztreonam, cephalosporins, piperacillin/tazobactam,
minocycline or doxycycline, and clindamycin.
Age Restrictions
16 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
14 days
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
DAPTOMYCIN
Products Affected
 Cubicin
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Diagnosis of pneumonia or left sided infective endocarditis caused by S.
aureus.
Required
Medical
Information
Osteomyelitis: Trial and failure of vancomycin. History of failure with
vancomycin or documented resistance to vancomycin.
Cellulitis/Skin infections: Trial and failure of
sulfamethoxazole/trimethoprim (Bactrim, Septra, SMX/TMP) or
doxycyline and vancomycin. Also, a diagnosis of possible MRSA or
confirmed MRSA infection.
Sepsis/Bacteremia: Culture and sensitivity with documented resistance to
vancomycin dated within the past 30 days and/or trial and failure of
vancomycin.
Endocarditis: Trial and failure of vancomycin. History of failure with
vancomycin or documented resistance to vancomycin.
Septic Arthritis: History or trial and failure with vancomycin or
documented resistance to vancomycin.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Osteomyelitis: 56dy; Cellulitis/Skin inf 14dy;
Sepsis/Bacteremia/Endocarditis: 42dy; Septic arth: 28dy
Other Criteria
N/A
Updated 09/2014
DASATINIB
Products Affected
 Sprycel
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication:
Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
(CML) in chronic phase.
Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML.
Acute lymphocytic leukemia (ALL): Statement indicating diagnosis of
Philadelphia chromosome-positive (Ph+) ALL.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
DEFERASIROX
Products Affected
 Exjade
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Doses above 40mg/kg and patients with poor performance status, highrisk myelodysplastic syndromes, or advanced malignancies.
Required
Medical
Information
Medical documentation of FDA approved diagnosis, serum ferritin level
and documentation of serum creatinine no greater than 2X the upper limit
of normal or creatinine clearance less than 40mL/min, and CBC
indicating platelet count greater than or equal to 50x109 cell/L.
Deferasirox is indicated for the treatment of chronic iron overload due to
blood transfusions in patients 2 years of age and older such as when the
patient is receiving transfusions and has a serum ferritin consistently
above 1000 mcg/L. In patients not adequately controlled with doses of 30
mg/kg (e.g. serum ferritin levels persistently above 2500 mcg/L and not
showing a decreasing trend over time), doses of up to 40 mg/kg may be
considered.
After commencing therapy, it is recommended that serum ferritin be
monitored every month and the dose adjusted if necessary every 3 to 6
months based on serum ferritin trends. If the serum ferritin falls
consistently below 500 mcg/L, consideration should be given to
temporarily interrupt therapy. Exjade is also indicated for the treatment of
patients 10 years and older who have chronic iron overload resulting from
a genetic blood disorder called non-transfusion-dependent thalassemia.
Age Restrictions
Covered for those 2 years of age and older with chronic iron overload due
to blood transfusions. 10 years and older for chronic iron overload
resulting from a genetic blood disorder called non-transfusion dependent
thalassemia.
Prescriber
Restrictions
N/A
Coverage
Duration
Six months
Other Criteria
N/A
Updated 09/2014
DEFERASIROX ORAL TABLETS
Products Affected
 Jadenu
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with poor performance status, high-risk myelodysplastic
syndromes, or advanced malignancies.
Required
Medical
Information
Medical documentation of FDA approved diagnosis, serum ferritin level
and documentation of serum creatinine no greater than 2X the upper limit
of normal or creatinine clearance not less than 40mL/min, and CBC
indicating platelet count greater than or equal to 50,000 cells/microliter.
Deferasirox is indicated for the treatment of chronic iron overload due to
blood transfusions in patients 2 years of age and older such as when the
patient is receiving transfusions and has a serum ferritin consistently
above 1000 mcg/L. In patients not adequately controlled with doses of 21
mg/kg (e.g. serum ferritin levels persistently above 2500 mcg/L and not
showing a decreasing trend over time), doses of up to 28 mg/kg may be
considered. After commencing therapy, it is recommended that serum
ferritin be monitored every month and the dose adjusted if necessary
every 3 to 6 months based on serum ferritin trends. If the serum ferritin
falls consistently below 500 mcg/L, consideration should be given to
temporarily interrupt therapy.
Deferasirox is also indicated for the treatment of patients 10 years and
older who have chronic iron overload resulting from a genetic blood
disorder called non-transfusion-dependent thalassemia.
Age Restrictions
Covered for those 2 years of age and older with chronic iron overload due
to blood transfusions and 10 years and older for chronic iron overload
resulting from a genetic blood disorder called non-transfusion dependent
thalassemia.
Prescriber
Restrictions
N/A
Coverage
Duration
Six months
Other Criteria
Max dose 28 mg/kg/day
Updated 08/2015
DENOSUMAB
Products Affected
 Xgeva
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis indicated for: Prevention of
skeletal-related events in patients with bone metastases from solid tumors.
Treatment of adults and skeletally mature adolescents with giant cell
tumor of bone that is unresectable or where surgical resection is likely to
result in severe morbidity.
Xgeva is not indicated for the prevention of skeletal-related events in
patients with multiple myeloma.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
DESVENLAFAXINE SUCCINATE
Products Affected
 Pristiq
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of major depressive disorder (MDD): Failure of
one (1) preferred antidepressants from two (2) different antidepressant
classes.
Preferred agents include: fluoxetine capsules, paroxetine, citalopram,
escitalopram, bupropion, mirtazapine/ mirtazapine ODT, trazodone,
amitriptyline, venlafaxine or venlafaxine er.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
DEXTROAMPHETAMINE
Products Affected
 Dexedrine Oral Tablet
 Dextroamphetamine Sulfate ER
 Dextroamphetamine Sulfate Oral Tablet
 Zenzedi Oral Tablet 10 MG, 5 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment to help produce weight loss.
Required
Medical
Information
Statement of FDA approved diagnosis of narcolepsy or attention-deficit
hyperactivity disorder (ADHD) AND
For the treatment of ADHD must have documented failure or adverse
effect to our preferred alternatives including: amphetamine salt combo
AND
at least one of the following: methylphenidate, methylphenidate SR,
methylphenidate ER 10 mg/ 20 mg, Metadate ER, or dexmethylphenidate.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 06/2015
DEXTROAMPHETAMINE/AMPHETAMINE
Products Affected
 Amphetamine-Dextroamphetamine
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment to help produce weight loss.
Required
Medical
Information
Statement of FDA approved diagnosis of narcolepsy or attention-deficit
hyperactivity disorder (ADHD).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
DEXTROMETHORPHAN/QUINIDINE
Products Affected
 Nuedexta
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Nuedexta has not been shown to be safe and effective in emotional
lability that can commonly occur, for example, in Alzheimer's disease and
other dementias.
Required
Medical
Information
Statement of FDA approved diagnosis for the treatment of pseudobulbar
affect (PBA). PBA occurs secondary to a variety of otherwise unrelated
neurological conditions, and is characterized by involuntary, sudden, and
frequent episodes of laughing and/or crying. PBA episodes typically
occur out of proportion or incongruent to the underlying emotional state.
Studies to support the effectiveness were performed in patients with
amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS).
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
DIGOXIN
Products Affected
 Digitek Oral Tablet 250 MCG
 Digoxin Oral Tablet 250 MCG
 Lanoxin Oral Tablet 0.25 MG, 187.5
MCG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
lab work including digoxin levels.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 03/2015
DIMETHYL FUMARATE
Products Affected
 Tecfidera
 Tecfidera Oral 120 & 240 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis for the treatment of patients with
relapsing forms of multiple sclerosis and trial and failure or
contraindication to two preferred platform therapies.
Preferred platform therapies include: Rebif, Extavia, and Copaxone.
Statement must also include a first MS attack with document MRI scan
abnormalities characteristic of MS, OR evaluation documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS. Statement must also include a first MS attack with
document MRI scan abnormalities characteristic of MS, OR evaluation
documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Coverage
Duration
Through benefit year
Other Criteria
Documentation within 6 months of recent complete blood cell count
(CBC) is recommended before initiation of therapy to identify patients
with pre-existing low lymphocyte counts.
Updated 10/2014
DIPYRIDAMOLE
Products Affected
 Dipyridamole Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternatives.
Preferred alternative includes: clopidogrel.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
DISOPYRAMIDE
Products Affected
 Norpace CR
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
DORIPENEM
Products Affected
 Doribax Intravenous Solution
Reconstituted 500 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation for use with culture and susceptibility information
for
1. Complicated Intra-Abdominal Infections: indicated as a single agent for
the treatment of complicated intra-abdominal infections caused by
Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa,
Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron,
Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius,
Streptococcus constellatus and Peptostreptococcus micros.
2. Complicated Urinary Tract Infections, Including Pyelonephritis:
indicated as a single agent for the treatment of complicated urinary tract
infections, including pyelonephritis caused by Escherichia coli including
cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus
mirabilis, Pseudomonas aeruginosa, and Acinetobacter baumannii.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
14 days
Other Criteria
N/A
Updated 09/2014
DOXEPIN
Products Affected
 Doxepin HCl Oral
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication including
physician indication for the continued use of the HRM (high risk
medication) with an explanation of the specific benefit established with
the medication, and how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives.
Preferred alternatives include: paroxetine, sertraline, venlafaxine,
duloxetine, citalopram, escitalopram, fluoxetine, and trazodone.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
DRONABINOL
Products Affected
 Dronabinol
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
For treatment of chemotherapy-induced nausea or vomiting refractory to
conventional antiemetic agents:
1. Patient is receiving cancer chemotherapy AND
2. Failure to preferred 5HT-3 receptor antagonist. Preferred agents
include: ondansetron or granisetron AND
3. Failure to one of the following agents:
a. Antihistamine
b. Corticosteroid
c. Prokinetic agent
d. Antipsychotic.
For treatment of anorexia associated with weight loss in patients with
HIV:
1. Patient is receiving AIDS anti-retroviral therapy AND
2. Experienced as least
a. 7.5% unintentional weight loss over 6 months
b. 10% unintentional weight loss over 12 months
c. 5% body cell mass (BCM) loss within 6 months
d. BMI less than 20 kg/m2
e. BCM less than 35% male (less than 23% female) and a BMI
less than 27 kg/m2 AND
3. Documentation of trial and failure, contraindication, or intolerance to
megestrol at doses up to 800mg daily.
Age Restrictions
18 years old and greater for the treatment of anorexia associated with
weight loss in patients with HIV.
Prescriber
Restrictions
N/A
Coverage
Duration
For N/V - 6 months, For anorexia in HIV positive patients - 3 months
Other Criteria
N/A
Updated 10/2014
ECALLANTIDE
Products Affected
PA Criteria
Covered Uses
Exclusion
Criteria
Required
Medical
Information
Age Restrictions
Prescriber
Restrictions
Coverage
Duration
Other Criteria
Updated 04/2015
 Kalbitor
PENDING CMS APPROVAL
ELIGARD
Products Affected
 Eligard
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Medication documentation for the palliative treatment of advanced
prostate cancer, patients must have stated failure or intolerance to
preferred agent Trelstar.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination. Members currently
taking this medication at time of enrollment will not be required to meet
prerequisites for prior authorization.
Updated 09/2014
ELTROMBOPAG
Products Affected
 Promacta
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
AST/ALT greater than 3 times baseline or 3 times the upper limit of
normal.
Required
Medical
Information
AST/ALT levels within the past 30 days and medical documentation of
1) Thrombocytopenia in patients with chronic immune (idiopathic)
thrombocytopenic purpura (ITP) who have had an insufficient response to
corticosteroids, immunoglobulins, or splenectomy. To be used only in
patients with ITP whose degree of thrombocytopenia and clinical
condition increases the risk for bleeding and should not be used in an
attempt to normalize platelet counts. Platelet counts from within the past
30 days should be provided and should be less than 50,000/mm3. Max
Dose: 75mg/day.
2) Thrombocytopenia in patients with Hepatitis C to allow them to initiate
and maintain interferon based therapy, requires diagnosis of hepatitis C,
currently taking interferon (or planning to start), platelet count within 30
days less than 50,000/mm3. Max dose: 100mg/day.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
6 months
Other Criteria
N/A
Updated 09/2014
ENZALUTAMIDE
Products Affected
 Xtandi
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use for the treatment of metastatic
castration-resistant prostate cancer who have previously received
docetaxel and have history of trial and failure or contraindication to
preferred alternative Zytiga.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at the time of enrollment will
not be required to meet prerequisites for authorization.
Updated 09/2014
EPOETIN ALFA
Products Affected
 Procrit
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Documented FDA approved diagnosis AND
no active gastrointestinal bleed AND
transferrin saturation should be at least 20% and ferritin at least 100
ng/mL AND
for patients with uncontrolled hypertension, blood pressure is adequately
controlled before initiation of therapy and closely monitored and
controlled during therapy.
Lab data within 30 days prior to DER request. Labs for review:
Hemoglobin, Ferritin, and Iron Saturation. Doses greater than 60,000
units will not be covered unless patient has normal iron saturation and has
received an adequate 4 weeks trial at a lower dose with other sources of
anemia ruled out.
Anemia in neoplastic disease, due to chemotherapy: the hgb level prior
to start of treatment is less than 10 g/dL (or the hct is less than 30%).
Must be receiving concomitant chemotherapy for a min of 2 months.
Anemia in chronic renal failure: the hgb level prior to initiation of
treatment is less than 10 g/dL.
Reduction of Allogeneic Red Blood Cell Transfusions in Patients
Undergoing Elective, Noncardiac, Nonvascular Surgery: Hgb 10 g/dL
to less than 13 g/dL.
Anemia in HIV-infected patients: Hgb less than 12 g/dL (Hct less than
36%).
Age Restrictions
N/A
Prescriber
Restrictions
For patients with cancer, prescribers must be under the ESA APPRISE
Oncology program
Coverage
Duration
2 months
Updated 09/2014
Other Criteria
Updated 09/2014
In patients whose hgb rises less than 1 g/dl (hct rise less than 3%)
compared to pretreatment baseline over 4 weeks of treatment and whose
hgb level remains below 10 g/dL after the 4 weeks of treatment (or the hct
is below 30%), the FDA label starting dose may be increased once by
25%. Continued use of the drug is not reasonable and necessary if the hgb
rises more than 1 g/dl (hct rise less 3%) compared to pretreatment
baseline by 8 wks of treatment or if there is a rapid rise in hgb more than
1 g/dl (hct less than 3%) over 2 wks of treatment unless the hgb remains
below or falls to less than 10g/dL (or hct is less than 30%).
Continuation and reinstitution of ESA therapy must include a dose
reduction of 25% from the previously administered dose.
Treatment duration for each course of chemotherapy includes the 8 weeks
following the final dose of myelosuppressive chemotherapy in a
chemotherapy regimen.
For continuation of therapy: Anemia in cancer patients on chemotherapy:
average Hgb level must be less than 12 g/dL (Hct less than 30%).
Anemia of chronic kidney disease: average Hgb level must be less
than/equal 10 g/dL (Hct less than 30%) for non-dialysis patient and
11g/dL (Hct less than 33%) for dialysis patient.
Anemia related to zidovudine therapy: average Hgb below 12.0 g/dL (Hct
less than 36%), must have serum erythropoietin levels less/equal 500
mUnits/mL, and be receiving a dose of zidovudine of less than or equal to
4200 mg/wk.
Reduction of allogeneic blood transfusion for elective, noncardiac,
nonvascular surgery in anemic patients: average Hgb of more than 10g/dL
to less than or equal to 13g/dL.
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
ERGOLOID MESYLATES
Products Affected
 Ergoloid Mesylates Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication including
physician indication for the continued use of the HRM (high risk
medication) with an explanation of the specific benefit established with
the medication, and how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
established indication.
Preferred alternatives for Alzheimer's disease/dementia are galantamine,
rivastigmine, and donepezil.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
ERLOTINIB
Products Affected
 Tarceva
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of medically accepted diagnosis AND
total bilirubin laboratory value within six months prior to initiation of
Tarceva.
Tarceva should be interrupted or discontinued if total bilirubin is greater
than 3 times ULN and/or transaminases are greater than 5 times ULN in
the setting of normal pretreatment values.
-First-line treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors have epidermal growth factor receptor (EGFR)
exon 19 deletions or exon 21 (L858R) substitution mutations as detected
by an FDA-approved test.
-Maintenance treatment of patients with locally advanced or metastatic
NSCLC whose disease has not progressed after four cycles of platinumbased first-line chemotherapy.
-Treatment of locally advanced or metastatic NSCLC after failure of at
least one prior chemotherapy regimen.
-First-line treatment of patients with locally advanced, unresectable or
metastatic pancreatic cancer, in combination with gemcitabine.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ESLICARBAZEPINE
Products Affected
 Aptiom Oral Tablet 200 MG, 400 MG,
600 MG, 800 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of use as adjunctive treatment of partial-onset
seizures.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
Through Benefit Year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ESTRAMUSTINE
Products Affected
 Emcyt
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with active thrombophlebitis or thromboembolic disorders,
except in those cases where the actual tumor mass is the cause of the
thromboembolic phenomenon and documentation the physician feels the
benefits of therapy may outweigh the risks.
Required
Medical
Information
Prescriber statement that medication is being requested for palliative
treatment of metastatic and/or progressive prostate cancer.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ESTROGENS
Products Affected
 Estradiol Oral
 Estradiol Transdermal Patch Weekly
 Estradiol-Norethindrone Acet
 Estropipate Oral
 Lopreeza
 Mimvey
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
established indication.
Preferred alternatives include:
-Vasomotor symptoms of menopause: requires provider
acknowledgement of HRM status
-Vulvar or vaginal atrophy: Estrace cream, Premarin cream
-Osteoporosis: alendronate, ibandronate, raloxifene.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 06/2015
ETANERCEPT
Products Affected
 Enbrel
 Enbrel Sureclick
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Rheumatoid Arthritis: Monotherapy or as adjunct therapy for the
treatment of moderately to severely active RA when the patient has failed
an adequate trial (defined by the ACR) to 2 preferred disease modifying
anthrheumatic drugs (DMARDs).
Psoriatic Arthritis: Monotherapy or as adjunct therapy for the treatment
of active arthritis in patients with moderate to severe psoriatic arthritis
with documented trial and failure or contraindication to methotrexate and
at least 1 other preferred DMARD.
Plaque Psoriasis: Failure of two oral agents including methotrexate and a
steroid, OR PUVA treatment.
Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JIA):
For the treatment of moderately to severely active polyarticular juvenile
idiopathic arthritis when patient had inadequate response to methotrexate
alone for the appropriate treatment period OR methotrexate is
contraindicated AND 1 preferred DMARD.
Ankylosing Spondylitis: Monotherapy for reducing signs and symptoms
of active ankylosing spondylitis when patient hasn't responded to
maximum tolerated doses of at least two NSAIDS.
-Preferred NSAIDs include: sulindac, naproxen, and diclofenac.
-Preferred DMARDs include: methotrexate, sulfasalazine,
hydroxychloroquine, cuprimine, azathioprine, leflunomide.
Age Restrictions
18 years old and greater for uses other than juvenile idiopathic arthritis. 2
years and older for juvenile idiopathic arthritis.
Prescriber
Restrictions
Rheumatologist- for RA, JRA/JIA; Psoriatic Arthritis, Anklyosing
spondylitis, Dermatologist for Plaque Psoriasis.
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
EVEROLIMUS
Products Affected
 Afinitor
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of FDA approved diagnosis for:
1. Treatment of patients with advanced renal cell cancer (RCC)
a) First line, member must have tried and failed or have a
contraindication to preferred agent Sutent.
b) Second line, member
must have tried and failed or have a contraindication to preferred
agent Inlyta.
2. Treatment of patients with subependymal giant cell astrocytoma
(SEGA) with tuberous sclerosis complex (TSC) who require therapeutic
intervention but are not candidates for curative surgical resection.
3. Treatment of patients with progressive neuroendocrine tumors of
pancreatic origin (PNET) that is unresectable, locally advanced, or
metastatic.
4. Postmenopausal women with advanced hormone receptor positive
HER2 - Negative breast cancer in combination with exemestane after
failure of treatment with letrozole or anastrozole.
5. Adults with renal angiomyolipoma and tuberous sclerosis complex
(TSC), not requiring immediate surgery.
For use of Afinitor Disperz, a statement that member has swallowing
difficulties or cannot tolerate Afinitor tablets must be included.
Age Restrictions
N/A
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
EVEROLIMUS DISPERZ
Products Affected
 Afinitor Disperz
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved indication and for use of Afinitor Disperz, a
statement that member has swallowing difficulties or cannot tolerate
Afinitor tablets must be included.
1. Treatment of patients with advanced renal cell cancer (RCC) after
failure of treatment with sunitinib or sorafenib.
2. Treatment of patients with subependymal giant cell astrocytoma
(SEGA) associated with tuberous sclerosis (TS) who require therapeutic
intervention but are not candidates for curative surgical resection.
3. Treatment of patients with progressive neuroendocrine tumors of
pancreatic origin (PNET) that is unresectable, locally advanced, or
metastatic.
Age Restrictions
N/A
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through the benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
EZOGABINE
Products Affected
 Potiga
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved indication for treatment as adjunctive therapy
for partial-onset seizures in patients who have responded inadequately to
several alternative treatments (valproic acid, carbamazepine, phenytoin,
topiramate, lamotrigine, gabapentin, oxcarbazepine or barbituates) and for
whom the benefits outweigh the risk of retinal abnormalities and potential
decline in visual acuity. Treatment should be discontinued if no
substantial clinical benefit is shown after adequate titration, due to
potential for retinal abnormalities with long-term use.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
FENTANYL CITRATE
Products Affected
 Fentanyl Citrate Buccal
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pain not related to cancer
Required
Medical
Information
Only approved for management of breakthrough cancer pain in patients
with malignancies who are already receiving and who are tolerant to
opioid therapy for underlying persistent cancer pain. Patients considered
opioid-tolerant are those who are taking at least 60 mg morphine/day or
an equianalgesic dose of another opioid for a week or longer.
Age Restrictions
16 years and older
Prescriber
Restrictions
Oncologist or Pain specialist
Coverage
Duration
6 months
Other Criteria
Available only to those enrolled in the Transmucosal Immediate Release
Fentanyl (TIRF) REMS Program. Not approved if patient is on Suboxone
or Subutex. Contraindicated for the management of acute or postoperative
pain including headache/migraines.
Updated 09/2014
FENTANYL NASAL
Products Affected
 Lazanda
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pain not related to cancer
Required
Medical
Information
Statement of FDA approved diagnosis for the management of
breakthrough pain in cancer patients 18 years of age and older who are
already receiving and who are tolerant to opioid therapy for their
underlying persistent cancer pain. Lazanda may be dispensed only to
patients enrolled in the TIRF REMS Access program except for
beneficiaries in the hospice or LTC setting.
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist or Pain Specialtist
Coverage
Duration
Through Benefit Year
Other Criteria
Available only to those enrolled in the Transmucosal Immediate Release
Fentanyl (TIRF) REMS Program. Not approved if patient is on Suboxone
or Subutex. Contraindicated for the management of acute or postoperative
pain including headache/migraines.
Updated 09/2014
FIDAXOMICIN
Products Affected
 Dificid
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment of systemic infections
Required
Medical
Information
Documented diagnosis of Clostridium difficile associated diarrhea AND
contraindication to preferred agents metronidazole (oral or systemic) or
oral vancomycin hydrochloride or failure of an adequate trial of 5-7 days
of metronidazole (oral or systemic) or oral vancomycin hydrochloride.
Contraindications to or failure of an adequate trial of metronidazole (oral
or systemic) or oral vancomycin is excluded in patients receiving
myelosuppressive chemotherapy, hematopoietic stem cell transplant
recipients, or patients receiving concomitant systemic antibiotics.
Age Restrictions
18 years and older
Prescriber
Restrictions
Gastroenterologist, Infectious disease specialist, or Oncologist
Coverage
Duration
10 days
Other Criteria
N/A
Updated 09/2014
FILGRASTIM
Products Affected
 Neupogen
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA approved diagnosis, and concurrent
chemotherapy treatment, if applicable. Absolute Neutrophil Count and
CBC with differential.
Chemo-induced Neutropenia: initiate therapy the next day up to 3-4
days after chemotherapy and treat through post-nadir recovery. Initial
dose should be 5 mcg/kg/day, adjust dose according to ANC goal of 1,500
to 10,000/mm3.
Cytotoxic Chemo-Induced Neutropenia after Bone Marrow
Transplantation: initiate therapy 24 hrs after cytotoxic chemotherapy.
Initial dose should be 10 mcg/kg/day, adjust dose according to ANC,
reduce dose to 5 mcg/kg/day if ANC greater than 1,000 for 3 consecutive
days, and discontinue therapy if ANC greater than 1,000 for 3 consecutive
days if already at 5 mcg/kg/day.
Severe Chronic Neutropenia: initiate therapy when severe neutropenic
(ANC less than 500mm3), initial dose for congenital neutropenia should
be 6 mcg/kg SC twice a day and initial dose for idiopathic or cyclic
neutropenia should be 5 mcg/kg SC once daily, adjust dose if ANC
greater than 10,000/mm3 or based on patient's clinical course.
Peripheral blood stem cell mobilization: start 4 days before the first
leukophoresis procedure and continue until the last leukophoresis
procedure. Initial dose should be 10 mcg/kg/day, adjust dose if ANC
greater than 10,000/mm3. Target ANC goal between 1,500/mm3 and
10,000/mm3. DC use of medication if ANC is greater than 10,000/mm3.
Age Restrictions
N/A
Prescriber
Restrictions
Hematologist and/or Oncologist
Updated 09/2014
Coverage
Duration
2 months or duration of chemotherapy
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
FINGOLIMOD
Products Affected
 Gilenya
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Recent occurrence (within the last 6 months) of myocardial infarction,
unstable angina, stroke, transient ischemic attack, decompensated heart
failure requiring hospitalization, class III or IV heart failure. History or
presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick
sinus syndrome, unless patient has a pacemaker. Baseline QTc interval
greater than or equal to 500ms. Treatment with Class Ia or Class III antiarrhythmic drugs.
Required
Medical
Information
Statement of FDA approved diagnosis for the treatment of patients with
relapsing forms of multiple sclerosis and trial and failure or
contraindication to two preferred platform therapies.
Preferred platform therapies include: Rebif, Extavia, and Copaxone.
Statement must also include a first MS attack with document MRI scan
abnormalities characteristic of MS, OR evaluation documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS. Statement must also include a first MS attack with
document MRI scan abnormalities characteristic of MS, OR evaluation
documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Updated 10/2014
Coverage
Duration
Through benefit year
Other Criteria
For patients previously treated with Tysabri: a minimum 3 month washout
period is required after discontinuation of Tysabri.
Updated 10/2014
FOSCARNET
Products Affected
 Foscarnet Sodium
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Trial and failure to preferred agent or contraindication/intolerance to
preferred medication. Indications for use:
1. Treatment of cytomegalovirus (CMV) retinitis in patients with acquired
deficiency syndrome (AIDS). Combination therapy with foscarnet and
ganciclovir is indicated for patients who have relapsed after monotherapy
with either drug.
2. Treatment of Mucocutaneous acyclovir-resistant herpes simplex virus
(HSV) infections in immunocompromised patients.
-For CMV: preferred alternative is valganciclovir.
-For Mucocutaneous acyclovir-resistant herpes simplex virus (HSV)
infections the preferred alternative is Famciclovir.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Herpes simplex- 21 days CMV Retinitis- through benefit year
Other Criteria
N/A
Updated 09/2014
GANCICLOVIR
Products Affected
 Ganciclovir Sodium
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis of Cytomegalovirus Infection
Prophylaxis, date of transplant if being used for prophylaxis following
organ transplant. Should not be administered if the absolute neutrophil
count (ANC) is less than 500 cells/ microL or the platelet count is less
than 25,000. FDA daily maximum single dose is 6 mg/kg by IV infusion
over one hour, 3000 mg/day PO (larger doses/faster infusions have
resulted in increased toxicity). Administration should be accompanied by
adequate hydration.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Six months
Other Criteria
N/A
Updated 10/2014
GLATIRAMER
Products Affected
 Copaxone Subcutaneous 20 MG/ML, 40
MG/ML
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from neurologist of definite or probable relapsingremitting MS, secondary progressive MS with relapses, or progressive
relapsing MS. Statement may include a first MS attack with document
MRI scan abnormalities characteristic of MS, OR evaluation documenting
EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 10/2015
GRANISETRON
Products Affected
 Granisetron HCl Oral
 Granisetron HCl Intravenous Solution 0.1
MG/ML, 1 MG/ML
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Nausea and vomiting due to chemotherapy, radiation therapy, or postoperative nausea/vomiting, AND intolerance or failure to preferred
alternative, ondansetron.
Preferred alternative: ondansetron (available as an oral solution, oral
tablet, solution for injection, and orally disintegrating tablet).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
GUANFACINE
Products Affected
 Guanfacine HCl Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
hypertension.
Preferred alternatives include: benazepril, benazepril-HCTZ, captopril,
captopril-HCTZ, enalapril, enalapril-HCTZ, fosinopril, fosinopril-HCTZ,
lisinopril, lisinopril-HCTZ, quinapril, ramipril, moxepril, moxeprilHCTZ, perindopril erbumine, quinapril-HCTZ, tradolapril.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
HARVONI
Products Affected
 Harvoni
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Use as chronic hepatitis C monotherapy in genotypes other than 1, 4 or 6
OR use with other products containing sofosbuvir OR use with simeprevir
OR use with rosuvastatin OR use with cobicistat, elvitegravir or
tipranavir. AND not taking rifampin, anticonvulsants, St. Johns Wort or
other prescribed products known to significantly decrease ledipasvir
and/or sofosbuvir plasma concentrations that may lead to a reduced
therapeutic effect of HARVONI.
Required
Medical
Information
Documented medical diagnosis of Chronic Hepatitis C. AND HCV-RNA
levels and fibrosis score documented within the past 90 days (Prescriber
must submit lab documentation indicating HCV genotype and quantitative
viral load). AND documentation of history of previous HCV therapies
(less than or equal to 2 weeks of SOV + RBV +/- PEG or PEG +/- RBV
due to RBV or PEG adverse drug reactions are considered treatment
naive).
Genotype (GT) 1:
-Treatment-naive (TN) w/o cirrhosis x 12 weeks (if HCV RNA less than 6
million option of x 8 weeks).
-TN w/ cirrhosis x 12 weeks.
-Treatment-experienced (TE) (PEG + RBV) w/o cirrhosis x 12 weeks.
-TE (PEG + RBV) w/ compensated cirrhosis (CC) x 24 weeks.
-TE (SOFOSBUVIR (SOF)-based) w/ CC +/- RBV x 24 weeks.
-TN/TE de-compensated cirrhosis (DCC) + RBV (initial dose 600mg) x
12 weeks.
-TE (SOF-based) w/ DCC + RBV (initial dose 600mg) x 24 weeks.
Genotype GT 4:
-TN w/o DCC x 12 weeks.
-TE (PEG + RBV) w/o DCC x 12 weeks.
-TN/TE w/ DCC RBV (initial dose 600mg) x 12 weeks.
-TE (SOF-based) w/ DCC + RBV (initial dose 600mg) x 24 weeks.
Genotype GT 6:
-TN w/o DCC x 12 weeks.
-TE w/o DCC x 12 weeks.
-Post liver transplant (PLT) treatment: TN/TE GT 1 or 4, F0 to F4 CC +
Updated 04/2015
RBV x 12 weeks, RBV intolerant x 24 weeks.
-PLT DCC: TN/TE: GT 1 or 4: + RBV (low initial dose) x 12 weeks.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
12 or 24 wk duration depending on genotype & cirrhosis status. See above
in Required Medical Info.
Other Criteria
N/A
Updated 04/2015
HYDROXYZINE
Products Affected
 Hydroxyzine HCl Intramuscular
 Hydroxyzine HCl Oral Solution
 Hydroxyzine HCl Oral Tablet
 Hydroxyzine Pamoate Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternatives.
-The preferred alternative for pruritis, urticaria, and seasonal or perennial
allergy is levocetirizine.
-The preferred alternatives for anxiety includes: buspirone, paroxetine,
duloxetine, and venlafaxine.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
IBANDRONATE
Products Affected
 Ibandronate Sodium Intravenous
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of contraindication or gastrointestinal intolerance of oral
bisphosphonate therapy.
Preferred oral bisphosphonates: alendronate, ibandronate (oral).
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
IBRUTINIB
Products Affected
 Imbruvica
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use as indicated for the treatment of
patients with mantle cell lymphoma (MCL) who have received at least
one prior therapy.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ICATIBANT
Products Affected
 Firazyr
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation for use as indicated for the treatment of acute
attacks of hereditary angioedema (HAE) in adults 18 years of age and
older.
Age Restrictions
18 years or older
Prescriber
Restrictions
Hematologist, Immunologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
ILOPERIDONE
Products Affected
 Fanapt
 Fanapt Titration Pack
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Schizophrenia: Documented treatment failure or intolerable side effects
from treatment with two formulary medications within the same class.
Formulary atypical antipsychotics include: risperidone, quetiapine,
olanzapine, ziprasidone, Latuda, Saphris, and Abilify.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
IMATINIB
Products Affected
 Gleevec Oral Tablet 100 MG, 400 MG
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis of one of the following:
-Newly diagnosed adult and pediatric patients with Philadelphia
chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic
phase.
-Patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in
chronic phase (CP) after failure of interferon-alpha therapy.
-Pediatric patients with Ph+ CML in chronic phase who are newly
diagnosed or whose disease has recurred after stem cell transplant or who
are resistant to interferon-alpha therapy.
-Adult patients with relapsed or refractory Ph+ acute lymphoblastic
leukemia (ALL).
-Adult patients with myelodysplastic/ myeloproliferative diseases
(MDS/MPD) associated with PDGFR (platelet-derived growth factor
receptor) gene re-arrangements.
-Adult patients with aggressive systemic mastocytosis without the D816V
c-Kit mutation or with c-Kit mutational status unknown.
-Adult patients with hypereosinophilic syndrome and/or chronic
eosinophilic leukemia who have the FIP1L1-PDGFRa fusion kinase
(mutational analysis or FISH demonstration of CHIC2 allele deletion) and
for patients with HES and/or CEL who are FIP1L1-PDGFRa fusion
kinase negative or unknown. Adult patients with unresectable, recurrent
and/or metastatic dermatofibrosarcoma protuberans (DFSP).
-Patients with Kit (CD117) positive unresectable and/or metastatic
malignant gastrointestinal stromal tumors (GIST). Or adjuvant treatment
of adult patients following resection of Kit (CD117) positive GIST.
-Pediatric patients with newly diagnosed ph+ acute lymphoblastic
leukemia in combination with chemotherapy.
Age Restrictions
N/A
Prescriber
Restrictions
Oncologist
Updated 09/2014
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
IMIGLUCERASE
Products Affected
 Cerezyme Intravenous Solution
Reconstituted 400 Unit
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis and trial and failure to preferred
agent Vpriv AND A confirmed diagnosis of Type 1 Gaucher disease that
results in one or more of the following conditions: anemia,
thrombocytopenia, bone disease, hepatomegaly or splenomegaly.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
IMIPRAMINE
Products Affected
 Imipramine HCl Oral
 Imipramine Pamoate
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication including
physician indication for the continued use of the HRM (high risk
medication) with an explanation of the specific benefit established with
the medication, and how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
established indication.
Preferred alternatives include:
-For depression: paroxetine, sertraline, venlafaxine, duloxetine,
citalopram, escitalopram, fluoxetine, and trazodone.
-For anxiety: paroxetine, venlafaxine, duloxetine, and buspirone.
-For postherpetic neurlagia: gabapentin.
-For nocturnal enuresis in children: approve.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
IMIQUIMOD
Products Affected
 Imiquimod External
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Approved upon failure to an adequate trial of preferred treatment or if
preferred treatment is contraindicated.
For trial and failure of a preferred agent, preferred agents include:
-For external perianal warts: Condylox gel
-For external genital warts: Podofilox, Condylox gel
-For basal cell CA: Fluorouracil topical
-For actinic keratosis (AK): Fluorouracil topical.
Age Restrictions
For external warts: 12 years or older. For basal cell CA and AK: 18 years
or older.
Prescriber
Restrictions
N/A
Coverage
Duration
16 weeks
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
IMMUNE GLOBULIN, GAMMA
Products Affected
 Carimune NF
 Gammagard Injection Solution 2.5
GM/25ML
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
IgA-deficient patients with antibodies to IgA and a history of
hypersensitivity.
Required
Medical
Information
Statement indicating FDA approved diagnosis. Documented
hypogammaglobulinemia (IgG less than 400 mg/dL).
Idiopathic Thrombocytopenic Purpura (ITP):
1. When there is an immediate need to increase the plt count (e.g., serious
bleeding episodes) AND plt count less than 30,000.
2. In preparation for splenectomy or other invasive procedures AND
platelet count less than 20,000.
3. In pregnant women at risk of bleeding AND
a. Plt count less than 10,000 at any time during the pregnancy OR
b. Plt count 10,000 to 30,000 in the second or third trimester OR
c. Clinically significant bleeding.
4. In chronic ITP not responding to steroids.
Kawasaki Disease:
1. Statement indicating diagnosis AND
2. Must be on concurrent aspirin therapy AND
3. Documented hypogammaglobulinemia (IgG less than 400 mg/dL).
Chronic Lymphocytic Leukemia (CLL):
1. Statement indicating diagnosis
2. Documented hypogammaglobulinemia (IgG less than 400 mg/dL).
Other applicable and relevant supporting medical information, such as
failure or contraindication to immunosuppression or alternative therapy.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):
1. Medical documentation of progressive weakness and impaired sensory
function in the legs and arms including difficulty walking which
progressively worsens over a few months, tingling or other abnormal
sensations, and a loss of reflexes, such as the knee and ankle jerk. Other
applicable and relevant supporting medical information, such as failure or
contraindication to immunosuppression or alternative therapy.
Age Restrictions
Updated 10/2014
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
ITP: 5 days. Kawasaki Syndrome: 4 days. Other uses: through benefit
year
Other Criteria
Part B coverage is available for IVIG administered in the home for
individuals whose diagnosis is primary immune deficiency disease. For
primary immunodeficiency diseases (e.g. agammaglobulinemia or
hypogammaglobinemia), IVIG is covered under Medicare Part B.
Updated 10/2014
INFLIXIMAB
Products Affected
 Remicade
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Rheumatoid Arthritis: Monotherapy or as adjunct therapy for the
treatment of moderately to severely active RA when the patient has failed
an adequate trial (defined by the ACR) to at least one disease modifying
antirheumatic drug (DMARD) OR NSAID AND one preferred TNF
Humira or Enbrel.
[-Preferred NSAIDs: ibuprofen, naproxen, ketoprofen, meloxicam.
-Preferred DMARDs: methotrexate, sulfasalazine, hydroxychloroquine,
cuprimine, azathioprine, leflunomide].
Psoriatic Arthritis: Monotherapy or as adjunct therapy for the treatment
of moderate to severe psoriatic arthritis in patients with adequate trial and
failure to preferred TNF Humira or Enbrel.
Plaque Psoriasis: Failure of methotrexate, OR a steroid, OR PUVA
treatment AND one preferred TNF Humira or Enbrel.
Ankylosing Spondylitis: Monotherapy in patients for reducing signs and
symptoms of active ankylosing spondylitis when patient hasn't responded
to maximum tolerated doses of preferred TNF Humira or Enbrel.
Crohn's disease: For inducing and maintaining clinical remission in
patients with moderately to severely active Crohn's disease AND patient
has failed to respond to at least one steroidal therapy (budesonide,
hydrocortisone, prednisone, prednisolone, methylprednisolone) AND
preferred TNF Humira.
Reauthorization: Documented decreased symptoms at 14 weeks.
Ulcerative Colitis: Diagnosis of moderate to severe ulcerative colitis.
Stated failure of one (1) conventional therapy regimens as outlined by the
American Gastroenterology Association including corticosteroid
treatment (hydrocortisone, prednisone, prednisolone,
methylprednisolone), balsalazide, mesalamine or sulfasalazine AND trial
and failure of Humira.
Updated 09/2014
Age Restrictions
6 years and older
Prescriber
Restrictions
Rheumatologist- for RA, Psoriatic Arthritis, Anklyosing spondylitis,
Dermatologist for Plaque Psoriasis, Gastroenterologist for Crohn's
disease, Ulcerative Colitis.
Coverage
Duration
CD: 4 months. Reauth: Through benefit year. All other uses: Through
benefit year
Other Criteria
N/A
Updated 09/2014
INTERFERON ALFA-2B
Products Affected
 Intron-A
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Type B viral Hepatitis (HBeAg positive): Serum HBsAg positive for at
least six months, AND
elevated serum ALT 2 times ULN or moderate to severe hepatitis or
fibrosis on biopsy. Type B Viral Hepatitis (HBeAg negative) HBsAG
positive for at least 6 months AND
BHV DNA level of 2000 IU/ml or more than 11,200 copies/ml AND
One of the following, persistent ALT 2 times UNL or moderate to severe
hepatitis or fibrosis on biopsy.
Documentation must be provided showing trial and failure to our
preferred agent Peg-Intron.
Chronic Hepatitis C: Positive HCV antibody and HCV RNA.
Documentation must be provided showing trial and failure to our
preferred agent Peg-Intron.
Condyloma Acuminatum or Perianal Warts: Must have documentation
of trial and failure to preferred alternative or intolerance/contraindication
to preferred alternatives. For external perianal warts, condylox gel, for
external genital warts, podofilox, or imiquimod.
Hairy Cell Leukemia: Medical documentation indicating diagnosis.
Malignant Melanoma: Indicated as adjuvant to surgical treatment with
malignant melanoma who are free of disease but at high risk for systemic
recurrence, within 56 days of surgery.
Follicular Lymphoma: Indicated for the initial treatment of clinically
aggressive follicular Non-Hodgkin's Lymphoma in conjunction with
anthracycline-containing combination chemotherapy. Efficacy in patients
with low-grade, low-tumor burden follicular Non-Hodgkin's Lymphoma
has not been demonstrated.
AIDS-Related Kaposi's Sarcoma: Indicated for the treatment of selected
patients. The likelihood of response to therapy is greater in patients who
are without systemic symptoms, who have limited lymphadenopathy and
who have a relatively intact immune system as indicated by total CD4
count.
Age Restrictions
For Hepatitis B- age 1 or older, For Hepatitis C - age 3 or older, All other
diagnoses- 18 years or older.
Updated 09/2014
Prescriber
Restrictions
N/A
Coverage
Duration
HCVgenotype 1: 16 wk, HCVgenotype 2/3: 24 wk max, HCVgenotype 4:
48 wk max, ChronicHep C/Others: 1yr
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization except to verify
Part B vs Part D coverage for therapy in neoplastic diseases.
Updated 09/2014
INTERFERON BETA-1A
Products Affected
 Rebif
 Rebif Rebidose
 Rebif Rebidose Titration Pack
 Rebif Titration Pack
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from neurologist of definite or probable relapsingremitting MS, secondary progressive MS with relapses, or progressive
relapsing MS. Statement may include a first MS attack with document
MRI scan abnormalities characteristic of MS, OR
evaluation documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
INTERFERON BETA-1B
Products Affected
 Extavia
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from neurologist of definite or probable relapsingremitting MS, secondary progressive MS with relapses, or progressive
relapsing MS. Statement may include a first MS attack with document
MRI scan abnormalities characteristic of MS, OR
evaluation documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
INTERFERON GAMMA-1B
Products Affected
 Actimmune
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients who develop or have known hypersensitivity to interferongamma, E. coli derived products, or any component.
Required
Medical
Information
Statement indicating FDA approved diagnosis of chronic granulomatous
disease or severe malignant osteopetrosis.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ITRACONAZOLE
Products Affected
 Itraconazole Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Approve for the diagnosis of aspergillosis or blastomycosis. For
onychomycosis, require stated trial and failure or contraindication to two
preferred products including, terbinafine tablets, griseofulvin, and topical
ciclopirox. For the diagnosis of histoplasmosis, documentation of trial and
failure or contraindication to ketoconazole.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Onychomycosis: 12 weeks. All other indications: through benefit year.
Other Criteria
N/A
Updated 09/2014
IVACAFTOR
Products Affected
 Kalydeco
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with a homozygous F508del mutation in the CFTR gene.
Required
Medical
Information
Medical documentation of cystic fibrosis AND statement that member has
a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N,
or S549R mutation in the CFTR gene.
Age Restrictions
6 years and older
Prescriber
Restrictions
Endocrinologist or Pulmonologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
KETOCONAZOLE
Products Affected
 Ketoconazole Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with acute or chronic liver disease and for the treatment of fungal
infections of the skin/nails or fungal meningitis.
Required
Medical
Information
Documentation of any of the following systemic fungal infections in
patients who have failed or who are intolerant to other therapies:
1. Blastomycosis with trial and failure or intolerance of 2 of the
following: amphotericin B, itraconazole, fluconazole, or voriconazole.
2. Coccidioidomycosis with trial and failure or intolerance of 2 of the
following: amphotericin B, itraconazole, or fluconazole.
3. Histoplasmosis with trial and failure or intolerance of 2 of the
following: amphotericin B, itraconazole, or fluconazole.
4. Chromomycosis with trial and failure or intolerance of flucytosine.
5. Paracoccidioidomycosis with trial and failure or intolerance of
amphotericin B and sulfadiazine. Healthcare professionals should assess
the liver status of the patient before starting this medication and monitor
serum ALT levels during treatment. If ALT values increase to a level
above the upper limit of normal or 30 percent above baseline, or if the
patient develops symptoms, ketoconazole treatment should be interrupted
and a full set of liver tests should be obtained. Adrenal function should be
monitored in patients with adrenal insufficiency or with borderline
adrenal function and in patients under prolonged periods of stress.
Age Restrictions
2 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
LANREOTIDE
Products Affected
 Somatuline Depot
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
1. Diagnosis of acromegaly AND
2. Inadequate response to surgery and/or radiotherapy, or for patients
unable to tolerate surgery or radiation AND
3. Stated trial and failure of preferred agent octreotide. Initial dose, 90 mg
SC q4weeks x 3 months. Labs needed for reauthorization: Growth
Hormone (GH) and Insulin Growth Factor-1 (IGF-1) level. Adjust dose
based on GH/IGF-1 levels. GH 1 - 2.5ng/ml and IGF-1 normal, symptoms
controlled, 90 mg sc q4weeks. GH greater than 2.5 ng/ml, IGF-1 elevated
and/or symptoms uncontrolled, 120 mg SC q4weeks. GH 1 ng/ml or less,
IGF-1 normal, symptoms controlled, 60 mg SC every q 4weeks. If patient
is stable at 60 or 90 mg SC q4weeks, can take 120 mg q6-8 weeks.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Initial: 3 months. Reauthorization: Through Benefit Year.
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
LAPATINIB
Products Affected
 Tykerb
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Approve if used in combination with
1. Xeloda (capecitabine) for the treatment of patients with advanced or
metastatic breast cancer whose tumors overexpress HER2 and who have
received prior therapy including an anthracycline, a taxane, and
trastuzumab. OR
2. Femara (letrozole) for the treatment of postmenopausal women with
hormone receptor positive metastatic breast cancer that overexpresses the
HER2 receptor for whom hormonal therapy is indicated.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
LENALIDOMIDE
Products Affected
 Revlimid
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy and treatment of patients with chronic lymphocytic leukemia
(CLL) as experimental treatment will not be approved.
Required
Medical
Information
Medical documentation of labs including CBC with platelet count and
ANC drawn within the last month and one of the following diagnoses:
1. Mantle cell lymphoma (MCL): Statement indicating need for the
treatment of mantle cell lymphoma in patients whose disease has relapsed
or progressed after two prior therapies, one of which included bortezomib
(Velcade).
2. Multiple myeloma (MM): Statement indicating need for the treatment
of multiple myeloma in combination with dexamethasone in patients who
have failed to respond to at least one prior therapy, Bortezomib (Velcade),
Carfilzomib (Kyprolis), Carmustine, Cyclophosphamide, Doxorubicin,
Melphalan (Alkeran).
3. Myelodysplastic syndromes (MDS): Transfusion-dependent anemia
due to low- or intermediate-1-risk associated with a deletion 5q
abnormality with or without additional cytogenetic abnormalities.
Age Restrictions
18 years and older
Prescriber
Restrictions
Registered in REVLIMID REMS
Coverage
Duration
Through benefit year
Other Criteria
Revlimid is only available through a restricted distribution program called
the REVLIMID REMS program. Information about the drug and the
program can be obtained at www.celgeneriskmanagement.com or by
calling 1-888-423-5436.
Updated 09/2014
LENVATINIB
Products Affected
 Lenvima 10 MG Daily Dose
 Lenvima 14 MG Daily Dose
 Lenvima 20 MG Daily Dose
 Lenvima 24 MG Daily Dose
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
1. Stated diagnosis of locally recurrent or metastatic, progressive,
radioactive iodine-refractory differentiated thyroid cancer (DTC).
2. Documentation of blood pressure controlled at less than or equal to
Grade 2 hypertension (systolic BP less than 180 mmHg and diastolic BP
less than 110 mmHg).
3. Documentation of labs including SCr, LFTs and calcium levels.
4. Documentation of the absence of NYHA Class III or IV heart failure.
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist, Endocrinologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 06/2015
LEUPROLIDE
Products Affected
 Leuprolide Acetate Injection
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Medical statement of FDA approved diagnosis.
For the treatment of central precocious puberty (CPP) submission of
pubertal gonadal sex steroid levels (in boys, testosterone levels greater
than 30 ng/dL and in girls, estradiol levels greater than 20 pg/mL) AND
a pubertal LH increase in response to stimulation by native GnRH, AND
pelvic ultrasound assessment in girls is required for approval along with
notes indicating premature development of secondary sexual
characteristics at or before the age of 8 years in girls and 9 years in boys
and significant advancement of bone age and/or a poor adult height
prediction. Magnetic resonance imaging or CT-scanning of the brain is
recommended to detect hypothalamic or pituitary tumors, or anatomical
changes associated with increased intracranial pressure. Other causes of
sexual precocity, such as congenital adrenal hyperplasia, testotoxicosis,
testicular tumors and/or other autonomous feminizing or masculinizing
disorders must be excluded by proper clinical hormonal and diagnostic
imaging examinations.
For the treatment of prostate cancer, patient must have stated failure or
intolerance to Trelstar.
Age Restrictions
For precocious puberty: 11 years or less in males and 10 years or less in
females.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year for the diagnosis of prostate cancer. Six months for
CPP.
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination. Members currently
taking this medication at time of enrollment will not be required to meet
prerequisites for prior authorization.
Updated 09/2014
LEVOMILNACIPRAN
Products Affected
 Fetzima
 Fetzima Titration
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of major depressive disorder (MDD) and
documented trial and failure or intolerable side effects from treatment of
two (2) preferred antidepressants from two different antidepressant
classes.
Preferred agents include: fluoxetine, paroxetine, citalopram, escitalopram,
sertraline, bupropion, mirtazapine/mirtazapine ODT, trazodone,
venlafaxine or venlafaxine er.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
LINEZOLID
Products Affected
 Linezolid
 Zyvox Oral Suspension Reconstituted
 Zyvox Oral Tablet
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating one of the following:
1. Infections caused by vancomycin-resistant enterococci (VRE)
documented by culture and sensitivity (C/S) report within past 30 days.
2. Nosocomial pneumonia caused by methicillin-resistant Staphylococcus
aureus (MRSA) documented by C/S report within past 30 days.
3. Nosocomial or community acquired pneumonia (CAP) caused by
methicillin susceptible Staphylococcus aureus (MSSA) or Streptococcus
pneumoniae documented by C/S report within past 30 days and failure to
2 (or resistance to all) preferred antibiotics.
-Preferred agents include: amoxicilin/clavulanate, azithromycin,
cephalexin, clarithromycin, levofloxacin.
4. Complicated skin and skin structure infections (SSI), including diabetic
foot infections, without osteomyelitis caused by MRSA documented by
C/S report within past 30 days.
5. Uncomplicated SSI caused by MRSA documented by C/S report within
past 30 days or empirical treatment of patients with uncomplicated or
community-acquired complicated SSI without osteomyelitis where
MRSA infection is likely, in patients who have failed two or has
resistance to preferred antibiotics.
-Preferred agents include: trimethoprim-sulfamethoxazole, tetracycline,
doxycycline, minocycline, clindamycin.
6. Uncomplicated or complicated SSI without osteomyelitis caused by
MSSA, Streptococcus pyogenes, or Streptococcus agalactiae (complicated
SSI only) documented by C/S report within past 30 days and failure to
two or resistance to preferred antibiotics.
-Preferred agents include: amoxicillin/clavulanate, cephalexin,
Updated 07/2015
ciprofloxacin, clindamycin, levofloxacin, trimethoprim/sulfamethoxazole,
dicloxacillin.
Age Restrictions
N/A
Prescriber
Restrictions
Infectious Disease
Coverage
Duration
VRE including concurrent bacteremia: 28 days. Other uses: 14 days.
Other Criteria
N/A
Updated 07/2015
LOMITAPIDE
Products Affected
 Juxtapid
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patient does not have any of the following contraindications to therapy: 1.
Pregnancy. 2. Concomitant administration of moderate or strong CYP3A4
inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir,
itraconazole, ketoconazole, lopinalvir/ritonavir, mibefradil, nefazodone,
nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin,
voriconazole, amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib,
darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir,
imatinib, verapamil, etc.). 3. Dosage regimen above 60 mg per day.
Required
Medical
Information
Documented diagnosis of homozygous familial hypercholesterolemia
(HoFH) defined as confirmation of one or more of the following
(laboratory results must be submitted for genetic testing and LDL-C
criteria):
1. Genetic testing results confirming two mutated alleles at the LDLreceptor consistent with HoFH (homozygosity or compound
heterozygosity for loss-of-function mutations in the LDLR gene encoding
the LDL receptor protein).
2. Fasting LDL-C plasma levels greater than 400 mg/dL AND clinical
evidence of one of the following:
a) cutaneous or tendon xanthomas,
b) valvular and supravalvular stenosis,
c) accelerated atherosclerosis manifesting in the first two decades
of life.
3. Fasting LDL-C plasma levels greater than 300 mg/dL despite optimal
medical therapy, including the use of combination antihyperlipidemic
therapy (e.g., HMG-CoA reductase inhibitors, ezetimibe, bile acid
sequestrants, niacin) and/or LDL apheresis. Reauthorization will require
documentation of a minimum reduction in LDL-C of 20% from pretreatment LDL-C and will be approved for one year.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Updated 09/2014
Coverage
Duration
Intial: 3 months. Reauthorization: through benefit year.
Other Criteria
Prescribers and pharmacies must be certified with the JUXTAPID REMS
Program in order to prescribe or dispense lomitapide. Information about
the drug and the program can be obtained by calling 1-855-898-2743 or
via email at [email protected].
Updated 09/2014
LYMPHOCYTE IMMUNE GLOBULIN
Products Affected
 Thymoglobulin
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of CBC with differential, Platelets, WBC and
diagnosis.
1. Acute renal transplant rejection in conjunction with concomitant
immunosuppression.
2. Kidney, cardiac, or pancreas transplant rejection prophylaxis.
3. Familial hemophagocytic lymphohistiocytosis.
4. Graft versus host disease prophylaxis. Recommended for all patients on
Thymoglobulin prior to initiation therapy, hematologic tests including
CBC w/ differential and platelet counts. Blood chemistries- including
renal and liver function tests.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
2 months
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
MECASERMIN
Products Affected
 Increlex
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Contraindicated in neonates, patients with closed epiphyses, and
suspected neoplasia.
Required
Medical
Information
Indicated for the long-term treatment of growth failure in children with
severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone
(GH) gene deletion that have developed neutralizing antibodies to GH.
Severe Primary IGFD is defined by, Height standard deviation score less
than or equal to -3.0 and Basal IGF-1 standard deviation score not
exceeding -3.0 and Normal or elevated growth hormone (GH). Patients
with mutations in the GH receptor (GHR), post-GHR signaling pathway,
and IGF-1 gene defects are not GH deficient, and therefore, they cannot
be expected to respond adequately to exogenous GH treatment.
Age Restrictions
2 to 18 years of age
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Not a substitute for GH treatment.
Updated 09/2014
MECHLORETHAMINE
Products Affected
 Valchlor
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of use for the topical treatment of Stage IA and
IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who
have received prior skin-directed therapy.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 03/2015
MEMANTINE
Products Affected
 Memantine HCl Oral Tablet 10 MG, 5
(28)-10 (21) MG, 5 MG
 Namenda Oral Solution
 Namenda Oral Tablet
 Namenda Titration Pak
 Namenda XR
 Namenda XR Titration Pack
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment of autism.
Required
Medical
Information
Medical documentation of FDA-approved Indication for the treatment of
moderate to severe dementia of the Alzheimer's type.
Age Restrictions
Prior authorization required for members less than 50 years of age.
Automatic approval for members greater than 50 years or older.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 10/2015
METHOXSALEN
Products Affected
 Methoxsalen Rapid
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with melanoma or have a history of melanoma, invasive
squamous cell carcinomas, or aphakia.
Required
Medical
Information
Statement of FDA approved indication:
1) Symptomatic control of severe, recalcitrant, disabling psoriasis not
adequately responsive to other forms of therapy and when the diagnosis
has been supported by biopsy. Methoxalen administered only in
conjunction with a schedule of controlled doses of long wave ultraviolet
radiation.
2) Cutaneous T-cell lymphoma.
3) Vitiligo.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
METHYLDOPA
Products Affected
 Methyldopa Oral
 Methyldopa-Hydrochlorothiazide
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
hypertension.
Preferred alternatives include - benazepril, benazepril-HCTZ, captopril,
captopril-HCTZ, enalapril, enalapril-HCTZ, fosinopril, fosinopril-HCTZ,
lisinopril, lisinopril-HCTZ, quinapril, ramipril, moxepril, moxeprilHCTZ, perindopril erbumine, quinapril-HCTZ, tradolapril.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
METHYLNALTREXONE
Products Affected
 Relistor Subcutaneous Kit
 Relistor Subcutaneous Solution 8
MG/0.4ML
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment with RELISTOR in patients with known or suspected
mechanical gastrointestinal obstruction.
Required
Medical
Information
Documented diagnosis of opioid-induced constipation AND
diagnosis of advanced illness AND
receiving palliative care with concomitant use of opioid therapy AND
documented trial and failure of two preferred alternatives OR
a documented contraindication, allergy or intolerance to the preferred
alternatives.
Preferred alternatives include laxatives (lactulose, polyethylene glycol
3350 (PEG)) or Amitiza.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
16 Weeks. Reauthorization needed for continuation of therapy
Other Criteria
Use of RELISTOR beyond four months has not been studied.
Updated 09/2014
MICAFUNGIN
Products Affected
 Mycamine
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of FDA approved diagnosis.
-For treatment of Patients with Candidemia, Acute Disseminated
Candidiasis, Candida Peritonitis and Abscesses.
-Treatment of Patients with Esophageal Candidiasis.
-Prophylaxis of Candida Infections in Patients Undergoing Hematopoietic
Stem Cell Transplantation.
-For the treatment of Candida albicans: patient must have stated failure or
intolerance to fluconazole.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Esophageal candidiasis: 21 days. Other candidimias: 47 days. Prophylaxis
during stem cell: 42 days
Other Criteria
N/A
Updated 10/2014
MIFEPRISTONE
Products Affected
 Korlym
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X and for patients who require concomitant
treatment with systemic corticosteroids for serious medical conditions or
illnesses (e.g., immunosuppression after organ transplantation).
Required
Medical
Information
Stated diagnosis to control hyperglycemia secondary to hypercortisolism
in adult patients with endogenous Cushing's syndrome who have type 2
diabetes mellitus or glucose intolerance and have failed surgery or are not
candidates for surgery. Korlym should not be used in the treatment of
patients with type 2 diabetes unless it is secondary to Cushing's syndrome.
Do not exceed 20 mg/kg per day.
Age Restrictions
18 years and older
Prescriber
Restrictions
Endocrinologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
MIGLUSTAT
Products Affected
 Zavesca
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Medical statement of approved diagnosis, mild to moderate type 1
Gaucher disease for whom enzyme replacement therapy is not a
therapeutic option (e.g., due to constraints such as allergy,
hypersensitivity, or poor venous access).
Age Restrictions
18 years and older
Prescriber
Restrictions
Hematologist or neurologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
MODAFINIL
Products Affected
 Modafinil
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Narcolepsy: Submission of sleep study confirming diagnosis as defined
by the International Classification of Sleep Disorders (ICSD), Obstructive
Sleep Apnea/Hypopnea Syndrome AND noted failure or contraindication
to two of the preferred medications is required.
Preferred meds include: methylphenidate ER, amphetamine salts, and
detroamphetamine. Reauthorization requires statement of symptomatic
relief of hypersomnolence with modafinil use.
Initial Therapy for Obstructive Sleep Apnea/Hypopnea Syndrome
(OSAHS):
1. Patient is not currently on any sedative medications.
2. One of the following:
a. 15 or more obstructive respiratory events, OR
b. More than 5 obstructive apneas, each greater than 10 seconds in
duration, per hour of sleep confirmed by a sleep study, and one of the
following:
i. Frequent arousals from sleep from apneas
ii. Bradycardia
iii. Arterial oxygen desaturation in association with apneas
iv. Unintentional sleep episodes
v. Daytime sleepiness
vi. Unrefreshing sleep
vii. Fatigue
viii. Insomnia
ix. Waking up gasping
x. Loud snoring
xi. Breathing interruptions during sleep.
Reauthorization for OSAHS: Patient is experiencing relief of
symptomatic hypersomnolence with modafinil use.
Shift Work Sleep Disorder (SWSD):
1. One of the following:
a. Symptoms of excessive sleepiness or insomnia, for at least 3 months,
which is temporally associated with a work period that occurs during
Updated 09/2014
the sleep phase
b. Sleep study demonstrating loss of a normal sleep-wake pattern. AND
2. Sleep disturbance causes significant distress or impairment, AND
3. No other disorder accounts for the symptoms.
Reauthorization for SWSD:
1. Pt is experiencing relief with use of modafinil, AND
2. Sleep disturbance continues to cause clinically significant distress or
impairment in occupational functioning.
Idiopathic Hypersomnia: Submission of sleep study confirming
diagnosis as defined by ICSD.
Age Restrictions
16 years and older
Prescriber
Restrictions
Sleep specialist, ENT specialist, Neurologist, Pulmonologist
Coverage
Duration
Initial approval: 3 months, Reauthorization: benefit year
Other Criteria
N/A
Updated 09/2014
NATALIZUMAB
Products Affected
 Tysabri
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Tysabri should not be used in combination with immunosuppressants or
inhibitors of TNF-a for CD.
Required
Medical
Information
Statement of FDA approved inciation for the treatment of
1. Multiple Sclerosis (MS): As monotherapy for the treatment of patients
with relapsing forms of multiple sclerosis to delay the accumulation of
physical disability and reduce the frequency of clinical exacerbations
generally recommended for patients who have had an inadequate response
to, or are unable to tolerate, an alternate MS therapy. Must have
documented trail and failure or contraindication to one platform and one
oral agent.
Preferred agents include: (platform) Rebif, Copaxone, or Extavia and
(oral) Tecfidera, Gilenya or Aubagio.
2. Crohn's Disease (CD): Inducing and maintaining clinical response and
remission in adult patients with moderately to severely active Crohn's
disease with evidence of inflammation who have had an inadequate
response to, or are unable to tolerate, conventional CD therapies and
inhibitors of TNF-a.
Must have documented trail and failure or contraindication to Humira and
Enbrel.
Age Restrictions
18 years or older
Prescriber
Restrictions
Neurologist for MS, Gastroenterologist for CD
Coverage
Duration
6 months
Other Criteria
Only available via limited distribution program called REMS TOUCH
Prescribing Program.
Updated 09/2014
NIFEDIPINE
Products Affected
 Nifedipine Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
vasospastic angina or chronic stable angina.
Preferred alternatives include: amlodipine/benazepril, amlodipine,
diltiazem tablet, nicardipine capsule, nifedipine er tablet, verapamil er
capsule, and verapamil tablet. For all other indications, approve.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
NILOTINIB
Products Affected
 Tasigna
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of diagnosis of Ph+ chronic or accelerated phase chronic
myeloid leukemia (CML). Documentation of potassium and magnenium
levels within normal limits potassium (3.5 - 5.5 mg/dL) and magnesium
(1.5 - 2.5 mg/dL) within the past 30 days. Hypokalemia or
hypomagnesemia must be corrected prior to initiation of therapy.
Documentation that patient does not have long QT syndrome verified by
ECG.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
NITISINONE
Products Affected
 Orfadin
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of diagnosis of hereditary tyrosinemia type 1 (HT-1)
AND current patient weight as dose must be within FDA approved dosing
range, maximum dosage for all patients is 2 mg/kg/day. When initiating
therapy, serum tyrosine should be below 500 mmol/L to avoid toxic
effects, and urinary succinylacetone levels should be undetectable.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through Benefit Year
Other Criteria
N/A
Updated 09/2014
NITROFURANTOIN
Products Affected
 Nitrofurantoin Macrocrystal Oral
 Nitrofurantoin Monohyd Macro
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternative.
Preferred alternative includes: sulfamethazole/trimethoprim
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 08/2015
NIVOLUMAB
Products Affected
 Opdivo
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Diagnosis of malignant melanoma, unresectable or metastatic disease with
progression, AND previous use of ipilimumab or a BRAF inhibitor (if
BRAF V600 mutation-positive).
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 04/2015
OCTREOTIDE ACETATE
Products Affected
 Octreotide Acetate Injection Solution 100
MCG/ML, 1000 MCG/ML, 200
MCG/ML, 50 MCG/ML, 500 MCG/ML
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Acromegaly: Documentation of inadequate response to surgery and/or
radiotherapy, or documentation that patient is not a candidate for surgery
and/or radiotherapy, or inadequate response to bromocriptine mesylate at
maximally tolerated doses.
Reauthorization will require statement indicating growth hormone (GH)
levels are stabilized at less than 5.0ng/mL and IGF-1 levels are
normalized (male less than 1.9U/mL or female less than 2.2U/mL) as
matched by age and gender, or the patient has a documented clinical
response defined by a reduction of tumor mass, a reduction in the signs
and symptoms of acromegaly, or an improvement in significant comorbidities.
Carcinoid tumors: Diagnosis of metastatic carcinoid tumors with severe
diarrhea or flushing and documentation of response to octreotide
injection.
Vasoactive Intestinal Peptide Tumors (VIPomas): Statement indicating
diagnosis of metastatic vasoactive peptide tumor, for symptomatic
treatment of diarrhea associated with VIP secreting tumors.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
OCTREOTIDE ACETATE LAR
Products Affected
 Sandostatin LAR Depot
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Acromegaly: Documentation of inadequate response to surgery and/or
radiotherapy, or documentation that patient is not a candidate for surgery
and/or radiotherapy.
Reauthorization will require statement indicating growth hormone (GH)
levels are stabilized at less than 5.0ng/mL and IGF-1 levels are
normalized (male less than 1.9U/mL or female less than 2.2U/mL) as
matched by age and gender, or the patient has a documented clinical
response defined by a reduction of tumor mass, a reduction in the signs
and symptoms of acromegaly, or an improvement in significant comorbidities.
Carcinoid tumors: Diagnosis of metastatic carcinoid tumors with severe
diarrhea or flushing and documentation of response to octreotide
injection.
Vasoactive Intestinal Peptide Tumors: Statement indicating diagnosis
of metastatic vasoactive peptide tumor, for symptomatic treatment of
diarrhea associated with VIP.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
OLANZAPINE ODT
Products Affected
 Olanzapine Oral Tablet Dispersible
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Schizophrenia: Documented treatment failure or intolerable side effects
from treatment with two formulary medications within the same class.
Formulary atypical antipsychotics include: risperidone, quetiapine,
ziprasidone, and olanzapine.
Bipolar mania or mixed episodes: Documented treatment failure or
intolerable side effects from treatment with one formulary medication
within the same class AND one lower tier traditional mood stabilizer.
Formulary atypical antipsychotics include: risperidone, quetiapine,
ziprasidone, and olanzapine, lower tier traditional mood stabilizers
include: lithium, divalproex sodium, lamotrigine or carbamazepine.
Major Depressive Disorder -MDD- (augmenting treatment):
Documented continuous treatment with an antidepressant as monotherapy
x 6 weeks AND documented treatment failure or intolerable side effects
from treatment with two formulary medications within the same class.
Members require stated trial and failure or contraindication to atypical
antipsychotics quetiapine and olanzapine. Members not on an
antidepressant require continuous trial with lower tier antidepressant
including fluoxetine, paroxetine, sertraline, citalopram, bupropion,
mirtazepine, venlafaxine, escitalopram, and citalopram solution.
For the use of the Olanzapine ODT, statement of swallowing difficulty
must be included and trial and failure of risperidone ODT, risperidone
oral solution, or Abilify oral solution for the diagnosis of schizophrenia or
bipolar mania and trial and failure of citalopram or escitalopram solution
for the diagnosis of MDD.
Age Restrictions
Updated 09/2014
18 years or older (adjunctive treatment for Major Depressive Disorder).
13 years or older (Schizophrenia and Bipolar Disorder)
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
OLAPARIB
Products Affected
 Lynparza
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category D
Required
Medical
Information
Medical documentation of use as monotherapy in patients with deleterious
or suspected deleterious germline BRCA mutated (as detected by an
FDA-approved test) advanced ovarian cancer who have been treated with
three or more prior lines of chemotherapy.
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 03/2015
OMACETAXINE
Products Affected
 Synribo
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use for the treatment of adult patients
with chronic or accelerated phase chronic myeloid leukemia (CML) with
resistance and/or intolerance to two or more tyrosine kinase inhibitors
(TKI). Preferred tyrosine kinase inhibitors include: imatinib (Gleevec),
dasatinib (Sprycel).
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at the time of enrollment will
not be required to meet prerequisites for authorization
Updated 09/2014
OMALIZUMAB
Products Affected
 Xolair
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment of relief of acute bronchospasm or status asthmaticus
Required
Medical
Information
Weight between 30 - 150 kg (current weight must be provided). Stated
diagnosis of moderate to severe persistent asthma (NAEPP/NIH
guideline). Peak flow rate less than 80% of predicted with at least a 30%
variability. Current use of a medium-dose inhaled corticosteroid and
adjunctive therapy (a long acting beta agonist or a leukotrine inhibitor) as
recommended by the NIH without disease control. Positive RAST or
allergy skin test. IgE level of 30 IU/ml to 700 IU/ml only. Guidelines
developed by WellCare Health Plans (In addition to above criteria) May
be covered under Part B. Continuous use of an inhaled corticosteroids
with a long acting beta-agonist or leukotriene inhibitor for 6 months
without disease control. Three or more episodes in the past twelve months
where appropriate controller medication has failed to control the patient's
symptoms, emergency room (or urgent care center or clinical office) visit
for acute treatment, or hospital admission. Enrolled in Asthma Case
Management Program for at least 6 months (if applicable as part of the
member's Benefit with WellCare Health Plans). For chronic urticaria,
refractory to all preferred agents: antihistamines, corticosteroids and
leukotriene modifiers, at least two of which must be used for a minimum
of 30 days within the last 3 months AND for which allergic urticaria and
other non-idiopathic urticaria is ruled out.
Preferred Inhaled Corticosteroids and Leukotriene Inhibitors include:
Advair, Dulera, or Pulmicort Flexhaler, Flovent, Asmanex (in
combination with Serevent), montelukast, and zafirlukast.
Age Restrictions
12 years and older
Prescriber
Restrictions
Pulmonologist or Allergist
Coverage
Duration
Through benefit year
Updated 09/2014
Other Criteria
Updated 09/2014
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
ONDANSETRON
Products Affected
 Ondansetron HCl Oral Solution
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Concomittant use of apomorphine is contraindicated
Required
Medical
Information
Documented medical notes that this medication is being used for
prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy or radiotherapy OR
prevention of postoperative nausea and/or vomiting. Statement that
member has swallowing difficulties and cannot tolerate Ondansetron
tablets or Ondansetron orally disintegrating tablets. Trial and failure of
Ondansetron tablets or Ondansetron orally disintegrating tablets.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
OPRELVEKIN
Products Affected
 Neumega
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement of FDA approved diagnosis AND platelet levels less
than 50,000 cells/microliter. Neumega is indicated for the prevention of
severe thrombocytopenia and the reduction of the need for platelet
transfusions following myelosuppressive chemotherapy in adult patients
with nonmyeloid malignancies who are at high risk of severe
thrombocytopenia. Efficacy was demonstrated in patients who had
experienced severe thrombocytopenia following the previous
chemotherapy cycle.
Neumega is not indicated following myeloablative chemotherapy. Dosing
should be initiated six to 24 hours after the completion of chemotherapy.
Platelet counts should be monitored periodically to assess the optimal
duration of therapy. Dosing should be continued until the post-nadir
platelet count is greater than or equal to 50,000/microliter. In controlled
clinical trials, doses were administered in courses of 10 to 21 days.
Dosing beyond 21 days per treatment course is not recommended.
Treatment with Neumega should be discontinued at least two days before
starting the next planned cycle of chemotherapy.
Age Restrictions
18 years and older
Prescriber
Restrictions
Hematologist and/or Oncologist
Coverage
Duration
2 months or duration of chemotherapy
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
OXANDROLONE
Products Affected
 Oxandrolone Oral Tablet 10 MG, 2.5 MG
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Statement indicating use to promote weight gain after weight loss
following extensive surgery, chronic infections, or severe trauma, and in
some patients who without definite pathophysiologic reasons fail to gain
or to maintain normal weight, and to offset the protein catabolism
associated with prolonged administration of corticosteroids.
Statement indicating use for orphan drug indication, short stature
associated with Turner syndrome, constitutional delay of growth and
puberty, moderate or severe acute alcoholic hepatitis, Duchenne and
Becker muscular dystrophy.
Initial Therapy for AIDS Wasting: Diagnosis of AIDS wasting/cachexia.
For treatment of anorexia associated with weight loss in patients with
HIV:
1. Patient is receiving AIDS anti-retroviral therapy AND
2. experienced as least
a. 7.5% unintentional weight loss over 6 months
b. 10% unintentional weight loss over 12 months
c. 5% body cell mass (BCM) loss within 6 months
d. BMI less than 20 kg/m2
e. BCM less than 35% male (less than 23% female) and a BMI
less than27 kg/m2 AND
3. documentation of trial and failure, contraindication, or intolerance to
megestrol at doses up to 800mg daily.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
HIV Wasting: 3 months. All other indications: Through the Benefit Year
Other Criteria
N/A
Updated 09/2014
OXYMETHOLONE
Products Affected
 Anadrol-50
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
1. Carcinoma of the prostate or breast in male patients. 2. Carcinoma of
the breast in females with hypercalcemia, androgenic anabolic steroids
may stimulate osteolytic resorption of bones. 3. Pregnancy 4. Nephrosis
or the nephrotic phase of nephritis. 5. Severe hepatic dysfunction.
Required
Medical
Information
Acquired Aplastic Anemia:
1. History of failure to erythropoietic stimulating agent, OR
2. Used in combination with antilymphocyte globulin or both
antilymphocyte globulin and corticosteroid treatment.
Hypoplastic Anemia:
1. Diagnosis of hypoplastic anemia due to myelotoxic drugs, AND
2. Failure to erythropoietic stimulating agent.
Pure Red Cell Aplasia: Failure of immunosuppressive therapy.
Anemia of Chronic Renal Failure: Failure to an erythropoietic
stimulating agent.
Preferred Erythropoietin Stimulating Agent: Procrit. Tablet should not
replace correcting iron, folic acid, and vitamin B12.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
PALBOCICLIB
Products Affected
 Ibrance
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Use as monotherapy.
Required
Medical
Information
Medical documentation indicating use as initial endocrine-based therapy,
in combination with letrozole, for the treatment of postmenopausal,
estrogen receptor (ER)-positive, human epidermal growth factor receptor
2 (HER2)-negative, metastatic advanced breast cancer.
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 05/2015
PALIPERIDONE
Products Affected
 Invega Oral Tablet Extended Release 24
HR 1.5 MG, 3 MG, 6 MG, 9 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Schizophrenia/Schizoaffective Disorder: Documented treatment failure
or intolerable side effects from treatment with two formulary medications
within the same class.
Formulary atypical antipsychotics include: risperidone, quetiapine,
olanzapine, ziprasidone, Latuda, Saphris, and Abilify.
Age Restrictions
12 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
PALIVIZUMAB
Products Affected
 Synagis Intramuscular Solution 50
MG/0.5ML
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
The safety and efficacy have not been established for treatment of RSV
disease
Required
Medical
Information
Medical documentation with notes for use for the prevention of serious
lower respiratory tract disease caused by respiratory syncytial virus (RSV)
in children at high risk of RSV disease. Safety and efficacy were
established in children with bronchopulmonary dysplasia (BPD), infants
with a history of premature birth (less than or equal to 35 weeks
gestational age), and children with hemodynamically significant
congenital heart disease (CHD). Only approved for a maximum of 5
doses during the RSV season according to the CDC and the American
Academy of Pediatrics (AAP) guidelines.
Age Restrictions
24 months or younger
Prescriber
Restrictions
N/A
Coverage
Duration
6 months
Other Criteria
N/A
Updated 09/2014
PANOBINOSTAT
Products Affected
 Farydak
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
1. Documentation of labs including CBC with platelet count and LFTs
drawn within the last month AND,
2. Statement indicating a diagnosis of multiple myeloma after relapsing
from at least 2 prior regimens, including bortezomib (Velcade) and an
immunomodulatory agent AND,
3. Documentation of use in combination with bortezomib and
dexamethasone AND,
4. ECG within 30 days without clinically significant ST-segment or Twave abnormalities
Age Restrictions
18 years or older
Prescriber
Restrictions
Oncologist, Hematologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 06/2015
PAZOPANIB
Products Affected
 Votrient
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Adipocytic (lipogenic) soft tissue sarcomaor GIST
Required
Medical
Information
Statement of medically accpeted diagnosis for treatment of the following
and maximum dose of 800mg/day:
1) Advanced renal cell carcinoma: Member must have tried and failed or
have a contraindication to preferred agent Sutent and Inlyta.
2) Soft-tissue sarcoma: In patients who have received any prior
chemotherapy.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist or nephrologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
PEGINTERFERON ALFA-2B
Products Affected
 Peg-Intron
 Peg-Intron Redipen
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Chronic Hepatitis C (HCV): Diagnosis of HCV with compensated liver
disease AND no signs or symptoms of jaundice, ascites, active
gastrointestinal bleeding, and encephalopathy.
Required Information for HCV: Baseline serum HCV RNA. Statement
indicating Hepatitis C genotype. Platelets greater than or equal to
90,000/mm3 (as low as 70,000/mm3 in patients with HCV and HIV).
ANC greater than or equal to 1,500/mm3. SCr less than 1.5 x ULN. TSH
and T4 WNL or adequately controlled thyroid function. Baseline Hgb
greater than 12 g/dl for women and 13 g/dl for men in monoinfected
patients.
In coinfected HIV pts: CD4 T-cell count greater than 100/mm3, baseline
Hgb greater than 11g/dL for women and 12g/dL in men.
Age Restrictions
For Hepatitis C: 3 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
HCVgenotype 1, initial: 12 wks, HCVgenotype 2/3: 24 wks max,
HCVgenotype 4: 48 wks max
Other Criteria
N/A
Updated 10/2014
PEGVISOMANT
Products Affected
 Somavert
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement indicating use for the treatment of acromegaly in patients who
have had an inadequate response to surgery and/or radiation therapy AND
octreotide, or for whom these therapies are not appropriate. The goal of
treatment is to normalize serum IGF-I levels. High Insulin like growth
factor-I (IGF-I) levels as compared to normal reference values by age and
gender. Growth hormone test during oral glucose tolerance test (must
NOT decline below 1ng/ml). LFTs should be less than 3 times the upper
limit of normal before initiating therapy. The maximum daily
maintenance dose should not exceed 30 mg.
Age Restrictions
18 years and older
Prescriber
Restrictions
Member under the care of, and prescribed by an endocrinologist.
Coverage
Duration
Initial, 3 months. Reauthorization, Through Benefit Year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
PEMBROLIZUMAB
Products Affected
 Keytruda
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Patient has unresectable or metastatic disease. Documentation of genetic
testing for the BRAF mutation.
Patient is either:
1) negative for the BRAF V600 mutation and has experienced disease
progression following therapy with ipilimumab (Yervoy) OR
2) positive for the BRAF V600 mutation and has experienced disease
progression following therapy with ipilimumab (Yervoy) AND a BRAF
inhibitor (eg, vemurafenib [Zelboraf], dabrafenib [Tafinlar]).
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 10/2015
PENTAMIDINE
Products Affected
 Pentam
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical notes indicating need for the prevention or treatment of
Pneumocystis jiroveci pneumonia (PJP) (high-risk HIV-infection, or
otherwise immunocompromised patients).
1) Must try and fail or have contraindication to SulfamethoxazoleTrimethoprim.
2) For prevention, CD4 count less than 200 cells/microliter or history of
oropharyngeal candidiasis or CD4 percentage less than 14% or a history
of an AIDS-defining illness
Age Restrictions
4 months or older
Prescriber
Restrictions
N/A
Coverage
Duration
Acute treatment: 21 days. Prophylaxis: through the benefit year.
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
PENTOSAN
Products Affected
 Elmiron
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D
Exclusion
Criteria
Known hypersensitivity to the drug, structurally
related compounds, or excipients
Required
Medical
Information
Diagnosis of bladder pain or discomfort associated with interstitial cystitis
Age Restrictions
16 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 03/2015
PERAMPANEL
Products Affected
 Fycompa
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of use as adjunctive therapy for the treatment of
partial-onset seizures with or without secondarily generalized seizures in
patients with epilepsy aged 12 years and older
Age Restrictions
12 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
PHENOBARBITAL
Products Affected
 Phenobarbital Oral Elixir
 Phenobarbital Oral Tablet
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
PHENYLEPHRINE/PROMETHAZINE
Products Affected
 Promethazine VC Plain
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
PIMECROLIMUS
Products Affected
 Elidel
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement for treatment as second-line therapy for the short-term
and non-continuous chronic treatment of mild to moderate atopic
dermatitis in nonimmunocompromised adults and children 2 years of age
and older, who have failed to respond adequately to other topical
prescription treatments, or when those treatments are not advisable and
trial and failure of an adequate treatment course of at least two preferred
topical corticosteroids.
Preferred corticosteroids include: alclometasone dipropionate,
betamethasone, clobetasol, dexamethasone, fluocinolone acetonide,
fluocinonide, mometasone furoate, and triamcinolone acetonide.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
6 weeks
Other Criteria
N/A
Updated 09/2014
PLERIXAFOR
Products Affected
 Mozobil
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation with notes for use in combination with
granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic
stem cells (HSCs) to the peripheral blood for collection and subsequent
autologous transplantation in patients with non-Hodgkin's lymphoma and
multiple myeloma.
Age Restrictions
18 years or older
Prescriber
Restrictions
Hematologist, Oncologist
Coverage
Duration
4 days
Other Criteria
N/A
Updated 09/2014
POMALIDOMIDE
Products Affected
 Pomalyst
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Stated diagnosis from oncologist for treatment for patients with multiple
myeloma who have received at least two prior therapies including
lenalidomide and bortezomib and have demonstrated disease progression
on or within 60 days of completion of the last therapy. Pomalyst should
only be given on days 1 through 21 days in 28 day cycle.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
PONATINIB
Products Affected
 Iclusig
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from oncologist for treatment of patients with one of the
following: Chronic myelogenous leukemia (CML) chronicphase,
accelerated phase, or blast phase, Philadelphia chromosome-positive acute
lymphocytic leukemia (ALL) AND trial and failure or contraindication to
preferred alternative Sprycel.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 03/2015
POSACONAZOLE
Products Affected
 Noxafil Oral Suspension
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis of Prophylaxis of Invasive
Aspergillus and Candida Infections in patients, 13 years of age and older,
who are at high risk of developing these infections due to being severely
immunocompromised, such as hematopoietic stem cell transplant (HSCT)
recipients with graft-versus-host disease (GVHD) or those with
hematologic malignancies with prolonged neutropenia from
chemotherapy. Treatment of Oropharyngeal Candidiasis Including
Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole
Age Restrictions
13 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Six months
Other Criteria
N/A
Updated 09/2014
PRAMLINTIDE
Products Affected
 SymlinPen 120
 SymlinPen 60
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement indicating patient has been diagnosed with type 1 diabetes and
is currently on insulin, OR diagnosed with type 2 diabetes and is currently
on insulin and metformin or a sulfonylurea, AND
patient has been compliant with current therapy for a minimum of 3
months.
-Preferred type 1 diabetic agents: Humulin, Humalog, Lantus, Levemir.
-Preferred type 2 diabetic agents: acarbose, metformin, glimepiride,
glipizide, pioglitazone, Humulin, Humalog, Lantus, Levemir, Byetta,
Bydureon.
Submission of HgbA1C drawn within past 90 days. Those with a
HgbA1C greater than 9% are not considered candidates for therapy with
pramlintide.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
PROMETHAZINE
Products Affected
 Phenadoz
 Phenergan Suppository
 Promethazine HCl Injection
 Promethazine HCl Oral Syrup
 Promethazine HCl Oral Tablet
 Promethazine HCl Suppository
 Promethegan Suppository 25 MG, 50
MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives if
available:
- For perennial and seasonal allergic rhinitis: levocetirizine
- For vasomotor rhinitis: azelastine
- For allergic conjunctivitis due to inhalant allergens and foods: patanol
- For mild, uncomplicated allergic skin manifestations of urticaria and
angioedema: levocetirizine, diphenhydramine
- For amelioration of allergic reactions to blood or plasma,
dermographism, anaphylactic reactions, as adjunctive therapy to
epinephrine and other standard measures after the acute manifestations
have been controlled: diphenhydramine
- For therapy adjunctive to meperidine or other analgesics for control of
post-operative pain and sedation in both children and adults as well as
relief of apprehension and production of light sleep from which the
patient can be easily aroused: approve
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Updated 03/2015
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 03/2015
PURIXAN
Products Affected
 Purixan
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved indication for treatment of patients with
acute lymphoblastic leukemia (ALL) as a component of acombination
maintenance therapy regimen.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 03/2015
QUININE SULFATE
Products Affected
 Quinine Sulfate Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment of severe or complicated P. falciparum malaria, Prevention of
malaria, Or Treatment or prevention of nocturnal leg cramps
Required
Medical
Information
Medical documentation noting need for this medication for treatment of
uncomplicated Plasmodium falciparum malaria and note of effectiveness
from specific geographical regions where resistance to chloroquine has
been documented.
Age Restrictions
16 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
7 days
Other Criteria
N/A
Updated 09/2014
RAMUCIRUMAB
Products Affected
 Cyramza
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of one of the following:
1) Use as a single agent, or in combination with paclitaxel, for the
treatment of patients with advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with disease progression on or after
prior fluoropyrimidine- or platinum-containing chemotherapy.
2) Use in combination with docetaxel, for the treatment of patients with
metastatic non-small cell lung cancer (NSCLC) with disease progression
on or after platinum-based chemotherapy. Patients with EGFR or ALK
genomic tumor aberrations should have disease progression on FDAapproved therapy for these aberrations prior to receiving CYRAMZA.
3) Use in combination with FOLFIRI (irinotecan, folinic acid, and 5fluorouracil), for the treatment of patients with metastatic colorectal
cancer (mCRC) with disease progression on or after prior therapy with
bevacizumab, oxaliplatin, and a fluoropyrimidine.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 10/2015
REGORAFENIB
Products Affected
 Stivarga
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use for the treatment of either:
1) Metastatic colorectal cancer (CRC) who have been previously treated
with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy,
an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
2) Locally advanced, unresectable or metastatic gastrointestinal stromal
tumor (GIST) who have been previously treated with imatinib mesylate
and sunitinib malate.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist or gastroenterologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at the time of enrollment will
not be required to meet prerequisites for authorization
Updated 09/2014
RILONACEPT
Products Affected
 Arcalyst
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement indicating a diagnosis of cryopyrin-associated periodic
syndromes (CAPS) including familial cold autoinflammatory syndrome
(FCAS) and Muckle-Wells syndrome (MWS).
Age Restrictions
12 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
RITUXIMAB
Products Affected
 Rituxan
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Non-Hodgkin's Lymphoma (NHL): Medical statement showing one of
the following- Diagnosis of diffuse large B-cell, CD20-positive, nonHodgkin's lymphoma and use in combination with CHOP
(cyclophosphamide, doxorubicin, vincristine, prednisone) or other
anthracycline-based chemotherapy regimens. Diagnosis of follicular,
CD20-positive, B-cell non-Hodgkin's lymphoma in combination with
CVP (cyclophosphamide, vincristine, prednisolone/prednisone)
chemotherapy or as a single agent for maintenance. Diagnosis of lowgrade, CD20-positive, B-cell non-Hodgkin's lymphoma in patients with
stable disease or who achieve a partial or complete response following
first-line treatment with CVP chemotherapy. Diagnosis of relapsed or
refractory, low grade or follicular CD20-positive, B-cell non-Hodgkin's
lymphoma.
Chronic lymphocytic leukemia (CLL): Medical statement showing use
in combination with fludarabine and cyclophosphamide for the treatment
of patients with previously untreated and previously treated CD20postiive chronic lymphocytic leukemia.
Rheumatoid Arthritis (RA): Medical statement indicating diagnosis of
moderately to severely active RA AND concurrent use of methotrexate
AND trial and failure of an adequate trial of at least two preferred
alternatives, one being a preferred TNF of Humira or Enbrel.
Preferred agents include: ibuprofen, naproxen, ketoprofen, meloxicam,
methotrexate, sulfasalazine, hydroxychloroquine, cuprimine, azathioprine,
leflunomide.
Microscopic polyangiitis (MPA): Medical statement indicating
diagnosis of MPA and concurrent use of prednisone and/or
cyclophosphamide.
Wegener's Granulomatosis (WG): Medical statement indicating
diagnosis of WG and concurrent use of prednisone.
Updated 09/2014
Age Restrictions
18 years and older
Prescriber
Restrictions
Cancer, Oncologist/Hematologist, RA- Rheumatologist
Coverage
Duration
Through benefit year
Other Criteria
Reauthorization for Rheumatoid Arthritis: Requires medical statement
indicating at least 20% improvement in the tender and swollen joint
count, and At least 20% improvements in 3 of the following- Patient
global assessment, Physician global assessment, Patient's assessment of
pain, Degree of disability, Acute phase reactant, and At least 16 weeks
since last Rituxan treatment. Members currently taking this medication at
time of enrollment will not be required to meet prerequisites for prior
authorization except to determine Part B vs Part D coverage. This drug
may be covered under Medicare Part B or D depending upon the
circumstances. Information may need to be submitted describing the use
and setting of the drug to make the determination.
Updated 09/2014
RUFINAMIDE
Products Affected
 Banzel Oral Suspension
 Banzel Oral Tablet
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Dosages over 3200mg/day and Familial Short QT Syndrome
Required
Medical
Information
Statement indicating FDA approved diagnosis. Documentation for
adjunctive treatment of seizures associated with Lennox-Gastaut
Syndrome and documented trial and failure or intolerance to 2 of the
following preferred agents: clonazepam, lamotrigine, and topiramate.
Age Restrictions
4 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
RUXOLITINIB
Products Affected
 Jakafi
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of diagnosis for treatment of patients with intermediate or highrisk myelofibrosis, including primary myelofibrosis, post-polycythemia
vera myelofibrosis and post-essential thrombocythemia myelofibrosis and
lab work indicating a complete blood count and platelet count before
initiating therapy and recent lab work indicating complete blood count
and platelet count for a dosage adjustment. Lab work must indicate
platelets are more than 50 x 109/L and dose must be less than 50 mg per
day. No dose increases will be approved within 4 weeks of therapy and
not more frequently than every 2 weeks. If no spleen reduction or
symptom improvement after 6 months then discontinue the drug.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
SAPROPTERIN
Products Affected
 Kuvan Oral Packet 500 MG
 Kuvan Oral Tablet Soluble
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement indicating diagnosis is required. Approve for indication
to reduce blood phenylalanine (Phe) levels in patients with
hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-)
responsive Phenylketonuria (PKU). This medication is to be used in
conjunction with a Phe-restricted diet. Discontinue sapropterin therapy if
blood Phe concentrations do not decrease after 1 month of treatment at 20
mg/kg/day. Documentation of baseline blood Phe levels and levels after 1
month of therapy indicating 30% reduction in Phe levels from baseline.
Age Restrictions
4 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Initial: 2 months. Reauthorization: Through benefit year
Other Criteria
N/A
Updated 10/2015
SARGRAMOSTIM
Products Affected
 Leukine Intravenous
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement indicating diagnosis AND
trial and failure of preferred agent neupogen AND
Absolute Neutrophil Count less than 1,500/mm3 and CBC with
differential.
Approved indications:
-Use following induction chemotherapy in older adult patients with acute
myelogenous leukemia (AML).
-Use for the mobilization of hematopoietic progenitor cells into peripheral
blood for collection by leukapheresis.
-Use for acceleration of myeloid recovery in patients with non-Hodgkin's
lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's
disease undergoing autologous bone marrow transplantation (BMT).
-Use for acceleration of myeloid recovery in patients undergoing
allogeneic BMT from HLA-matched related donors.
-Use for patients who have undergone allogeneic or autologous bone
marrow transplantation (BMT) in whom engraftment is delayed or has
failed.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
2 months
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
SELEGILINE
Products Affected
 Emsam
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Concurrent therapy with 1. selective serotonin reuptake inhibitors 2. dual
serotonin and norepinephrine reuptake inhibitors 3. tricyclic
antidepressants 4. bupropion hydrochloride 5. Meperidine 6. Analgesic
agents such as tramadol, methadone, and propoxyphene 7.
Dextromethorphan 8. St. John?s wort 9. Mirtazapine 10. Cyclobenzaprine
11. Carbamazepine or oxcarbazepine 12. Oral selegiline or other MAO
inhibitors.
Required
Medical
Information
Major depressive disorder: Failure of two (2) preferred antidepressants
from two (2) different antidepressant classes. For patients with
swallowing difficulty mirtazapine orally disintegrating tablets and
citalopram solution should be tried.
Preferred agents include: Fluoxetine capsules, Paroxetine, Citalopram,
Bupropion, Mirtazapine/Mirtazapine ODT, Trazodone, escitalopram,
Venlafaxine er, phenelzine sulfate, or tranylcypromine sulfate.
Age Restrictions
12 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
SILDENAFIL
Products Affected
 Sildenafil Citrate Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Should not be used in combination with organic nitrates.
Required
Medical
Information
Statement of FDA approved diagnosis of pulmonary arterial hypertension
Age Restrictions
18 years and older
Prescriber
Restrictions
Cardiologist or Pulmonologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
SIMEPREVIR
Products Affected
 Olysio
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnant women or men whose female partners are pregnant with use of
ribavirin and peginterferon alfa. Use as monotherapy. Chronic hepatitis C
virus genotypes 2, 3, 5, and 6.
Required
Medical
Information
Trial and failure or intolerance to Harvoni.
Documented medical diagnosis of chronic HCV genotype 1 or genotype
4. AND initial HCV RNA levels within the past 30 days. AND Screening
for NS3 Q80K polymorphism. AND documentation of a fibrosis score.
Therapy based on Genotype:
1. Genotype 1 or 4: Treatment naive and prior relapse patients including
those with cirrhosis: Olysio with Peginterferon alpha and Ribavirin for 12
weeks followed by Peginterferon alpha and Ribavirin for an additional 12
weeks. If peginterferon alfa and ribavirin are discontinued, Olysio must
be discontinued.
2. Genotype 1 or 4: Prior non-responder patients, (including partial and
null responders), including those with cirrhosis: Olysio with Peginterferon
alpha and Ribavirin for 12 weeks followed by Peginterferon alpha and
Ribavirin for an additional 36 weeks. If peginterferon alfa and ribavirin
are discontinued, Olysio must be discontinued.
3. Genotype 1 or 4 ineligible for Peginterfon alpha, ineligible defined as
one or more of the following: intolerance to interferon, autoimmune
hepatitis and other immune disorders, decompensated hepatic disease,
major uncontrolled depressive illness, a baseline neutrophil count below
1500, a baseline platelet count below 90,000 or a baseline hemoglobin
below 10, or a history of preexisting cardiac disease: Olysio with Sovaldi
for 12 weeks.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
12 weeks
Other Criteria
N/A
Updated 03/2015
SODIUM OXYBATE
Products Affected
 Xyrem
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with succinic semialdehyde dehydrogenase deficiency.
Required
Medical
Information
1. Treatment of excessive daytime sleepiness in patients with
narcolepsy:
a. Submission of sleep study confirming the diagnosis of
narcolepsy, as defined by the International Classification of Sleep
Disorders (1997), AND
b. Patient is currently NOT taking any sedative hypnotic agents
(including but not limited, to opioid analgesics, benzodiazepines,
sedating antidepressants or antipsychotics, general anesthetics,
muscle relaxants, and/or illicit CNS depressants) or other CNS
depressants, AND
c. Patient and Physician is enrolled in the Xyrem Sucess Program
AND
d. Patient has experienced inadequate response or intolerable side
effects to two of the following preferred products modafinil,
methylphenidate, or dextroamphetamine AND
e. The requested dose does not exceed the FDA indicated
maximum (9gm/night).
2. Treatment of cataplexy in patients with narcolepsy:
a. Submission of sleep study confirming the diagnosis of
narcolepsy, as defined by the International Classification of Sleep
Disorders (1997), AND
b. Patient is currently NOT taking any sedative hypnotic agents
(including but not limited, to opioid analgesics, benzodiazepines,
sedating antidepressants or antipsychotics, general anesthetics,
muscle relaxants, and/or illicit CNS depressants) or other CNS
depressants, AND
c. does not have sleep apnea, AND
d. Patient and Physician is enrolled in the Xyrem Sucess Program,
AND
e. The dose does not exceed the FDA indicated maximum
(9gm/night).
For reauthorization: documentation of evidence of efficacy needed for
continuation of therapy.
Updated 10/2014
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
3 months
Other Criteria
N/A
Updated 10/2014
SOFOSBUVIR
Products Affected
 Sovaldi
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Use as monotherapy, OR use for genotypes (GTs) other than 2 or 3 for
treatment in decompensated liver disease - defined as Child-TurcottePugh score greater than 6 [class B and C] or MELD (Model for End-Stage
Liver Disease) score greater than 15, OR use with other products
containing sofosbuvir.
Required
Medical
Information
Documented medical diagnosis of Chronic Hepatitis C, AND HCV-RNA
levels and fibrosis score documented within the past 90 days (Prescriber
must submit lab documentation indicating HCV genotype and quantitative
viral load), AND
documentation of history of previous HCV therapies (less than or equal to
2 weeks of SOV + RBV +/- PEG or PEG +/- RBV due to SOV, RBV or
PEG adverse drug reactions are considered treatment naive), AND
not taking rifampin, anticonvulsants, St. John’s Wort or other prescribed
products known to significantly decrease sofosbuvir plasma
concentrations that may lead to a reduced therapeutic effect of SOVALDI.
GT 1: Sovaldi (SOV) +/- ribavirin (RBV) +/- PEG-IFN is NOT
recommended for HCV GT 1. Harvoni (HAR) is Preferred.
GT 2: Approve for SOV + RBV for 12 weeks for treatment naive (TN),
and to 16 weeks for patients failing RBV+PEG-IFN.
GT 3: Approve for SOV + RBV for 24 weeks for TN and for patients
failing RBV + PEG-IFN.
GT 4: Approve for SOV + RBV for 24 weeks for TN or for patients
failing RBV+PEG-IFN, approve for SOV + RBV + PEG-IFN for 12
weeks. (HAR for 12 weeks is PREFERRED for GT 4).
GT 5 or 6: Approve for SOV+RBV+ PEG-IFN for 12 weeks for TN or
failed previous treatment (HAR for 12 weeks is PREFERRED for GT 6).
For members GT 2 or 3 who may or may not be awaiting liver transplant
with decompensated cirrhosis, the Provider shall document the Milan
criteria and Member’s placement on a liver transplant list (if awaiting
Updated 05/2015
transplant): Approve for SOV+RBV for a maximum of 48 weeks or until
transplant, whichever occurs first.
Age Restrictions
18 years or older
Prescriber
Restrictions
N/A
Coverage
Duration
See Required Medical Information for Preferred and Secondary regimens
Other Criteria
N/A
Updated 05/2015
SOMATROPIN
Products Affected
 Genotropin MiniQuick Subcutaneous
Solution Reconstituted 0.4 MG, 0.8 MG
 Genotropin Subcutaneous Solution
Reconstituted 12 MG
 Humatrope
 Norditropin FlexPro
 Norditropin NordiFlex Pen Subcutaneous
Solution 30 MG/3ML
 Nutropin AQ NuSpin 5
 Nutropin AQ Pen Subcutaneous Solution
20 MG/2ML
 Omnitrope
 Saizen Injection Solution Reconstituted 5
MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Children with closed epiphyses
Required
Medical
Information
Documented prior trial and failure to preferred agent Omnitrope and
medical documentation as follows:
Pediatric GHD:
1. Diagnosis of GH deficiency based on two GH stimulation tests or low
Insulin-like growth factor 1 (IGF-1) levels AND
2. Demonstrate growth failure based on growth velocity or height shorter
than 2 standard deviations (SD) below the mean height for age.
Prader-Willi Syndrome or Small for Gestational Age:
1. Diagnosis of PWS confirmed by appropriate genetic testing OR
2. Diagnosis of SGA confirmed by birth wt of less than 2500g at gestation
of more than 37 wks or at birth weight or length below the 3rd percentile
for gestational age who failed catch up by 2 y.o.
Turner Syndrome:
1. Treatment of short stature in females with bone age less than 15 y.
associated with TS.
Idiopathic short stature:
1. Diagnosis of idiopathic short stature with documentation of SHOX
deficiency.
Noonan syndrome, only Norditropin indicated:
1. Treatment of short stature in females with bone age less than 15 y.
associated with NS OR
Updated 10/2014
2. Treatment of short stature in males with bone age less than 17 y.
associated with NS.
Growth Retardation associated with Chronic Renal Insufficiency,
only Nutropin indicated:
1. Diagnosis of chronic renal insufficiency, AND
2. Height shorter than or equal to 2 SD below the median age for children
or where growth velocity falls to below 4.5 cm/year.
Age Restrictions
N/A
Prescriber
Restrictions
Member under the care of, and prescribed by an endocrinologist.
Coverage
Duration
Through benefit year
Other Criteria
Adult Onset Growth Hormone Deficiency: 1. Patients with GHD alone or
multiple hormone deficiencies because of pituitary disease or insult,
hypothalamic disease, surgery, or radiation treatment, AND 2. IGF-1 level
less than 77 mcg/L or 2 SD below the mean value, matched by age and
gender. Childhood Onset GH Deficiency in Adults: 1. Childhood onset in
patients who were GH deficient during childhood who have GH
deficiency confirmed as an adult before replacement treatment with GH is
started, AND 2. Persistent deficiency of GH documented by GH
stimulation tests. Isolated GH Deficiency in Adults: Documented
deficiency of GH documented by 2 GH stimulation tests. Reauthorization
for GHD in Children PWS, SGA, TS, NS, GRCRF: 1. Increase in growth
velocity of at least 2 cm/year during previous year of treatment AND 2.
Males with bone age less than 17 yrs or females with bone age less than
15 yrs. Reauthorization of ISS: 1. Increase in growth velocity of at least
4.5 cm/year during previous year of treatment AND 2. Males with bone
age less than 17 yrs. Or females with bone age less than 15 yrs.
Updated 10/2014
SORAFENIB
Products Affected
 Nexavar
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Contraindicated in combination with carboplatin and paclitaxel in patients
with squamous cell lung cancer
Required
Medical
Information
Medical statement of FDA approved diagnosis for treatment of:
1) Advanced renal cell carcinoma:
a) First line, Member must have tried and failed or have a
contraindication to preferred agent Sutent.
b) Second line, Member must have tried and failed or have a
contraindication to preferred agent Inlyta.
2) Unresectable hepatocellular carcinoma.
3) Differentiated Thyroid Carcinoma: refractory to radioactive iodine
treatment.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist, nephrologist, endocrinologist, hepatologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
SUNITINIB
Products Affected
 Sutent
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
CBCs with platelet count and serum chemistry including phosphate
should be performed at the beginning of each treatment cycle. Medical
documentation required indicating treatment of one of the following: For
Gastrointestinal stromal tumor (GIST) member must have documented
trial and failure, disease progression or contraindication/intolerance to
preferred agent, Gleevec (imatinib). Advanced renal cell carcinoma
(RCC). Progressive, well-differentiated pancreatic neuroendocrine tumors
(pNET) in patients with unresectable locally advanced or metastatic
disease. RCC and GIST only, will be approved for FDA approved dosing:
4 weeks on, 2 weeks off pNET only will be approved for FDA approved
dosing once daily.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist, nephrologist, or gastroenterologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 03/2015
SYLATRON
Products Affected
 Sylatron Subcutaneous Kit 296 MCG, 4
X 296 MCG, 4 X 444 MCG, 444 MCG,
888 MCG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from oncologist of treatment needed for the adjuvant
treatment of melanoma with microscopic or gross nodal involvement
within 84 days of definitive surgical resection including complete
lymphadenectomy.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
TACROLIMUS XR
Products Affected
 Astagraf XL
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis the prophylaxis of organ rejection
in patients receiving a kidney transplant with mycophenolate mofetil and
corticosteroids, with or without basiliximab induction AND trial and
failure of immediate-release tacrolimus capsules.
Age Restrictions
16 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination. Members currently
taking this medication at time of enrollment will not be required to meet
prerequisites for prior authorization.
Updated 09/2014
TADALAFIL
Products Affected
 Adcirca
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis of pulmonary arterial hypertension
WHO group I with NYHA class II - III symptoms AND documented trial
and failure or contraindication to sildenafil.
Age Restrictions
18 years and older
Prescriber
Restrictions
Cardiologist or Pulmonologist
Coverage
Duration
Through benefit year
Other Criteria
Adcirca should not be used in combination with organic nitrates.
Updated 09/2014
TEDIZOLID
Products Affected
 Sivextro Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation indicating use for the treatment of acute bacterial
skin and skin structure infections (ABSSSI) caused by susceptible isolates
of the following Gram-positive microorganisms: Staphylococcus aureus
(including methicillin-resistant [MRSA] and methicillin-susceptible
[MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae,
Streptococcus anginosus Group (including Streptococcus anginosus,
Streptococcus intermedius, and Streptococcus constellatus), and
Enterococcus faecalis.
Documented culture and sensitivity report within past 30 days.
Age Restrictions
18 years or older
Prescriber
Restrictions
Infectious Disease
Coverage
Duration
6 days
Other Criteria
N/A
Updated 03/2015
TELBIVUDINE
Products Affected
 Tyzeka
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Hepatitis B: Labs indicating hepatitis B infection, evidence of viral
replication, and either evidence of persistent elevations in serum
aminotransferases (ALT or AST) or histologically active disease AND
trial and failure of preferred agent in patients with no documented
resistance. Preferred agent is lamivudine HBV. Reauthorization: HBV
DNA less than 300 copies/mL.
Age Restrictions
16 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Initial: 6 months. Reauthorization: Through the Benefit Year
Other Criteria
N/A
Updated 09/2014
TERIFLUNOMIDE
Products Affected
 Aubagio
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis for the treatment of patients with
relapsing forms of multiple sclerosis and trial and failure or
contraindication to two preferred platform therapies.
Preferred platform therapies include: Rebif, Extavia, and Copaxone.
Statement must also include a first MS attack with document MRI scan
abnormalities characteristic of MS, OR evaluation documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS. Statement must also include a first MS attack with
document MRI scan abnormalities characteristic of MS, OR evaluation
documenting EITHER,
history of at least two focal neurological deficits (e.g. loss of vision,
double vision, localized numbness or weakness), in which the first
resolved and the second followed after a period of at least 6 months, OR
history of one focal neurological deficit which has resolved, and an MRI
suggestive of MS.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 10/2014
TERIPARATIDE
Products Affected
 Forteo
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Approve for the following indications:
1. Treatment of postmenopausal women with osteoporosis at high risk for
fracture OR,
2. Increase of bone mass in men with primary or hypogonadal
osteoporosis at high risk for fracture, and, meet any of the following
criteria:
a. member had had at least one fracture OR
b. member had BMD screening results of -2.5 or below OR
c. member had previously used any of the following: alendronate,
ibandronate, or zoledronic acid.
3. Treatment of men and women with osteoporosis associated with
sustained systemic glucocorticoid therapy at high risk for fracture, and
meet any of the following criteria:
a. member has had at least one fracture, OR
b. member has multiple risk factors for fracture, OR
c. member had previously used any of the following: raloxifene,
alendronate, Premarin, Prempro, Estradiol, Actonel, Jinteli 1/5,
ibandronate, or zoledronic acid.
Preferred bisphosphonate agents include: alendronate or ibandronate (PO
or Inj).
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year but not more than 2 years total
Updated 09/2014
Other Criteria
Updated 09/2014
Treatment failure is defined as documented continued bone loss after at
least three months despite treatment with a bisphosphonate or SERM
(raloxifene). Note: Since the effects of long-term treatment with
teriparatide are not known at this time, therapy for more than 2 years
duration is considered experimental and investigational. Because of an
increased incidence of osteosarcoma, Forteo should not be prescribed for
patients who are at increased baseline risk for osteosarcoma (including
those with Paget's disease of bone or unexplained elevations of alkaline
phosphatase, open epiphyses, or prior radiation therapy involving the
skeleton).
TESAMORELIN
Products Affected
 Egrifta Subcutaneous Solution
Reconstituted 2 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X. Patients with active malignancy or patients with
disruption of the hypothalamic-pituitary axis due to hypophysectomy,
hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.
Required
Medical
Information
Statement of FDA approved indication: Reduction of excess abdominal
fat in HIV-infected patients with lipodystrophy. Patient must be receiving
anti-retroviral therapy at time of request AND documentation of a waist to
hip ratio greater than 0.94 for men or greater than 0.88 for women.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
6 months
Other Criteria
N/A
Updated 09/2014
TESTOSTERONE
Products Affected
 Testim
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X. Not covered for erectile dysfunction (ED).
Required
Medical
Information
Statement indicating diagnosis of hypogonadism in men with
pretreatment total testosterone level below normal physiological value of
300 ng/dl or below normal reference level provided by the laboratory
required. In addition to testosterone levels, baseline PSA and hematocrit
levels are required for initial therapy. For continuation of therapy, labs
within the past 60 days including recent testosterone levels, PSA, and
hematocrit level within normal limits are required.
Age Restrictions
12 years of age or older
Prescriber
Restrictions
N/A
Coverage
Duration
Through the Benefit Year
Other Criteria
N/A
Updated 09/2014
TETRABENAZINE
Products Affected
 Xenazine Oral Tablet 12.5 MG, 25 MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis. Initial therapy for Huntington's
Disease: Diagnosis of chorea in patients with Huntington's disease.
Reauthorization for Huntington's Disease: Documented clinical response
and benefit from therapy.
Age Restrictions
18 years and older
Prescriber
Restrictions
Neurologist
Coverage
Duration
Initial therapy: 3 months. Reauthorization: through benefit year
Other Criteria
N/A
Updated 09/2014
THALIDOMIDE
Products Affected
 Thalomid
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category X
Required
Medical
Information
Tx should not be started if pt has an ANC below 750/mm3.
MM: Newly diagnosed MM with concurrent use of dexamethasone or
conventional dose chemo, or combination tx with high dose chemo or
stem cell rescue, or use as salvage tx in refractory/relapsed MM after
primary tx, or use in combination with dexamethasone, doxorubicin,
cyclophosphamide and etoposide as part of induction regimen in prep for
autologous transplant.
ENL: Acute tx of the cutaneous manifestations of moderate to severe
ENL. Not indicated as monotx in the presence of moderate to severe
neuritis OR maintenance tx for prevention and suppression of the
cutaneous manifestations of ENL recurrence.
Aphthous stomatitis (AS) or ulcers: Indication of one of the following,
ulcer of the mouth in immunocompetent and HIV-infected patients or
ulcers of the esophagus in HIV patients, OR recurrent AS in
immunocompromised pt.
Crohn's disease: Failure of two of the standard tx regimens, including
one corticosteroid (budesonide, hydrocortisone, prednisone, prednisolone,
methylprednisolone) AND Humira.
GVHD: Diagnosis of chronic or refractory GVHD and failure of two of
the following tx options: Corticosteroids, Azathioprine, Tacrolimus,
Cyclosporine and Atithymocyte globulin.
Primary Brain Tumors: Use as adjuvant tx to current cytotoxic
therapies or previous failure of cytotoxic therapies and/or tumor resection.
HIV associated wasting syndrome or cancer cachexia: For tx of
anorexia associated with wt loss in pt with HIV/cancer cachexia:
1. Pt is receiving anti-retroviral or chemo tx. AND
Updated 09/2014
2. has as least
a. 7.5% unintentional wt loss over 6 months,
b. 10% unintentional wt loss over 12 months,
c. 5% body cell mass (BCM) loss within 6 months,
d. BMI less than20 kg/m2,
e. BCM less than 35% male (less than 23% female) and a BMI
less than 27 kg/m2. AND
3. Documentation of trial/failure/contraindcation to megestrol at doses up
to 800mg qd.
Age Restrictions
12 years and older
Prescriber
Restrictions
Registered with the THALOMID REMS program
Coverage
Duration
MM: Through Benefit Year. ENL,GVHD,Primary Brain Tumors: 6
months. AS: 1 month. Other uses: 3 months
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
THIOGUANINE
Products Affected
 Tabloid
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of medically accepted diagnosis: Acute nonlymphocytic
leukemia or acute myeloid leukemia. Maximum dose (as a single agent) is
3mg/kg/day orally.
Age Restrictions
N/A
Prescriber
Restrictions
Hematologist, or Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
TIGECYCLINE
Products Affected
 Tygacil
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved indications and trial and failure or
contraindication to two preferred alternatives listed below.
1) Complicated skin and skin structure infections, preferred alternatives
include: clindamycin, piperacillin-tazobactam, levofloxacin.
For MRSA: preferred alternative includes: vancomycin.
2) Complicated intra-abdominal infections, preferred alternatives include:
piperacillin-tazobactam, meropenem, imipenem-cilastatin, cefoxitin.
3) Community acquired bacterial pneumonia, preferred alternative
include: azithromycin, clarithromycin, erythrocin, levofloxacin,
ampicillin-sulbactam, ceftriaxone.
For MRSA, preferred alternative includes: vancomycin.
Age Restrictions
18 years and older
Prescriber
Restrictions
Infectious Disease
Coverage
Duration
14 days
Other Criteria
N/A
Updated 10/2014
TOBRAMYCIN
Products Affected
 Tobramycin Inhalation
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical notes describing indication for the management of cystic fibrosis
patients with P. aeruginosa infection of the respiratory tract. Will be only
approved for repeating cycles of dosing of 28 days on the drug, then 28
days off.
Age Restrictions
6 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Safety and efficacy has not been demonstrated in patients colonized with
Burkholderia cepacia. This drug may be covered under Medicare Part B
or D depending upon the circumstances. Information may need to be
submitted describing the use and setting of the drug to make the
determination.
Updated 09/2014
TOBRAMYCIN PODHALER
Products Affected
 Tobi Podhaler
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical notes describing indication for the management of cystic fibrosis
patients with Pseudomonas aeruginosa and with forced expiratory volume
in 1 second (FEV1) greater than 25% or less than 80%. Will only be
approved for repeating cycles of dosing of 28 days on the drug, then 28
days off.
Age Restrictions
6 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Safety and efficacy have not been demonstrated in patients with forced
expiratory volume in 1 second (FEV1) less than 25% or greater than 80%,
or patients colonized with Burkholderia cepacia
Updated 09/2014
TOLVAPTAN
Products Affected
 Samsca
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation noting indication for the treatment of clinically
significant hypervolemic and euvolemic hyponatremia defined by serum
sodium less than 125 mEq/L or less marked hyponatremia that is
symptomatic and has resisted correction with fluid restriction and baseline
liver enzyme and bilirubin levels. This includes patients with heart failure
and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Not
approvable when it is not started in a hospital setting, if it is be used to
raise serum sodium urgently to prevent or to treat serious neurological
symptoms, if the indication is hypovolemic hyponatremia, and for doses
greater than 60mg/day. Should be avoided in patients with underlying
liver disease (ALT/AST levels greater than 3 x ULN, Bilirubin level
greater than 2 x ULN) including cirrhosis.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
1 month
Other Criteria
N/A
Updated 09/2014
TOPIRAMATE
Products Affected
 Trokendi XR
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis AND trial and failure of
immediate-release topiramate.
1. Partial Onset Seizure and Primary Generalized Tonic-Clonic Seizures initial monotherapy in patients 10 years of age and older with partial onset
or primary generalized tonic-clonic seizures and adjunctive therapy in
patients 6 years of age and older with partial onset or primary generalized
tonic-clonic seizures.
2. Lennox-Gastaut Syndrome (LGS) - adjunctive therapy in patients 6
years of age and older with seizures associated with Lennox-Gastaut
syndrome.
Age Restrictions
6 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
TRAMETINIB
Products Affected
 Mekinist
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients who have received prior BRAF-inhibitor therapy, in pregnancy,
and when used in combination with Zelboraf
Required
Medical
Information
Medical documentation indicating use for the treatment of patients with
unresectable or metastatic melanoma with BRAF V600E or V600K
mutations as detected by an FDA-approved test. MEKINIST, in
combination with dabrafenib (Tafinlar), is indicated for the treatment of
patients with unresectable or metastatic melanoma with BRAF V600E or
V600K mutations, as detected by an FDA-approved test.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
TREPROSTINIL
Products Affected
 Remodulin
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical statement indicating diagnosis of pulmonary arterial
hypertension. In patients with WHO Group 1, and NYHA Class II - IV,
stated trial and failure of one (1) preferred phosphdiesterase-5 inhibitor
(sildenafil) AND Letairis OR documented contraindication, allergy, or
intolerance to the preferred alternatives. Approve for patients with WHO
Group 1, class IV pulmonary hypertension.
Age Restrictions
N/A
Prescriber
Restrictions
Cardiologist or Pulmonologist
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
TRIHEXYPHENIDYL
Products Affected
 Trihexyphenidyl HCl
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Patients with narrow-angle glaucoma
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
TRIMIPRAMINE
Products Affected
 Surmontil
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of medically accepted indication including
physician indication for the continued use of the HRM (high risk
medication) with an explanation of the specific benefit established with
the medication, and how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to two preferred alternatives for
established indication.
Preferred alternatives for depression are paroxetine, sertraline,
venlafaxine, duloxetine, citalopram, escitalopram, fluoxetine, and
trazodone.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
VANCOMYCIN
Products Affected
 Vancomycin HCl Oral
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Treatment with oral vancomycin for infections other than staphlococcal
enterocolitis or C. difficile-associated diarrhea
Required
Medical
Information
Statement of FDA approved indication:
Antibiotic-associated pseudomembranous colitis caused by
Clostridium difficile: Stool culture report within the previous 30 days
indicating positive C. difficile toxin AND
patient is symptomatic AND
documented trial and failure or contraindication to preferred agent:
metronidazole.
Staphylococcus aureus (including methicillin-resistant strains)
enterocolitis: Approve.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Initial: 14 days. Patients with multiple relapses: 6 weeks
Other Criteria
N/A
Updated 10/2014
VANDETANIB
Products Affected
 Caprelsa Oral Tablet 100 MG, 300 MG
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis of treatment of symptomatic or progressive medullary
thyroid cancer in patients with unresectable locally advanced or metastatic
disease with maximum dose of 300 mg/day AND
documentation of potassium and magnesium levels within normal limits
potassium (3.5 - 5.5 mg/dL) and magnesium (1.5 - 2.5 mg/dL) within the
past 30 days. Hypokalemia or hypomagnesemia must be corrected prior to
initiation of therapy AND
documentation that patient does not have long QT syndrome verified by
ECG.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist or Endocrinologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
VELAGLUCERASE ALFA
Products Affected
 Vpriv
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Statement of FDA approved diagnosis, Type 1 Gaucher Disease. It is
suggested that patients be monitored periodically for IgG antibody
formation during their first year of treatment and as clinically indicated.
Age Restrictions
N/A
Prescriber
Restrictions
Hematologist or neurologist
Coverage
Duration
Through benefit year
Other Criteria
This drug may be covered under Medicare Part B or D depending upon
the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination.
Updated 09/2014
VEMURAFENIB
Products Affected
 Zelboraf
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Stated diagnosis from oncologist of unresectable or metastatic melanoma
whose tumors express a gene mutation called BRAF V600E detected by
an FDA approved test with a maximum dose of 1920 mg/day orally.
Vemurafenib is not recommended for use in patients with wild-type
BRAF melanoma.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
VIGABATRIN PACKET
Products Affected
 Sabril
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Previously tried and failed two medications for the diagnosis of refractory
complex partial seizures including carbamazepine, ethotoin, felbamate,
fosphenytoin, gabapentin, lacosamide, lamotrigine, levetiracetam,
oxcarbazepine, phenytoin, pregabalin, primidone, tiagabine, topiramate,
valproic acid, divalproex sodium, zonisamide. For use of packet, a
statement that member has swallowing difficulties or cannot tolerate
Sabril tablets must be included. Previously tried and failed topiramate for
the diagnosis of infantile spasms.
Age Restrictions
Age 1 month to 2 years old
Prescriber
Restrictions
Neurologist registered with the SHARE program
Coverage
Duration
Initial approval- 3 months. Reauthorization- through the benefit year.
Other Criteria
Register with SHARE (Support, Help and Resources for Epilepsy). The
potential benefits must outweigh the potential risk for developing
permanent vision loss. Members currently taking this medication at time
of enrollment will not be required to meet prerequisites for prior
authorization.
Updated 09/2014
VIGABATRIN TABLET
Products Affected
 Sabril
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Previously tried and failed two medications for the diagnosis of refractory
complex partial seizures including carbamazepine, ethotoin, felbamate,
fosphenytoin, gabapentin, lacosamide, lamotrigine, levetiracetam,
oxcarbazepine, phenytoin, pregabalin, primidone, tiagabine, topiramate,
valproic acid, divalproex sodium, zonisamide.
Age Restrictions
10 years and older
Prescriber
Restrictions
Neurologist registered with the SHARE program
Coverage
Duration
Initial approval- 3 months. Reauthorization- through the benefit year.
Other Criteria
Register with SHARE (Support, Help and Resources for Epilepsy). The
potential benefits must outweigh the potential risk for developing
permanent vision loss. Members currently taking this medication at time
of enrollment will not be required to meet prerequisites for prior
authorization.
Updated 09/2014
VISMODEGIB
Products Affected
 Erivedge
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
Doses above 150mg/day
Required
Medical
Information
Medical documentation of treatment of a patient with metastatic basal cell
carcinoma or locally advanced basal cell carcinoma that has occurred
following surgery or who is not a candidate for surgery or radiation.
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
VORICONAZOLE
Products Affected
 Voriconazole Intravenous
 Voriconazole Oral Tablet 200 MG, 50
MG
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Documentation of invasive aspergillosis, bronchopulmonary aspergillosis,
candidemia (non-neutropenic) and disseminated candidiasis in skin,
abdomen, kidney, bladder wall and wounds, esophageal candidiasis, and
serious infections caused by the Scedosporium apiospermum and
Fusarium sp., in patients intolerant of or refractory to other therapy.
Age Restrictions
12 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
6 months
Other Criteria
N/A
Updated 09/2014
VORINOSTAT
Products Affected
 Zolinza
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Cutaneous T-Cell Lymphoma (CTCL): diagnosis of progressive,
persistent, or recurrent disease and has failed or is intolerant to two
systemic therapies. Must try and fail at least two systemic therapies for
CTCL with a maximum dose of 400mg/day. Examples of systemic
therapies include: oral retinoids (e.g., bexarotene (Targretin)),
photopheresis, fusion proteins (e.g., denileukin diftitox (Ontak)),
interferon, and systemic chemotherapy, topical methclorethamine, topical
carmustine, Psoralen + ultraviolet A (PUVA), methotrexate, gemcitabine,
cyclophosphamide, chlorambucil, doxarubicin, isotretinoin, pentostatin,
fludarabine, cladarabine, glucocorticoids (e.g., prednisone,
dexamethasone).
Age Restrictions
18 years and older
Prescriber
Restrictions
Oncologist
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
VORTIOXETINE
Products Affected
 Brintellix
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of major depressive disorder (MDD) and
documented trial and failure or intolerable side effects from treatment of
two (2) preferred antidepressants from two different antidepressant
classes.
Preferred agents include: fluoxetine, paroxetine, citalopram, escitalopram,
sertraline, bupropion, mirtazapine/mirtazapine ODT, trazodone,
venlafaxine or venlafaxine er.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 09/2014
ZALEPLON
Products Affected
 Zaleplon
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternative trazodone.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
ZOLEDRONIC ACID
Products Affected
 Zometa Intravenous Solution
 Zoledronic Acid Intravenous Concentrate
PA Criteria
Criteria Details
Covered Uses
All medically accepted indications not otherwise excluded from Part D.
Exclusion
Criteria
Pregnancy Category D
Required
Medical
Information
Medical statement indicating diagnosis is required AND
trial and failure of one preferred oral bisphosphonate AND
ibandronate injectable OR Prolia for the diagnosis of osteoporosis and
osteoporosis prophylaxis.
Preferred oral bisphosphonates include alendronate and ibandronate.
Approve for the indications of:
1. Hypercalcemia of malignancy.
2. Patients with multiple myeloma and patients with documented bone
metastases from solid tumors, in conjunction with standard antineoplastic
therapy. Prostate cancer should have progressed after treatment with at
least one hormonal therapy. Maximum dosing is 4 mg/dose IV. Important
limitation of use, The safety and efficacy of medication has not been
established for use in hyperparathyroidism or nontumor-related
hypercalcemia.
Age Restrictions
N/A
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
ZOLPIDEM
Products Affected
 Zolpidem Tartrate
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
N/A
Required
Medical
Information
Medical documentation of FDA-approved indication including physician
indication for the continued use of the HRM (high risk medication) with
an explanation of the specific benefit established with the medication, and
how that benefit outweighs the potential risk. AND
The physician must document the ongoing monitoring plan for the agent.
AND
The physician must document that patient counseling has and will
continue to take place outlining the risks and potential side effects of the
medication. AND
trial and failure or contraindication to preferred alternative trazodone.
Age Restrictions
Prior authorization required for members 64 years or older. Automatic
approval for members less than 64 years of age.
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
N/A
Updated 09/2014
ZYDELIG
Products Affected
 Zydelig
PA Criteria
Criteria Details
Covered Uses
All FDA-approved indications not otherwise excluded from Part D.
Exclusion
Criteria
History of serious allergic reactions including anaphylaxis and toxic
epidermal necrolysis.
Required
Medical
Information
Statement of FDA approved indication for treatment of patients with:
1. Relapsed chronic lymphocytic leukemia (CLL): in combination with
rituximab, in patients for whom rituximab alone would be considered
appropriate therapy due to other co-morbidities.
2. Relapsed follicular B-cell non-Hodgkin lymphoma (FL): in patients
who have received at least two prior systemic therapies.
3. Relapsed small lymphocytic lymphoma (SLL): in patients who have
received at least two prior systemic therapies.
Age Restrictions
18 years and older
Prescriber
Restrictions
N/A
Coverage
Duration
Through benefit year
Other Criteria
Members currently taking this medication at time of enrollment will not
be required to meet prerequisites for prior authorization.
Updated 03/2015