STAT Bulletin. Drug Therapy Guideline Updates. To: All Primary Care Physicians and Specialists Contracts Affected: All Lines of Business

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1 STAT Bulletin November 28, 2011 Volume 17: Issue 34 To: All Primary Care Physicians and Specialists Contracts Affected: All Lines of Business Drug Therapy Guideline Updates Why you re receiving this Stat The attached Drug Therapy Guidelines are effective January 1, These updates are a result of the annual guideline review and new drug evaluations performed quarterly by our Pharmacy and Therapeutics Committee, or as a result of new medications entering the market. What you need to know The updated Drug Therapy Guidelines will be available for review online as of December 1, 2011 at bcbswny.com. Select I m a Provider > Tools and Resources > Pharmacy Services. What you need to do If you do not have access to the internet, paper copies are available, upon request, as of December 1, by calling Provider Service at or HNNY CC1624 1

2 Prescription Drug/Policy Sylatron Non-Formulary ication Coverage Exceptions Adcetris New Guidelines Policy Summary (See guidelines for all specifics) Covered for FDA-approved indication of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy (full Sylatron policy found in the Drug Therapy Guidelines: Abbreviated Criteria document on our website) Considerations used to determine coverage when requests for non-formulary medications are submitted are outlined in this policy Covered for FDA-approved indication (per the Global Authorization Criteria) or Actemra Drug Therapy Guideline Title Actimmune Amevive Guidelines with changes that will impact the review process Policy Criteria Changes Summary (See guidelines for specifics) Dosage information added with regards to ANC, plts, and AST/ALT Lab values required for renewal are more lenient Specialist criteria added to the policy Hematologist, immunologist, infectious disease specialist for chronic granulomatous disease Endocrinologist for osteopetrosis Addition of diagnostic criteria Addition of specific requirements for other therapies (topical, oral, biologic, photo) first (including both Enbrel and Humira) Addition of specialist requirements Addition of age requirements 2 or Ampyra No changes Antinarcoleptic Agents Specialist notes/polysomnography required for narcolepsy diagnosis if not requested by a neurologist or pulmonologist Coverage duration for narcolepsy increased to 2 years Apokyn Policy abolished Benign Prostatic Hyperplasia (BPH) Therapy No changes Changed wording from chronic daily headache to wording as found in the Botox Prescribing Information

3 Drug Therapy Guideline Title Botulinum Toxins Policy Criteria Changes Summary (See guidelines for specifics) Indication Included specific examples of first line therapies for hyperhidrosis Coverage for the treatment of plantar hyperhidrosis considered investigational and not covered Coverage for sialorrhea available when associated with neurological disorders Policy exclusion list limited Criteria added for coverage in piriformis syndrome Renewal criteria specified as same as initial criteria Approval duration extended 3 or Colony Stimulating Factors Enbrel No changes Erectile Dysfunction Coverage duration increased Agents Daily dosing covered for Cialis 2.5mg and 5mg tablets Forteo Requirement of diagnostic DXA scan and/or FRAX score added Gonadotropin-Releasing Hormone Agonist Requirement of iron usage timeframes added for anemia secondary to uterine leiomyomata Quantity allowances and coverage duration revised Removal of diagnosis from autopay, will now be reviewed Central precocious puberty (259.1) no longer autopay diagnosis, will be reviewed o Coverage criteria outlined based on age o Renewal criteria outlined based on age Clarification of pharmacy benefit vs. medical benefit made Coverage criteria for breast and ovarian cancers included Humira No changes Idiopathic / Thrombocytopenia Purpura (ITP) Agents No changes Incretin Mimetics Trial with Byetta no longer required for coverage of Victoza Injectable Fertility No changes ications Inspra Policy abolished Approval duration extended Intranasal Steroids Triamcinolone added as preferred agent Nasarel, Nasacort AQ removed from policy Iressa Recommendation to abolish policy based on lack of inappropriate and low use Leukotriene Receptor Antagonists

4 Drug Therapy Guideline Title Policy Criteria Changes Summary (See guidelines for specifics) or Nutritional Supplements No changes Orencia Addition of Orencia SC to the policy / Proton Pump Inhibitors (PPIs) Coverage of non-preferred PPIs require trial with preferred agents at maximum dosing (i.e. twice daily) with failure to provide benefit Pulmonary Arterial Hypertension (PAH) Agents Addition of Veletri to policy Removal of Black Box warning from Letairis Implement prior authorization reviews of Ventavis, Flolan, and Veletri Clarification of pharmacy vs. medical benefit made / RANKL Inhibitors Addition of diagnostic criteria for osteoporosis Sedative Hypnotics No changes Selective Serotonin Reuptake Inhibitors Requirement of trial with at least two generic SSRIs first This represents a change from old policy for Lexapro, which required two generic SSRIs, one of which must have been citalopram Based on indication of and new safety concerns with citalopram, policy changed to allow for any two generics Addition of GIST coverage Gleevec trial required prior to coverage for CML Sprycel accelerated or blast crisis phase Requirement of Ph+ or BCR/ABL+ verification for first line use in CML in chronic phase Coverage criteria added for pancreatic neuroendocrine Sutent tumor treatment, soft tissue sarcoma treatment, and thyroid carcinoma treatment Tasigna Specific criteria outlined for each phase of CML Testosterone Replacements Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Approval duration extended Initial coverage duration for Voltaren Gel and Pennsaid extended Urinary Agents Approval duration extended 4

5 Auto-Pay ICD-9 Codes for Selected ical ications Some medical benefit medications will automatically pay when billed with the following diagnoses as listed below: ication (J code) Auto-pay ICD-9 codes Arzerra (J9302) 204.1, , , Avastin (J9035, C9257) Rituxan (J9310) , , , , , , , , , ( ), ( ), ( ), ( ), ( ), ( ), ( ), ( ), ( ), ( ), ( ), Lupron, Lupron Depot, Eligard (J1950, J9217, J9218) 185 IVIg (J1459, J1557, J1561, J1566, J1568, J1569, J1572, J1599) 446.1, Dacogen, Vidaza (J0894, J9025) 205.1, , , , Botox, Myobloc, Dysport, Xeomin (J0585, J0586, J0587, J0588) 333.6, 333.7, , , , , , , 334.1, 340, 341, 341.0, 341.1, 341.2, , 341.8, 341.9, 342.1, , 343, , 344.0, , 344.1, 344.2, 344.4, , 351.8, 378, , , , 530.0, 564.6, 565.0, 723.5, 854, 854.0, 854.1, , 952, ,

6 ical Reference Guide The following list of medications require preauthorization when administered by a health care professional. Drug Code Actemra J3262 Actimmune J9216 *Adcetris - non-institutional use J9999 *Adcetris - institutional use C9287 Amevive J0215 Arzerra J9302 Avastin C9257 Avastin J9035 Benlysta J0490 Berinert J0597 Boniva J1740 Botox J0585 Cimzia J0718 Cinryze J0598 Dacogen J0894 Dysport J0586 Eligard J9217 Erbitux J9055 Flebogamma J1572 *Flolan J1325 Gammagard J1569 Gammaplex J1557 Gamunex J1561 Gamunex-C J1561 H.P. Acthar Gel J0800 Halaven J9179 Herceptin J9355 Hizentra J1559 Istodax J9315 IVIg (NOS) J1599 IVIg Powder J1566 Jevtana J9043 Kalbitor J1290 Krystexxa J2507 Drug Code Lucentis J2778 Lupron Depot J1950 Lupron J9218 Macugen J2503 Makena J1725 Mozobil J2562 Myobloc J0587 Nplate J2796 Octagam J1568 Orencia J0129 Privigen J1459 ProliaTM J0897 Provenge Q2043 Qutenza J7335 Reclast J3488 Remicade J1745 Remodulin J3285 Rituxan J9310 Simponi J3590 Soliris J1300 Stelara J3357 Synagis Torisel J9330 Tysabri J2323 Vectibix J9303 *Veletri J1325 *Ventavis Q4074 Vidaza J9025 Vivaglobin J1562 Xeomin J0588 Xgeva J0897 Xolair J2357 Yervoy J9228 *New as of January 1,

7 Reminder of Pharmacy Updates for icaid and Family Health Plus As of October 1, 2011, BlueCross BlueShield of Western New York icaid and Family Health Plus (FHP) members began to receive their pharmacy benefits through BlueCross BlueShield instead of New York state. Their coverage will now follow the guidelines in our drug list. Please note that brand name prescription drugs that have a generic equivalent available are not included in the icaid/fhp formulary. Here are some the most commonly prescribed brand name medications that are no longer covered for these members, along with covered alternatives. Non-formulary medication Formulary alternatives* (no preauth requirement) Crestor Lipitor, simvastatin, lovastatin, pravastatin Lovaza fenofibric acid, gemfibrozil, niaspan Focalin XR Metadate CD, Ritalin LA, methylphenidate extended release tablet Vyvanse amphetamine/dextroamphetamine extended release Maxalt sumatriptan, naratriptan Relpax sumatriptan, naratriptan OxyContin Opana ER, morphine sulfate ER, fentanyl patch Abilify risperidone, Seroquel, paroxetine, sertaline Lyrica gabapentin, amitriptyline, venlafaxine, valproic acid Nexium omeprazole, lansoprazole, pantoprazole *Quantity limits may still apply 7