Download Formulary and Medication Policy Updates - Q1 2008

Attention:
Physicians, Medical Directors, Pharmacy Directors, Utilization Management Directors
FIRST QUARTER 2008 FORMULARY AND MEDICATION POLICY UPDATES
EFFECTIVE MARCH 20TH, 2008
The Blue Shield of California (BSC) Pharmacy and Therapeutics (P&T) Committee, consisting of
network physicians and pharmacists, regularly evaluates drugs for formulary inclusion and
medication policy coverage criteria. The First Quarter 2008 P&T Committee decisions on injectable
medication policy updates and formulary changes are summarized below:
INJECTABLE MEDICATION POLICIES:
The following coverage policies are effective on March 20th, 2008 (unless stated otherwise) and
available on the BSC Internet site, Provider Portal: https://www.blueshieldca.com/provider/ >
Guidelines > Eligibility & Benefits Resources >
Blue_Shield_Medication_Policies_(Injectable,_Implantable,_w/DME).
Refer to medication policy for complete details.
Summary of Changes to Medication Policies – (Injectable)– 1Q2008
Injectable Medication
Coverage Policy Change
Infantile spasm– New
Added coverage criteria for Infantile Spasm, aka West Syndrome. Coverage criteria
requires diagnosed by or being prescribed by a pediatric neurologist or neonatalogist.
Multiple sclerosis (MS), acute exacerbations– New
Added coverage criteria for treatment of acute exacerbations of MS. Coverage
criteria requires: 1) being prescribed by a neurologist or MS specialist, and 2) patient
has contraindication or intolerance to steroids that is not also expected with use of
Acthar, and 3) patient is currently on maintenance treatment for MS.
Acthar® (corticotropin)
Adrenocortical function diagnostic testing– New
Added coverage criteria for diagnostic testing of adrenocortical function. Coverage
criteria requires: 1) being used for diagnostic testing of adrenocortical function in an
outpatient setting, and 2) being used to distinguish between secondary and tertiary
adrenal insufficiency following an initial diagnosis of adrenal insufficiency confirmed by
laboratory testing.
Various FDA-approved inflammatory conditions– New
Added coverage criteria for remaining FDA-approved indications. Coverage criteria
requires: 1) being prescribed by a specialist, and 2) patient has contraindication or
intolerance to corticosteroids that is not also expected with use of Acthar, and 3)
patient has failed all standard therapies other than steroids.
Primary hyperhidrosis – Update
Botox® (botulinum toxin)
Blue Shield of California,
Health Care Services
March 2008
Modified coverage criteria for primary hyperhidrosis to cover the following: 1) failure to
respond to or intolerant to one of the following: topical therapy, or pharmacotherapy,
and 2) evidence that hyperhidrosis is significantly disrupting professional and/or social
life, or skin maceration with secondary infection.
Page 1 of 4
Summary of Changes to Medication Policies – (Injectable)– 1Q2008
Injectable Medication
Coverage Policy Change
Congenital protein C deficiency – New
Ceprotin® (protein C
concentrate)
NEW POLICY
The following condition will be covered and not require Preservice review:
•
Diagnosis is prevention and treatment of venous thrombosis and purpura
fulminans in patients with severe congenital Protein C deficiency.
All other requests for Ceprotin will require Preservice review and coverage
determination will be made on a case-by-case basis.
Growth hormone deficiency (GHD) – Update
Growth hormone in adults
Modified coverage criteria to require failure of at least one adult provocative GH
stimulation test after age 18 and either: evidence of pituitary disease or low IGF-1.
Plaque psoriasis, moderate to severe – New
Humira® (adalimumab)
Added coverage criteria for moderate to severe plaque psoriasis. Coverage criteria
requires: 1) patient is ≥ 18 years old, and 2) prescribed by a dermatologist or
rheumatologist, and 3) baseline PASI score of 10 or more, and 4)
failure/contraindication/intolerance to the use of PUVA or UVB treatment, or has
difficulty accessing and 5) failure or intolerance to the use of at least 1 of the following
3 medications or contraindication to all 3 of the following medications: methotrexate,
cyclosporine and acitretin (unless actively trying to conceive).
Crohn’s disease – Update
Added coverage for dose escalation to 40 mg weekly in Crohn’s disease if patient
either flared or had a loss in response after at least one maintenance dose.
Myasthenia Gravis (MG) – Update
Modification of coverage criteria for MG to cover if being prescribed by a neurologist
and patient is refractory or intolerant to a steroid or an immunomodulator.
IVIG
Initial authorization will cover up to 2 gm/kg monthly for up to three months. Annual reauthorization based upon response to therapy.
Chronic inflammatory demyelinating polyneuropathy (CIDP) – Update
Clarification of covered doses for extended treatment: up to a total dose given over a
2 week period that does not exceed 2 gm/kg. Added coverage for maintenance
therapy to cover annually as long as patient continues to respond to treatment.
Rheumatoid arthritis (RA) – Update
Rituxan® (rituximab)
Added coverage for re-treatment with rituximab in RA patients who have a
documented response to rituximab with subsequent loss of response on therapy and retreatment is being requested at least 16 weeks following prior rituximab infusion.
Systemic lupus erythematosus (SLE) – New
Added coverage for SLE if being prescribed by a rheumatologist and patient has
failure or intolerance to two conventional therapies.
AIDS wasting syndrome– Update
Serostim® (somatropin)
Step therapy requirement for coverage updated to reflect nandrolone’s removal from
market. Step therapy will require patient has failure/ contraindication/ intolerance to
the use of Oxandrin, and not being used in combination with Oxandrin.
Crohn’s Disease – New
Tysabri® (natalizumab)
Blue Shield of California,
Health Care Services
March 2008
Added coverage criteria for moderate to severe Crohn’s disease. Coverage criteria
requires: 1) treatment failure or intolerance to one of the following: corticosteroids OR
immunosuppressants (e.g. azathioprine, mercaptopurine, methotrexate, or
cyclosporine), and 2) treatment failure or intolerance to a TNF-α inhibitor, and 3) not
taking immunosuppressants, a TNF-α inhibitor, or anakinra concomitantly.
Page 2 of 4
PHARMACY BENEFIT
FORMULARY UPDATE:
Note: For Medicare beneficiaries who are enrolled in an employer group Medicare Part D plan, the
commercial formulary status applies unless otherwise stated.
The following drugs were ADDED to the Formulary:
Drug
(Added to Formulary)
Coverage Restrictions
Medicare status (if differs)
Kaletra (ritonavir/ lopinavir) 25 mg-100 mg
Mirapex (pramipexole) 0.75 mg
Renvela (sevelamer carbonate) 800 mg
Stalevo 200 (carbidopa/ levodopa/
entacapone)
Tikosyn (dofetilide)
Oxycontin (oxycodone) 15, 30 mg
sustained-release
QVAR (beclomethasone)
Quantity limit: 2 canisters per month
Soma (carisoprodol) 250 mg
Quantity limit: 4 tablets per day
Tamiflu (oseltamivir) 30, 45 mg
Quantity limit: 1 fill every 6 months
Preferred Brand tier with quantity limit
of 1 fill every 6 months
Kuvan (sapropterin)
Prior authorization required
Specialty tier with prior authorization
Oxycontin (oxycodone) 60 mg sustainedrelease
Tasigna (nilotinib)
Quantity limit: 12 tablets per day
Prior authorization required
Prior authorization required
Specialty tier with prior authorization
The following drugs were NOT added to the Formulary; may have additional coverage restrictions as noted.
These drugs are available at the non-formulary brand copayment except for members with a closed formulary
benefit, where prior authorization is required for coverage.
Drug
(Non-formulary)
Coverage Restrictions
Medicare status (if differs)
Formulary Alternatives
(generics in lower case)
CitraNatal 90 DHA prenatal vitamin
Exclusion (no FDA
application)
generic prenatal
vitamins, O-cal FA
CitraNatal DHA prenatal vitamin
Exclusion (no FDA
application)
generic prenatal
vitamins, O-cal FA
CitraNatal Rx prenatal vitamin
Exclusion (no FDA
application)
generic prenatal
vitamins, O-cal FA
Combigan (brimonidine/timolol) 0.2%0.5%
brimonidine, timolol
Corvite 150 multivitamin
Exclusion (no FDA
application)
generic multivitamin
Corvite Free multivitamin
Exclusion (no FDA
application)
generic multivitamin
Natelle Plus prenatal vitamin
Exclusion (no FDA
application)
generic prenatal
vitamins, O-cal FA
Nature-Throid (pork thyroid) 16.25 mg
Exclusion (no FDA
application)
Synthroid, Levoxyl,
Unithroid
Salex (salicylic acid/ ceramides) 6%
combination kit
Exclusion (no FDA
application)
6% salicylic acid cream,
gel, and lotion
Blue Shield of California,
Health Care Services
March 2008
Page 3 of 4
Drug
(Non-formulary)
Coverage Restrictions
Medicare status (if differs)
Formulary Alternatives
(generics in lower case)
Exclusion (no FDA
application)
generic multivitamin
Non-Formulary
tretinoin
Non-preferred brand with
step edit requirement
and quantity limit of 1
tablet per day
oxybutynin immediaterelease, oxybutinin
extened-release
Vusion (miconazole nitrate/ zinc oxide)
Age limit: Prior
authorization
required for > 4
year-olds
Non-Formulary
econazole,
ketoconazole cream,
nystatin ointment
Altace (ramipril) tablets
Prior authorization
required
Non-Formulary
ramipril capsules
Vital-D Rx multivitamin
Atralin (tretinoin) 0.5% topical gel
Sanctura XR (trospium) 60 mg
extended-release
Age limit: Prior
authorization
required for > 40
year-olds
Step edit requirement
Quantity limit: 1 tablet
per day
Prior authorization
required
Bystolic (nebivolol)
Flector (diclofenac epolamine)
transdermal patch
Quantity limit: 1 tablet Non-Formulary
per day for 2.5 and
5 mg; 4 tablets per
day for 10 mg
Prior authorization
required
Quantity limit: 2
patches per day
Non-Formulary
SymlinPen (pramlintide) pen injector
Prior authorization
required
Injectable tier with prior
authorization
Veregen (sinecatechins)
Prior authorization
required
Non-Formulary
atenolol, metoprolol,
bisoprolol, propranolol,
timolol, nadolol,
labetalol, bisoprolol,
propranolol, carvedilol
choline magnesium
trisalicylate, diclofenac,
diflunisal, etodolac,
fenoprofen, flurbiprofen,
ibuprofen,
indomethacin,
ketoprofen, meloxicam,
nabumetone, naproxen,
piroxicam, sulindac,
tolmetin
glipizide, glipizide
extended-release,
glyburide, metformin,
metformin extendedrelease,
glyburide/metformin,
Actos, Actoplus Met,
Avandia, Avandamet,
human insulin,
insulin lispro, insulin
NPH/lispro, Lantus,
Levemir, Levemir penfill
Aldara, Condylox gel,
podofilox solution
The following drugs are Pharmacy benefit exclusions:
Drug
Zyrtec (cetirizine)
Zyrtec-D (cetirizine/pseudoephedrine)
Comment
Product contains an OTC ingredient.
Product contains OTC ingredients.
For additional information, please call 1-800-535-9481.
Blue Shield of California,
Health Care Services
March 2008
Page 4 of 4
Attention:
Physicians, Medical Directors, Pharmacy Directors, Utilization Management Directors
SECOND QUARTER 2008 FORMULARY AND MEDICATION POLICY UPDATES
EFFECTIVE JUNE 19TH, 2008
The Blue Shield of California (BSC) Pharmacy and Therapeutics (P&T) Committee, consisting of
network physicians and pharmacists, regularly evaluates drugs for formulary inclusion and
medication policy coverage criteria. The Second Quarter 2008 P&T Committee decisions on
injectable medication policy updates and formulary changes are summarized below:
INJECTABLE MEDICATION POLICIES:
The following coverage policies are effective on June 19th, 2008 (unless stated otherwise) and
available on the BSC Internet site, Provider Portal: https://www.blueshieldca.com/provider/ >
Guidelines > Eligibility & Benefits Resources >
Blue_Shield_Medication_Policies_(Injectable,_Implantable,_w/DME).
Refer to medication policy for complete details.
Summary of Changes to Office Administered Medication Policies (Injectable) – 2Q2008
Office Administered
Medication
Coverage Policy Change
Cryopyrin-Associated Periodic Syndromes – New
Coverage requires the following:
Arcalyst® (rilonacept)
NEW POLICY
Avastin® (bevacizumab)
•
Diagnosis is Cryopyrin-Associated Periodic Syndromes (CAPS), and
•
Patient is 12 years of age or older, and
•
Dose does not exceed a loading dose of 320 mg (160mg x 2 injections given on
the same day), and a maintenance dose of 160 mg once a week, and
•
Not used in conjunction with an anti-TNF drug or anakinra
Metastatic breast cancer – Update effective July 21, 2008
Modification of criteria to cover only for first-line treatment of HER2-negative metastatic
breast cancer in combination with paclitaxel, based upon new FDA indication.
Previous criteria covered for diagnosis of metastatic breast cancer.
Glioblastoma, refractory - New
Inclusion of glioblastoma multiforme as a covered indication with preservice
requirement.
Macular edema - New
Inclusion of diabetic macular edema and macular edema secondary to retinal vein
occlusion as covered off-label indications without preservice requirement.
Migraine – Update effective July 21, 2008
Botox® (botulinum toxin)
Blue Shield of California,
Health Care Services
June 2008
Modification of drug criteria to cover for use as migraine prophylaxis in patients
experiencing inadequate control of migraines with previous prophylactic and
abortive therapies.
Page 1 of 7
Summary of Changes to Office Administered Medication Policies (Injectable) – 2Q2008
Office Administered
Medication
Campath® (alemtuzumab)
Camptosar® (irinotecan)
Coverage Policy Change
Chronic lymphocytic leukemia (CLL) – Update
Modified coverage criteria to not require Prior Authorization/Preservice for the
diagnosis of chronic lymphocytic leukemia.
Glioblastoma, refractory - New
Added coverage for glioblastoma multiforme with preservice requirement.
Metastatic pancreatic cancer – New
Added coverage without preservice requirement.
Locally advanced and/or metastatic non–small cell lung carcinoma (NSCLC),
small cell lung cancer (SCLC), metastatic cervical cancer,
metastatic gastroesophageal cancers,
metastatic carcinoma of the colon or rectum – Update
Coverage for the uses listed above will no longer require preservice review.
Crohn’s disease – New
Cimzia® (certolizumab pegol)
NEW POLICY
New coverage criteria for moderate to severe Crohn’s disease.
Coverage requires the following:
• Diagnosis is Moderate to Severe Active Crohn’s Disease, and
• Patient has failed, or a documented intolerance or contraindication to one
agent from either of the following classes: oral corticosteroids (e.g. Entocort EC,
prednisone) or immunosuppressants (e.g. azathioprine, mercaptopurine,
methotrexate, or cyclosporine), and
• Not currently taking another anti-TNF drug or anakinra.
Metastatic esophageal cancer - New
Metastatic ovarian cancer - New
Eloxatin® (oxaliplatin)
Metastatic pancreatic cancer– New
Metastatic diffuse large B-cell lymphoma - New
Added coverage with preservice review requiring documented diagnosis.
Chemotherapy-induced nausea and vomiting – New
Coverage requires the following:
Diagnosis for the prevention of acute and delayed nausea and vomiting
associated with repeat courses of moderately emetogenic and highly emetogenic
chemotherapy, and
• Emend IV (115 mg) is administered as part of a three-day antiemetic regimen as
follows: Emend IV (115 mg) on Day 1; Emend 80 mg orally on Days 2 and 3, and
• Patient had intolerable side effect to oral Emend 125 mg on Day 1 of a previous
chemotherapy regimen, AND documented medical reason to support patient's
medical condition will benefit from IV Emend versus oral Emend 125 mg as the firstdose of the three-day antiemetic regimen.
Juvenile idiopathic arthritis – Update
•
Emend® (fosaprepitant)
NEW POLICY
Enbrel® (etanercept)
Blue Shield of California,
Health Care Services
June 2008
Modified DMARD step therapy requirement for coverage of juvenile idiopathic arthritis,
also known as juvenile rheumatoid arthritis, to require inadequate response to a
DMARD or a medical reason patient is unable to take methotrexate and
sulfasalazine.
Page 2 of 7
Summary of Changes to Office Administered Medication Policies (Injectable) – 2Q2008
Office Administered
Medication
Coverage Policy Change
Juvenile idiopathic arthritis – New
Added coverage criteria for juvenile idiopathic arthritis. Coverage requires the
following:
Humira® (adalimumab)
Imitrex® (sumatriptan)
IVIG
Macugen® (pegaptanib)
Mycamine® (micafungin)
Neulasta® (pegfilgrastim)
•
•
•
Diagnosis is juvenile rheumatoid arthritis or juvenile idiopathic arthritis, and
Diagnosed by a rheumatologist, and
Inadequate response to a DMARD or a medical reason patient is unable to take
methotrexate and sulfasalazine, and
• Not used in conjunction with another anti-TNF drug or anakinra.
Cluster headaches – New
Added coverage criteria for cluster headaches. Coverage requires the following:
Diagnosis is cluster headaches, and
Recommended by neurologist or headache specialist, and
Currently on a prophylactic therapy: prednisone, dexamethasone, ergotamine,
verapamil, lithium, methysergide, or topiramate OR contraindication or intolerance
or failure on all prophylactic therapies.
Acute migraine – Update
•
•
•
Aligned coverage criteria for acute migraine with pharmacy drug criteria. Pre-service
required for greater then 4 kits (2 injections per kit) per month.
Hematopoietic stem cell transplant, prophylaxis in patients with severe
hypogammaglobulinemia– Update
Modification of coverage criteria to cover initial authorization for up to six months and
cover re-treatment every three months based upon response to therapy and IgG
levels below normal.
Diabetic macular edema – New
Added coverage for diabetic macular edema without preservice requirement.
Invasive candidiasis/candidemia – New
Added coverage for invasive candidiasis/candidemia without preservice requirement.
Neutropenia, prophylaxis in conjunction with every14-day myelosuppressive
chemotherapy regimen – Update
Added coverage for use in conjunction with an every 14-day myelosuppressive
chemotherapy regimen in which patient previously experienced neutropenia.
Juvenile idiopathic arthritis – New
Orencia® (abatacept)
Remicade® (infliximab)
Added coverage criteria for coverage criteria for juvenile idiopathic arthritis, also
known as juvenile rheumatoid arthritis. Coverage requires the following
• Diagnosis is moderate to severe juvenile idiopathic arthritis, and
• Diagnosis by a rheumatologist, and
• Inadequate response to a DMARD or a medical reason patient is unable to take
methotrexate and sulfasalazine, and
• Inadequate response to at least one TNF antagonist: etanercept (Enbrel®),
infliximab (Remicade®), or adalimumab (Humira®)
Plaque psoriasis – Update effective July 21, 2008
Modification of criteria for first reauthorization to require a 50% improvement in PASI
score.
Chronic lymphocytic leukemia (CLL) – New
Treanda® (bendamustine)
Coverage requires the following:
NEW POLICY
•
•
Blue Shield of California,
Health Care Services
June 2008
Diagnosis of CLL, and
Dose does not exceed 100mg/m2 on Days 1 and 2 of each 28-day cycle
Page 3 of 7
Blue Shield of California,
Health Care Services
June 2008
Page 4 of 7
PHARMACY BENEFIT
FORMULARY UPDATE:
Note: For Medicare beneficiaries who are enrolled in an employer group Medicare Part D plan, the
commercial formulary status applies unless otherwise stated.
The following drugs were ADDED to the Formulary:
Drug
(Added to Formulary)
Simcor (niacin extended-release/
simvastatin)
Intelence (etravirine)
Fexofenadine 30mg, 60mg & 180mg
tablets
Vytorin (ezetimibe/ simvastatin)
Coverage Restrictions
Medicare status (if differs)
Quantity limit: 2 tablets per day
Step edit: antiretroviral agent
Prior authorization requirement
removed
Quantity limit: 1 tablet per day
Step edit: maximum tolerated dose
of a generic statin
Formulary
Step edit requirement removed
Formulary Brand Tier and quantity
limit of 1 tablet per day
The following drug was ADDED to the Home Self-Injectable Tier for 3-tier and closed formulary plans:
Drug
(Home Self Injectable)
Coverage Restrictions
Arcalyst (rilonacept)
Prior authorization required
Nutropin AQ (somatropin) 20mg/2mL pen
cartridge
Prior authorization required
Humira (adalimumab) 20mg/0.4ml
injection kit
Prior authorization required
Medicare status (if differs)
Specialty tier with prior
authorization
Specialty tier with prior
authorization
Specialty tier with prior
authorization
The following drugs were NOT added to the Formulary; may have additional coverage restrictions as noted.
These drugs are available at the non-formulary brand copayment except for members with a closed formulary
benefit, where prior authorization is required for coverage.
Drug
(Non-formulary)
Coverage Restrictions
Dazidox (oxycodone HCl) 10, 20 mg
tablets
Medicare status (if differs)
Exclusion
Fenoglide (fenofibrate) 40, 120 mg
tablets
Formulary Alternatives
(generics in lower case)
oxycodone
fenofibrate, gemfibrozil,
Tricor
Ibudone (hydrocodone/ ibuprofen)
5/200, 10/200
Exclusion
combination narcotic
analgesics
Lidamantle HC (hydrocortisone
acetate/lidocaine HCl) 2%-2%
medicated pad
Exclusion
hydrocortisone/
lidocaine
fluvoxamine, fluoxetine,
sertraline, paroxetine,
venlafaxine IR (generic),
Paxil CR (generic
available), Effexor XR
Luvox CR (fluvoxamine)
Omnaris (ciclesonide)intranasal spray
Blue Shield of California,
Health Care Services
June 2008
Quantity limit: 1 bottle
per month
Non-preferred brand
flunisolide, fluticasone,
Nasonex
Page 5 of 7
Drug
(Non-formulary)
Coverage Restrictions
Medicare status (if differs)
Formulary Alternatives
(generics in lower case)
Non-preferred brand with
step edit of Effexor XR or
venlafaxine IR (generic) venlafaxine IR , Effexor XR
Pristiq (desvenlafaxine)
Formulary status for commercial plans
pending further review at 3Q2008
P&T committee meeting
Quantity limit: 1 tablet per
day for 50 mg; 4 tablets
per day for 100 mg
Umecta (0.4 urea) 40% topical nail film,
applicator
Exclusion
urea 40%
Zervalx (L-methylfolate) 1 mg
Exclusion
folic acid
Zoderm (benzoyl peroxide/ urea)
5.75%-10% liquid
Exclusion
benzoyl peroxide/ urea
Non-preferred brand with
prior authorization
generic fexofenadine,
flunisolide, fluticasone,
Astelin , Nasonex
Non-Formulary
ACE-inhibitors, beta
blockers, calcium
channel blockers,
diuretics
Non-Formulary
dexmethylphenidate,
methylphenidate,
dextroamphetamine,
amphetamine/
dextroamphetamine,
Adderall XR, Concerta
Exclusion
Levitra (prior
authorization required)
Quantity limit: 2 tablets
per day
Allegra ODT (fexofenadine) 30 mg
Tekturna HCT (aliskiren/HCTZ) 300/25,
300/12.5, 150/25,150/12.5
Vyvanse (lisdexamfetamine
dimesylate) 20, 40, and 60 mg
capsules
Cialis (tadalafil) 2.5 mg
Lamisil Granules (terbinafine)
Olux/Olux-E (clobetasol propionate)
0.05-0.05% foam
Treximet (sumatriptan/ naproxen)
Voltaren (diclofenac) 1% topical gel
Blue Shield of California,
Health Care Services
June 2008
Step edit: intranasal
steroid or intranasal
antihistamine
Quantity limit: 1 tablet
per day
Step edit: ACEinhibitor, ARB, and
one of the
following: calcium
channel blocker,
beta blocker, or
thiazide
Quantity limit: 1
capsule per day
Step edit:
amphetamine and
methylphenidate
Quantity limit: 6 tablets
per month
Prior authorization
required
Quantity limit: 2
packets per day for
125 mg; 1 packet
Non-Formulary
per day for 187 mg
Prior authorization
required
ciclopirox cream, gel,
suspension; econazole;
ketoconazole cream;
nystatin ointment,
powder
Prior authorization
required
Non-Formulary
clobetasol cream,
ointment, solution, gel,
cream emollient
Non-Formulary
naproxen, Imitrex,
Maxalt, Amerge
Non-Formulary
oral diclofenac
Quantity limit: 9
tablets per month
Prior authorization
required
Quantity limit: 10
tubes per month
Prior authorization
required
Page 6 of 7
The following drugs are Pharmacy benefit exclusions:
U
Drug
PreviDent 5000 (sodium fluoride) 1.10%
gel
U
U
Commercial
Benefit exclusion
Medicare
Non-formulary
For additional information, please call 1-800-535-9481.
Blue Shield of California,
Health Care Services
June 2008
Page 7 of 7
Attention:
Physicians, Medical Directors, Pharmacy Directors, Utilization Management Directors
THIRD QUARTER 2008 FORMULARY AND MEDICATION POLICY UPDATES
EFFECTIVE SEPTEMBER 22ND, 2008
The Blue Shield of California (BSC) Pharmacy and Therapeutics (P&T) Committee, consisting of
network physicians and pharmacists, regularly evaluates drugs for formulary inclusion and
medication policy coverage criteria. The Third Quarter 2008 P&T Committee decisions on injectable
medication policy updates and formulary changes are summarized below:
INJECTABLE MEDICATION POLICIES:
The following coverage policies are effective on September 22nd, 2008 (unless stated otherwise)
and available on the BSC Internet site, Provider Portal: https://www.blueshieldca.com/provider/ >
Guidelines > Eligibility & Benefits Resources >
Blue_Shield_Medication_Policies_(Injectable,_Implantable,_w/DME).
Refer to medication policy for complete details.
Summary of Changes to Office Administered Medication Policies (Injectable) – 3Q2008
Office Administered
Medication
Coverage Policy Change
Metastatic ovarian cancer – New covered indication
Avastin (bevacizumab)
Added coverage criteria for off-label use for metastatic ovarian cancer, requiring
diagnosis and patient is refractory to previous systemic chemotherapy.
Hyperhidrosis – Criteria modification
Botox (botulinum toxin)
Clarification of coverage criteria for hyperhidrosis to include gustatory hyperhidrosis
(Frey syndrome) as a covered indication.
Glioblastoma – Criteria modification
Camptosar (irinotecan)
Cimzia (certolizumab)
Effective October 23, 2008
Faslodex (fulvestrant)
Miacalcin (calcitonin)
Blue Shield of California,
Health Care Services
September 2008
Modified maximum covered dose to include irinotecan dosing for patients taking
enzyme-inducing anti-epileptic drugs (EIADs).
Crohn’s disease – Criteria modification
Effective October 23, 2008, additional step therapy of inadequate response or
intolerance to adalimumab or infliximab will be required prior to coverage.
Breast cancer– Criteria modification
Modified criteria to cover for recurrent, locally advanced or metastatic breast cancer.
Postmenopausal osteoporosis – Criteria modification
Removed requirement that calcitonin not be used with other agents for osteoporosis.
Glucocorticoid-induced osteoporosis – Criteria modification
Removed requirement that calcitonin not be used in with other agents for osteoporosis.
Coverage criteria requires diagnosis of glucocorticoid-induced osteoporosis.
Paget’s disease – Criteria modification
Modification to cover up to 100iu daily for up to 18 months.
Bone pain due to malignancy – New covered indication
Added coverage for up to 200iu daily for up to 6 months.
Page 1 of 5
Summary of Changes to Office Administered Medication Policies (Injectable) – 3Q2008
Office Administered
Medication
Coverage Policy Change
Rheumatoid arthritis – Criteria modification
Orencia (abatacept)
Modification of coverage period to cover annually, based upon continued response to
therapy.
Pre-operative prevention in anemic patients – Criteria modification
Procrit (epoetin alfa)
Effective October 23, 2008
Effective October 23, 2008, covered dose is < 600 units/kg/week for 4 weekly doses, or
300 units/kg/day for 15 days.
Effective October 23, 2008, coverage period is 2 months per surgery with total length of
epoetin alfa therapy not to exceed 15 days for daily dosing or 4 weekly doses for
once weekly dosing.
Osteoporosis – Criteria modification
Reclast (zoledronic acid)
Added coverage criteria for treatment of osteoporosis in men and women, based
upon new FDA indication.
Coverage criteria requires: 1) diagnosis is for the treatment of osteoporosis, as
evidenced by a T-score of more than -2.5 SD below the young normal or history of
non-traumatic fracture, AND 2) unable to take oral bisphosphonates.
Opioid-induced constipation in terminally ill patients – New policy
Coverage criteria requires the following:
Relistor (methylnaltrexone)
• Diagnosis is opioid-induced constipation and
NEW POLICY
• Patient is receiving palliative (end of life) care or in hospice, and
• Dose does not exceed 1 dose in 24 hours
Coverage period: One year
Section (1) Special Instructions and pertinent Information - Operational modification
Remicade (infliximab)
Rituxan (rituximab)
Removed requirement restricting home infusion administration to approved vendors
only.
Rheumatoid arthritis – Criteria modification
Removed step therapy requirement of inadequate response to abatacept (Orencia).
Prevention of RSV infection– Criteria modification
Synagis (palivizumab)
Modification of coverage criteria for more than five doses during the RSV season to
require that the RSV season is extended in the region in which the patient is residing,
as documented by specific regional data, e.g. DHS data, CDC data.
Multiple myeloma - Criteria modification
Velcade (bortezomib)
Added coverage of multiple myeloma as first-line therapy, based upon new FDA
indication.
Allergic asthma – Criteria modification
Xolair (omalizumab)
Modified criteria, decreasing requirement of “three or more acute asthma
exacerbations requiring oral systemic steroids” to “two or more acute asthma
exacerbations requiring oral systemic steroids” as one of the qualifying conditions
for coverage.
Hormone responsive breast cancer-New covered indication
Zometa (zoledronic acid)
Blue Shield of California,
Health Care Services
September 2008
Added coverage for hormone-responsive breast cancer requiring diagnosis and
currently on aromatase inhibitor or tamoxifen therapy. Covered dose is 4 mg every
6 months with annual review.
Page 2 of 5
PHARMACY BENEFIT
FORMULARY UPDATE:
Note: For Medicare beneficiaries who are enrolled in an employer group Medicare Part D plan, the
commercial formulary status applies unless otherwise stated.
The following drugs were ADDED to the Formulary:
Drug
Coverage Restrictions
Medicare status (if differs)
(Added to Formulary)
Asmanex (mometasone) 110mcg inhaler
Quantity limit: 1 inhaler per month
Formulary Brand with quantity limit
of 1 inhaler per month
Prezista (darunavir) 600 mg
Step edit: antiretroviral agent
Formulary Brand
Sprycel (dasatinib) 100 mg
Prior authorization required
Specialty tier with PA
The following drug was ADDED to the Home Self-Injectable Tier for 3-tier and closed formulary plans:
Drug
(Home Self Injectable)
Relistor (methylnaltrexone)
Coverage Restrictions
Prior authorization required
Medicare status (if differs)
Specialty tier with PA
The following drugs were NOT added to the Formulary; may have additional coverage restrictions as noted.
These drugs are available at the non-formulary brand copayment except for members with a closed formulary
benefit, where prior authorization is required for coverage.
Drug
(Non-formulary)
Doryx (doxycycline) 150 mg
Ferralet 90 (iron/ folic acid/ vitamin
B12/docusate sodium) 90-150mg
Millipred (prednisolone sodium
phosphate) 10mg/5ml oral
solution
Neotic (antipyrine/benzocaine/
zinc) combination ear drops
Papfyll (papain/urea/chlorophyllin)
520k-100/gram topical
Renatabs with Iron (vitamin B
complex with iron/ folic acid/
vitamin C & E) 100-1-60mg
Salkera (salicylic acid) 6% topical
foam
Strovite Advance +D
(multivitamin/folic acid/ vitamin
D) 1-1000-15 mg
Xolegel Corepak
(ketoconazole/hydrocortisone)
2%-1% topical gel
Blue Shield of California,
Health Care Services
September 2008
Coverage
Restrictions
Medicare status
Formulary Alternatives
(if differs)
(generics in lower case)
Non-preferred
brand
doxycycline, Oracea, Vibramycin
syrup and suspension
Exclusion
variety of multivitamin preparations
with iron
prednisolone solution, syrup
Exclusion
antipyrine/ benzocaine ear drops
Exclusion
papain/urea ointments and spray,
(generic Accuzyme), papain/urea/
chlorophyllin ointment (generic
Panafil), trypsin/balsam peru/castor
oil ointment (generic Xenaderm) and
spray (generic Granulex), Santyl
ointment
Exclusion
variety of multivitamins with iron and
folic acid
Exclusion
6% salicylic acid cream, lotion, or
shampoo
Exclusion
variety of multivitamins with folic
acid and minerals
hydrocortisone cream, lotion, and
ointment and 2% ketoconazole
cream
Page 3 of 5
Drug
(Non-formulary)
Actonel (risedronate) 150 mg
Lunesta (eszopiclone)
Nexium (esomeprazole) 10 mg
suspension powder packet
Patanase (olopatadine) 0.60% nasal
spray
Amitiza (lubiprostone) 8 mcg
Coverage
Restrictions
Quantity limit: 1
tablet per
month
Step edit:
alendronate
Quantity limit: 1
tablet per day
Step edit:
generically
available
Ambien and
Ambien CR
Step edit:
Aciphex,
omeprazole,
pantoprazole,
and Prevacid
(prerequisite
therapy
required for
Prevacid only)
Quantity limit: 1
bottle per
month
Step edit: Astelin
Quantity limit: 2
capsules per
day
Prior authorization
required
Glumetza (metformin) 1g sustainedrelease tablet
Prior authorization
required
Medicare status
Formulary Alternatives
(if differs)
(generics in lower case)
Non-Formulary
alendronate
Non-preferred
brand with step
edit of
generically
available
Ambien and
quantity limit of 1
tablet per day
zolpidem, Ambien CR (pre-requisite
therapy required for Ambien CR)
Non-preferred
brand
Aciphex, pantoprazole and
omeprazole
Non-Formulary
Astelin
Non-preferred
brand with PA
bulk-forming, fiber therapy,
stimulants, hyperosmotics, stool
softeners, saline laxatives, lubricants
Non-Formulary
extended-release metformin
Liquadd (dextroamphetamine
sulfate) 5mg/ 5ml oral solution
Prior authorization
required
Non-Formulary
Adderall XR, amphetamine/
dextroamphetamine, Concerta
dexmethylphenidate
dextroamphetamine,
methylphenidate
Neobenz Micro (benzoyl peroxide)
Prior authorization
required
Exclusion
benzoyl peroxide products
Xyzal (levocetirizine) 2.5mg/5ml oral
solution
Prior authorization
required
Non-preferred
brand with PA
generically available fexofenadine,
fluticasone, flunisolide and Nasonex
& Astelin which are available as
brand products
The following drugs are Pharmacy benefit exclusions:
Drug
CNL 8 kit (ciclopirox)
Desowen (desonide/emollient)
combination kit
Tricare DHA (prenatal vitamin and fish
oil)
Ultravate PAC
(halobetasol/ammonium lactate)
Blue Shield of California,
Health Care Services
September 2008
Commercial
Medicare
Benefit exclusion
Non-formulary
Benefit exclusion
Non-formulary
Benefit exclusion
Non-formulary
Benefit exclusion
Non-formulary
Page 4 of 5
For Medicare only, the following drugs were ADDED to the Formulary Brand Tier:
Name
Medicare status
Acular LS (ketorolac tromethamine)
Formulary brand
Alamast (pemirolast potassium)
Formulary brand
Alomide (lodoxamide tromethamine)
Formulary brand
Alphagan P (brimonidine tartrate)
Formulary brand
Betoptic-S (betaxolol Hcl)
Formulary brand
FML S.O.P. (fluorometholone)
Formulary brand
Macrodantin (nitrofurantoin macrocrystal)
Formulary brand
Navane (thiothixene) 20 mg
Formulary brand
Nitro-DUR (nitroglycerin) 0.3 mg/hr, 0.8 mg/hr transdermal patches
Formulary brand
Pancrease MT4 (amylase/ lipase/ protease)
Formulary brand
Pancrecarb MS-16
Formulary brand
Pancrecarb MS-4
Formulary brand
Pancrecarb MS-8 (amylase/ lipase/ protease)
Formulary brand
Sular (nisoldipine)
Formulary brand
Tasmar (tolcapone)
Formulary brand
Tegretol-XR (carbamazepine)
Formulary brand
Viokase 8, 16 (amylase/ lipase/ protease)
Formulary brand
Welchol (colesevelam)
Formulary brand
For additional information, please call 1-800-535-9481.
Blue Shield of California,
Health Care Services
September 2008
Page 5 of 5
Attention:
Physicians, Medical Directors, Pharmacy Directors, Utilization Management Directors
FOURTH QUARTER 2008 FORMULARY AND MEDICATION POLICY UPDATES
EFFECTIVE DECEMBER 18TH, 2008
The Blue Shield of California (BSC) Pharmacy and Therapeutics (P&T) Committee, consisting of
network physicians and pharmacists, regularly evaluates drugs for formulary inclusion and
medication policy coverage criteria. The Fourth Quarter 2008 P&T Committee decisions on injectable
medication policy updates and formulary changes are summarized below:
INJECTABLE MEDICATION POLICIES:
The following coverage policies are effective on December 18th, 2008 (unless stated otherwise) and
available on the BSC Internet site, Provider Portal: https://www.blueshieldca.com/provider/ >
Guidelines > Eligibility & Benefits Resources >
Blue_Shield_Medication_Policies_(Injectable,_Implantable,_w/DME).
Refer to medication policy for complete details.
Summary of Changes to Office Administered Medication Policies (Injectable) – 4Q2008
Office Administered
(Injectable) Medication
Abraxane® (protein-bound
paclitaxel)
Coverage Policy Change
Metastatic breast cancer – Expansion of coverage
Expanded coverage criteria to include coverage for patients unable to undergo
treatment with paclitaxel.
Metastatic non-small cell lung cancer (NSCLC), first-line –New covered indication
Alimta® (pemetrexed)
Added coverage criteria for use in combination with cisplatin as first-line treatment of
locally advanced or metastatic non-small cell lung cancer (NSCLC).
Non-small cell lung cancer (NSCLC) – Expansion of coverage
Expanded coverage criteria for NSCLC to require that bevacizumab is being used as
part of a first-line chemotherapy regimen. Previous criteria required use specifically
in combination with paclitaxel and carboplatin as first-line treatment for NSCLC.
Avastin® (bevacizumab)
Coverage period for all covered indications – Restriction of coverage
Effective January 19, 2009:
Modified coverage period to cover for requested number of cycles or up to one year,
whichever is less. Previous coverage did not require re-review following initial
approval.
Breast cancer– Expansion of coverage
Faslodex® (fulvestrant)
Blue Shield of California,
Health Care Services
December 2008
Expanded covered dosing to cover a loading dose regimen of one dose of 500 mg
and up to two doses of 250 mg in the first month.
Page 1 of 5
Summary of Changes to Office Administered Medication Policies (Injectable) – 4Q2008
Office Administered
(Injectable) Medication
Coverage Policy Change
Methotrexate rescue or impaired elimination - New policy
Fusilev® (levoleucovorin)
NEW POLICY
Coverage criteria requires the following:
•
Patient has osteosarcoma, OR use is intended to diminish the toxicity and
counteract the effects of impaired methotrexate elimination and of inadvertent
overdosage of folic acid antagonists
AND
•
Patient has had intolerable side effect to use of leucovorin that would not also be
expected with levoleucovorin.
Osteoarthritis– Expansion of coverage
Modified NSAID requirement from previously requiring a trial of 4 full-dose NSAIDs, which
included two prescription NSAIDs to now requiring a trial of two prescription-strength
NSAIDs as follows:
Hyaluronic acids (Synvisc,
Hyalgan, Euflexxa, Orthovisc,
Supartz)
Intron A® (interferon alfa)
Irinotecan
For patients with no history of GI bleed or ulcer, cover if:
•
Trial of 2 prescription strength NSAIDs of minimum one week duration each,
resulting in failure due to inadequate control of pain and/or inflammatory
symptoms OR
•
Trial of 2 prescription strength NSAIDs of minimum one week duration each,
resulting in failure due to GI intolerance, one of which must have been tried in
combination with a PPI.
Bladder cancer – New covered off-label indication
Coverage criteria requires diagnosis only.
Covered indications – Expansion of coverage
Coverage expanded to only require documented diagnosis for covered indications.
Immune (idiopathic) thrombocytopenic purpura (ITP) – New policy
NplateTM
(romiplostim)
NEW POLICY
Coverage criteria requires the following: 1) Patient has chronic, refractory ITP, and 2)
platelet count <30, 000/mcl (i.e. <30 x109/L), and 3) refractory to, or has an
intolerance/contraindication to two of the following treatments: corticosteroids,
IVIG, anti-D antibody, danazol, rituximab, or splenectomy.
Autoimmune hemolytic anemia (AIHA) – New covered indication
Added coverage for off-label use in autoimmune hemolytic anemia (including AIHA
following allogenic bone marrow transplantation).
Chronic lymphocytic leukemia (CLL) – Expansion of coverage
Rituxan® (rituximab)
Expanded coverage for use of rituximab in CLL. Coverage criteria requires the
following:
•
Diagnosis is chronic lymphocytic leukemia (CLL), and
•
Being used alone or in combination with other agents for treatment of CLL.
Waldenstrom’s macroglobulinemia (WM) – Expansion of coverage
Expanded coverage of WM to only require diagnosis for coverage. Previous criteria
required patient be refractory to 1st-line therapy.
Central precocious puberty – New policy Effective January 19, 2009
Supprelin LA® (histrelin implant)
Cover criteria requires:
NEW POLICY
•
Effective January 19, 2009
Covered dose:
•
Blue Shield of California,
Health Care Services
December 2008
Documented diagnosis of central precocious puberty (neurogenic or idiopathic)
1 implant every 12 months and review on a yearly basis.
Page 2 of 5
Summary of Changes to Office Administered Medication Policies (Injectable) – 4Q2008
Office Administered
(Injectable) Medication
Coverage Policy Change
Non-Hodgkin’s Lymphoma (NHL) -New covered indication
Added coverage criteria for NHL. Cover if:
•
Treanda® (bendamustine)
OR
•
Velcade® (bortezomib)
Vidaza® (azacitadine)
Being used as a single agent for indolent NHL and patient has progressed during or
within six months of treatment with rituximab or a rituximab-containing regimen
Diagnosis is follicular lymphoma or mantle cell lymphoma, and being used with or
without rituximab as second-line treatment (patient has already received first-line
therapy)
Cutaneous or peripheral T-cell lymphoma, relapsed or refractory – New covered offlabel indication
Cover if:
•
Diagnosis is relapsed or refractory cutaneous or peripheral T-cell lymphoma, AND
•
Patient has disease recurrence or progression on or following treatment with prior
chemotherapy
MDS - Criteria modification
Extended reauthorization coverage period to cover every six months based upon
continued response to therapy and hematologic values are being obtained.
Blue Shield of California,
Health Care Services
December 2008
Page 3 of 5
PHARMACY BENEFIT
FORMULARY UPDATE:
Note: For Medicare beneficiaries who are enrolled in an employer group Medicare Part D plan, the
commercial formulary status applies unless otherwise stated.
The following drugs were ADDED to the Formulary:
Drug
Coverage Restrictions
Medicare status (if differs)
(Added to Formulary)
Hycamtin (topotecan) oral capsules
Part B
Prezista (darunavir)
Stalevo 75, 125
(carbidopa/levodopa/entacopone)
Aptivus (tipranavir/vitamin E) 100 mg/ml
oral solution
Specialty tier
Step Edit: prior use of HIV drug
Formulary Brand
The following drug was ADDED to the Home Self-Injectable Tier for 3-tier and closed formulary plans:
Drug
(Home Self Injectable)
Forteo (teriparatide) pen injector
Coverage Restrictions
Prior authorization required
Medicare status (if differs)
Specialty tier with PA
The following drugs were NOT added to the Formulary; may have additional coverage restrictions as noted.
These drugs are available at the non-formulary brand copayment except for members with a closed formulary
benefit, where prior authorization is required for coverage.
Drug
(Non-formulary)
Alvesco (ciclesonide)
Bactroban Nasal (mupirocin)
Coverage
Restrictions
Medicare status
Formulary Alternatives
(if differs)
(generics in lower case)
Quantity Limit: 1
canister/ month
(80mcg); 2
canisters/ month
(160mcg)
Asmanex, Flovent HFA , Pulmicort,
QVAR
Centratex (multivitamin with folate
and iron)
Non-preferred brand mupirocin 2% ointment
a variety of multivitamins with iron
Exclusion (no FDA
and folic acid
application)
Digex NF
(hyoscyamine/phenyltoloxamine)
Exclusion (no FDA
application)
Durezol (difluprednate)
Gesticare (prenatal vitamin)
OB-Natal One (prenatal
vitamin/omega 3)
Primacare One (prenatal
vitamin/omega 3)
Blue Shield of California,
Health Care Services
December 2008
hyoscyamine, antihistamines
Alrex, dexamethasone, FML, FML
Forte, Lotemax, Pred Mild,
prednisolone acetate, prednisolone
sodium phosphate
prenatal vitamins
prenatal vitamins
prenatal vitamins
Page 4 of 5
Drug
(Non-formulary)
Pristiq (desvenlafaxine)
Remains Non-Formulary –
Status pending additional P&T
review
Coverage
Restrictions
Remains Non-Formulary –
Status pending additional P&T
review
Formulary Alternatives
(if differs)
(generics in lower case)
Non-preferred brand
with step-edit of
venlafaxine IR,
Quantity Limit: 1
Effexor XR, or
tablet/day for 50
Venlafaxine ER;
mg and 4
and a quantity
tabs/day for 100
limit of 1
mg strength
tablet/day for 50
mg and 4
tabs/day for 100
mg strength
Spectracef 400 mg (cefditoren
pivoxil)
Venlafaxine ER (venlafaxine
extended-release) tablets
Medicare status
venlafaxine IR, Effexor XR
cephalexin, cefaclor, cefuroxime
Non-preferred brand cefadroxil, cefpodoxime, Omnicef
Quantity limit: 1
tablet/day for
each strength
Veripred 20 (prednisolone) oral
solution
Zacare Kit (benzoyl peroxide/
hyaluronate)
Zenieva (emollient combination)
Non-preferred brand
with PA and a
quantity limit of 1
tablet/day for
each strength
venlafaxine IR, Effexor XR
Exclusion (no FDA
application)
prednisolone 5mg/5ml or 15mg/5ml
solutions
4% or 8% benzoyl peroxide cleansing
lotions, 0.2% hyaluronate sodium gel
Exclusion (no FDA
application)
a variety of corticosteroid
preparations
Non-Formulary
levetiracetam
Keppra XR (levetiracetam)
Step Edit: Keppra
IR (immediate
release)
Aczone (dapsone)
Prior authorization
required
Non-Formulary
clindamycin 1% gel, solution, lotion,
medicated swab, benzoyl
peroxide/ erythromycin,
erythromycin solution, isotretinoin
Prior authorization
required
Non-Formulary
prenatal vitamins
Prior authorization
required
Non-Formulary
prenatal vitamins
Non-Formulary
mesalamine
Non-Formulary with
quantity limit of 1
patch/
prescription
granisetron, ondansetron
Duet DHA EC (prenatal vitamin and
omega 3 fatty acids)
combination pack
Gesticare DHA (prenatal vitamin
and omega 3 fatty acids)
combination pack
Rowasa Kit (mesalamine
enema/cleansing wipe)
Sancuso (granisetron)
Stavzor (valproic acid delayed
release)
Prior authorization
required
Quantity Limit: 1 kit
of 28 enemas
per month
Prior authorization
required
Quantity Limit: 1
patch/
prescription
Prior authorization
required
Non-preferred brand valproic acid or divalproex sodium
with PA
For additional information, please call 1-800-535-9481.
Blue Shield of California,
Health Care Services
December 2008
Page 5 of 5