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Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
Non-Formulary
Medication
Guideline
Requests for Non-Formulary Medications that do not have specific Prior Authorization Guidelines
will be reviewed based on the following:
• An appropriate diagnosis/indication for the requested medication,
• An appropriate dose of medication based on age and indication,
• Documented trial of 2 formulary agents for an adequate duration have not been effective or
tolerated
OR
• All other formulary medications are contraindicated based on the patient’s diagnosis, other
medical conditions or other medication therapy,
OR
• There are no other medications available on the formulary to treat the patient’s condition
Medications
requiring Prior
Authorization
Medications
requiring Step
Therapy
Aetna Medicaid determines patient medication trials and adherence by a review of pharmacy claims
data over the preceding twelve months. Additional information may be requested on a case-by-case
basis to allow for proper review.
Requests for Medications requiring Prior Authorization (PA) will be reviewed based on the PA
Guidelines/Criteria for that medication. Scroll down to view the PA Guidelines for specific
medications. Medications that do not have a specific PA guideline will follow the Non-Formulary
Medication Guideline. Additional information may be required on a case-by-case basis to allow for
adequate review.
Medications that require Step Therapy (ST) require trial and failure of formulary agents prior to their
authorization. If the prerequisite medications have been filled within the specified time frame, the
prescription will automatically process at the pharmacy. Prior Authorization will be required for
prescriptions that do not process automatically at the pharmacy.
For a list of agents that have a Step Therapy requirement, go to our health plan website and review
the Step Therapy Requirements document at:
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
• Minimum of 3 months,
depending on the diagnosis,
to determine adherence,
efficacy and patient safety
monitoring
Renewal:
• Minimum of 6 months
• Maintenance medications
may be approved Indefinite
As documented in the individual
guideline
Initial Approval:
Indefinite
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
https://www.aetnabetterhealth.com/newjersey/assets/pdf/providers/New_Jersey_Step_Therapy.pd
f
Brand Name
Medication
Requests
Acamprosate i
Actemra
ii
Aetna Medicaid requires use of generic agents that are considered therapeutically equivalent by the
FDA. For authorization of a brand name medication, please submit a copy of the FDA MedWatch
form detailing trial and failure of, or intolerance/adverse side effect to generic formulations made by
2 different manufacturers. The completed form should also be submitted to the FDA. The FDA
MedWatch form is available at:
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf
For patients that meet all of the following:
• Diagnosis of alcohol use disorder
• Patient is abstinent from alcohol
• Patient is enrolled in and compliant with substance abuse treatment program or recovery plan
• Patient does not have severe renal dysfunction (CrCl ≤ 30 mL/min)
• Previous failure of or contraindication/intolerance to naltrexone or disulfiram
General Criteria for All Indications:
• Patient is NOT on another biological DMARD or other anti-TNF agent
• Prescribed by, or consultation with, a rheumatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
• Patient has an absolute neutrophil count (ANC) >2000 per mm3.
• Patient has a platelet count >100,000 per mm3.
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
Indefinite
Initial Approval: 3 months
Renewal: 1 year
Requires:
Compliance with substance
abuse treatment program or
psychosocial support plan
QLL: 6 tablets per day
Initial Approval:
4 months
Renewal:
Indefinite
Requires:
• At least 20% symptom
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
•
Patient does NOT have elevated ALT or AST >1.5× ULN.
Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA):
• Patient is at least 2 years old
• Patient has continued synovitis in >1 joint despite treatment for at least 1 month with
methotrexate or leflunomide
• Request is for IV use (SQ use is not FDA approved for this indication)
Duration of Approval if
Requirements Are Met
improvement
• ANC >500 per mm3
• Platelets >50,000 per mm3
• ALT and AST are <5× ULN
Dosing:
• SJIA (<30kg): 12mg/kg every
2 weeks
Additional Criteria for Polyarticular Juvenile Idiopathic Arthritis (PJIA):
• SJIA (>30kg): 8mg/kg every 2
• Patient is at least 2 years old
weeks
• Patient has moderate to severe disease despite an adequate 3-month trial of methotrexate and a • PJIA (<30kg): 10mg/kg every
formulary anti-TNF
2 weeks
• PJIA (>30kg): 8mg/kg every 2
• Request is for IV use (SQ use is not FDA approved for this indication)
weeks
Additional Criteria for Rheumatoid Arthritis (RA):
• RA (IV infusion): initial is
4mg/kg every 4 weeks. Can
• Patient is at least 18 years old
be increased to 8mg/kg given
• Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
every 4 weeks
following:
• RA (SQ, <100kg): 162mg
o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX)
every other week. Can be
unless contraindicated)
increased to weekly.
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF,
• RA (SQ, >100kg): 162mg
MTX+SSZ, SSZ+HCQ
weekly
o ONE formulary anti-TNF (Note: anti-TNF’s require PA)
ADHD
PA is required for members who are <6 years old and >18 years old.
Last Update: 09/08/2016
Initial Approval:
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Medication Age
Limits
Amphetamine
mixed salts IR/LA
Daytrana
Dextroamphetamin
e IR/LA
methylin
methylphenidate
IR/CR/ER
Requirements
Criteria for < 6 years old:
• Diagnosis of ADHD AND
• Documentation stating that psychosocial issues and non-medical interventions are being
addressed by the clinical team AND
• The requested dose is NOT greater than FDA recommended maximum daily dosage
Duration of Approval if
Requirements Are Met
1 year
Renewal:
1 year
Patients who are >18 years old must have ONE of the following diagnoses:
• ADHD
• Narcolepsy (for methylphenidate, amphetamine/dextroamphetamine, or dextroamphetamine)
• Cancer-related fatigue (for methylphenidate)
• Fatigue due MS (for methylphenidate)
• Idiopathic hypersomnia (for methylphenidate, amphetamine/dextroamphetamine, or
dextroamphetamine)
dexmethylphenidat
e IR/ER
Vyvanse
Methamphetamine
Afinitor iii
Afinitor may be authorized when the following criteria are met:
• Prescribed by an oncologist
• Patient has one of the following diagnoses:
o Recurrent or stage IV hormone receptor positive (ER/PR +) breast cancer that progressed
or recurred while on letrozole or anastrozole:
 Patient is postmenopausal OR premenopausal and has had ovarian
ablation/suppression
Last Update: 09/08/2016
Initial Approval:
1 year
Renewal:
1 year
Continued authorization will be
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
o
o
o
o
Ampyra iv
 Must be used in combination with exemestane
Pancreatic neuroendocrine tumors (PNET) that are locally advanced, metastatic or
unresectable
Tuberous sclerosis complex (TSC) with ONE of the following manifestations:
 Renal angiomyolipoma
 Subependymal giant cell tumor that is unresectable
Relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of predominant clear cell
histology following treatment with a tyrosine kinase inhibitor (i.e., Sutent, Nexavar,
Inlyta, or Votrient)
Relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of non-clear cell histology
Afinitor Disperz may be authorized when the following criteria are met:
• Prescribed by an oncologist
• Pediatric patient at least 1 year old
• Diagnosis of tuberous sclerosis complex (TSC) with subependymal giant cell tumor that is
unresectable
May be approved when the following criteria are met:
• Prescribed by, or in consultation with a neurologist
• Patient is between 18 and 70 years old
• Diagnosis of multiple sclerosis with impaired walking ability defined as a baseline 25-ft walking
test between 8 and 45 seconds OR Expanded Disability Status Scale (EDSS) between 4.5 and 6.5
• Patient is stabilized on disease modifying therapy for MS (i.e., no recent exacerbations)
• Patient is NOT wheelchair-bound
• Patient does not have a history of seizures
• Patient does not have moderate to severe renal impairment (Crcl < 50 ml/min)
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
granted for members with stable
disease (tumor size within 25% of
baseline).
Discontinuation is appropriate
when there is evidence of disease
progression.
Initial Approval:
2 months
Renewal:
1 year
Requires:
At least 20% improvement in
timed walking speeds on 25-ft
walk within 4 weeks of starting
medication
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
Anticoagulants Injectable v
Fragmin, fondaparinux, and enoxaparin should pay at the point of sale for an initial duration of 21
days without a PA.
Enoxaparin
Fondaparinux
Fragmin
Iprivask
For prescriptions of enoxaparin, fondaparinux, and Fragmin that do not pay at the point of sale,
prior authorization requests can be authorized for the following indications:
• All 3 agents:
o VTE prophylaxis in patients undergoing hip or knee replacement or hip fracture surgery
o VTE treatment in patients who are taking warfarin until the INR is in therapeutic range
for 2 days
o Bridge therapy for perioperative warfarin discontinuation
o Prophylaxis or treatment of thrombotic complications in a high risk pregnancy
o VTE prophylaxis in patients with restricted mobility during acute illness
o Treatment of superficial vein thrombosis (SVT) of the lower limb of at least 5 cm in
length
o Treatment of acute upper-extremity DVT (UEDVT) that involves the axillary or more
proximal veins
•
Fragmin and enoxaparin only:
o VTE treatment after trial and failure of warfarin or for patients who are not candidates
for warfarin
o VTE treatment in patients who have cancer
o VTE prophylaxis in cancer patients with solid tumors who are at high risk of thrombosis
(i.e., previous VTE, immobilization, hormonal therapy, angiogenesis inhibitors,
thalidomide, and lenalidomide)
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Note: Less than 50% of patients
respond to treatment
Initial Approval:
• Prophylaxis post ortho
surgery) - Up to 35 days
• Prophylaxis (non-ortho
surgery and major trauma) Up to 14 days
• Prophylaxis (post-surgery
with CA)- 4 weeks
• VTE treatment, bridge
therapy, acute illness -10
days or as requested
• High risk pregnancy - Until 6
weeks after delivery (EDC
required for authorization)
• Prophylaxis in cancer - 6
months
• Upper extremity DVT - 3
months
• Lower-limb SVT - 45 days
• VTE treatment for warfarin
failure or in cancer - 6
months
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
o
o
o
o
Anticoagulants Oral
Eliquis
Pradaxa
Xarelto
Antidepressants
Non-Formulary vi
VTE prophylaxis in patients with AFib undergoing cardioversion (up to 3 weeks before
and 4 weeks after)
VTE prophylaxis in patients with acute ischemic stroke and restricted mobility
VTE prophylaxis in patients undergoing general and abdominal-pelvic surgery who are at
moderate to high risk for VTE
VTE prophylaxis in patients with major trauma
Iprivask may be authorized if all the following criteria are met:
• VTE prophylaxis in patients undergoing hip replacement surgery
• Patient had therapeutic failure or intolerance to enoxaparin or Fragmin and fondaparinux
OR
• Patient has contraindication to enoxaparin, fondaparinux, and Fragmin (i.e., allergic to pork,
history of heparin induced thrombocytopenia)
Prescriptions for Eliquis, Pradaxa, and Xarelto will automatically process for up to a 45 day duration
to prevent delays in therapy. A PA will be required for prescriptions filled after the initial 45 days.
Eliquis, Pradaxa, and Xarelto may be approved for patients who are at least 18 years old for the
treatment of non-valvular atrial fibrillation, DVT, and PE. Patients do NOT need a trial of warfarin.
Non-formulary antidepressants can be authorized for patients >18 years old who meet ANY of
the following criteria:
• Patients with treatment resistant depression:
Pristiq (SNRI)
o Documented failure or intolerance to THREE formulary agents from at least 2 different
Brintellix (SSRI)
classes of antidepressants (SSRI, SNRI, bupropion, or mirtazapine) at an adequate dose
Viibryd (SSRI)
and duration (at least 4 weeks).
Fetzima (SNRI)
o One of these trials must be with a preferred formulary agent from the same class (SSRI
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Renewal:
Length of renewal authorization
based on anticipated length of
therapy, indication and/or recent
INR if on warfarin
Initial Approval:
Atrial fibrillation
• Indefinite
Acute VTE
• 6 months
Initial approval:
Indefinite
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
or SNRI)
Patients who are currently stable on the requested non-formulary antidepressant:
o Provider feels that changing to a formulary medication would incur unacceptable risk
of destabilization.
Enbrel, Humira, Remicade, Cimzia, Simponi
Duration of Approval if
Requirements Are Met
•
Anti-TNF Agents
See Detailed document: https://www.aetnabetterhealth.com/newjersey/assets/pdf/Anti-TNFs.pdf
ARBs vii
Benicar
Edarbi
Eprosartan
Telmisartan
Atypical
Antipsychotics –
Long-Acting
Injectables viii
Invega Sustenna
Non-preferred ARBs can be approved for members who have failed THREE formulary preferred ARBs
AND meet one of the following:
1. Treatment of HTN with chronic kidney disease (CKD);
OR
2. Treatment of HTN without CKD for patients who have failed a trial with a formulary agent from
another class that is considered a first-line treatment per JNC8 (i.e., thiazide-type diuretic,
calcium channel blocker, angiotensin-converting enzyme inhibitor) or require combination
therapy to achieve BP goal
Preferred ARBs include:
• Losartan (or losartan/HCTZ)
• Irbesartan (or irbesartan/HCTZ)
• Candesartan (or candesartan/HCTZ)
• Valsartan (or valsartan/HCTZ, valsartan/amlodipine, or valsartan/amlodipine/HCTZ)
Non-formulary approval is authorized for members who:
• Are at least 18 years of age
• Prescribed by or in consultation with a psychiatrist
• Have received the recommended oral dosage (per FDA approved labeling) to confirm tolerability
and efficacy prior to receiving the long-acting injectable medication
Last Update: 09/08/2016
Initial approval:
Indefinite
Initial approval:
Indefinite
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
Invega Trinza
Risperdal Consta
Abilify Maintena
Zyprexa Relprevv
•
Duration of Approval if
Requirements Are Met
Will not receive concomitant oral antipsychotics after the initial overlap period (per FDA
approved labeling)
• Are not taking a CYP3A4 inducer (Abilify only)
• Have an FDA approved indication:
o Invega Sustenna/Trinza: schizophrenia or schizoaffective disorder
o Risperdal Consta: schizophrenia or bipolar I
o Abilify Maintena: schizophrenia
o Zyprexa Relprevv: schizophrenia
• Non-adherence to oral antipsychotic medications which places the patient at risk for poor
outcomes
Botulinum Toxins Botox, Myobloc, Dysport, Xeomin
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/providers/Botulinum%20Toxins.pdf
Buprenorphine
May be authorized for the treatment of opioid dependence in patients over 16 years of age when
the following are met:
• Documentation of a comprehensive substance abuse treatment plan including: opioid
agreement, psychosocial counseling or recovery support, random urine drug screens, assessment
and treatment of other substance dependence behaviors and mental health disorders.
• Random urine drug screens (UDS) are completed within 30 days before renewals and are
negative for opioids and all controlled substances (e.g., benzodiazepines, amphetamines, illicit
drugs) and positive for buprenorphine.
• If UDS is positive for controlled substances, the prescriber must include a treatment plan that
addresses tapering/discontinuing positive substances.
• The dose does not exceed 16 mg/day. (24mg/day is no longer considered the appropriate dosage
except in rare instances that will be considered on a case by case basis).
Last Update: 09/08/2016
Initial approval:
3 months
Renewal:
6 months
Documentation required:
• UDS results (see criteria for
specific requirements)
• Continued psychosocial
counseling or recovery
support
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
Duration of Approval if
Requirements Are Met
•
•
Cambia ix
Capecitabinex
Prescriber possesses DATA 2000 waiver (is SAMHSA-certified)
Prescriber attests that the New Jersey Prescription Monitoring Program database has been
reviewed for other controlled substances.
• In addition for Suboxone Film, Zubzolv, or Bunavail: Must have tried and failed
buprenorphine/naloxone sublingual tablets
• In addition for plain buprenorphine tablets: member must be pregnant or have a true allergy to
naloxone
May be authorized for patients who meet the following criteria:
• Diagnosis of migraine headaches
• 18 years of age or older
• Tried and failed at least 2 formulary triptans (e.g., sumatriptan, naratriptan) or has a
contraindication to triptans
• Tried and failed at least 2 formulary NSAIDs (e.g., Ibuprofen, naproxen, diclofenac)
May be authorized when prescribed by an oncologist for patients who are at least 18 years old
who have ANY of the following indications:
• Metastatic colorectal cancer
• Adjuvant (post-surgery) treatment of Dukes’ C colon cancer
• Metastatic breast cancer that is refractory to both paclitaxel and an anthracycline-containing
chemotherapy regimen
• Metastatic breast cancer that is refractory to paclitaxel when the patient is not appropriate for
anthracycline therapy
• Metastatic breast cancer that has progressed on an anthracycline-containing chemotherapy
when used in combination with docetaxel
• Locally advanced anal/rectal cancer when used in combination with radiation
• Pancreatic cancer when used in combination with radiation
• HER2 positive advanced/recurrent or metastatic breast cancer:
Last Update: 09/08/2016
Initial approval:
Indefinite
Limit of 9 packets (1 box per
month)
Initial Approval:
1 year
Renewal:
3 years based on therapeutic
response.
Requires:
• Crcl >30mL/min
• neutrophils >1 × 109/L
• platelets >50 × 109/L
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
o
o
Disease has progressed after receiving prior therapy with an anthracycline
(doxorubicin, daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel),
AND trastuzumab (Herceptin)
Must be used in combination with Tykerb
Duration of Approval if
Requirements Are Met
Note: Capecitabine is contraindicated in severe renal impairement (Crcl <30mL/min).
Note: Patients with baseline neutrophil counts of <1.5 × 109/L or platelet counts of <100 × 109/L
should not be treated with capecitabine
xi
Caprelsa
May be authorized for adults when the following criteria are met:
• Prescribed by an oncologist
• Patient is at least 18 years old
• No history of congenital long QT syndrome (Black Box Warning)
• Patient meets ONE of the following:
o Diagnosis of locally recurrent or metastatic differentiated thyroid carcinoma (including
papillary, follicular, and Hurthle cell) after surgical resection that is progressive or
symptomatic AND is refractory to radioactive iodine treatment AND Nexavar or
Lenvima
o Diagnosis of medullary thyroid cancer and one of the following:
 Local disease progression or recurrence after surgery which is unresectable
 Symptomatic disease progression or recurrence after surgery with distant
metastases
 Asymptomatic disease progression or recurrence after surgery with distant
metastases that is unresectable
Celecoxibxii
Celecoxib should pay at the point of sale when ONE of the following step therapy criteria are met
without requiring a PA:
• Patient has filled 3 formulary NSAIDs or tramadol in the previous 180 days
Last Update: 09/08/2016
Initial approval:
1 year
Renewal:
3 years
Initial Approval:
Indefinite
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
•
Chantix xiii
Cialis xiv
Patient has filled a PPI, H2 receptor antagonist, prednisone, warfarin, Xarelto, Pradaxa, or Eliquis
in the previous 90 days
Prescriptions that do not pay at the point of sale require prior authorization and may be
authorized for patients who meet the following criteria:
• No recent history (in the past 6 months) of acute coronary syndrome (ACS) or CABG
• Age >2 years old for juvenile rheumatoid arthritis (JRA) OR >18 years old for all other indication
• Patient meets ONE of the following:
o Was unable to achieve clinical benefit with 3 formulary NSAIDs
o Has a history of NSAID-induced gastritis confirmed by EGD
o Is at high-risk for adverse GI events (e.g., >65 years of age, concomitant corticosteroid or
anticoagulant use, or history of GI bleed, PUD, GERD, or gastritis) AND not currently
taking a daily aspirin
For patients who meet all of the following:
• Is a current smoker who desires to quit
• Does NOT have unstable behavioral health symptoms (e.g., active psychosis, suicidal thoughts,
active mania)
• Had a therapeutic trial and failure of at least one combination smoking cessation regimen (e.g.,
nicotine patch + gum, nicotine patch + lozenge, or nicotine patch + bupropion);
OR
• Had a previous successful quit attempt using Chantix but has now relapsed
For male patients who meet the following:
• Diagnosis of BPH
• Trial and failure of ALL of the following:
o Alfuzosin
o Tamsulosin
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Dose limits:
• OA: 200 mg/day
• RA, acute pain,
dysmenorrhea, ankylosing
spondylitis, psoriatic arthritis:
400 mg/day
• JRA:
o >25 kg: 100mg BID
o 10-25 kg: 50mg BID
Initial Approval: 12 weeks
Renewal: 12 weeks
Requires:
Smoking cessation by week 12 of
treatment. Total duration is
limited to 24 weeks per
treatment.
Initial Approval: 3 months
Renewal: 6 months
Requires:
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
o
Finasteride (for at least 6 months) in combination with an alpha-blocker (e.g., alfuzosin,
tamsulosin, doxazosin, terazosin) unless the patient is unable to tolerate an alphablocker
NOTE: Use of Cialis for treatment of erectile dysfunction is not a covered benefit.
ColonyStimulating
Factors (CSF)
Granix, Leukine, Neupogen, Neulasta, Zarxio
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Colony_Stimulating_Factors.p
df
Cometriq xv
May be authorized when the following criteria are met:
• Prescribed by an oncologist
• Patient is at least 18 years old
• Documented diagnosis of medullary thyroid cancer AND ONE of the following:
o Local disease progression or recurrence after surgery which is unresectable
o Symptomatic disease progression or recurrence after surgery with distant metastases
o Asymptomatic disease progression or recurrence after surgery with distant metastases
that is unresectable
• No evidence of moderate or severe hepatic impairment
• Patient is not currently taking a strong CYP3A4 inducer or inhibitor
Compounds are not a covered benefit with the following exceptions:
• Use in pediatric patients under the age of 6
• Use of 17-alpha hydroxyprogesterone caproate when medically necessary for the prevention of
Compounds
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Demonstration of improvement
in BPH symptoms
QLL: 2.5mg or 5mg; #30 tablets
per 30 days (Note: 10mg and
20mg are not indicated for BPH
and not covered)
Initial Approval:
1 year - Recommended
dose: 140 mg ORALLY once daily
Renewal:
3 years - Discontinuation is
appropriate upon disease
progression or drug toxicity
Initial Approval:
• For market shortages: 3 months
• All others: 1 year
Aetna Better Health® of New Jersey
Pharmacy Prior Authorization
Non-Formulary and Prior Authorization Guidelines
Scroll down to see PA Criteria by drug class, or Ctrl+F to each document by drug name
PA Guideline
Requirements
•
•
•
preterm birth in women who are pregnant with a singleton pregnancy and have history of a prior
spontaneous preterm birth.
If a patient has an allergy and requires a medication to be compounded without a certain active
ingredient (e.g. dyes, preservatives, fragrances). This situation requires submission of an FDA
MedWatch form consistent with DAW1 guidelines.
If a patient cannot consume the medication in any of the available formulations and the
medication is medically necessary (i.e., unable to swallow).
If the prescription product is unavailable due to a market shortage and it is medically necessary.
Duration of Approval if
Requirements Are Met
Renewals:
• For market shortages: 3 months
• All others: 1 year
NOTE: Compounds for pediatric patients under the age of 6 and for 17-alpha hydroxyprogesterone
caproate should process at the point of sale without a rejection. All other prescriptions for
compounds will require a PA.
These proprietary bases are excluded from coverage:
PCCA Lipoderm Base, PCCA Custom Lipo-Max Cream, Versabase Cream, Versapro Cream, PCCA
Pracasil Plus Base, Spirawash Gel Base, Versabase Gel, Lipopen Ultra Cream, Lipo Cream Base,
Pentravan Cream/Cream Plus, VersaPro Gel, Versatile Cream Base, PLO Transdermal Cream,
Transdermal Pain Base Cream, PCCA Emollient Cream Base, Penderm, Salt Stable LS Advanced
Cream, Ultraderm Cream, Base Cream Liposome, Mediderm Cream Base, Salt Stable Cream.
Cystic Fibrosis
Pulmozyme:
(pulmonary)
• Age >/= 5 years (Per label: Pulmozyme was studied in patients 3 months to 5 years of age; while
xvi
Medications
clinical trial data are limited in patients <5 years, the use of Pulmozyme should be considered for
Pulmozyme
pediatric patients with CF who may experience potential benefit in pulmonary function or who
Tobi Podhaler
may be at risk of respiratory tract infection.
Bethkis
• Diagnosis of moderate to severe cystic fibrosis
Cayston
OR
Kalydeco
• Diagnosis of mild cystic fibrosis after failure of inhaled hypertonic saline
Last Update: 09/08/2016
Initial Approval:
Kalydeco and Orkambi:
• 3 months
All others
• Indefinite
Renewal:
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Orkambi
Requirements
Tobramycin inhalation solution (generic for Tobi):
• Diagnosis of cystic fibrosis
• Age >/= 6 years
• FEV1 between 25-80% predicted
• Sputum cultures positive for P.aeruginosa
• Not colonized with Burkholderia cepacia
Tobi Podhaler or Bethkis:
• Must meet criteria listed above for tobramycin inhalation solution, PLUS patient must have
contraindication/intolerance to or failure of tobramycin nebulizer solution (generic)
Cayston will be authorized for patients that meet the following:
• Diagnosis of cystic fibrosis
• Age >/= 7 years
• FEV1 between 25-75% predicted
• Sputum cultures positive for P.aeruginosa
• Not colonized with Burkholderia cepacia
• Contraindication/intolerance to tobramycin
Kalydeco can be recommended for approval for patients who meet the following:
• Diagnosis of cystic fibrosis with one of the following CFTR gene mutations: G551D, G1244E,
G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H
• Not homozygous for the F508del mutation in the CFTR gene
• Member is 2 years of age or older
• NOTE: Patients should be on other CF agents to manage and control symptoms (i.e., dornase
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Kalydeco and Orkambi:
• 6 months
Documentation to support
response to therapy including
current lab results to support
ALT/AST and bilirubin levels
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Requirements
•
Daliresp xvii
Daraprim xviii
alpha, tobramycin, hypertonic saline, or Cayston)
NOTE: all reviews must be sent to MDR for final decision
Orkambi can be recommended for approval for patients who meet the following:
• Prescribed by a pulmonologist
• Member is 12 years of age or older
• Diagnosis of Cystic Fibrosis and lab results to support homozygous F508Del at the CFTR gene. (If
the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect
the presence of the F508del mutation on both alleles of the CFTR gene)
• Current lab results to support ALT/AST and bilirubin
• Not used with strong CYP3A inducers such as rifampin, rifabutin, phenobarbital, carbamazepine,
phenytoin, and St. John’s wort
• NOTE: Patients should be on other CF agents to manage and control symptoms (i.e., dornase
alpha, tobramycin, hypertonic saline, or Cayston)
• Note: all reviews must be sent to MDR for final decision
For patients who meet all of the following:
• Adult 40 years of age or older
• Prescribed by or in consultation with a pulmonologist
• Diagnosis of severe COPD with chronic bronchitis with FEV1<50% predicted based on postbronchodilator FEV1
• Documented symptomatic exacerbations within the last year while compliant with dual longacting bronchodilator treatment [long-acting beta-agonist (LABA) plus long-acting muscarinic
antagonist (LAMA)] for at least 3 months
• Daliresp will be used in conjunction with a LABA and LAMA unless contraindicated/intolerant
• Will not be used in combination with theophylline
Daraprim may be authorized for the treatment and secondary prevention of Toxoplasmosis in
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
6 months
Renewals:
Indefinite; requires improvement
in the number of COPD
exacerbations
Initial Approval:
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Requirements
patients with HIV:
• Dose for initial treatment of Toxoplasmosis is 50-75mg per day for 6 weeks
• Dose for secondary prophylaxis after completing initial 6-week treatment is 25-50mg per day to
prevent relapse.
• Secondary prophylaxis may be discontinued when the following apply:
o Patient is asymptomatic
o Patient is receiving antiretroviral therapy (ART)
o Patient has a suppressed HIV viral load
o Patient has maintained a CD4 count >200 cells/microL for at least six months
• Maintenance therapy may be reinitiated if the CD4 cell count declines to <200 cells/microL
Daraprim may also be authorized for Pneumocystis Pneumonia (PCP) when the following criteria
are met:
• Patient is allergic to sulfa or has another contraindication to TMP/SMX use
• For PCP prophylaxis in patients with HIV:
o Patient has ONE of the following:
 CD4 count <200 cells/microL
 Oropharyngeal candidiasis
 CD4 count percentage <14 percent
 CD4 cell count between 200 and 250 cells/microL when frequent monitoring
(e.g., every three months) of CD4 cell counts is not possible
o Patient has a trial and failure or contraindication to atovaquone AND dapsone
• For PCP treatment:
o Patient is diagnosed PCP infection
o Patient has a trial and failure or contraindication to atovaquone
Daraprim is not covered for treatment or prevention of malaria:
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
• Acute Toxoplasmosis - 6
weeks
• Acute PCP - 21 days
• PCP prophylaxis - 3 months
Renewals:
• Secondary Prophylaxis after
Acute Toxoplasmosis
treatment - 6 months
• PCP prophylaxis - 3 month; If
CD4 count is <200 or CD4
count % is <14%
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Requirements
Duration of Approval if
Requirements Are Met
•
•
•
Diabetic Testing
Supplies
Daraprim is no longer recommended for malaria treatment or prophylaxis.
Treatment of malaria is VERY individualized.
Refer to the CDC website for recommendations for acute treatment of malaria.
o http://www.cdc.gov/malaria/resources/pdf/algorithm.pdf
o http://www.cdc.gov/malaria/diagnosis_treatment/treatment.html
http://www.cdc.gov/malaria/resources/pdf/treatmenttable.pdf.
• Refer to the CDC website for recommendations for prevention of malaria
o http://www.cdc.gov/malaria/travelers/country_table/a.html
Diabetic Test Strip and Glucometer Quantity Limits:
• All diabetic test strips are limited to 150ct/30 days
• Glucometers are limited to 1 glucometer/12 months
Criteria to Receive Non-Formulary Diabetic Supplies
• Member with hematocrit level that is chronically less than 30% or greater than 55%
o Accu-Chek Aviva Plus and Nano SmartView are accurate for Hct 10-65%
o One Touch Verio IQ is accurate for Hct 20-60%
• Member with physical limitation (manual dexterity or visual impairment) that limits utilization
of formulary product
• Member with an insulin pump that requires a specific test strip
Criteria to Receive >150 Test Strips Per Month
• Members newly diagnosed with diabetes or with gestational diabetes
• Children with diabetes (age ≤ 12 )
• Members on insulin pump
• Members on high intensity insulin therapy with documentation of need to routinely test more
than 4-5 times daily
Last Update: 09/08/2016
Initial Approval:
1 year
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PA Guideline
Direct Renin
Inhibitors xix
Tekturna
Tekturna HCT
Tekamlo
Amturnide
Duavee xx
Requirements
Criteria to Receive >1 Glucometer Per Year
• Current glucometer is unsafe, inaccurate, or no longer appropriate based on patients medical
condition
• Current glucometer no longer functions properly, has been damaged, or was lost or stolen.
For patients that meet the following:
• Treatment of HTN
• At least 18 years old
• Inadequate response or inability to tolerate a trial of a formulary ARB AND an ACE inhibitor and
at least one other formulary antihypertensive agent from a different class:
o Thiazide-type diuretic
o Calcium channel blocker
o Beta-blocker
• Will not be used in combination with an ACE inhibitor or an ARB
Note: The long-term benefit on major cardiovascular or renal outcomes with direct renin inhibitors
in the treatment of HTN has not been established, therefore it is recommended to use medications
from other classes first.
Duavee can be approved for adult women under the age of 75 who have an intact uterus and who
meet the following criteria based on indication:
• Treatment of vasomotor symptoms associated with menopause (VMS):
o Patient has failed or has an intolerance to at least 2 formulary estrogen/progestin
products (e.g., estradiol tablets/patch, Prempro, Estrace)
• Prevention of postmenopausal osteoporosis:
o Patient has tried and failed (or has contraindication/intolerance to) raloxifene AND
alendronate
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
Indefinite
Initial Approval:
• 5 years
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PA Guideline
Requirements
o
Egrifta
Erythropoiesis-
Patient has osteopenia (T-score between -1.0 and -2.5) OR is at high risk for OP
fracture (as defined by any of the following):
 FRAX risk ≥3.0% for hip fracture OR ≥20% for any major OP-related fracture;
OR
 Patient has >1 risk factor for fracture:
a. low body mass index
b. previous fragility fracture
c. parental history of hip fracture
d. glucocorticoid treatment
e. current smoking
f. alcohol intake of 3 or more units per day
g. rheumatoid arthritis
h. secondary causes of osteoporosis
May be authorized for treatment of excess abdominal fat in HIV-infected patients with
lipodystrophy when the following are met:
• Patient is 18-65 years of age
• No evidence of active neoplastic disease
• No evidence of acute critical illness
• No disruption of the hypothalamic-pituitary axis (e.g. hypothalamic-pituitary-adrenal (HPA)
suppression) due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, radiation
therapy of the head or head trauma
• Patient is not using Egrifta for weight loss
• Patient is at risk for medical complications due to excess abdominal fat
• If female, patient is not pregnant and is using a reliable form of birth control (pregnancy category
X)
Epogen, Procrit, Aranesp
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
3 years with documentation of a
clinical response
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Requirements
Stimulating
Agents
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/ESA's_(Procrit-EpogenAranesp).pdf
Growth
Hormone
Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Tev-Tropin, Zorbtive
Growth
Hormone
Antagonists
Somavert
GnRH Analogs xxi
See Detailed document:
Leuprolide
acetate
Lupron Depot
Lupron DepotPED
Eligard
Trelstar
Vantas
Synarel
Supprelin LA
Endometriosis
(Lupron Depot, Synarel, Zoladex [3.6 mg dose only])
• Prescribed by or in consultation with a gynecologist or obstetrician
• 18 years of age or older
• Trial and failure of at least one formulary hormonal cycle control agent (such as Portia, Ocella,
Previfem), medroxyprogesterone, or Danazol
• Patient is not pregnant or breastfeeding
Duration of Approval if
Requirements Are Met
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Growth_Hormone.pdf
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Growth_Hormone_
Antagonists(Somavert).pdf
For patients who meet the following based on diagnosis:
Uterine Leiomyoma (fibroids)
(Lupron Depot, Synarel, Zoladex [3.6 mg dose only])
Last Update: 09/08/2016
Initial Approval:
Central Precocious Puberty
• Supprelin LA: 12 months
• All others: 6 months
Endometriosis
• 6 months
Uterine Leiomyoma (fibroids)
• 6 months
Dysfunctional uterine bleeding
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Requirements
Zoladex
•
•
•
•
Prescribed by or in consultation with a gynecologist or obstetrician
18 years of age or older
Prescribed to improve anemia and/or reduce uterine size for 3-6 months prior to planned
surgical intervention
Patient is not pregnant or breastfeeding
Dysfunctional Uterine Bleeding
(Zoladex [3.6mg dose only])
• Prescribed by or in consultation with a gynecologist or obstetrician
• 18 years of age or older
• Prescribed to thin endometrium prior to planned endometrial ablation or hysterectomy within
the next 4-8 weeks
• Patient is not pregnant or breastfeeding
Central Precocious Puberty (CPP)
(Lupron Depot-PED, leuprolide acetate solution, Synarel, Supprelin LA)
• Prescribed by, or in consultation with an Endocrinologist
• MRI or CT Scan has been performed to rule out lesions
• Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males
• Response to a GnRH stimulation test (or if not available, other labs to support CPP such as
luteinizing hormone levels, estradiol and testosterone level)
• Bone age advanced 1 year beyond the chronological age
• Baseline height and weight
• Age restriction (leuprolide acetate solution for injection [once daily regimen]): must be at least
1 year old
• Age restriction (Lupron Depot-Ped [1-month or 3-month regimen]): must be at least 2 years old
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
• 2 months
Prostate/Breast Cancer
• 2 years
Renewal:
Central Precocious Puberty
• 6 months - 1 year (up to age
11 for females and age 12 for
males)
Requires:
• Clinical response to
treatment (i.e., pubertal
slowing or decline, height
velocity, bone age, LH, or
estradiol and testosterone
level)
Endometriosis Retreatment
• Lupron only (treatment with
Synarel and Zoladex not
recommended beyond 6
months): 6 months
Requires:
• Bone mineral density within
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Requirements
Advanced Prostate Cancer
(Lupron Depot, Leuprolide acetate solution, Eligard, Zoladex,Vantas Trelstar)
• Prescribed by, or in consultation with oncologist or urologist
• Age restriction: must be at least 18 years old
Advanced Breast Cancer
(Zoladex [3.6mg dose only])
• Prescribed by, or in consultation with oncologist
• Age restriction: must be at least 18 years old
Hemophiliaxxii
Factor VIIa
Factor VIII
Factor IX
Hemophilia Factor Replacement Products:
• Factor VIIa: Novoseven RT
• Factor VIII: Advate, Bioclate, Eloctate, Genarc, Helixate FS, Kogenate FS, Recombinate, ReFacto,
Xyntha, Alphanate, Hemofil M, Monarc-M, Koate-DVI, Monoclate-P, Humate-P, Novoeight
• Factor IX: Alphanine SD, Mononine, Bebulin VH, Proplex T, Profilnine SD, Benefix, Rixubis,
Alprolix, Ixinity
• Anti-Inhibitor Coagulant Complex: FEIBA NF
Hemophilia A is a deficiency in factor VIII
Hemophilia B is a deficiency in factor IX
Von Willebrand’s is a dysfunction in VWF and deficiency in factor VIII
Factor VIII and IX is authorized for Members who meet ONE of the following criteria:
• Treatment of hemorrhagic complications in patients with hemophilia A, hemophilia B or von
Willebrand's disease, OR
• Prevention of bleeding in surgical or invasive procedures in patients with hemophilia A,
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
normal limits
• Use in combination with
norethindrone acetate
Uterine Leiomyoma (fibroids) or
Dysfunctional Uterine Bleeding
• Long-term use is not
recommended
• Retreatment may be
considered on a case by case
basis
Initial Approval:
3 months
Renewal:
1 year
Factor VIII and IX should be
discontinued upon development
of a Factor inhibitor resulting in
lack of response to factor VIII or
IX
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Requirements
hemophilia B or von Willebrand's disease, OR
• Primary prophylactic therapy for patients with severe hemophilia A or hemophilia B (less than
1% of normal factor (less than 0.01 IU/ml)), OR
• Secondary prophylactic therapy for patients with hemophilia A or hemophilia B (regardless of
normal factor levels) with documented history of two or more episodes of spontaneous bleeding
into joints
• NOTE: Only Humate-P, Alphanate, and Wilate contain von Willebrand factor in addition to factor
VIII and are effective for von Willebrand’s disease
Novoseven (factor VIIa) is authorized for members who meet ONE of the following:
• Treatment of hemorrhagic complications OR prevention of bleeding in surgical or invasive
procedures in a patient with one of the following indications:
o Hemophilia A or hemophilia B with inhibitors
o Congenital factor VII (FVII) deficiency
o Glanzmann’s thrombasthenia when refractory to platelet transfusions
o Acquired hemophilia
FEIBA NF (Anti-Inhibitor Coagulant Complex) is authorized for members who meet the following:
• Treatment of hemorrhagic complications OR prevention of bleeding in surgical or invasive
procedures in a patient with hemophilia A or hemophilia B with inhibitors
Hepatitis C
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Daklinza_Guideline_NJ.pdf
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Zepatier_Guideline_NJ.PDF
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Technivie_Guideline_NJ.PDF
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Viekira_Pak_Guideline_NJ.PD
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
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F
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Sovaldi_Guideline_NJ.PDF
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Harvoni_Guideline_NJ.PDF
Duration of Approval if
Requirements Are Met
Hetlioz xxiii
For patients that meet all of the following:
• At least 18 years old
• Diagnosis of non-24 sleep-wake disorder
• Completely blind with NO light perception
• History of at least 3 months of difficulty initiating sleep, difficulty awakening in the morning, or
excessive daytime sleepiness
• No other concomitant sleep disorder (i.e., sleep apnea, insomnia)
Initial Approval
Indefinite
HP Acthar for
MS xxiv
HP Acthar can be authorized for adults when the following criteria are met:
• Prescribed by a neurologist
• Prescribed for ACUTE exacerbation of MS
• Symptoms of current exacerbation include functionally disabling symptoms with objective
evidence of neurologic impairment such as loss of vision, motor symptoms (i.e., partial or full
paralysis, spasticity, clonus), and/or cerebellar symptoms (i.e., gait imbalance, difficulty with
coordinated movement, slurred speech, intention tremor, nystagmus)
• Patient meets ONE of the following:
o Continues to have functionally disabling symptoms despite a 7 day course of high dose IV
corticosteroids (i.e., methylprednisolone 1000mg per day) for the CURRENT exacerbation
o Had significant side effects with high dose IV corticosteroids
Initial Approval:
3 weeks
HP Acthar
Note: All requests should be forwarded to MDR for final determination.
Last Update: 09/08/2016
Prolonged use may lead to
adrenal insufficiency or recurrent
symptoms which make it difficult
to stop the treatment, therefore
treatment beyond 3 weeks for
the same episode is not
recommended.
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Hyperlipidemia
Medications xxv
Rosuvastatin can be approved when the following criteria are met:
• Patient is at least 10 years old; AND
• Patient has failed to achieve LDL goal on a compliant regimen of maximum tolerated dose of
atorvastatin;
OR
• Patient requires a high intensity statin (i.e., diagnosis of familial hypercholesterolemia or high
ASCVD risk per provider evaluation) AND patient had a trial and failure of atorvastatin
Rosuvastatin
Lovaza
Vascepa
Epanova
Juxtapid
Kynamro
Non-formulary medications for hypertriglyceridemia (Lovaza, Vascepa, and Epanova) can be
approved when the following criteria are met:
• Patient is at least 18 years old
• Drug will be used as an add-on to lifestyle interventions to include diet and exercise
• Treatment of severe hypertriglyceridemia (triglyceride level greater than or equal to 500
mg/dL)
• Trial and failure of OTC fish oil and at least ONE other formulary medication such as
fenofibrate, fenofibric acid, gemfibrozil, or niacin or contraindication to all formulary agents
Juxtapid and Kynamro can be approved when ALL of the following criteria are met:
• Diagnosis of homozygous familial hypercholesterolemia with a documented LDL of >300 mg/dl
(within the past 90 days)
• Failure of a compliant, 60 day trial of 2 different high potency statins* (atorvastatin and
rosuvastatin) at maximum tolerated doses used in combination with Zetia, niacin, or a bile acid
sequestrant
• Juxtapid or Kynamro will be used in combination with maximum tolerated doses of a statin* in
combination with Zetia, niacin, or a bile acid sequestrant AND lifestyle interventions to include
diet and exercise (low-fat diet recommended, <20% of calories from fat)
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
Juxtapid, Kynamro:
• 3 months
• All others: 6 months
Renewal:
Juxtapid, Kynamro:
• 6 months
• All others: indefinite
Requires:
Improvement in fasting lipids and
documentation of recommended
safety monitoring parameters
(such as liver enzymes)
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Requirements
•
•
•
•
Duration of Approval if
Requirements Are Met
Patient has tried and failed or is not a candidate for LDL apheresis
Patient is at least 18 years old
Recommended baseline labs are submitted: Fasting lipid panel, ALT, AST, alk phos, total bili,
and negative pregnancy test (if applicable)
Patient does not have moderate to severe hepatic impairment (Child-Pugh B or C) or active
liver disease
NOTE: All requests must be forwarded to MDR for final approval
Idiopathic
Pulmonary
Fibrosis
Agents xxvi
Esbriet
Ofev
* Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at
least one trial being a moderate to high potency statin). Documentation will include chart notes
supporting skeletal muscle related symptoms that resolved when statin therapy was discontinued;
and documentation the member has been rechallenged at a lower dose or with a different statin.
Non-formulary use of Esbriet or Ofev can be approved when the following are met:
• Diagnosis of mild to moderate idiopathic pulmonary fibrosis
o Confirmed by high resolution computed tomography (HRCT), lung biopsy, or
bronchoscopy
o Interstitial lung disease cannot be attributed to another cause (i.e., rheumatoid
arthritis, lupus, systemic sclerosis, asbestos exposure, or hypersensitivity pneumonitis)
o Forced vital capacity (FVC) between 50 and 80% predicted
• Documentation of baseline liver function tests (LFT’s) prior to initiating treatment
• Patient age must be 18 years or greater
• Patient is not a current smoker
• Prescribed by, or in consultation with, a pulmonologist
Note: There is no conclusive evidence to support the use of any drugs to increase the survival of
Last Update: 09/08/2016
Initial Approval:
3 months
Renewal:
6 months
Requires:
• Documentation of stable FVC
(recommended to
discontinue if there is a >10%
decline in FVC over a 12
month period)
• Attestation that LFT’s are
being monitored
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Ilaris xxvii
Requirements
people with idiopathic pulmonary fibrosis.
General Criteria for All Indications:
• Patient is NOT on another biological DMARD or other anti-TNF agent
• Prescribed by, or consultation with, a rheumatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA):
• Patient is at least 2 years old
• Patient weighs at least 7.5kg
• Patient currently has ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy,
hepatomegaly, splenomegaly, or serositis)
• Patient has continued synovitis in >1 joint despite treatment for at least 1 month with Kineret or
Actemra AND methotrexate or leflunomide (Note: both Kineret and Actemra are also nonformulary and require PA)
Additional Criteria for Cryopyrin-Associated Periodic Syndromes (CAPS)
• Diagnosis has been confirmed by positive genetic test for NALP3, CIAS1, or NLRP3 mutation
• Patient is at least 4 years old
• Patient weighs at least 15kg
• Patient has failed a 3-month minimum trial of Kineret (Note: Kineret is also non-formulary and
requires PA)
Imatinib xxviii
Can be authorized for patients who meet the following:
• Prescribed by an oncologist
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
4 months
Renewal:
2 years
Requires:
At least 20% symptom
improvement
Dosing/QLL:
CAPS (>40 kg): 150mg every 8
weeks, 1 vial per 56 days
CAPS (<40 kg): 2mg/kg every 8
weeks, 1 vial per 56 days. Dose
may be increased to 3mg/kg
given every 8 weeks
SJIA: 4mg/kg (max 300mg) every
4 weeks
• QLL for <180mg: 1 vial per 28
days
• QLL for >180mg: 2 vials per
28 days
Approval Duration:
• GIST, CML, ASM, or HES/CEL:
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Requirements
•
Injectable
Osteoporosis
Agents
IL-17
Antagonists xxix
Prescribed to treat one of the following FDA-approved or NCCN compendium listed indications:
o Primary treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+
CML)
o Newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) in combination with
chemotherapy or corticosteroids
o Relapsed or refractory acute lymphoblastic leukemia (Ph+ ALL)
o Myelodysplastic / myeloproliferative diseases (MDS/MPD) associated with PDGFR
(platelet-derived growth factor receptor) gene rearrangements in adults
o Aggressive systemic mastocytosis (ASM)
o Adults with Hypereosinophilic syndrome (HES) and / or chronic eosinophilic leukemia
(CEL)
o Unresectable, recurrent and / or metastatic dermatofibrosarcoma protuberans (DFSP)
in adults
o Soft tissue sarcoma – Desmoid tumors
o Recurrent bone cancer- chordoma
o Unresectable, recurrent, or metastatic gastrointestinal stromal tumors (GIST)
o Kit (CD117) positive gastrointestinal stromal tumors (GIST) after surgical resection
Duration of Approval if
Requirements Are Met
Yearly
In the presence of disease
progression or a
demonstrated insufficient
response to therapy, a dose
increase may be considered
in the absence of severe
adverse reactions and/or
cytopenias.
•
All other indications: Yearly
as long as there is no
evidence of progressive
disease or unacceptable
toxicity.
*This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia for
the determination of medically-accepted indications.
Forteo, Prolia, Zoledronic
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/Injectable%20OP%20Agents.pdf
May be authorized for Plaque Psoriasis when the following criteria is met:
• Patient is at least 18 years old
Last Update: 09/08/2016
Initial Approval:
6 months
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PA Guideline
Cosentyx
Increlex
Requirements
•
•
•
•
•
•
Prescribed by a dermatologist
Patient is up to date with all recommended vaccinations
Patient has been screened for latent TB
Symptoms are not controlled with topical therapy
Disease has a significant impact on physical, psychological or social wellbeing
Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true
contraindication to both
• Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a
PASI score of more than 10)
• Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse
is defined as greater than 50% of baseline disease severity within 3 months)
• Patient has failed a compliant, 3-month trial of at least ONE formulary anti-TNF
For patients that meet the following:
• Prescribed by or in consultation with pediatric endocrinologist
• Patient is ≥ 2 years old
• No evidence of epiphyseal closure
• No evidence of neoplastic disease
• Documentation supports diagnosis of Growth hormone (GH) gene deletion and development of
neutralizing antibodies to GH
OR
• Documentation supports a diagnosis of Severe, Primary IGF-1 deficiency
o Height standard deviation score less than or equal to −3
o Basal IGF-1 standard deviation score less than or equal to −3
o Normal or elevated growth hormone levels
o No evidence of secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition,
hypothyroidism, or chronic treatment with pharmacologic doses of corticosteroids
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Renewal:
2 years
Requires:
Clinical notes documenting an
improvement (e.g., reduction in
PASI, decreased swollen/painful
joints)
Initial Approval:
6 months
Renewal:
• 6 months if at least doubling
of pretreatment growth
velocity
• 1 year if growth velocity ≥ 2.5
cm/yr and epiphyses are
open
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PA Guideline
Inlyta xxx
Insulin Pens
Humulin N
Humulin 70/30
Novolog
Humalog
Apidra
Toujeo
Tresiba
Ryzodeg
Requirements
•
May be authorized when the following criteria are met:
• Patient is 18 years of age or older
• Prescribed by an oncologist
• Patient does not have uncontrolled blood pressure
• Patient is not taking a strong CYP3A4 inducer or inhibitor
• Patient has relapsed or stage IV, unresectable, renal cell carcinoma (RCC) of predominant
clear cell histology and has failed treatment with a formulary tyrosine kinase inhibitor
(Nexavar, Sutent, or Votrient).
Note: the formulary TKI’s require PA.
For patients with diabetes mellitus who meet the following:
• Request is for an insulin that is formulary preferred
o Requests for NON-formulary insulins require T/F of 2 formulary insulins within the same
class (i.e. rapid, regular, or basal)
• In addition, for children:
o Patient is a school-aged child requiring multiple daily injections of insulin
• In addition, for adults must meet ONE of the following:
o Patient is homeless; OR
o Patient does not have a caregiver who can administer insulin using vials and syringes and
is unable to effectively use insulin vials and syringes to self-administer insulin due to ANY
of the following:
 Patient has uncorrectable visual disturbances (e.g., macular degeneration,
retinopathy, vision uncorrectable by prescription glasses)
 Patient has a physical disability or dexterity problems due to stroke, peripheral
neuropathy, trauma, or other physical condition
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
3 years
Requires:
Evidence of stable disease
(tumor size within 25% of
baseline)
Initial Approval:
Indefinite
Age restrictions:
• Novolog: > 2 years
• Humalog: > 3 years
• Apidra: > 4 years
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Requirements
Duration of Approval if
Requirements Are Met
NOTE: Requests for Toujeo may be approved for patients who require >100 units per day of BASAL
insulin (i.e., Lantus or Levemir). Since Toujeo is not available in vials, patient does NOT need to meet
the other insulin pen criteria.
Integrin Receptor
Antagonists for
Inflammatory
Bowel
Diseases xxxi
Entyvio
Tysabri
This guideline describes the criteria for use of Tysabri and Entyvio in inflammatory bowel diseases.
To see the criteria for use in of Tysabri in MS, refer to the section titled, “MS Agents.”
Initial Approval:
3 months
General Criteria:
• Prescribed by a gastroenterologist
• 18 years of age or older
• Will be used as monotherapy and NOT in combination with antineoplastic, immunosuppressive,
or immunomodulating agents (e.g., azathioprine, 6-mercaptopurine cyclosporine, methotrexate,
TNF-inhibitors)
First Renewal:
3 months
Additional Criteria for Inducing Remission in Crohn’s Disease: (Tysabri or Entyvio)
STEROID-DEPENDENT CROHN’S :
• Patient meets ONE of the following:
o Relapse occurs within three months of stopping glucocorticoids
o Glucocorticoids cannot be tapered to <10 mg/day within three months without symptom
recurrence
• Patient has failed a compliant, 3-month trial of ONE of the following:
o 6-mercaptopurine(6-MP) or azathioprine (AZA)
o Methotrexate (for patients with a contraindication to 6-MP and AZA)
• Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF
Additional Renewals:
6 months (if patient is
responding)
Last Update: 09/08/2016
Requires:
At least 20% symptom
improvement
NOTE: If member is unable to
taper off of steroids in the first 6months, d/c Tysabri
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Requirements
STEROID-REFRACTORY CROHN’S:
• Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch
to IV glucocorticoids for patients who are not responding to oral glucocorticoids)
• Patient has failed a compliant, 3-month trial of ONE formulary anti-TNF
Additional Criteria for Steroid-Dependent Ulcerative Colitis: (Entyvio)
• Relapse occurs within three months of stopping glucocorticoids OR tapering prednisone to <10
mg/day
• Patient has failed a compliant, 3-month trial of ONE of the following:
o 6-mercaptopurine(6-MP) or azathioprine (AZA)
o Sulfasalazine 4-6g per day, mesalamine 4.8g per day, or balsalazide 6.75g per day (if
patient has a contraindication to 6-MP and AZA)
• Patient has failed a 3-month trial of ONE formulary anti-TNF
Additional Criteria for Steroid-Refractory Ulcerative Colitis: (Entyvio)
• Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch
to IV glucocorticoids FIRST for patients who are not responding to oral glucocorticoids)
• Patient meets ONE of the following:
o Patient had a previous failure on 6-MP and AZA or a contraindication to both
medications and is therefore not a candidate for treatment with these agents for current
episode
o Patient has symptoms after surgical intervention
o Patient is not a surgical candidate or refuses surgery AND had an inadequate response to
cyclosporine (NOTE: Switching to anti-TNF’s after cyclosporine failure is not
recommended by clinical practice guidelines
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
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Requirements
Patient has a contraindication to cyclosporine (NOTE: cyclosporine is used as a bridge
therapy for patients who will be started on the slower acting 6-MP or AZA)
• Patient has failed a 3-month trial of ONE formulary anti-TNF
Chronic Hepatitis B Infection: (Intron A, Pegasys)
• Patient has HBeAg-positive or HBeAg-negative chronic hepatitis B (HBsAg positive for more
than six months)
• Prescribed by, or in consultation with an infectious disease physician, HIV specialist,
gastroenterologist, hepatologist, or transplant physician
• Patient has compensated liver disease (e.g., normal bilirubin, albumin within normal limits, no
cytopenias)
• There is evidence of viral replication (HBeAg titer and/or HBV DNA levels >20,000 IU/mL for
HBeAg-positive patients and >2000 IU/mL for HBeAg-negative patients)
• There is evidence of liver inflammation (e.g., elevated ALT, inflammation or fibrosis on liver
biopsy)
• Age restriction (Pegasys): Must be at least 18 years old
• Age restriction (Intron A): Must be at least 1 year old
Duration of Approval if
Requirements Are Met
o
Interferons xxxii
α-Interferon
Infergen
Intron A
Pegasys
Pegintron
Sylatron
β-Interferon
See Multiple
Sclerosis Agents
γ-Interferon
Actimmune
Initial Approval:
Hepatitis B:
• Intron A – 16 weeks
• Pegasys – 48 weeks
Malignant Melanoma:
• Intron A: 1 year
• Sylatron: up to 5 years
Osteopetrosis, CGD, Kaposi’s
sarcoma:
• 6 months
AIDS-related Kaposi's sarcoma: (Intron A [powder for solution ONLY])
• Prescribed by, or in consultation with an infectious disease physician or HIV specialist
• Not being used for the treatment of visceral AIDS-related Kaposi's sarcoma associated with
rapidly progressive disease
• Patient must be at least 18 years old
Hairy cell leukemia:
• 6 months
Hairy-cell Leukemia: (Intron A)
• Prescribed by, or in consultation with a hematologist/oncologist
• Patient has demonstrated less than complete response to cladribine or pentostatin or has
All other indications:
• 1 year
Last Update: 09/08/2016
Condylomata acuminate:
• 3 weeks
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Requirements
•
•
relapsed within 1 year of demonstrating a complete response
Patient has indications for treatment such as:
o Systemic symptoms – fatigue, weakness, weight loss, fever, night sweats, recurrent
infection
o Symptomatic splenomegaly or adenopathy
o Significant cytopenias – hemoglobin < 12 g/dL, platelets < 100,000/mcL, or ANC <
1000/mcL
Patient is at least 18 years old
Malignant Melanoma: (Intron A, Sylatron)
• Prescribed by, or in consultation with a hematologist/oncologist
• Patient has undergone surgical resection AND is at high risk for recurrence (e.g., primary tumor
> 4 mm thick, presence of ulceration, lymph node involvement)
• Patient is at least 18 years old
Chronic Granulomatous Disease: (Actimmune)
• Prescribed by, or in consultation with an immunologist or infectious disease specialist
• Patient is also receiving antifungal and antibacterial prophylaxis (such as itraconazole and
trimethoprim/sulfamethoxazole)
• Patient is at least 1 year old
Malignant Osteopetrosis: (Actimmune)
• Prescribed by, or in consultation with a hematologist/oncologist
• Prescribed for the treatment of severe, malignant osteopetrosis
• Patient is at least 1 year old
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Renewal:
Hepatitis B:
• Intron A: additional 16 weeks
if still HBeAg-positive
• Intron A: up to 2 years for
HBeAg-negative patients
Osteopetrosis:
• 1 year if no evidence of
disease progression
CGD:
• 1 year if number and/or
severity of infections has
decreased
Condylomata acuminate:
• 16 weeks
All other indications:
• 1 year
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Requirements
Condylomata acuminata (genital or venereal warts): (Intron A, Alferon N-HPV)
• Patient at least 18 years old
• For intralesional use
• Lesions are small and limited in number
• Trial and failure of topical treatments or surgical technique ( ie imiquimod cream, Condylox,
cryotherapy, laser surgery, electrodessication, surgical excision)
Intravaginal
Progesterone
Products xxxiii
Crinone
Endometrin
Firstprogesterone
suppositories
Jakafi xxxiv
This list is not inclusive. All off-label use will be reviewed in nationally recognized compendia for the
determination of medically-accepted indications.
For patients that meet the following:
• Prescribed by, or in consultation with, a provider of obstetrical care
• Patient is not on Makena (17-hydroxyprogesterone)
• Patient is pregnant with singleton gestation and meets either of the following:
o History of spontaneous preterm birth (i.e. delivery of an infant < 37 weeks gestation)
o Cervical length < 25 mm before 24 weeks of gestation
Criteria for the use in myelofibrosis:
• Patient is at least 18 years old
• Prescribed by, or in consultation with, a hematologist/oncologist
• Diagnosis of primary myelofibrosis, post-polycythemia vera myleofibrosis or post-essential
thrombocythemia myelofibrosis
• Intermediate or high risk disease defined as having two or more of the following risk factors
o Age > 65 years
o Constitutional symptoms (weight loss > 10% from baseline or unexplained fever or
excessive sweats persisting for more than 1 month)
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
Approve as requested until 37
weeks gestation
Begin progesterone use no
earlier than 16 weeks, 0 days and
no later than 23 weeks, 6 days
Initial Approval:
6 months
Renewal:
1 year; if benefit is
demonstrated, as evidenced by
spleen size reduction (at least
35% decrease), symptom
improvement and absence of
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Requirements
•
Kineret xxxv
o Hemoglobin < 10g/dL
o WBC count > 25 x 109/L
o Peripheral Blood blasts > 1%
Baseline complete blood count (CBC) with platelet count of at least 100 X 109/L prior to
initiating therapy
Criteria for the use in polycythemia vera:
• Patient is at least 18 years old
• Prescribed by, or in consultation with, a hematologist/oncologist
• Previous treatment failure with hydroxyurea
• Patient has splenomegaly and requires phlebotomy to control symptoms
• Baseline Hct of 40-45%
General Criteria for All Indications:
• Patient is NOT on another biological DMARD or other anti-TNF agent
• Prescribed by, or consultation with, a rheumatologist
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
Additional Criteria for Systemic Juvenile Idiopathic Arthritis (SJIA):
• Patient is at least 2 years old
• Patient currently has ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy,
hepatomegaly, splenomegaly, or serositis) AND synovitis in at least 1 joint; OR
• Patient does NOT have currently ACTIVE systemic features but has continued synovitis in >1 joint
despite treatment for 3 months with MTX or leflunomide
Additional Criteria for Cryopyrin-Associated Periodic Syndromes (CAPS)
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
disease progression.
Therapy should be gradually
tapered if patient fails to achieve
at least 35% decrease from
baseline in spleen volume or
experiences unacceptable
toxicities
Initial Approval:
4 months
Renewal:
Indefinite
Requires:
At least 20% symptom
improvement
QLL:
30 syringes per 30 days
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Requirements
•
•
Diagnosis has been confirmed by positive genetic test for NALP3, CIAS1, or NLRP3 mutation
Patient is at least 2 years old
Duration of Approval if
Requirements Are Met
Additional Criteria for Rheumatoid Arthritis (RA):
• Patient is at least 18 years old
• Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different non-biologic DMARD regimens (1 of which must include methotrexate (MTX)
unless contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF,
MTX+SSZ, SSZ+HCQ
o ONE formulary anti-TNF (Note: anti-TNF’s require PA)
Long-Acting
Muscarinic
Antagonists
(LAMA)
Tudorza Pressair and Incruse Ellipta are the formulary preferred agents for the treatment of COPD
and do not require PA. Spiriva for COPD requires ST therapy and will pay at the point of sale if
there is at least one fill of either Tudorza or Incruse. Prior Authorization will be required for
prescriptions that do not process automatically at the pharmacy.
Criteria for the use of Spiriva Respimat for Asthma:
• Patient is at least 12 years old
• Patient is currently taking an inhaled corticosteroid (ICS) and will continue an ICS when Spiriva
is initiated
• Patient has had a trial and failure to at least 2 formulary agents:
o Inhaled corticosteroid
o Inhaled corticosteroid with a long-acting beta-2 agonist
o Montelukast or zafirlukast
Last Update: 09/08/2016
Spiriva
HandiHaler
Spiriva Respimat
Initial Approval:
Indefinite
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Long Acting
Opioids
Oxycontin
Butrans Patch
Exalgo
Oxymorphone ER
Zohydro ER
Xartemis XR
Nucynta ER
Morphine Sulfate
ER
Fentanyl Patch
Methadone
Requirements
NOTE: Spiriva HandiHaler, Tudorza, and Incruse are NOT FDA-approved for asthma
Criteria for ALL long-acting opioids (formulary and non-formulary):
• Patient has a treatment plan that includes the diagnosis and goals of therapy
• Prescriber has completed an addiction risk assessment for the specific therapy
• Prescriber has recently reviewed the state Prescription Monitoring Program (PMP) database
• Patient has a pain management contract that addresses the following:
o Consequences of unexplained loss or shortage of medications
o Consequences of obtaining similar prescription medications from other prescribers
o An agreement with the member to only use one pharmacy
In Addition, STEP criteria for Oxymorphone ER:
• Treatment of chronic pain
• At least 18 years old
• Failed a minimum of 2 week trials of maximum tolerated doses of at least TWO formulary longacting opioids (i.e., fentanyl patch, morphine sulfate ER, methadone) OR have contraindications
to all formulary agents.
In Addition, Criteria for Oxycontin and Non-Formulary Long-Acting Opioids:
• Treatment of malignant pain and pain due to sickle cell anemia (Oxycontin)
OR
• Treatment of chronic non-malignant pain:
o At least 18 years old
o Failed a minimum of 2 week trials of maximum tolerated doses of at least THREE
formulary long-acting agents (i.e., fentanyl patch, morphine sulfate ER, methadone,
oxymorphone ER) one of which must be oxymorphone ER
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
1 year
NOTE: QL’s may exist
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Requirements
•
Lyricaxxxvi
OR
Treatment of diabetic peripheral neuropathy (Nucynta ER only):
o At least 18 years old
o Failed an adequate trial (at least 4 weeks at maximum tolerated doses) of duloxetine
and tramadol and at least ONE additional formulary medication (i.e., gabapentin,
amitriptyline, nortriptyline, or topical capsaicin)
Lyrica is authorized for members who are 18 years of age or older with a diagnosis of post
herpetic neuralgia and partial onset seizures.
Duration of Approval if
Requirements Are Met
Initial Approval:
Indefinite
Criteria for the diagnosis of fibromyalgia:
• Patient is 18 years of age or older
• Failure of a compliant 3-month trial of BOTH of the following:
o Duloxetine at maximum tolerated doses
o Gabapentin OR a tricyclic antidepressant (i.e., amitriptyline or nortriptyline) at
maximum tolerated doses
Makena xxxvii
Criteria for the diagnosis of neuropathic pain associated with diabetic peripheral neuropathy,
spinal cord injury, or cancer-related neuropathic pain:
• Patient is 18 years of age or older
• Trial and failure of a compliant 3-month trial of duloxetine AND at least 1 other generic
formulary agent such as topical capsaicin, tricyclic antidepressants, tramadol, venlafaxine, or
gabapentin at maximum tolerated doses
For members who meet the following criteria:
• Prescribed by, or in consultation with, a provider of obstetrical care
• Patient is currently pregnant with singleton gestation
Last Update: 09/08/2016
Initial Approval:
Until 37 weeks gestation
Injections begin no earlier than
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Requirements
•
Modafinil
Armodafinil xxxviii
Patient has a history of a spontaneous preterm singleton delivery (i.e. delivery of an infant < 37
weeks gestation)
Modafanil is the preferred formulary agent, however still requires PA. Armodafinil is nonformulary and may be authorized if the patient meets criteria and also has a documented trial and
failure of modafanil.
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated
with narcolepsy when the following is met:
• Diagnostic testing, such as multiple sleep latency test (MSLT) or polysomnography, supports
diagnosis of narcolepsy
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated
with Obstructive Sleep Apnea (OSA) when the following is met:
• Prescribed by, or in consultation with, a sleep specialist
• Polysomnography has confirmed the diagnosis of OSA
• Patient remains symptomatic despite compliance with CPAP or BIPAP for at least 1 month
• CPAP or BIPAP will be continued after modafinil or armodafinil is started
• The daytime fatigue is significantly impacting, impairing, or compromising the patient’s ability
to function normally
May be authorized for patients at least 17 years old for excessive daytime sleepiness associated
with Shift-Work Disorder (SWD) when the following is met:
• Prescribed by, or in consultation with, a sleep specialist
• Polysomnography has ruled out other types of sleep disorders
• Symptoms have been present for >3 months
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
16 weeks, 0 days and no later
than 23 weeks, 6 days
Initial Approval:
6 months
Renewal:
1 year
Requires:
• Response to treatment
• For OSA: patient must be
compliant with CPAP or
BIPAP
• For SWD: patient must still
be a shift-worker
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Requirements
•
Duration of Approval if
Requirements Are Met
The sleepiness is significantly impacting, impairing, or compromising the patient’s ability to
function normally
May be authorized for patients at least 17 years old for the treatment of excessive sleepiness
associated with idiopathic hypersomnia when the following criteria is met:
• Prescribed by, or in consultation with, a sleep specialist
• Trial and failure of 2 formulary stimulants (e.g., amphetamine/dextroamphetamine,
methylphenidate)
• Diagnosis is supported by polysomnography, MSLT, and clinical evaluation including the
following:
o Daily periods of irrepressible need to sleep or daytime lapses into sleep for at least
three months
o MSLT documents fewer than two sleep-onset rapid eye movement periods (SOREMPs),
or no SOREMPs if the REM sleep latency on the preceding polysomnogram was ≤15
minutes
o The presence of at least one of the following:
 MSLT shows a mean sleep latency of ≤8 minutes
 Total 24-hour sleep time is ≥660 minutes (typically 12 to 14 hours) on 24-hour
polysomnography or by wrist actigraphy in association with a sleep log
o Other causes of sleep disorder have been ruled out
• The sleepiness is significantly impacting, impairing, or compromising the patient’s ability to
function normally
Multaq xxxix
Multaq will be authorized when prescribed by, or in consultation with a cardiologist. If not
prescribed by or in consultation with a cardiologist, the following must be met:
• Diagnosis is atrial fibrillation
• Patient has tried and failed amiodarone
• Age restriction: must be at least 18 years old.
Last Update: 09/08/2016
Initial Approval:
Indefinite
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Requirements
Multiple
Sclerosis Agents
Aubagio, Avonex, Betaseron, Copaxone, Extavia, Gilenya, Lemtrada, Mitoxantrone, Plegridy, Rebif,
Tecfidera, Tyasbrai
Duration of Approval if
Requirements Are Met
See Detailed document: https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/MSDisease-Modifying-Agents.pdf
Neumegaxl
May be authorized for the treatment of chemotherapy-induced thrombocytopenia when the
following are met:
• Prescribed by a hematologist/oncologist
• Patient is at least 12 years old
• Patient has a non-myeloid malignancy and is receiving myelosuppressive chemotherapy
• Patient is at high risk of severe thrombocytopenia or has experienced severe
thrombocytopenia with a previous chemotherapy cycle
• Administered 6 – 24 hours after the completion of chemotherapy
• NOT being used in the following situations:
o After myeloablative therapy
o Chemotherapy regimen longer than 5 days
o Concurrently with agents associated with delayed myelosuppression (e.g.,
nitrosoureas, mitomycin C)
Last Update: 09/08/2016
Initial Approval:
• Up to 21 days’ supply
• Refills if number of cycles
provided
Renewal:
• Approval up to 1 year
Requires:
Recent platelet count
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Requirements
Nexavar xli
Nexavar, when prescribed by an oncologist for patients at least 18 years old, can be authorized
for the following indications:
• Treatment of relapsed or unresectable stage IV predominantly clear cell renal cell carcinoma
(RCC) after treatment failure with Sutent or Votrient
• Treatment of relapsed or unresectable stage IV NON-clear cell renal cell carcinoma (RCC) after
treatment failure with Sutent
• Treatment of unresectable hepatocellular carcinoma in a patient who is not a transplant
candidate
• Treatment of metastatic hepatocellular carcinoma
• Treatment of differentiated thyroid carcinoma that is refractory to radioactive iodine
treatment
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
3 years if evidence of stable
disease (tumor size within 25% of
baseline)
Note: Patients with advanced cardiac conditions should not receive Nexavar
Non-Calcium
Based Phosphate
Binders xlii
Fosrenol
Velphoro
Onychomycosis
and Tinea xliii
Note: Nexavar should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
For patients that meet all of the following:
• Treatment of hyperphosphatemia due to ESRD
• Receiving dialysis
• At least 18 years old
• Failed Renvela or Renagel (sevelamer) AND failed a calcium-based phosphate binder or has
contraindications to both. (Note: Patients with elevated total serum calcium after correcting for
albumin should not receive a calcium-based product)
Luzu can be approved as non-formulary for members who meet the following:
• Topical treatment of tinea pedis, tinea cruris, and tinea corporis.
Last Update: 09/08/2016
Initial Approval:
Indefinite
Initial Approval:
Luzu:
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PA Guideline
Luzu
Jublia
Kerydin
Orencia[viii]
Requirements
•
•
•
At least 18 years old
Failure of OR contraindication to terbinafine cream
Failure of at least 1 other formulary topical antifungal agents (i.e. clotrimazole, ciclopirox,
econazole, ketoconazole, miconazole, etc.) OR contraindication to all formulary agents
Jublia or Kerydin can be approved as non-formulary for members who meet the following:
• Treatment of onychomycosis of the toenails with ONE of the following comorbidities:
o Diabetes
o HIV
o Immunosuppression (i.e. receiving chemotherapy, taking long term oral
corticosteroids, taking anti-rejection medications)
o Peripheral vascular disease
o Pain caused by the onychomycosis
• At least 18 years old
• Failure of 2 OR contraindication to all formulary antifungal agents indicated for onychomycosis
(i.e. ciclopirox, griseofulvin, itraconazole and terbinafine tablets)
General authorization criteria for all indications:
• Prescribed by a rheumatologist
• Patient is NOT on another biological DMARD
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
In addition, May be authorized for Rheumatoid Arthritis (RA) when the following are met:
• Patient is at least 18 years old
• If patient has COPD, the prescriber confirms that the benefit of using Orencia outweighs the
risk in the patient
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
• 30 days
Renewal:
Luzu:
• 30 days if responding to
therapy
Jublia or Kerydin:
• 48 weeks
Initial Approval:
4 months
Renewals:
Indefinite
Renewals require at least 20%
symptom improvement
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Requirements
•
Otezlaxliv
Duration of Approval if
Requirements Are Met
Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different oral DMARD regimens (1 of which must include methotrexate (MTX) unless
contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF,
MTX+SSZ, SSZ+HCQ
o One formulary anti-TNF (Note: anti-TNF’s require PA)
In addition, May be authorized for Juvenile Idiopathic Arthritis (JIA) when the following are met:
• Patient is at least 6 years old
• Request is for the IV formulation
• For severe Polyarticular JIA:
o Patient has failed an adequate 3-month trial with one formulary anti-TNF
• For MODERATE Polyarticular JIA:
o Patient has failed an adequate 3-month trial of MTX AND one formulary anti-TNF
• For Systemic JIA:
o Patient does not have currently ACTIVE systemic features (i.e., fever, evanescent rash,
lymphadenopathy, hepatomegaly, splenomegaly, or serositis)
o Patient has continued synovitis in >1 joint despite treatment for 3 months with MTX or
leflunomide and one formulary anti-TNF
Criteria for Psoriatic Arthritis (PsA):
• Patient is at least 18 years old
• Prescribed by or in consultation with a rheumatologist
• Patient is currently on an NSAID and will be continued when Otezla is initiated OR has a
contraindication to NSAID use
Last Update: 09/08/2016
Initial Approval:
4 months
Renewal:
12 months
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Requirements
•
PCSK9’s xlv
Repatha
Praluent
Patient has active PsA (>3 swollen/tender joints) despite a 3-month trial of adequate dose MTX
(or leflunomide or sulfasalazine if MTX is contraindicated)
Criteria for Plaque Psoriasis:
• Patient is at least 18 years old
• Prescribed by or in consultation with a dermatologist
• Symptoms are not controlled with topical therapy
• Disease has a significant impact on physical, psychological or social wellbeing
• Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true
contraindication to both
• Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a
PASI score of more than 10)
• Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse
is defined as greater than 50% of baseline disease severity within 3 months)
Criteria for all patients and indications:
• Current lipid panel results within the past 90 days
• Failed an adequate 60 day trial of 2 high intensity statins* ( e.g., atorvastatin ≥ 40 mg and
rosuvastatin ≥ 20 mg) at maximum tolerated doses and in combination with other lipid lowering
therapies such as Zetia (ezetimibe), bile acid sequestrants or niacin
• Will be used in combination with maximum tolerated dosed statin* and other lipid lowering
therapies such as Zetia (ezetimibe), bile acid sequestrants or niacin or LDL apheresis
Additional Criteria based on Indication:
• ASCVD (For Repatha or Praluent):
o There is supporting evidence of high CVD risk (i.e., history of acute coronary syndrome,
history of MI, stable or unstable angina, coronary or other revascularization (PCI/CABG),
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Requires:
• At least 20% symptom
improvement
• Patient is not experiencing
depression and/or suicidal
thoughts.
• Patient’s BMI is >18.5
QLL (after initial 5 day titration):
60 tablets per 30 days
Initial Approval: 3 months
Renewal: 6 months
Requires:
• Current Lipid Panel within
the past 3 months
• Claims history to support
compliance or adherence
• LDL reduction from baseline
Age Restriction:
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Requirements
•
•
stroke, TIA, Peripheral Arterial Disease (PAD) presumed to be of atherosclerotic origin)
o Lab results to support an LDL ≥ 70 mg/dL (treated)
Heterozygous Familial Hypercholesterolemia (HeFH) (For Repatha or Praluent):
o There is evidence of ONE of the following:
 LDL-C > 190 mg/dL (age ≥ 18 years) either pretreatment or highest on treatment
and physical evidence of tendon xanthomas or evidence of these signs in a 1st
or 2nd degree relative
 DNA based evidence of an LDL receptor (LDLR) mutation, APO-B100, or PCSK9
mutation or
 Who/Dutch Lipid Network Criteria result with a score of > 8 points
o Lab results to support a current LDL ≥ 70 mg/dL on treatment
Homozygous Familial Hypercholesterolemia (HoFH) (For Repatha only):
o Genetic confirmation of 2 mutant alleles at LDLR, APO-B100, or PCSK9
OR
o History of untreated LDL at 500mg/dL or LDL 300mg/dL on maximum dosed statin AND
evidence of ONE of the following:
 Presence of cutaneous xanthoma before the age of 10
 HeFH in both parents
o LDL reduction was <50% on current lipid lowering therapy (high intensity statin +
another treatment)
Duration of Approval if
Requirements Are Met
• Praluent: at least 18 years old
• Repatha for HeFH or ASCVD:
at least 18 years old
• Repatha for HoFH: at least 13
years old
QLL:
• Praluent: 2 syringes per 28
days
• Repatha (for ASCVD or
HeFH): 2 syringes per 28
days. May be increased to 3
(140mg) syringes OR 1
(420mg) syringe per 28 days
if LDL is >70 after initial trial
• Repatha (for HoFH): 3
(140mg) syringes OR 1
(420mg) syringe per 28 days
* Exception to statin therapy trials requires documentation of intolerance to at least 2 statins (at
least one trial being a moderate to high potency statin). Documentation will include chart notes
supporting skeletal muscle related symptoms that resolved when statin therapy was discontinued;
and documentation the member has been rechallenged at a lower dose or with a different statin.
Platelet
Effient or Brilinta can be approved for patients who meet the following:
Last Update: 09/08/2016
Initial Approval:
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Requirements
Inhibitors xlvi
•
•
Effient
Brilinta
Zontivity
•
•
•
Pulmonary
Hypertension
Agents
Diagnosis of ACS (unstable angina, STEMI, NSTEMI)
Failure or contraindication/intolerance to clopidogrel, including patients identified as CYP2C19
poor metabolizers
No active pathological bleeding, history of intracranial hemorrhage, or planned CABG
In addition, for Effient:
o Age <75 unless patient is considered high thromboembolic risk
o Taking concomitant 75-325mg/day aspirin
o No history of TIA or stroke
In addition, for Brilinta:
o Taking concomitant 75-100mg/day aspirin
o No severe hepatic impairment
o No concomitant use with medications known to interact with Brilinta (i.e., potent
CYP3A4 inhibitors/inducers and simvastatin or lovastatin in doses >40mg/day) without
provider documentation that benefit outweighs the risk
Zontivity can be approved for patients who meet the following:
• Prescribed for the secondary prevention of atherothrombosis in patients with PAD or history of
MI (drug NOT indicated for ACS)
• Must be used with aspirin and/or clopidogrel according to the standard of care for the patient’s
diagnosis
• No evidence of contraindications: history of stroke, transient ischemic attack (TIA), or
intracranial hemorrhage (ICH); or active pathological bleeding
Adcirca, Adempas, epoprostenol, Letairis, Opsumit, Remodulin, Revatio (sildenafil), Tracleer, Tyvaso,
Ventavis, Uptravi
See Detailed Document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Pulmonary_Hypertension.pdf
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Effient and Brilinta:
• 12 months
• Indefinite approval can be
given to patients with history
of stent thrombosis or
restenosis
Zontivity:
• Indefinite
Renewals:
Effient and Brilinta:
• 12 months
Requires:
Documentation from cardiologist
that risk of thrombosis outweighs
bleeding risk with long-term use
of antiplatelets
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Requirements
Duration of Approval if
Requirements Are Met
Promactaxlvii
Chronic idiopathic thrombocytopenic purpura (ITP):
• Patient is at least 1 year old
• Patient had insufficient response to corticosteroids, immunoglobulins, or splenectomy
• Promacta is being used to prevent major bleeding in a patient with a platelet count of
<30,000/mm3 and NOT in an attempt to achieve platelet counts in the normal range i.e.,
150,000-450,000/mm3
Initial Approval: 4 weeks
Hepatitis C with thrombocytopenia:
• Patient is at least 18 years old
• Patient has chronic hepatitis C with baseline thrombocytopenia (platelet count < 90,000/mm3)
which prevents initiation of interferon-based therapy when interferon is required
Severe aplastic anemia:
• Patient is at least 18 years old
• Diagnosis of severe aplastic anemia is confirmed by ONE of the following:
o Bone marrow biopsy showing <25% of normal cellularity; OR
o Bone marrow biopsy showing <50% of normal cellularity AND at least TWO of the
following:
 Absolute neutrophil count <500/mm3
 Platelet count <20,000/mm3
 Absolute reticulocyte count <40,000/mm3 (value may be given as percent of
RBCs)
• Anemia is refractory to a previous first line treatment including hematopoietic cell
transplantation or immunosuppressive therapy with a combination of cyclosporine A and
antithymocyte globulin (ATG)
Last Update: 09/08/2016
Renewal:
• ITP (with PLT increase to
>50,000): Indefinite at
current dose.
• ITP (without PLT increase to
>50,000): 4 additional weeks
with dose increase to 75mg.
• HCV (with PLT increase to
>90,000): Duration of Peg-INF
treatment
• HCV (without PLT increase to
>90,000): 4 additional weeks
with a dose increase of 25mg
every 2 weeks until platelets
are >90,000 or to a maximum
of 100mg.
• Aplastic anemia (with PLT
increase to >50,000):
Indefinite at current dose.
• Aplastic Anemia (without PLT
increase to >50,000): Every 4
weeks with a dose increase
of 50mg every 2 weeks until
PLT >50,000 or to a
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Requirements
When to Discontinue Promacta:
• Decrease dose if PLT >200,000 and stop if >400,000.
• ITP: If PLT is NOT >50,000 after 4 weeks of 75mg dose, discontinue treatment.
• HCV: If PLT is NOT >90,000 after 8 weeks or on max dose of 100mg, discontinue treatment.
• Aplastic Anemia: Discontinue if NONE of the following occur after 16 weeks; 1) platelet increase
by 20,000 above baseline; 2) Stable platelet counts with transfusion independence for >8 weeks;
3) hemoglobin increase by >1.5 g/dL; 4) Decrease of >4 units of RBC transfusions for
8 consecutive weeks; 5) Doubling of baseline ANC or an increase >500.
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
maximum of 150mg.
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Requirements
Proton Pump
Inhibitors xlviii
Prilosec OTC, Nexium OTC, and Prevacid OTC are the formulary preferred agents. Pantoprazole
requires step therapy through at least 2 of the formulary preferred agents.
Omeprazole
Prilosec OTC
Non-preferred PPI’s can be authorized when the following criteria are met:
• Trial and failure of at least TWO formulary PPI’s
• Trial and failure of at least ONE formulary PPI at double-daily dose:
o Prilosec OTC 40mg
o Nexium OTC 40mg
o Prevacid OTC 60mg
Lansoprazole
Prevacid OTC
Prevacid Solutab
Aciphex Sprinkle
Rabeprazole
Pantoprazole
Esomeprazole
Nexium
suspension
Nexium OTC
Dexilant
Ranexa xlix
High Dose PPI’s can be authorized when the following criteria are met:
• Provider must submit rationale for high dose (e.g., patient has unsatisfactory or partial
response to once daily dosing, night-time symptoms, severe erosive esophagitis, stricture,
Zollinger-Ellison)
• Patient must have failed Prilosec OTC 40mg, Nexium OTC 40mg, and Prevacid OTC 60mg
For patients age 18 years of age or older who meet all of the following:
• Diagnosis of chronic angina
• Patient meets ONE of the following:
o Ranexa is prescribed as ADD-on therapy after failure to achieve therapeutic benefit on
at least 1 formulary agent from EACH of the following 3 drug classes:
 Beta blockers: acebutolol, atenolol, carvedilol, metoprolol, nadolol,
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
Once daily NF:
Indefinite
High dose: 12 months
Renewal:
High dose: 12 months
Requires:
Response to therapy and
rationale for continuing BID
dosing
Initial Approval:
Indefinite
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Requirements
propranolol
Calcium channel blockers: amlodipine, diltiazem, felodipine, isradipine,
nifedipine, nicardipine, verapamil
 Long acting nitrates: Isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
patch
o Has a documented contraindication or intolerance to beta blockers, calcium channel
blockers, AND long-acting nitrates
Rectiv may be authorized when the following criteria are met:
• Patient has a diagnosis of pain associated with anal fissures.
Duration of Approval if
Requirements Are Met

Rectiv
Revlimid l
May be authorized when prescribed by an oncologist for patients at least 18 years old for any of
the following diagnoses:
• Multiple myeloma (MM) when used with dexamethasone
• Mantle cell lymphoma (MCL) after relapse or progression with two prior therapies, one of
which includes Velcade®(bortezomib)
• Transfusion-dependent anemia associated with low- or intermediate-1 risk myelodysplastic
syndrome (MDS) POSITIVE for the del(5q) cytogenetic abnormality. (Transfusion dependence is
defined as having ≥ 2 units of red blood cells within 8 weeks of treatment)
• Transfusion-dependent anemia associated with low- or intermediate-1 risk MDS that is
NEGATIVE for the del(5q) cytogenetic abnormality AND
o serum EPO >500 mU/mL AND
o Patient has any of the following characteristics:
 Age >60 years old
 >5% marrow blasts
 Non-hypocellular marrow
Last Update: 09/08/2016
Initial Approval:
6 months
Renewal:
1 year
Initial Approval:
6 months
Renewal:
MDS:
6 months if benefit is
demonstrated, as evidenced by
transfusion independence within
the past two months.
Multiple Myeloma, Mantle Cell
Lymphoma:
6 months if benefit is
demonstrated, as evidenced by
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Savella li
Second
Generation
Tyrosine Kinase
Inhibitors for
CML and ALL lii
Requirements
 HLA-DR15 negative
 PNH clone negative
For Patients who meet all of the following:
• 13 years of age or older
• Diagnosis of fibromyalgia or juvenile fibromyalgia
• Failure of a 2-month, consecutive trial of at least ONE formulary medication used in fibromyalgia
such as duloxetine, amitriptyline/nortriptyline, gabapentin, cyclobenazeprine, or tramadol
Imatinib (a first generation TKI) is the preferred agent for CML and ALL (see imatinib guideline for
coverage criteria). Imatinib should NOT be used in patients who have had a treatment failure with
a second generation TKI. Tasigna is the formulary preferred second generation TKI.
Non-preferred TKI’s when prescribed for adult patients (at least 18 years of age) by an oncologist
may be authorized when the following criteria are met:
Bosulif
• Patient has ONE of the following diagnoses:
Iclusig
o Philadelphia chromosome positive or BCR-ABL1 positive chronic myeloid leukemia (Ph+
Sprycel
CML) in chronic phase or accelerated phase
Tasigna
o Relapsed, refractory Ph+ CML in blast phase when it is of lymphoid type (not myeloid)
o Relapsed, refractory Ph+ acute lymphoblastic leukemia (Ph+ ALL)
• In addition for Tasigna (formulary with PA) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with imatinib
o Presence of any of the following mutations that are resistant to imatinib: F317L/V/I/C,
T315A, V299L
o Intolerance, disease progression, or resistance to prior therapy with a second
generation TKI (Sprycel, Bosulif, or Iclusig)
• In addition for Sprycel or Bosulif (non-formulary) patient has ONE of the following:
o Intolerance, disease progression, or resistance to prior therapy with imatinib AND
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
absence of disease progression.
Initial Approval: Indefinite
Savella can be dosed up to a
maximum daily dose of 200mg
Initial Approval:
1 year
Renewal:
• 3 years approved as long as
there is no evidence of
disease progression or
unacceptable toxicity.
• Renewals should be based on
documentation of major
cytogenetic response (≤35%
Ph+ metaphases) and until
disease progression or death.
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Requirements
Tasigna
Presence of any of the following mutations that are resistant to imatinib and Tasigna:
Y253H, E255K/V, F359V/C/I
o Intolerance, disease progression, or resistance to prior therapy with a second
generation TKI (Tasigna, Bosulif, Sprycel or Iclusig)
• In addition for Iclusig (non-formulary) patient has ONE of the following:
o Presence of the T315I mutation that is resistant to other TKI’s
o Intolerance, disease progression, or resistance to prior therapy with 2 different TKI’s
(imatinib, Tasigna, Sprycel, or Bosulif)
Octreotide, Sandostatin LAR, Signifor, Signifor LAR
Duration of Approval if
Requirements Are Met
o
Somatostatin
Analogs
Stelara liii
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/providers/Somatostatin%20Analogs.pdf
May be authorized for Plaque Psoriasis when the following criteria is met:
• Patient is at least 18 years old
• Prescribed by a dermatologist
• Symptoms are not controlled with topical therapy
• Disease has a significant impact on physical, psychological or social wellbeing
• Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true
contraindication to both
• Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a
PASI score of more than 10)
• Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse
is defined as greater than 50% of baseline disease severity within 3 months)
• Patient has failed a compliant, 3-month trial of at least ONE formulary anti-TNF
Last Update: 09/08/2016
Initial Approval:
6 months
Renewal:
2 years, with clinical notes
documenting an improvement
(e.g., reduction in PASI,
decreased swollen/painful joints)
NOTE: Safety and efficacy of
ustekinumab have not been
established beyond 2 years of use
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Sutent liv
Requirements
May be authorized for Psoriatic Arthritis when the following criteria is met:
• Patient is at least 18 years old
• Prescribed by a dermatologist or rheumatologist
• Patient is currently on an NSAID which will be continued when Stelara is initiated OR has a
contraindication to NSAID use
• Patient meets ONE of the following:
o Has active PsA despite a 3-month trial of adequate dose MTX (or leflunomide or
sulfasalazine if MTX is contraindicated)
o Patient has predominantly axial disease AND active PsA despite a 3-month trial of TWO
different NSIADs at an adequate dose OR has a contraindication to NSAID use
• Patient has failed a compliant, 3-month trial of at least ONE formulary anti-TNF
Can be authorized when prescribed by an oncologist for adult patients (at least 18 years old), can
be authorized for the following indications:
• Treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance
to imatinib
• Treatment of relapsed or unresectable stage IV renal cell carcinoma (RCC)
• Treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in
patients with unresectable locally advanced or metastatic disease in combination with or after
disease progression on a somatostatin analog (i.e. octreotide, Sandostatin LAR)
o Patients with an insulinoma do not require treatment with a somatostatin analog
for approval
Note: Patients with advanced cardiac conditions should not receive Sutent.
Note: Sutent should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
3 years if stable disease (tumor
size within 25% of baseline)
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Note: Patients receiving strong CYP3A4 inhibitors may require a lower dose to avoid toxicity.
May be authorized for patients in the following groups when the criteria is met:
• Preterm Infants without Chronic Lung Disease (CLD):
o Gestational Age (GA) < 29 weeks, 0 days
o 12 months of age or younger at the start of RSV season
• Preterm Infants with Chronic Lung Disease (CLD):
o Gestational Age (GA) < 32 weeks, 0 days
o Patient meets ONE of the following:
 Is <12 months of age at the start of RSV season AND has required >21% oxygen
for >28 days after birth
 Is between 12 and 24 months of age at the start of RSV season AND continues
to require medical support (e.g., supplemental oxygen, chronic systemic
corticosteroid therapy, diuretic therapy, or bronchodilator therapy) within 6
months of the start of RSV season
• Infants with Hemodynamically Significant Congenital Heart Disease:
o Patient meets ONE of the following:
 Is between 12 and 24 months of age at the start of RSV season AND has
undergone cardiac transplantation during RSV season
 Is <12 months of age at the start of RSV season AND meets ONE of the
following:
• Has a diagnosis of acyanotic heart disease that will require cardiac
surgery AND is currently receiving medication to control heart failure
• Diagnosis of cyanotic heart disease AND prophylaxis is recommended
by a Pediatric Cardiologist
• Diagnosis of moderate to severe pulmonary hypertension
• Children with Anatomic Pulmonary Abnormalities or Neuromuscular Disorder:
Last Update: 09/08/2016
Synagis lv
Duration of Approval if
Requirements Are Met
Initial Approval:
1 dose per month for a maximum
of 5 doses per season
**Note: infants born during RSV
season may require fewer than 5
doses**
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Requirements
Is 12 months of age or younger at the start of RSV season
Disease or congenital anomaly impairs ability to clear secretions from the upper airway
because of ineffective cough
Immunocompromised Children:
o Is 24 months of age or younger at the start of RSV season
o Child is profoundly immunocompromised during RSV season
Duration of Approval if
Requirements Are Met
o
o
•
Tarceva lvi
Note: The following groups are not at increased risk of RSV and should NOT receive Synagis:
• Infants and children with hemodynamically insignificant heart disease (eg, secundum atrial
septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis,
mild coarctation of the aorta, and patent ductus arteriosus)
• Infants with lesions adequately corrected by surgery, unless they continue to require
medication for congestive heart failure
• Infants with mild cardiomyopathy who are not receiving medical therapy for the condition
• Children with cystic fibrosis (unless the child has clinical evidence of CLD and/or nutritional
compromise in the first year of life) or Down Syndrome (unless qualifying heart disease or
prematurity)
When prescribed by an oncologist for patients at least 18 years old, can be authorized for the
following indications:
• Metastatic pancreatic cancer when used in combination with gemcitabine (Gemzar) in patients
with a good performance status
• Metastatic non-small cell lung cancer (NSCLC) that is positive for a sensitizing epidermal growth
factor receptor (EGFR) mutation [i.e., exon 19 deletions or exon 21 (L858R) substitution]
• Locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen
• Locally advanced or metastatic NSCLC that remains stable (no disease progression) after 4 to 6
cycles of platinum-based first-line chemotherapy since platinum-based chemotherapy is NOT
Last Update: 09/08/2016
Initial Approval:
1 year
Renewal:
3 years if benefit (control of
tumor growth, or disease-related
symptom improvement)
Tx should be discontinued if any
of the following occur:
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Requirements
•
recommended beyond 6 cycles
Treatment of relapsed or unresectable stage IV NON-clear cell renal cell carcinoma (RCC)
Note: Tarceva should not be used with PPI’s. If taken concomitantly with H2-receptor antagonists
(i.e., ranitidine), Tarceva should be dosed 10 hours after and 2 hours before taking the H2-receptor
antagonist.
Testosterone
agents lvii
Preferred:
Testosterone
enanthate
Testosterone
cypionate
Testosterone gel
Testosterone
packets
The formulary preferred agents will be authorized using the following criteria based on the indication
being treated. Requests for Branded agents must also meet the Brand Name Medication criteria for
approval.
Criteria for the use in Hypogonadism:
• Confirmation of diagnosis confirmed by two separate A.M. serum testosterone measurements
with results below normal range as evidenced by ONE of the following:
o At least one low total testosterone level (below the normal range for the laboratory)
WITH elevated FSH and/or LH; OR
o At least two total testosterone levels, both of which are less than normal based upon
the laboratory reference range WITH at least one low free testosterone level (below
the normal range for the laboratory)
Branded
• Patient presents with symptoms associated with hypogonadism, such as but not limited to the
Products
following:
Non-Preferred
o Breast discomfort/gynecomastia; OR
Androderm
o Loss of body (axillary and pubic) hair, reduced shaving need; OR
Androgel
o Very small (especially less than 5 mL) or shrinking testes; OR
Android
o Inability to father children or low/zero sperm count; OR
Androxy
o Height loss, low trauma fracture, low bone mineral density; OR
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
• Interstitial Lung Disease (ILD)
• Severe hepatic toxicity that
does not resolve
• Severe renal failure
• Severe bullous, blistering or
exfoliating skin conditions
• Corneal perforation or severe
ulceration
Initial Approval:
• 6 months for hypogonadism
and delayed puberty
• Indefinite for other
indications
Renewal:
Delayed puberty:
• 6 months
• Requires X-ray of the hand
and wrist every 6 months to
determine bone age and to
assess the effect of
treatment on the epiphyseal
centers.
Hypogonadism:
• Indefinite
• Requires testosterone within
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Aveed
Axiron
Fortesta
Methitest
Natesto
Striant
Testopel
Testred
Vogelxo
Requirements
Hot flushes, sweats; OR
Other less specific signs and symptoms including decreased, energy, depressed
mood/dysthymia, irritability, sleep disturbance, poor concentration/memory,
diminished physical or work performance.
Patient does not have:
o Metastatic prostate cancer
o Breast cancer
o Unevaluated prostate nodule or induration
o PSA >4 ng/ml (>3 ng/ml in individuals at high risk for prostate cancer, such as
African-Americans or men with first-degree relatives who have prostate cancer)
o Hematocrit >50%
o Uncontrolled or poorly controlled congestive heart failure
o Severe lower urinary tract symptoms associated with benign prostatic hypertrophy
as indicated by AUA/IPSS>19
o
o
•
Criteria for the use in Aids-Associated Wasting:
• Must meet criteria noted above for hypogonadism regarding labs and symptoms.
• There is documentation of adequate nutritional support/caloric intake
• Note: Eugonadal men will be reviewed on case by case basis by the Medical Director based on
clinical documentation to support Medical Necessity.
Criteria for the use in Delayed Puberty:
• Patient is an adolescent male
• Baseline x-ray of the hand and wrist was completed to determine bone age
Criteria for the use in palliative treatment of inoperable breast cancer in women :
• Prescribed by oncologist
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
normal range and/or
improvement in symptoms
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Duration of Approval if
Requirements Are Met
Criteria for the use in Transexualism:
• Patient must be 18 years of age or greater
• Female to male gender change
Thalomidlviii
May be authorized when prescribed by an oncologist for patients at least 12 years old for any of
the following diagnoses:
• Multiple myeloma (MM) when used with dexamethasone
• Erythema nodosum leprosum
• Chronic or subacute cutaneous systemic lupus erythematosus (SLE) after trial and failure of
topical corticosteroids AND 2 of the following for a duration of at least 12 weeks:
o Hydroxychloroquine
o Chloroquine
o Methotrexate
o Azathioprine
o Cyclosporine
o Cyclophosphamide
o Mycophenolate
o Sulfasalazine
Topical
Elidel and tacrolimus are covered for patients between 2 and 10 years of age.
Calcineurin
For other age groups, Elidel and tacrolimus require step therapy with topical corticosteroids.
Inhibitors lix
• If patient has filled 2 topical corticosteroids in the last 60 days, the prescription will
automatically process at the pharmacy.
Elidel
• Prior Authorization will be required for prescriptions that do not process automatically at the
Tacrolimus
pharmacy. In those cases, Elidel and tacrolimus will be reviewed for the treatment of eczema
or atopic dermatitis based upon the affected area being treated:
o Body/extremities – authorized after trial and failure or intolerance to at least 2
Last Update: 09/08/2016
Initial Approval:
1 year
Renewal:
3 years based on therapeutic
response
Initial Approval:
Indefinite
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Requirements
o
o
different formulary topical corticosteroids.
Face – authorized after trial and failure of one formulary low-potency topical
corticosteroid
Eyelid or other sensitive area – authorized without trial and failure of topical
corticosteroids
Duration of Approval if
Requirements Are Met
Topical
Hyaluronic Acid
Agents
NOTE: Can also be approved for vitiligo if other criteria is met
When used for treatment of burns, dermal ulcers, wounds, radiation dermatitis:
• Prescriber must be a dermatologist
• Patient must be at least 18 years old
Initial Approval:
Burns or dermatitis:
• 3 fills of generic agent
Bionect
HyGel
Hylira
XClair
When used for treatment of xerosis:
• Prescriber must be a dermatologist
• Trial and failure of ammonium lactate or a topical corticosteroid
• Patient must be at least 18 years old
Xerosis:
• Up to 1,000 grams of
equivalent generic agent per
30 days for three months
Topical NSAIDs lx
Diclofenac 1% gel
Pennsaid
Flector patch
May be approved for adults, age 18 and older, who meet the following criteria:
• Diclofenac 1% Gel: Diagnosis of OA of knee or hand
• Pennsaid: Diagnosis of OA of knee
• History of, or high risk for, adverse GI effects associated with oral NSAID use AND trial and
failure of celecoxib; OR
• High risk for other adverse effects associated with oral NSAID use (i.e., CHF, renal failure,
concomitant use of lithium); OR
• Failure on TWO formulary NSAIDs
Last Update: 09/08/2016
Renewal:
3 months
Initial Approval:
Flector Patch: 1 month
All others: 1 year
Renewal:
Flector Patch: 1 month
All others: 1 year
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Requirements
Note: Flector patch is only FDA approved for acute pain. Requests for Flector patch for chronic pain
should be denied. If patient meets all other criteria above, offer Diclofenac 1% Gel or Pennsaid as
an alternative.
Tranexamic acid
tablets lxi
The risk factors that correlate strongly to adverse GI effects of oral NSAID use are:
• History of GERD, GI bleed, or ulcer
• Chronic oral steroid use
• Current anticoagulant or antiplatelet use
• Age 65 or greater
Criteria for the treatment of cyclic heavy menstrual bleeding:
• Trial and failure, intolerance or contraindication to oral NSAIDs
• Trial and failure, intolerance or contraindication to ANY of the following: oral hormonal cycle
control combinations, oral progesterone, Mirena, Depo Provera
• Age restriction: 12 years of age or older
Tranexamic acid may also be authorized for the treatment of acute bleeding episodes in patients
with hemophilia.
Tykerb lxii
May be authorized when prescribed by an oncologist for patients at least 18 years old who have
ONE of the following indications:
• Hormone-receptor positive, HER2 positive metastatic breast cancer:
o Used in combination with letrozole
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
• 90 days for menstrual
bleeding
• Indefinite for hemophilia
Renewal:
• Indefinite
QLL:
• 30 tablets per 30 days for
menstrual bleeding
• 84 tablets per 30 days for
hemophilia
Initial Approval:
1 year
Renewal:
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Requirements
•
o Patient is postmenopausal
HER2 positive advanced/recurrent or metastatic breast cancer:
o Disease has progressed after receiving prior therapy with an anthracycline
(doxorubicin, daunorubicin, epirubicin, idarubicin), a taxane (paclitaxel, docetaxel),
AND trastuzumab (Herceptin)
o Used in combination with capecitabine or Herceptin
Note: Tykerb should not be given to patients with an abnormal LVEF.
Vancomycin
Oral lxiii
Note: Tykerb should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
NOTE: Because oral vancomycin is not absorbed systemically, it should not be used for the treatment
of systemic infection.
Oral vancomycin can be approved for members who meet the following:
• Treatment of culture confirmed, Enterocolitis caused by Staphylococcus aureus (MSSA or MRSA);
OR
• Treatment of C.difficile infection (CDI) associated diarrhea:
o For Mild-to-moderate CDI in patients who are:
 Intolerant/allergic to metronidazole; OR
 Still symptomatic after 7 days of metronidazole when CDI has been
confirmed by labs [e.g., toxin enzyme immunoassay (EIA), nucleic acid
amplification (NAAT)]; OR
 Pregnant or breastfeeding
o For initial episode of severe CDI (WBC > 15,000 OR Scr > 1.5x Normal)
o For severe, complicated CDI with hypotension or shock, ileus, or megacolon
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
3 years based on therapeutic
response or until disease
progression or unacceptable
toxicity
Requires no evidence of:
• severe hepatotoxicity
• interstitial lung disease
Doses and Approval Durations:
• Standard adult dose: 125mg
QID for 10 days
• Pediatric dose: 40 mg/kg/day
in 3 or 4 divided doses for 7
to 10 days. Total daily dosage
should not exceed 2 g
• For severe, complicated CDI
with no significant abdominal
distention: 125mg QID with
IV metronidazole. Approve
for duration requested by
provider
• For severe, complicated CDI
with ileus or toxic colon
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Requirements
o
o
o
For first recurrence of CDI when previously treated with vancomycin if CDI has been
confirmed by labs [e.g., toxin enzyme immunoassay (EIA), nucleic acid amplification
(NAAT)];
For first recurrence of severe, CDI regardless of previous agent used
For second recurrence* of CDI that has been confirmed by labs [e.g., toxin enzyme
immunoassay (EIA), nucleic acid amplification (NAAT)];
 Pulsed vancomycin regimen is recommended
 Fecal microbiota transplant should be considered after failing pulsed
vancomyin regimen
Viscosupplement
s
Hyalgan, Gel-One, Euflexxa, Synvisc, Orthovisc
See Detailed document:
https://www.aetnabetterhealth.com/newjersey/assets/pdf/pharmacy/Viscosupplements.pdf
Vivitrol
For patients who meet all of the following:
• Must be at least 18 years of age
• Not experiencing acute opiate agonist withdrawal
• Not receiving opioid analgesics ( e.g.; must pass naloxone challenge test or negative urine drug
screen for opiates)
• Must be enrolled in and compliant with a substance abuse treatment program or psychosocial
support plan
• Must be and remain abstinent from using all substances of abuse (as verified by random urine
drug testing)
In addition, for Alcohol dependence:
• Abstinent from alcohol for at least 7 days in an ambulatory setting prior to the initiation of
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
and/or significant abdominal
distention: 500mg oral QID
with rectal vancomycin and
IV metronidazole. Approve
for duration requested by
provider.
• Staphylococcal enterocolitis:
500-2000mg per day in 3 or 4
divided doses for 7 to 10
days.
Initial Approval:
90 days
Renewal:
• 90 days – 1 year
• Member must be compliant
per Rx history
• UDS completed
• Compliant with a substance
abuse treatment program or
psychosocial support plan
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Requirements
•
•
Votrient lxiv
treatment
If also opioid-dependent, must be opioid-free for a minimum of 7-10 days before starting
treatment in order to prevent unintentional withdrawal.
Documentation supports trial and failure of, intolerance to, or non-compliance with oral
naltrexone, acamprosate, and/or disulfram, or a rationale is provided to support the necessity of
Vivitrol injections
In addition, for Opioid dependence:
• Opioid-free for a minimum of 7-10 days prior to the initiation of treatment in order to prevent
unintentional withdrawal
• Documentation supports trial and failure of, intolerance to, or non-compliance with oral
naltrexone and/or oral buprenorphine with or without naloxone (Subutex or Suboxone), or a
rationale is provided to support the necessity of Vivitrol injections.
Votrient can be authorized when prescribed by an oncologist for a patient at least 18 years old
for any of the following indications:
• Diagnosis of relapsed or unresectable stage IV predominantly clear-cell renal cell carcinoma
(RCC)
• Diagnosis of advanced soft tissue sarcoma after treatment with a prior chemotherapy
Note: Votrient should not be used in combination with a strong CYP3A4 inducer (e.g.,
dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John's Wort) unless there is no alternative to the CYP3A4 inducer
Note: Patients receiving strong CYP3A4 inhibitors may require a lower dose to avoid toxicity.
Weight
For patients who meet all of the following:
Reduction
• BMI ≥ 30 kg/m 2 (obese); OR
lxv
Medications
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Initial Approval:
1 year
Renewal:
3 years if evidence of stable
disease (tumor size within 25% of
baseline) and ALT is <8 times
ULN. Patients with ALT between
3 and 8 times ULN should have
ALT monitored weekly until <3
times ULN
Initial Approval:
4 months (Saxenda)
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Belviq
benzphetamine
phentermine
phendimetrazine
diethylpropion
Qsymia
Contrave
Saxenda
Xenical/Alli
Requirements
•
•
•
•
•
BMI ≥ 27kg/m2 (overweight) and ONE of the following obesity-related risk factors:
o Coronary heart disease
o Dyslipidemia:
 HDL <35mg/dl or
 LDL ≥ 160mg/dL, or
 Triglycerides ≥ 400mg/dl
o Hypertension
o Type II diabetes mellitus
o Sleep apnea
o Polycystic ovary syndrome
o Osteoarthritis
Patient is not pregnant (confirmed by negative pregnancy test for women of childbearing age) or
breastfeeding
Patient is not receiving other medications for weight loss
Patient will be using the requested drug as an adjunct to diet, exercise, and behavioral
modification
Age restrictions:
o Xenical/Alli or benzphetamine: > 12 years old
o Phentermine: >16 years old
o Phendimetrazine or diethylpropion: >17 years old
o Qsymia, Belviq, Contrave, Saxenda: >18 years old
Patients with the following contraindications should not receive phentermine, phendimetrazine,
benzphetamine, diethylpropion, or Qsymia:
• Hyperthyroidism
• Glaucoma
• Agitation or uncontrolled anxiety
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
3 months for all others
First Renewal:
9 months
Requires documentation of
weight loss of >5% of baseline
weight
Note: Use of phentermine,
phendimetrazine,
benzphetamine, and
diethylpropion beyond 3 months
is not recommended and should
be reviewed on a case by case
basis
Additional Renewal:
Requirements for renewal:
1. Documentation showing
member continues weight
loss plan
2. Patient has maintained at
least 67% of their initial
weight loss
3. Patient’s BMI is >24 kg/m2
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Requirements
•
•
•
•
•
•
MAOI use within 14 days
History of drug abuse
Concomitant use with CNS stimulants
Uncontrolled hypertension
Advanced arteriosclerosis (diethylpropion and benzphetamine only)
History of cardiovascular disease (stroke, coronary artery disease, arrhythmias, and congestive
heart failure) (phentermine, phendimetrazine, and Qsymia only)
In addition for Xenical/Alli:
• Patient does not have any of the following contraindications:
o Chronic malabsorption syndrome
o Cholestasis
o Hepatic disease
o Concomitant use with warfarin or antiepileptic medications
• Patients receiving levothyroxine must separate medications by >4 hours
• Patient must be able to adhere to a low fat diet (<30% of calories from fat)
In addition for Belviq:
• Patient does not have any of the following contraindications:
o Concomitant use with SSRIs, SNRIs, MAOIs, linezolid, triptans, tramadol, bupropion,
dextromethorphan, St. John’s wort
o CHF
o Severe renal impairment
In addition for Saxenda:
• Patient does not have any of the following contraindications:
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Xenical/Alli and Belviq:
1 year (no more than 4 years)
All others: Use beyond 1 year has
not been studied. Requests
should be reviewed on a case by
case basis considering patient
response, safety, and current
guidelines
Note: Other than Xenical/Alli and
Saxenda, available weight loss
drugs are controlled substances
and should therefore not be
granted indefinite approval
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Requirements
o
o
Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome
type 2.
Concomitant use with insulin
Duration of Approval if
Requirements Are Met
In addition for Contrave:
• Member must be abstinent from opioids for a minimum of 7 – 10 days (up to 14 days if taking
long-acting opioid) prior to starting naltrexone/bupropion
• Patient does not have any of the following contraindications:
o MAOI use within 14 days
o Uncontrolled hypertension
o Seizure disorder
Xeljanz lxvi
May be authorized for Rheumatoid Arthritis (RA) when the following are met:
• Patient is at least 18 years old
• Prescribed by a rheumatologist
• Patient is NOT on a biological DMARD or azathioprine or cyclosporine
• Patient is up to date with all recommended vaccinations
• Patient has been screened for latent TB and hepatitis B
• Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the
following:
o 2 different non-biologic DMARD regimens (1 of which must include methotrexate
(MTX) unless contraindicated)
 Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF)
 Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF,
MTX+SSZ, SSZ+HCQ
o ONE formulary anti-TNF (Note: anti-TNF’s require PA)
Xolair lxvii
For the treatment of moderate-severe persistent asthma:
Last Update: 09/08/2016
Initial Approval:
3 months
Renewal:
Indefinite
Renewals require at least 20%
symptom improvement
Initial Approval:
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Requirements
•
•
•
•
•
•
•
•
•
Prescribed by, or after consultation with a pulmonologist, or allergist/immunologist
12 years of age or older
Baseline IgE levels between 30-700 IU/ml
Weight is less than 150 kg (330 lbs.)
Allergic sensitization demonstrated by positive skin testing or in vitro testing for allergenspecific IgE to an allergen that is present year round (a perennial allergen), such as dust mite,
animal dander, cockroach, or molds
Evidence of reversible disease (12% or greater improvement in FEV1 with at least a 200-ml
increase or 20% or greater improvement in PEF as a result of a short-acting bronchodilator
challenge)
Patient should be non-smoking or actively receiving smoking cessation treatment
Patient has tried and failed conventional immunotherapy or immunotherapy is not indicated.
(Immunotherapy has demonstrated efficacy against dust mites, animal dander, and pollens but
not against molds and cockroach allergies).
Asthma symptoms are not adequately controlled by high dose inhaled corticosteroids AND a
long-acting beta agonist (LABA) for 6 months
o Inadequate control is defined as:
 Requirement for systemic corticosteroids (oral, parenteral) to treat asthma
exacerbations; OR
 Daily use of rescue medications (short-acting inhaled beta-2 agonists); OR
 2 ED visits or 1 hospitalization for asthma in the last 12 months; OR
 2-3 unscheduled office visits with documentation of intensive care for acute
asthma exacerbation; OR
 Nighttime symptoms occurring more than once a week
For the treatment of chronic urticaria:
Last Update: 09/08/2016
Duration of Approval if
Requirements Are Met
Asthma: 6 months
Chronic urticaria: 3 months
Renewal:
Asthma: 1 year
Requires demonstration of
clinical improvement (e.g., ↓ use
of rescue medications or
systemic corticosteroids, ↑ in
FEV1 from pre-treatment
baseline, ↓ in number of ED
visits or hospitalizations) and
compliance with asthma
controller medications, and nonsmoking status.
Chronic urticaria:
6 months
Requires demonstration of
adequate symptom control (e.g.,
↓ itching)
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Requirements
•
•
•
•
•
•
•
•
Duration of Approval if
Requirements Are Met
Symptoms continuously or intermittently present for at least 6 weeks.
Prescribed by an allergist/immunologist or dermatologist
12 years of age or older
Currently receiving H1 antihistamine therapy
Failure of a 4 week, compliant trial of at least two high dose H1 antihistamines
AND
Failure of a 4-week, compliant trial of at least one of the following medications (used in addition
to H1 antihistamine therapy):
o Leukotriene inhibitor (montelukast or zafirlukast)
o H2 antihistamine (ranitidine or cimetidine)
o Doxepin
AND
Failure of a 4 week, compliant trial of low dose cyclosporine (used in addition to H1
antihistamine therapy) or contraindication to cyclosporine.
NOTE: Anti-inflammatory medications (dapsone, sulfasalazine, or hydroxychloroquine) may be
useful in treating urticaria, however the evidence is limited
**Note: Off-label and not covered for diagnosis of Allergic Rhinitis or food allergy**
i
Acamprosate References
1. VA Pharmacy Benefits Management Services. Alcohol Use Disorder Pharmacotherapy: Naltrexone, Acamprosate, and Disulfiram Recommendations for Use. Prepared December 2013.
Reviewed by the Substance Use Disorder Ad Hoc Advisory Panel to the PBM-MAP and the Psychopharmacology Field Advisory Committee. Accessed 2 Feb. 2016.
http://www.pbm.va.gov/PBM/clinicalguidance/clinicalrecommendations.asp
2. Campral (acamprosate calcium) package insert. St. Louis, MO: Forest Pharmaceuticals, Inc
3. Daily Med [Internet database] . NIH U.S. National Library of Medicine. Acamprosate. Bethesda, MD. Updated 26 Nov. 2012.
Last Update: 09/08/2016
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4.
Department of Veteran Affairs. Department of Defense. VA/Dod Clinical Practice Guideline for the Management of Substance Use Disorders.Version 3.0. Based on evidence reviewed
through January 2015. http://www.healthquality.va.gov/guidelines/MH/sud/
ii
Actemra References
5. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
6. Actemra (tocilizumab) [package insert]. South San Francisco, CA; Genetec, Inc; Revised November 2014.
7. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic-juvenileidiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016.
8. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrinassociated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016.
9. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
iii
Afinitor References:
1. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized placebo-controlled phase III trial. The Lancet. 2008
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf Version
3.2015. Accessed September 8, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Breast Cancer. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version
3.2015. Accessed September 8, 2015.
4. Besalga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9.
5. National Guideline Clearinghouse (NGC). Guideline summary: Guidelines on renal cell carcinoma. In: National Guideline Clearinghouse (NGC).
http://www.guideline.gov/content.aspx?id=45321&search=advanced+renal+cell+carcinoma#Section420. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); cited 2015
August 10. Available: http://www.guideline.gov.
6. Owens, James. Tuberous sclerosis complex: Management. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed on August 10,2015).
7. Torres, Vicente. Renal angiomyolipomas. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed on August 10, 2015).
8. Chan Ang, Jennifer. Metastatic pancreatic neuroendocrine tumors and poorly differentiated gastroenteropancreatic neuroendocrine carcinomas: Systemic therapy options to control
tumor growth and symptoms of hormone hypersecretion. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed August 10, 2015).
9. Ellis, Matthew. Treatment approach to metastatic hormone receptor-positive breast cancer: Endocrine therapy. In UpToDate, Post TW (Ed.), Waltham, MA, (accessed August 10, 2015).
10. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Neuroendocrine Tumors.
http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Version 1.2015. Accessed September 8, 2015.
iv
Ampyra References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
2. National Multiple Sclerosis Society Disease Management Consensus Statement-Recommendations from the MS Information Sourcebook; 2007 Update. National Multiple Sclerosis Society.
Available at: http://www.nationalmssociety.org/For-Professionals/Clinical-Care/Managing-MS. Accessed on Sept 2, 2014
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v
Injectable Anticoagulants References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
2. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
3. PL Detail-Document, Comparison of Injectable Anticoagulants. Pharmacist’s Letter/Prescriber’s Letter. August 2012,26(9):260902
4. Kahn SR., Lim W., Dunn AS., et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines), Chest 2012; 141 (Suppl 2): e195S-e226S
5. Gould MK., Garcia DA., Wren SM,, et al. Prevention of VTE in Nonorthopedic Surgical Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest
Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e227S-e277S
6. Falck-Ytter Y., Francis CW., Johanson NA,, et al. Prevention of VTE in Orthopedic Surgery Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of
Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e278S-e325S
7. Douketis JD., Spyropoulos AC., Spencer FA., et al. Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College
of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl 2): e326S-e350S
8. Kearon C., Akl EA., Comerota AJ., et al. Antithrombotic Therapy for VTE Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e419S-e494S.
9. You JJ., Singer DE., Howard PA., et al. Antithrombotic Therapy for Atrial Fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e531S-e575S
10. Lansberg MG., O’Donnell MJ., Khatri P., et al. Antithrombotic and Thrombolytic Therapy for Ischemic Stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American
College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e601S-e636S.
11. Bates SM., Greer IA., Middeldorp S., et al. VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College
of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2_suppl):e691S-e736S.
vi
Antidepressant References
1. American Psychiatric Association: Practice guideline for the treatment of patients with major depressive disorder 3rd edition. Am J Psychiatry. 2010;167(suppl):1-104.
2. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report. Am J Psychiatry.
2006;163:1905-1917.
vii
ARBs References
1. Gold Standard. (2010, April 9). Benicar. Tampa, Florida. Retrieved November 1, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2750&sec=monindi&t=0
2. Gold Standard. (2012, April 19). Tektuna. Tampa, Florida, USA. Retrieved November 1, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=3555&sec=monindi&t=0
3. Gold Standard. (2014, May 29). Valsartan. Tampa, Florida, USA. Retrieved November 1, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2119&sec=monindi&t=
4. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint
National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427.
viii
Long-Acting Injectable Atypical Antipsychotics References:
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1.
2.
3.
4.
5.
Risperidal Consta [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; Revised 4/2014
Invega Sustenna [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; Revised 11/2014
Abilify Maintena [package insert]. Tokyo. Japan: Otsuka Pharmaceutical Co., Ltd.:12/2014
Zyprexa Relprevv [package insert]. Indianapolis, IN: LillyUSA, LLC: Revised 12/19/2014
Kishimoto T, Robenzadeh A, Leucht C, et al. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr Bull. 2014;
40 (1):192-213.
ix
Cambia References
1. Cambia [full prescribing information]. Newark, CA: Depomed Inc.; Revised 01/2014.
2. Marmura MJ, Silberstein SD, Schwedt TJ. The Acute Treatment of Migraines in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache.
2015;55:3-20.
x
Xeloda References
1. Xeloda [capecitabine] prescribing information. South San Francisco, CA: Genentech, inc. Updated: March, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Colon Cancer. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Version
2.2016. Accessed December 17, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Anal Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Version
2.2015. Accessed November 4, 2015.
4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Brest Cancer. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Version
1.2016. Accessed December 17, 2015.
5. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma.
http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Version 2.2015. Accessed December 17, 2015.
xi
Caprelsa References
1. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Thyroid Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf.
Version 2.2015. Accessed September 8, 2015.
2. Aetna CPB: Antineoplastics Accessed August 2015
3. Vandetanib. In: Clinical Pharmacology Online. Atlanta, GA: Elsevier / Gold Standard; [Updated 7/30/2014;Accessed August 2015] http://clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=3722&sec=monindi&t=0
xii
Celecoxib References
1. Standard, G. (2013, May 13). Celebrex. Tampa, Florida, USA. Retrieved August 27, 2015from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=689&sec=monindi&t=0
xiii
Chantix References
1. Treating Tobacco Use and Dependence: 2008 Update Tobacco Use and Dependence Guideline Panel. Rockville (MD): US Department of Health & Human Services; 2008 May.
http://www.ncbi.nlm.nih.gov/books/NBK63952/
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2.
VA : Recommendations for Use of Combination Therapy in Tobacco Use Cessation April 2009 VHA Pharmacy Benefits Management Services, Medical Advisory Panel, Tobacco Use
Cessation Technical Advisory Group, and Public Health Strategic Healthcare Group
http://www.pbm.va.gov/PBM/clinicalguidance/clinicalrecommendations/CombinationTherapyinTobaccoUseCessationRecommendations.doc
xiv
Cialis References
1. Gold Standard. (2014, March 7). Cialis. Tampa, Florida, USA. Retrieved November 3, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2701&sec=monindi&t=0
2. Walters Kluwer Health Inc. (2014, June 1). Cialis. St Louis, Missouri, USA. Retrieved November 3, 2014, from http://online.factsandcomparisons.com/MonoDisp.aspx?monoID=fandchcp1415&quick=264475%7c5&search=264475%7c5&isstemmed=True&NDCmapping=-1&fromTop=true#firstMatch
3. Cunningham GR, Kadmon D. Medical treatment of benign prostatic hyperplasia. Waltham, MA: UptoDate; Last modified October 8, 2015. http://www.uptodate.com/contents/medicaltreatment-of-benign-prostatic-hyperplasia?source=search_result&search=benign+prostatic+hypertrophy&selectedTitle=1%7E150#H186693674. Accessed March 22, 2016.
xv
Cometriq References
1. Cabozantinib. [Prescribing Information]. Exelixis. San Francisco, CA. November 2012.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Thyroid Carcinoma. http://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf.
Version 2.2015. Accessed September 8, 2015.
3. Medullary thyroid cancer: management guidelines of the American Thyroid Association, accessed September 2015
4. American Thyroid Association Guidelines Task Force, Kloos RT, Eng C, Evans DB, Francis GL, Gagel RF, Gharib H, Moley JF, Pacini F, Ringel MD, Schlumberger M, Wells SA Jr. Thyroid.
2009;19(6):565.
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Cystic Fibrosis Medications References
1. Katkin, JP. Cystic fibrosis: Clinical manifestations and diagnosis. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on February 24, 2014.).;
2. Simon, RH. Cystic fibrosis: Antibiotic therapy for lung disease. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on February 24, 2014.).;
3. Tobi Podhaler [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2013;
4. Cayston [package insert]. Foster City, CA: Gilead Sciences, Inc; 2012;
5. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2014. URL: http://www.clinicalpharmacology.com. Updated October, 2010;
6. Micromedex Healthcare Series. DRUGDEX System. Greenwood Village, CO: Truven Health Analytics, 2014. http://www.thomsonhc.com/. Accessed March 21, 2014;
7. Fakhoury, K; Kanu, A. Management of bronchiectasis in children without cystic fibrosis. In: UpToDate, Mallory, GB (Ed), UpToDate, Waltham, MA. (Accessed on March 21, 2014.).
8. Amorim , A. (2013). New advances in the therapy of non-cystic fibrosis bronchiectasis. Revista Portuguesa de Pneumologia, 19(6)(266), 266-275. Retrieved from
http://www.elsevier.pt/en/revistas/revista-portuguesa-pneumologia-320/artigo/new-advances-in-the-therapy-of-non-cystic-fibrosis-90251782
9. Mogayzel P, Naureckas E, Robinson K, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013 Apr 1;187(7):680-9.
10. Pulmozyme [package insert]. San Francisco, CA: Genentech, Inc; 2014;
11. Kalydeco [package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2015;
12. Tobi-tobramycin solution [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2014;
13. Bethkis-tobramycin solution [package insert]. Cary, NC: Chiesi USA, Inc.; 2014;
xvii
Daliresp References
1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org
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xviii
Daraprim References
1. Gandhi RT. Toxoplasmosis in HIV-infected patients. Waltham, MA: UptoDate; Last modified September 21, 2015. http://www.uptodate.com/contents/toxoplasmosis-in-hiv-infectedpatients?source=search_result&search=daraprim&selectedTitle=6%7E47. Accessed September 25, 2015.
2. Thomas CF, Limper AH. Treatment and prevention of Pneumocystis pneumonia in non-HIV-infected patients. Waltham, MA: UptoDate; Last modified January 6, 2015.
http://www.uptodate.com/contents/treatment-and-prevention-of-pneumocystis-pneumonia-in-non-hiv-infectedpatients?source=search_result&search=pneumocystis&selectedTitle=4%7E150. Accessed September 25, 2015.
3. Sax PE. Treatment and prevention of Pneumocystis infection in HIV-infected patients. Waltham, MA: UptoDate; Last modified August 27, 2015.
http://www.uptodate.com/contents/treatment-and-prevention-of-pneumocystis-infection-in-hiv-infectedpatients?source=search_result&search=pneumocystis&selectedTitle=2%7E150#H2384560994. Accessed September 25, 2015.
xix
Direct Renin Inhibitors References
1. Gold Standard. (2011, January 14). Aliskiren; Amlodipine; Hydrochlorothiazide. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
2. Gold Standard. (2012, February 1). Aliskiren; Amlodipine. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
3. Gold Standard. (2010, February 12). Aliskiren; Hydrochlorothiazide. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
4. Gold Standard. (2013, September 18). Aliskiren. Tampa, Florida, USA. Retrieved March 20, 2015, from http://www.clinicalpharmacology-ip.com
5. James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint
National Committee (JNC 8). JAMA. 2014;311(5):507-520. doi:10.1001/jama.2013.284427.
xx
Duavee References
1. Duavee ® [package insert] 10/2013. Philadelphia, PA: Wyeth Pharmaceuticals Inc.
2. Gold Standard, Inc. (2014, September 29). Duavee. Clinical Pharmacology [database online]. Retrieved from http://www.clinicalpharmacology.com
3. Daily Med [Internet database]. NIH U.S. National Library of Medicine. Duavee. Bethesda, MD. Updated 26 Nov. 2012.
4. Cosman, F., de Beur, S.J., LeBoff, M.S., et al. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoprosis International. 24 Jun. 2014.
xxi
GnRH Agonists References
1. American College of Obstetricians and Gynecologists (ACOG). Management of endometriosis. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2010 Jul.
(ACOG practice bulletin; no. 1114). Available at : http://www.guideline.gov/content.aspx?id=16327
2. Gold Standard, Inc. Eligard, Lupron, Synarel and Supprelin. Clinical pharmacology [database online] Available at http://www.clinicalpharmacology.com Accessed Jun 2013.
3. Gold Standard, Inc. Trelstar, Zoladex, and Vantas. Clinical pharmacology [database online] Available at http://www.clinicalpharmacology.com Jun 2013.
4. Kaplowitz, MD, PhD, Paul B. Precocious Puberty. emedicine [database online] Available at http://emedicine.medscape.com/article/924002-overview. Accessed April 6, 2010.
5. Lupron Depot [Prescribing Information]: AbbVie Inc., North Chicago, IL; Jan 2013. http://www.rxabbvie.com/pdf/lupron3month11_25mg.pdf. and
http://www.rxabbvie.com/pdf/lupron3_75mg.pdf. Accessed Jun 2013
6. Lupron Depot Ped [Prescribing Information]: AbbVie Inc., North Chicago, IL; April 2013. http://www.rxabbvie.com/pdf/lupronpediatric.pdf. Accessed Jun 2013
7. Supprelin LA [Prescribing Information]: Endo Pharmaceuticals Inc., Malvern, PA; April, 2013. http://www.endo.com/File%20Library/Products/Prescribing%20Information/supprelinla.pdf.
Accessed Jun 2013;
8. Synarel [Prescribing Information]: Pfizer; New York, NY; Jan 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019886s030lbl.pdf. Accessed June 2013
9. Eligard [Prescribing Information]: Bridgewater, NJ: Sanofi-Aventis US LLC; Feb 2013. http://products.sanofi.us/eligard/eligard.html. Accessed June 2013
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10. Zoladex [Prescribing Information]: AstraZeneca Pharmaceuticals LP, Wilmington DE. 6/2013. http://www1.astrazeneca-us.com/pi/zoladex3_6.pdf. and http://www1.astrazenecaus.com/pi/zoladex10_8.pdf; Accessed Jun 2013.
11. Vantas [Prescribing Information]: Endo Pharmaceuticals Inc., Malvern, PA; Rev Apr 2013. http://www.endo.com/File%20Library/Products/Prescribing%20Information/vantas.pdf.
Accessed Jun 2013
12. Trelstar [Prescribing Information]: Watson Pharma, Inc., Parsippany, NJ: Mar 2013. http://pi.actavis.com/data_stream.asp?product_group=1684&p=pi&language=E. Accessed Jun 2013
13. ACOG Updates Guideline on Diagnosis and Treatment of Endometriosis. http://www.aafp.org/afp/2011/0101/p84.html. accessed 8/23/12
14. National Guideline Clearing House Management of Endometriosis. Available http://guidelines.gov/content.aspx?id=16327; accessed 8/23/12
15. National Guideline Clearing House Alternatives to hysterectomy in the management of leiomyoma. http://guidelines.gov/content.aspx?id=13318; accessed 8/23/12 for fibroids
16. Schenken, RS: Treatment of endometriosis. In UpToDate, Barbieri, RL (Ed), UpToDate, Waltham, MA, Jan 2013.
17. Saenger, P: Treatment of precocious puberty. In UpToDate, Snyder, PJ (Ed), UpToDate, Waltham, MA, April 2013.
18. ESHRE Guideline for the Diagnosis and Treatment of Endometriosis. http://guidelines.endometriosis.org/concise-pain.html; Accessed 8/23/2012
19. Pain Management of Endometrosis. http://www.acog.org/About_ACOG/News_Room/News_Releases/2010/Pain_Management_of_Endometriosis. Accessed 8/23/2012
20. Dysfunctional Uterine Bleeding: http://emedicine.medscape.com/article/257007-medication#8. Accessed 9/7/2012
21. NCCN Prostate Cancer Treatment Guidelines for Patients: http://www.psa-rising.com/download/nccnguidelines.pdf. Accessed 9/7/12
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Hemophilia Factor References:
1. Blanchette VS. Prophylaxis in the haemophilia population. Haemophilia. 2010;16:181-188.
2. Fischer K, Van der Boom JG, Molho P, Negrier C, Mauser-Bunschoten EP, Roosendaal G, et al. Prophylactic versus on-demand treatment strategies for severe haemophilia: a comparison of
costs and long-term outcome. Haemophilia. 2002;8:745-752.
3. Hay CRM. Prophylaxis in adults with haemophlia. Haemophilia. 2007;13:10-15.
4. Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Eng J
Med. 2007;357:535-544.
5. National Hemophilia Foundation Medical and Scientific Advisory Council. MASAC recommendation concerning prophylaxis (regular administration of clotting factor concentrate to prevent
bleeding), document #179. November 2007. http://www.hemophilia.org/NHFWeb/Resource/StaticPages/menu0/menu5/menu57/masac179.pdf. Accessed October 24, 2011.
6. Walsh CE, Valentino LA. Factor VIII prophylaxis for adult patients with severe haemophilia A: results of a US survey of attitudes and practices. Haemophilia. 2009;15:1014-1021.
7. Novoseven RT. [package insert]. Plainsboro, NJ: Novo Nordisk; revised June 2005.
8. FEIBA NF (Anti-Inhibitor Coagulant Complex). [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; revised June 2011.
9. Guidelines for the management of hemophilia. 2nd ed. Montreal (Quebec): World Federation of Hemophilia; 2012; 1-74.
10. Medical and Scientific Advisory Council (MASAC). MASAC Recommendation Regarding the Use of Bypassing Agents in Patients with Hemophilia A or B and Inhibitors. MASAC Document
#167. Adopted by the NHF Board of Directors on June 3, 2006. Accessed 9/13/15. Available from http://www.hemophilia.org/sites/default/files/document/files/167.pdf
11. Hoots W.K., Shapiro A.D. (Aug 2015 ). Treatment of hemophilia. UpToDate. (D.H. Mahoney, J.S. Tirnauer, Eds.) Waltham, MA. Retrieved August 27, 2015, from
http://www.uptodate.com/contents/treatment-of-hemophilia?source=search_result&search=hemophilia&selectedTitle=2%7E150
12. Hoots W.K., Shapiro A.D. (Aug 2015 ). Factor VIII and factor IX inhibitors in patients with hemophilia. UpToDate. (L.K. Leung, D.H. Mahoney, J.S. Tirnauer, Eds.) Waltham, MA. Retrieved
August 27, 2015, from http://www.uptodate.com/contents/factor-viii-and-factor-ix-inhibitors-in-patients-withhemophilia?source=search_result&search=hemophilia&selectedTitle=3%7E150
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Hetlioz References
1. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
2. Hetlioz™ [package insert]. Washington, D.C.: Vanda Pharmaceuticals, Inc.; January 2014
3. Vanda Pharmaceuticals. Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder. In: ClinicalTrials.gov [Internet].
Bethesda (MD): National Library of Medicine (US). 2000- [cited 2014 Mar 20]. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01163032 NLM Identifier: NCT01163032.
xxiv
HP Acthar References
10. H.P. Acthar (corticotropin) [package insert]. Hazelwood, MO; Mallinckrodt ARD Inc; Revised January 2015.
11. Olek MJ. Treatment of acute exacerbations of multiple sclerosis in adults. Waltham, MA. UpToDate. Last modified. July 14, 2015. http://www.uptodate.com/contents/treatment-of-acuteexacerbations-of-multiple-sclerosis-in-adults?source=search_result&search=multiple+sclerosis&selectedTitle=8%7E150. Accessed August 11, 2015
xxv
Hyperlipidemia Medication References
1. Berglund L, et al. Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2012; 97(9): 2969–2989.
2. Cuchel M, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position paper from the Concensus
Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014;
3. Goldberg AC, et al. Familial Hypercholesterolemia: Screening, diagnosis and management of pediatric and adult patients Clinical guidance from the National Lipid Association Expert Panel
on Familial Hypercholesterolemia. J Clin Lipidol. 2011;(5):S1-S8.
4. Jacobson TA, et al. National lipid association recommendations for patient-centered management of dyslipidemia: Part 1 – executive summary. J Clin Lipidol. 2014;8:473-488.
5. Robinson JG. Management of familial hypercholesterolemia: a review of the recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J
Manag Care Pharm. 2013;19(2):139-49.
6. Stone NJ, et al. 2013 ACC/AHA blood cholesterol guideline. Circulation. 2013;
7. Watts GF, et al. Integrated guidance on the care of familial hypercholesterolaemia from the International FH Foundation. Int J Cardiol. 2014;
8. Crestor® [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised June 2015.
9. Epanova ® [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Revised September 2014.
10. Juxtapid ® [package insert]. Cambridge, MA: Aegerion Pharmaceuticals, Inc.; Revised April 2015.
11. Kynamro ® [package insert]. Cambridge, MA: Genzyme Corporation; Revised April 2015.
12. Livalo® [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised August 2011.
13. Lovaza ® [package insert]. RTP, NC: GlaxoSmithKline; Revised September 2014.
14. Vascepa ® [package insert]. Bedminster, NJ: Amarin Pharmaceuticals; Revised May 2014.
15. Zetia ® [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; Revised September 2013.
xxvi
Idiopathic Pulmonary Fibrosis Agents References
1. Esbriet [package insert]. Brisbane, CA: InterMune, Inc.; 2014.
2. National Clinical Guideline Centre. Idiopathic pulmonary fibrosis. The diagnosis and management of suspected idiopathic pulmonary fibrosis. London (UK): National Institute for Health
and Care Excellence (NICE); 2013 Jun. 32 p. (Clinical guideline; no. 163).
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3.
National Institute for Health and Care Excellence (NICE). Pirfenidone for treating idiopathic pulmonary fibrosis. London (UK): National Institute for Health and Care Excellence (NICE); 2013
Apr. 66 p.
4. Raghu G, Collard HR, Egan JJ et al. for the ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis:
Evidence-based Guidelines for Diagnosis and Management. Am J Respir Crit Care Med 2011; 183: 788-824.
5. Ofev [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; Revised October 2014.
xxvii
Ilaris References
12. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
13. Ilaris (canakinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; Revised October 2014.
14. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic-juvenileidiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016.
15. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrinassociated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016.
xxviii
Gleevec References
1. Gleevec [full prescribing information]. East Hanover, NJ: Novartis U.S.; Revised 02/2013
2. NCCN Drugs and Biologics Compendium http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=18 accessed 3/18/2010, 3/24/11, 3/27/12
3. National Comprehensive Cancer Network. Practice Guidelines in Oncology – Chronic Myelogenous Leukemia, Version I.2014 09/09/13.
4. National Comprehensive Cancer Network. Practice Guidelines in Oncology – Acute Lymphoblastic Leukemia, Version I.2013 03/25/13.
5. Alvarado Y, Apostolidou E, Swords R, Giles FJ. Emerging therapeutic options for Philadelphia-positive acute lymphocytic leukemia. Expert Opin Emerg Drugs. 2007 Mar;12(1):165-79
6. National Institute for Clinical Excellence (NICE). Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours. London (UK): National Institute for Clinical
Excellence (NICE); 2004 Oct. 38 p.
7. Pardanani A, Ketterling RP, Brockman SR, et al: CHIC2 deletion, a surrogate for FIP1L1-PDGFRA fusion, occurs in systemic mastocytosis associated with eosinophilia and predicts response
to imatinib mesylate therapy. Blood 2003 Nov 1; 102(9): 3093-6
8. McArthur G. Dermatofibrosarcoma Protuberans: Recent Clinical Progress. Ann Surg Oncol. 2007 Jul 24
9. Fletcher S, Bain B. Diagnosis and treatment of hypereosinophilic syndromes. Curr Opin Hematol. 2007 Jan;14(1):37-42
xxix
IL-17 Antagonist References:
1. Cosentyx (secukinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; January 2015.
2. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.
3. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence
(NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
xxx
Inlyta References:
1. Inlyta (axitinib) [package insert]. NY, NY; Pfizer: Revised January 2012.
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Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomized phase 3 trial. Lancet 2011;378:1931-39.
NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf Version
3.2015. Accessed September 8, 2015.
4. Inlyta. In: Clinical Pharmacology online. Gold Standard: [Updated June 24, 2015; Accessed August 26, 2015]. http://www.clinicalpharmacologyip.com/Forms/Mono graph/monograinph.aspx?cpnum=3751&sec=mo ndesc&t=0
xxxi
Integrin Receptor Antagonist References
1. Terdiman JP, Gruss CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT. American gastroenterological association institute guideline on the use of thiopurines, methotrexate, and anti–TNF-a
biologic drugs for the induction and maintenance of remission in inflammatory crohn’s disease. Gastroenterol. 2013;145:1459–1463.
2. The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults. Am J Gastroenterol. 2010;105:501-523.
3. Farrell RJ, Peppercorn MA. Overview of the medical management of severe or refractory Crohn disease in adults. Waltham, MA: UpToDate; Last modified June 10, 2015.
http://www.uptodate.com/contents/overview-of-the-medical-management-of-severe-or-refractory-crohn-disease-inadults?source=search_result&search=crohns&selectedTitle=2%7E150. Accessed October 1, 2015
4. Cohen RD., Stein AC. Approach to adults with steroid-refractory and steroid-dependent ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015.
http://www.uptodate.com/contents/approach-to-adults-with-steroid-refractory-and-steroid-dependent-ulcerative-colitis?source=see_link. Accessed August 11, 2015.
5. Peppercorn MA., Farrell RJ. Management of severe ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015. http://www.uptodate.com/contents/management-of-severeulcerative-colitis?source=search_result&search=ulcerative+colitis&selectedTitle=2%7E150. Accessed August 11, 2015
xxxii
Interferon References:
1. American Association for the Study of Liver Diseases. (2014, August 11). Recommendations for Testing, Managing, and Treating Hepatitis C. Retrieved September 13, 2014, from American
Association for the Study of Liver Diseases and the Infectious Diseases Society of America: http://www.hcvguidelines.org/fullreport
2. Gold Standard, Inc. (2013, October 13). Interferon Gamma-1b. Clinical Pharmacology. Tampa, FL, USA. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com
3. Gold Standard, Inc. (2014, April 22). Interferon Alfa-2b. Clinical Pharmacology. Tampa, FL, USA. Retrieved from http://www.clinicalpharmacology-ip.com
4. Gold Standard, Inc. (2014, April 22). Interferon Alfacon-1. Clinical Pharmacology. Tampa, FL, USA. Retrieved from http://www.clinicalpharmacology-ip.com
5. Gold Standard, Inc. (2014, August 18). Peginterferon Alfa-2b. Clinical Pharmacology. Tampa, FL, USA. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com
6. Lok, A. S., & McMahon, B. J. (2009, September). Chronic Hepatitis B: Update 2009. Retrieved September 14, 2014, from American Association for the Study of Liver Diseases:
www.aasld.org
7. National Comprehensive Cancer Network. (2014, April 22). Melanoma. Retrieved September 13, 2014, from NCCN Guidelines: http://www.nccn.org
8. National Comprehensive Cancer Network. (2014, August 22). Non-Hodgkin's Lymphomas. Retrieved September 13, 2014, from NCCN Guidelines : http://www.nccn.org
9. Rosenzweig, S. D., & Holland, S. M. (2014, January 24). Chronic granulomatous disease: Treatment and prognosis. Retrieved September 13, 2014, from Up To Date:
http://www.uptodate.com
10. Schering Corporation. (2014, August). Infergen. Whitehouse Station, NJ, USA.
11. Sosman, J. A. (2014, June 10). Adjuvant immunotherapy for melanoma. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com
12. Tallman, M. S. (2014, February 13). Treatment of hairy cell leukemia. Retrieved September 13, 2014, from Up To Date: http://www.uptodate.com
13. The NIH Osteoporosis and Related Bone Diseases ~ National Resource Center. (2012, December). Osteopetrosis Overview. Retrieved from http://www.niams.nih.gov/health_info/bone/
14. Thomson Micromedex. (2014, August 08). DRUGDEX System. Retrieved September 13, 2014, from Interferon Gamma: http://www.thomsonhc.com
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3.
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xxxiii
Intravaginal Progesterone Products References
1. The American College of Obstetricians and Gynecologists. Committee on Practice Bulletins – Obstetrics, Practice Bulletin: Prediction and Prevention of Preterm Birth. Obstetrics &
Gynecology. Oct 2012; 120;4: 964-973.
2. National Institute for Health and Care Excellence. Preterm labour and birth (NG25): NICE guideline. 20 Nov. 2015.
3. O’brien, J.M., DeFranco, E.A., Adair, C.D., Lewis, D.F., Hall, D.R., How, H., Bsharat, M., and Creasy, G.W. Effect of progesterone on cervical shortening in women at risk for preterm birth:
secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 2009; 34:653-659.
4. Coomarasamy, A., Williams, H., Truchanowicz, E., et al. A randomized trial of progesterone in women with recurrent miscarriages. N Engl J Med. 2015;373:2141-8.
xxxiv
Jakafi References
1. Jakafi™ (ruxolitinib) tablets prescribing information. Incyte, Corp. Greenville, NC; June, 2012.
2. Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and
Treatment. Blood 2009;113:2895-2901.
3. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med 2012;366:787-98.
4. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med 2012;366:799-807.
xxxv
Kineret References
16. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
17. Kineret (anakinra) [package insert]. Stockholm, Sweden; Swedish Orphan Biovitrum AB; Revised November 2013.
18. Kimura Y. Systemic juvenile idiopathic arthritis: Treatment. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/systemic-juvenileidiopathic-arthritis-treatment?source=search_result&search=juvenile+idiopathic+arthritis&selectedTitle=3%7E150. Accessed February 4, 2016.
19. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. Waltham, MA: UptoDate; Last modified December 10, 2015. http://www.uptodate.com/contents/cryopyrinassociated-periodic-syndromes-and-related-disorders?source=search_result&search=Cryopyrin-Associated+Periodic+Syndromes&selectedTitle=1%7E23. Accessed February 4, 2016.
20. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
xxxvi
Lyrica References
1. Decker, J. E., & Hergenroeder, A. C. (2012, September 21). Overview of cervical spinal cord and cervical peripheral nerve injuries in the child or adolescent athlete. Retrieved from Up To
Date: http://www.uptodate.com/contents/overview-of-cervical-spinal-cord-and-cervical-peripheral-nerve-injuries-in-the-child-or-adolescentathlete?source=preview&search=pain+due+to+spinal+cord+injury&selectedTitle=7%7E150&language=en-US&anchor=H2#H13
2. Gold Standard, Inc. (2012, June 21). Pregabalin. Retrieved September 13, 2014, from Clinical Pharmacology: http://www.clinicalpharmacology-ip.com
3. Gold Standard, Inc. (2013, May 09). Gabapentin. Retrieved September 13, 2014, from http://www.clinicalpharmacology-ip.com
4. Portenoy, R. K., Ahmed, E., & Keilson, Y. Y. (2014, July 30). Cancer pain management: Adjuvant analgesics (coanalgesics). Retrieved September 13, 2014, from Up To Date:
http://www.uptodate.com/contents/cancer-pain-management-adjuvant-analgesicscoanalgesics?source=machineLearning&search=neuropathic+pain+treatment&selectedTitle=3%7E150&sectionRank=1&anchor=H18#H21
5. Thomson Micromedex. (2014, September 11). Duloxetine. DRUGDEX System. Greenwood Village, CO. Retrieved September 13, 2014, from DRUGDEX System: http://www.thomsonhc.com
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6. Thomson Micromedex. (2014, September 10). Gabapentin. Greenwood Village, CO. Retrieved September 13, 2014, from http://www.thomsonhc.com
7. Thomson Micromedex. (2014, September 10). Pregabalin. Greenwood Village, CO. Retrieved September 13, 2014, from http://www.thomsonhc.com
xxxvii
Makena References
1. Makena (17- hydroxyprogesterone caproate) [package insert]. St. Louis, MO: Ther-Rx Corporation; Feb 2011.
2. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-85.
3. Makena [Daily Med]. NIH, U.S. National Library of Medicine. Updated 28 Feb. 2015. Accessed 25 Feb. 2016.
xxxviii
Modafinil/Nuvigil
1. Gold Standard, Inc. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed .August 2015
2. Fosnocht, KM. Approach to the adult patient with fatigue. In: UpToDate, Fletcher, RH (Ed), UpToDate, Waltham, MA. (Accessed on August 15, 2014.)
3. Escalante, CP. Cancer-related fatigue: Treatment. In: UpToDate, Hesketh, PJ (Ed), UpToDate, Waltham, MA. (Accessed on August 15, 2014.)
4. Lavault, S., Dauvilliers, Y., Drouot, X., Leu-Semenescu, S., Golmand, J.-L., Lecendreux, M., et al. (2011). Benefit and risk of modafinil in idiopathic hypersomnia vs. narcolepsy. Sleep
Medicine, 550-556.
5. Bruera E, Y. S. (2014, May 8). Palliative care: Overview of fatigue, weakness, and asthenia. Retrieved September 15, 2014, from Uptodate: http://www.uptodate.com
6. Chevrin R, C. (2014, April 23). Idiopathic hypersomnia. Retrieved September 15, 2014, from Up To Date: http://www.uptodate.com.
7. Nuvigil prescribing information. Cephalon, Inc. July 2008.
8. Provigil prescribing information. Cephalon, Inc. March 2008.
9. Stankoff B, Waubant E, Confavreux C,, et al. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005;64(7):1139-1143.
xxxix
Multaq References
1. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
2. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
3. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing committee to revise the 2001 guidelines for the
management of patients with atrial fibrillation). J Am Coll Cardiol 2006; 48:e14
4. MULTAQ Dronedarone tablets prescribing information products.sanofi.us/Multaq/Multaq.pdf.
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Neumega References
1. Neumega. . In: DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2014. http://nvezproxy.roseman.edu:3305/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/B11C95/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/2B8F26/ND_PG/e
videncexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=1757&contentSetId=31&title=OPRELVEKIN&servicesTitle=OPREL
VEKIN. (Accessed on April 9, 2015).
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Nexavar References
1. Nexavar prescribing information. Bayer Healthcare Pharmaceuticals Inc.; Wayne, NJ: December 2012.
2. Bukowski R, Cella D, Gondek K, et al. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007
Jun;30(3):220-7
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3.
Sorafenib, NCCN Drugs and Biologics Compendium. [cited 3/25/2010]. Available from: URL: http://www.nccn.org/professionals/
drug_compendium/MatrixGenerator/Matrix.aspx?AID=134.
4. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Fort Washington, PA: National Comprehensive Cancer Network, 2013. (Accessed March 4, 2013, at http://www.nccn.org/
professionals/ physician_gls/ PDF/kidney.pdf )
5. NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary Cancer. Fort Washington, PA: National Comprehensive Cancer Network, 2012. (Accessed March 4, 2013, at
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xlii
Non-Cacium Based Phosphate Binder References
3. Gold Standard. (2014, April 21). Velphoro. Tampa, Florida, USA. Retrieved 19 December, 2014, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2575&sec=monindi&t=0
4. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease: Am J Kidney Dis. 2003 Oct;42(4):s1-s201
xliii
Onychomycosis and Tinea References
1. El-Gohary M, van Zuuren EJ, Fedorowicz Z, Burgess H, Doney L, Stuart B, Moore M, Little P. Topical antifungal treatments for tinea cruris and tinea corporis. Cochrane Database of
Systematic Reviews 2014, Issue 8. Art. No.: CD009992. DOI: 10.1002/14651858.CD009992.pub2.
2. Bell-Syer SEM, Khan SM, Torgerson DJ. Oral treatments for fungal infections of the skin of the foot. Cochrane Database of Systematic Reviews 2012, Issue 10. Art. No.: CD003584. DOI:
10.1002/14651858.CD003584.pub2.
3. Luzu [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; June 2014.
4. Jublia [Prescribing Information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; February 2015
5. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001;63:663-672
6. Facts and Comparisons. (2014, September 1). St Lois, Missouri, USA.
7. Gold Standard, Inc. (2013, November 20). Luzu. Retrieved April 08, 2015, from http://www.clinicalpharmacology.com: http://www.clinicalpharmacology.com
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[viii]
Orencia References:
1. Orencia (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; Revised June 2015.
2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
3. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations
for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res.
2013;65(10):1551-1563.
4. Weiss PF. Polyarticular juvenile idiopathic arthritis: Clinical manifestations and diagnosis. Waltham, MA: UptoDate; Last modified September 29, 2015.
http://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritis-treatment?source=search_result&search=juvenile+arthritis&selectedTitle=8%7E150 Accessed October 5,
2015.
xliv
Otezla References
21. Otezla (apremilast) [package insert]. Summit, NJ; Celgene Corporation; Revised December 2015.
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22. Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum
Dis. 2012;71:4-12.
23. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence
(NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
24. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.
xlv
PCSK9 References
4. Repatha [Prescribing Information]. Thousand Oaks, CA: Amgen Inc.; Aug 2015
5. Praluent [Prescribing Information]. Bridgewater, NJ,: Regeneron and Sanofi Aventis LLC; Oct 2015
6. Stone, NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the
American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; doi:10.1016/j.jacc.2013.11.002.
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G&usg=AFQjCNEDp9VnIHhpJLov4D4lQgRPWNuQLQ
8. Cuchel M, Bruckert E, Ginsberg HN, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position
paper from the Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014 Aug 21;35(32):2146-57. doi: 10.1093/eurheartj/ehu274.
Epub 2014 Jul 22.
xlvi
Platelet Inhibitors References:
1. Gordon H. Guyatt, MD, FCCP, Elie A. Akl, MD, PhD, MPH, et al. Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical
Practice Guidelines. CHEST Journal February 2012; 141(2_suppl)
2. Simons, Michael. "Antiplatelet agents in acute non-ST elevation acute coronary syndromes." UpToDate.http://www.uptodate.com (accessed March 24, 2014).
3. Cutlip, Donald. “Antithrombotic therapy for percutaneous coronary intervention: General Use.” UpToDate.http://www.uptodate.com (accessed March 24, 2014).
4. Lincolff, Michael A. “Antiplatelet agents in acute ST elevation myocardial infarction.” UpToDate.http://www.uptodate.com (accessed March 24, 2014).
5. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically
6. Effient (prasugrel) package insert. Indianapolis, IN: Eli Lilly and Company
7. Brilinta (ticagrelor) package insert. Wilmington, DE:AstraZeneca LP
8. (O'Gara, Kushner, & Ascheim, 2013)
9. Amsterdam EA, et al. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation
10. Acute Coronary Syndromes: Executive Summary. J Am Coll Cardiol. 2014;64(24):e139-228.
11. Eikelboom JW, Hirsh J, Spencer FA, Baglin TP, Weitz JI. Antiplatelet drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians EvidenceBased Clinical Practice Guidelines. CHEST Journal February 2012; 141 (2)(Suppl):e89S–e119S
12. Weitz JI, Eikelboom JW, Samama MM. New Antithrombotic Drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based
Clinical Practice Guidelines. CHEST Journal February 2012; 141 (2)(Suppl) :e120S–e151S
13. Zontivity (vorapaxar) package insert.
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xlvii
Promacta References
1. Promacta [package insert]. Research Triangle Park, NC: GlaxoSmithKline; Revised June 2015.
2. Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood.
2011;117(16):4190-4207.
3. Schrier SL. Aplastic anemia: Pathogesis; clinical manifestations; and diagnosis. Waltham, MA: UptoDate; Last modified November 11, 2015. http://www.uptodate.com/contents/aplasticanemia-pathogenesis-clinical-manifestations-and-diagnosis?source=search_result&search=aplastic+anemia&selectedTitle=1%7E150#H21 Accessed March 30, 2016.
4. Judith C. W. Marsh, e. a. (2009). Guidelines for the diagnosis and management of aplastic. British Journal of Hematology.
5. Marsh, J. R. (2010). Aplastic Anemia: First-line Treatment by Immunosuppression and Sibling Marrow Transplantation. ASH Education Book.
xlviii
Proton Pump Inhibitors References:
1. Katz P, Gerson L, Vela M. Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol 2013; 108:308-328; doi:10.1038/ajg.2012.444; published
online 19 February 2013
2. Fass R, Sontag SJ, Traxler B, Sostek M. Treatment of Patients With Persistent Heartburn Symptoms: A Double-Blind, Randomized Trial. Clin Gastroenterol Hepatol; 2006;4:50–56.
3. Fass R, Murthy U, Hayden CW, et al. Omeprazole 40 mg once a day is equally effective as lansoprazole 30 mg twice a day in symptom control of patients with gastro-oesophageal reflux
disease (GERD) who are resistant to conventional-dose lansoprazole therapy-a prospective, randomized, multi-centre study. Aliment Pharmacol Ther. 2000; 14: 1595-1603.
4. Fass, R. Approach to refractory gastroesophageal reflux disease in adults. In: UpToDate. Talley NJ, ed. UpToDate, Waltham, MA: UpToDate; 2015. Available at:
http://www.uptodate.com/home. Accessed June 15, 2015.
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Ranexa References
1. Fihn SD, G. J. (December 2012). 2012 American College of Cardiology Foundation/American Heart Association/American College of Physicians/American Association for Thoracic
Surgery/Preventive Cardiovascular Nurses Association/Society for Cardiovascular Angiography and Interventions/Socie. Journal of the American College of Cardiology, Volume 60 Issue 24.
2. Gold Standard, Inc. (2013, Decemember 25). Ranexa. Retrieved August 25, 2015, from ClinicalPharmacology: http://www.clinicalpharmacology.com
3. Kannam, J. e. (201, August 12). Stable ischemic heart disease: Overview of care . Retrieved August 25, 2015, from Up to Date: http://www.uptodate.com.
4. National Institute for Health and Care Excellence (NICE). Management of stable angina. NICE Clinical Guideline 126 (July 2011). From https://www.nice.org.uk/guidance/cg126/chapter/1Guidance#anti-anginal-drug-treatment Accessed September 17, 2015.
l
Revlimid References
1. Revlimid® (lenalidomide) prescribing information. Celgene Corp., June 2013.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Multiple Myeloma. http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf.
Version 2.2016. Accessed December 10, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Myelodysplastic Syndrome. http://www.nccn.org/professionals/physician_gls/pdf/mds.pdf.
Version 1.2016. Accessed December 10, 2015.
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Savella References
1. Savella [package insert]. St. Louis, MO: Forest Laboratories, Inc; December 2009.
2. Gold Standard, Inc. Savella. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed May 14, 2012.
3. Wolfe F, Smythe HA, Yunas MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia. Report of the
Multicenter Criteria Committee. Arthritis Rheum 1990;33:160-72.
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Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled
study. Am J Med. 2003:114(7):537-545.
5. Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck PE Jr. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with
fibromyalgia. Am J Med. 2002: 112(3):191-197
6. Carette S, Bell MJ, Reynolds WJ, Haraoui B, McCain GA, Bykerk VP, Edworthy SM, Baron M, Koehler BE, Fam AG, et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the
treatment of fibromyalgia. A randomized, double-blind clinical trial. Arthritis Rheum. 1994 Jan;37(1):32-40.
7. Goldenberg DL, Mayskiy M, Mossey C, Ruthazar R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitryptyline in the treatment of fibromyalgia. Arthritis Rheum
1996;39: 1852-9.
8. Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a
randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44.
9. Carette S, McCain GA, Bell DA, Fam AG. Evaluation of amitriptyline in primary fibrositis. A double-blind, placebo-controlled study. Arthritis Rheum. 1986 May;29(5):655-9.
10. Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986
Nov;29(11):1371-7.
11. Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a
randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44.
12. Carette S, McCain GA, Bell DA, Fam AG. Evaluation of amitriptyline in primary fibrositis. A double-blind, placebo-controlled study. Arthritis Rheum. 1986 May;29(5):655-9.
13. Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 1986
Nov;29(11):1371-7.
14. Goldenberg DL, Burckhardt C, Crofford L. Management of fibromyalgia syndrome. JAMA. 2004; 292(19):2388-2395
15. Fibromyalgia Agents - Savella - Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription. Aetna Clinical Pharmacy Bulletins
16. Arnold LM, Bateman L, Palmer RH, Lin Y. Preliminary experience using milnacipran in patients with juvenile fibromyalgia: lessons from a clinical trial program. Pediatr Rheumatol Online J.
2015 Jun 26;13(1):27
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Second Generation TKI References
1. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Chronic Myelogenous Leukemia.
http://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Version 1.2015. Accessed September 8, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Acute Lymphoblastic Leukemia.
http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Version 1.2015. Accessed September 8, 2015.
3. Bosulif [full prescribing information]. New York, NY: Pfizer U.S.; Revised 09/2013.
4. Gleevec [full prescribing information]. East Hanover, NJ: Novartis U.S.; Revised 02/2013.
5. Cortes JE, et al, Bosutinib Versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: Results From the BELA Trial. J Clin Oncol, 2012;30(28):3486-3492.
6. Cortes JE, et al, Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib.
Blood. 2011;118(17): 4567-4576.
7. Khoury HJ, et al, Bosutinib is active in chronic phase chronic myeloid leukemia after imatinib and dasatinib and/or nilotinib therapy failure. Blood, 2012;119(15)3403-3412.
8. Shieh MP, Mitsuhashi M, LillyM. Moving on up: Second-Line Agents as Initial Treatment for Newly-Diagnosed Patients with Chronic Phase CML. Clin Med Insights Oncol, 2011;5:185-199.
4.
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9. Antineoplastics - Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan. Aetna Clinical Pharmacy Bulletins
Stelara References:
4. Ustekinumab. (2015) In Clinical Pharmacology online. Retrieved from http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=3586&n=Stelara&t=0.
5. Stelara (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 2014 March.;
6. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedTitle=1%7E150#H42. Accessed September 25, 2015.
7. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence
(NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
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Sutent References
1. Sutent prescribing information. Pfizer Inc.;New York, NY; Updated 5/2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Version
1.2016. Accessed October 30, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Neuroendocrine Tumors.
http://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf. Version 1.2015. Accessed October 30, 2015.
4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Soft Tissue Sarcoma. http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf.
Version 1.2015. Accessed October 30, 2015.
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Synagis References
1. Aetna.com. 2014. Clinical Policy Bulletin: Synagis (Palivizumab). [online] Available at: http://www.aetna.com/cpb/medical/data/300_399/0318.html [Accessed: 28 Jul 2014].
2. Perrin, MD, FAAP, J., Meissner, MD, FAAP, H. and Ralston, MD, FAAP, S. 2014. Updated AAP Guidance for Palivizumab Prophylaxis For Infants and Young Children at Increased Risk of RSV
Hospitalization. [e-book] pp. 1-23. Available through: American Academy of Pediatrics http://www.aap.org/en-us/my-aap/Pages/rsv.aspx [Accessed: 28 Jul 2014].
3. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection, COMMITTEE ON
INFECTIOUS DISEASES AND BRONCHIOLITIS GUIDELINES COMMITTEE, Pediatrics 2014;134;415; originally published online July 28, 2014; DOI: 10.1542/peds.2014-1665, Accessed online on
8/13/2014 at http://pediatrics.aappublications.org/content/134/2/415.full.html
lvi
Tarceva References
1. Tarceva® (erlotinib) prescribing information. Genentech, Inc.: South San Francisco, CA. Updated: May, 2015.
2. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Kidney Cancer. http://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Version
1.2016. Accessed October 30, 2015.
3. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Pancreatic Adenocarcinoma.
http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Version 2.2015. Accessed December 15, 2015.
4. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Non-Small Cell Lung Cancer.
http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Version 2.2016. Accessed December 15, 2015.
lvii
Testosterone References:
1. Fernández-Balsells MM, Murad MH, Lane M, Lampropulos JF, et al. Clinical review 1: Adverse effects of testosterone therapy in adult men: a systematic review and meta-analysis. J Clin
Endocrinol Metab. 2010;95(6):2560-75
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2.
Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM, Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency
syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010 Jun;95(6):2536-59.
3. http://www.aetna.com/cpb/medical/data/300_399/0345.html
4. Tang AM, Forrester J, Spiegelman D, et al. Weight loss and survival in HIV-positive patients in the era of HAART. J Acquir Immune Defic Syndr 2002:31:230-236.
5. Micromedex: Testosterone, http://www.micromedexsolutions.com accessed 12.30.15
lviii
Thalomid References
4. Thalomid® (thalidomide) prescribing information. Celgene Corp., Updated 8/2015.
5. NCCN: National Comprehensive Cancer Network. NCCN Clinical Practice Guideline in Oncology: Multiple Myeloma.
http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Version 2.2016. Accessed December 10, 2015.
6. Clarke J. Management of refractory discoid lupus and subacute cutaneous lupus. Waltham, MA: UptoDate; Last modified October 22, 2015.
http://www.uptodate.com/contents/management-of-refractory-discoid-lupus-and-subacute-cutaneouslupus?source=search_result&search=thalidomide&selectedTitle=15%7E150#H1088110. Accessed December 15, 2015.
7. Schur PH, Moschella SL. Mucocutaneous manifestations of systemic lupus erythematosus. Waltham, MA: UptoDate; Last modified April 16, 2014.
http://www.uptodate.com/contents/mucocutaneous-manifestations-of-systemic-lupus-erythematosus?source=search_result&search=sle&selectedTitle=5%7E150#H18.
Accessed December 15, 2015.
8. Scollard D, Stryjewska B. Treatment and prevention of leprosy. Waltham, MA: UptoDate; Last modified December 7, 2015. http://www.uptodate.com/contents/treatmentand-prevention-of-leprosy?source=search_result&search=erythema+nodosum+leprosum&selectedTitle=2%7E11#H89888451. Accessed December 15, 2015.
lix
Topical Calcineurin Inhibitor References
1. Gold Standard. (2013, September 26). Elidel. Tampa, Florida, USA. Retrieved August 1, 2015, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=2670&sec=monindi&t=0
2. Gold Standard. (2013, October 16). Tacrolimus. Tamp, Florida, USA. Retrieved August 1, 2015, from http://www.clinicalpharmacologyip.com/Forms/Monograph/monograph.aspx?cpnum=587&sec=monindi&t=0
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Topical NSAID References
1. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. 2000 Sep (revised
2012 Apr).
2. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of glenohumeral joint osteoarthritis. 2009 Dec 4 (reaffirmed 2014).
3. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis of the knee, 2nd edition. 1996 (revised 2013 May 18).
4. VA/DoD clinical practice guideline for the non-surgical management of hip and knee osteoarthritis. 2014.
5. Voltaren Gel (diclofenac sodium topical gel) package insert. Parsippany, NJ: Novartis Consumer Health; 2007 Oct.
6. Pennsaid (diclofenac sodium) topical solution package insert. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc; 2013 Oct.
7. Flector (diclofenac epolamine) [prescribing information]. Bristol, TN: King Pharmaceuticals; August 2011.
8. Beers MH, Ouslander JG, Rollingher I, et al. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med
1991;151:1825-32.
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The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J
Am Geriatr Soc 2012;60:616-31.
10. Bhatt DL, Scheiman J, Abraham NS, et al. ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use: a report of the
American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation 2008;118:1894-909.
11. Masso Gonzalez EL, Patrignani P, Tacconelli S, Garcia Rodriguez LA. Variability among nonsteroidal anti-inflammatory drugs in risk of upper gastrointestinal bleeding. Arthritis Rheum
2010;62:1592-601.
12. Lanza FL, Chan FK, Quigley EM, Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J
Gastroenterol 2009;104:728-38.
13. Hernandez-Diaz S, Rodriguez LA. Incidence of serious upper gastrointestinal bleeding/perforation in the general population: review of epidemiologic studies. J Clin Epidemiol 2002;55:15763.
14. Roth SH, Fuller P. Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older. Clin Interv Aging 2012;7:12737.
15. Derry S, Moore RA, Rabbie R. Topical NSAIDs for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev 2012;(9):CD007400.
16. Altman RD. Safety advantages of topical versus oral nonsteroidal antiinflammatory drugs. J Rheumatol 2011;38:572.
17. Sprix (ketorolac tromethamine) Nasal Spray package insert. Shirley, NY: American Regent, Inc.; 2014 Apr.
lxi
Tranexamic acid References
1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically
2. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically. Product Information. Lysteda®, tranexamic acid. Ferring Pharmaceuticals, Inc., Bethesda,
MD 20814. October, 2013.
3. American College of Obstetricians and Gynecologists. Committee on Gynecologic Practice: Management of Acute Abnormal and Uterine Bleeding in Nonpregnant Reproductive-Aged
Women. Resources & Publications. Number 557. Apr 2013. Reaffirmed 2015. Accessed Feb 6. 2016. http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committeeon-Gynecologic-Practice/Management-of-Acute-Abnormal-Uterine-Bleeding-in-Nonpregnant-Reproductive-Aged-Women
4. Lysteda ® [package insert] 10/2013. Parsippany, NJ. Ferring Pharmaceuticals, Inc.
5. Lukes, Andrea S, et al. Tranexamic Acid Treatment for Heavy Menstrual Bleeding. Obstetrics & Gynecology. 116(4) Oct 2010: 865-875.
lxii
Tykerb References
1. Tykerb Prescribing Information. GlaxoSmithKline. December. 2012.
2. National Comprehensive Cancer Network. Breast Cancer Treatment Guidelines for Patients – Version 1.2013, 3/5/13. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
3. Wolff AC, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer.
J Clin Oncol. Jan 2007; 25(1): 118-145.
4. Geyer CE, et al. Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer. N Engl J Med 2006;355:2733-43.
5. Xeloda® (capecitabine) prescribing information. Roche Pharmaceuticals, Inc., 2/2011. http://www.rocheusa.com/products/xeloda/pi.pdf
6. Tykerb. DrugDex. Micromedex website. www.thomsonhc.com. Accessed 4/12/12.
7. Tykerb. Clinical Pharmacology. Clinical Pharmacology Website. www.clinicalpharmacology.com. Accessed 4/12/12.
8. Revlimid. AHFS Drug Information. Ovid website. http://ovidsp.tx.ovid.com. Accessed. 4/12/12
9.
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lxiii
Oral Vancomycin References
1. Cohen, Stuart H., Gerding, Dale N., Johnson, Stuart, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of
America (SHEA) and the Infectious Diseases Society of America (IDSA). Infection Control and Hospital Epidemiology. May 2010. 31;5:431-455.
2. Surawicz, Christina M., Brandt, Lawrence J., Binion, David G. et al. Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections. Am J Gastroenterol. Feb 2013.
108:478-498.
3. Gilbert, David N., Moellering Jr., Robert C., Eliopoulos, George M., Chambers, Henry F., Saag, Michael S. The Sanford Guide to Antimicrobial Therapy 2011: Forty-First Edition. Antimicrobial
Therapy, Inc. Sperryville, VA. 2011.
4. Uptodate [database]. Clostridium difficile in adults: Treatment. Updated 2015 Nov 23. Accessed 2016. Feb 22. http://www-uptodate-com.libproxy1.usc.edu/contents/clostridium-difficilein-adults-treatment?source=search_result&search=clostridium+difficile+treatment&selectedTitle=1%7E150
5. Vancocin [Prescribing Information]. Exton, PA: ViroPharma Incorporated 2005.
6. Vancomycin. Facts and Comparisons. (2014, September 1). St Louis, Missouri, USA.
lxiv
Votrient References
1. Votrient prescribing information. GlaxoSmithKline; Research Triangle Park, NC; August 2013.
2. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Fort Washington, PA: National Comprehensive Cancer Network, Inc. 2013. (Accessed Feb. 26, 2013, at
http://www.nccn.org/professionals/physician_gls/ PDF/kidney.pdf )
3. NCCN Clinical Practice Guidelines in Oncology: Soft Tissue Sarcoma. Fort Washington, PA: National Comprehensive Cancer Network, Inc. 2013 (Accessed September 13, 2013, at
http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf)
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Weight Reduction Medications:
1. American Association of Clinical Endocrinologists. (2013). Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery
Patient—2013 Update: Cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society fo. Endocrine Practice(Volume 19, Number 2/MarchApril 2013), 337-372.
2. Thomson Micromedex. (2014, September 19). Naltrexone hydrochorlide/bupropion hydrochloride. DRUGDEX System. Greenwood Village, CO. Retrieved Spetember 22, 2014, from
DRUGDEX System: http://www.thomsonhc.com
3. Endocrine Society. Pharmacological management of obesity: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-362.
4. Jensen MD, et al. 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults: A Report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines and The Obesity Society. Circulation. 2013;00:000-000.
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Xeljanz References:
1. Xeljanz (tafacitinib citrate) [package insert]. NJ, NJ; Pfizer Labs; Revised November 2012.
2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents
in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639.
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Xolair References
1. Barnes, P. J. (May 2015 ). Anti-IgE therapy. UpToDate. (B. S. Bochner, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved June 16, 2015, from http://www.uptodate.com/contents/anti-igetherapy?source=related_link#H7764932
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2.
3.
4.
5.
6.
DRUGDEX® Evaluations. (n.d.). Omalizumab. DRUGDEX System. Greenwood Village, CO. Retrieved June 16, 2015, from http://nvezproxy.roseman.edu:3305/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/E8C454/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/318DA6/ND_PG/e
videncexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.Intermedi
Khan, D. A. (2013, September 19). education, Chronic urticaria: Standard management and patient. UpToDate. (S. Saini, J. Callen, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved from
http://www.uptodate.com/contents/chronic-urticaria-standard-management-and-patient-education?source=see_link
Khan, D. A. (May 2015 ). Chronic urticaria: Treatment of refractory symptoms. UpToDate. (S. Saini, J. Callen, & A. M. Feldweg, Eds.) Waltham, MA. Retrieved June 16, 2015, from
http://www.uptodate.com/contents/chronic-urticaria-treatment-of-refractory-symptoms?source=see_link#H1
National Heart, Blood, and Lung Institute Expert Panel Report 3 (EPR 3): Guidelines for the Diagnosis and Management of Asthma. NIH Publication no. 08-4051, 2007.
Gold Standard. (2015) Xolair. Retrieved http://www.clinicalpharmacology-ip.com/Forms/drugoptions.aspx?cpnum=2633&n=Xolair&t=0.
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