Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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