Yervoy (ipilmumab) Last Review Date: 03/25/2014 Date of Origin: 11/28/2011. Prior Auth Available: Post-Service Edit:

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1 Yervoy (ipilmumab) Date of Origin: 11/28/2011 Prior Auth Available: Post-Service Edit: Dates Reviewed: 12/13/2011, 03/2012, 06/19/2012, 09/06/2012, 12/06/2012, 05/16/2013, 06/06/2013, 09/05/2013, 12/05/2013, 03/25/2014 The medical necessity criteria were developed by ICORE Healthcare for the purpose of making clinical review determinations for requests for medications commonly used in various diseases. The clinical disciplines of oncology, hematology, rheumatology, neurology, internal medicine, pharmacy and nursing were consulted as part of the criteria development. The development followed an extensive literature search pertaining to established clinical guidelines and accepted prescribing patterns for each individual drug. The indications for the medications are consistent with FDA approved indications, CMS coverage guidelines, National Comprehensive Cancer Network (NCCN) guidelines and/or other published peer reviewed research literature. I. Medication Description: Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and blocks the interaction of CTLA-4 with its ligands CD80/CD86. Blockade of CTLA-4 augments T cell activation and proliferation. The mechanism of Ipilimumab s action for melanoma is possibly through T-cell mediated anti-tumor immune responses. Ipilimumab was approved by the FDA in March II. Length of Authorization: Certification will be provided for 12 weeks and may be extended to 16 weeks if 4 doses were not administered within the 12 week time frame III. Review Criteria: Malignant Melanoma Initial Induction: o Patient is 18 or older; AND o Must be used as a single agent; AND o Patient s disease is unresectable or metastatic or recurrent Re-Induction: o Patient is 18 or older; AND o Must be used as a single agent; AND o Patient s disease is unresectable or metastatic or recurrent; AND o Patient has completed initial induction (completion of 4 cycles within a 16 week period); AND o The patient has had stable disease, partial response or complete response for at least 3 months after completion of the initial induction cycle; AND o Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: immune-mediated enterocolitis; immune-mediated hepatitis (AST or ALT elevations>2.5 times the ULN); immune-mediated dermatitis (Stevens-Johnson syndrome); immune-mediated neuropathies (Guillian-Barre-like syndromes); immune mediated endocrinopathies (hypopituitarism, hypothyroidism, hypogonadism, or adrenal insufficiency); and immune-mediated ocular disease that is unresponsive to local immunosuppressive therapy. Page 1 of 5

2 IV. Renewal Criteria: See Re-Induction V. Dosage/Administration: Indication Malignant Melanoma Dose 3mg/kg every 3 weeks for a total of 4 doses VI. Billing Information : JCode: J9228 Yervoy (BMS) 50mg, 200mg injection: 1 billable unit = 1mg Max Units (per dose and over time): Male: 350 billable units per 21 days Female: 300 billable units per 21 days Covered Diagnosis: ICD-9 Codes Diagnosis Malignant neoplasm of eye, part unspecified Secondary malignant neoplasm of brain and spinal cord Disseminated malignant neoplasm without specification of site Other malignant neoplasm without specification of site V10.82 Personal history of malignant melanoma of skin VII. Centers for Medicare and Medicaid Services (CMS): Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub ), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: Additional indications may be covered at the discretion of the health plan. Page 2 of 5

3 Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 9(N) ICD-9 Codes NCD/LCD Document (s): A51567 Diagnosis Malignant neoplasm of anal canal Malignant neoplasm of anus, unspecified Malignant neoplasm of vagina Malignant neoplasm of labia majora Malignant neoplasm of labia minoro Malignant neoplasm of prepuce Malignant neoplasm penis, part unspecified Malignant neoplasm of scrotum Malignant neoplasm of male genital organ, unspecified Malignant neoplasm of eyeball, except conjunctiva, cornea, retina, and choroid Malignant neoplasm of orbit Malignant neoplasm of lacrimal gland Malignant neoplasm of conjunctiva Malignant neoplasm of retina Malignant neoplasm of choroid Malignant neoplasm of eye, part unspecified Jurisdiction(s): 5,8 NCD/LCD Document (s): L28576 ICD-9 Codes Diagnosis Page 3 of 5

4 VIII. Criteria Exclusions: Any indications not described in authorization requirements are not covered and may be considered experimental or investigational. IX. Black Box Warnings/Contraindications: Contraindications: N/A Black Box Warnings: o Yervoy can result in severe and fatal immune-mediated reactions due to T-cell activation and proliferation. o These immune-mediated reactions may involve any organ system; however, the most common severe immunemediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. o Permanently discontinue Yervoy and initiate systemic high-dose corticosteroid therapy for severe immunemediated reactions. o Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. X. References: 1. Yervoy [package insert]. Princeton, NJ; Bristol Meyers Squib; December Accessed March Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium ) ipilimumab. National Comprehensive Cancer Network, The NCCN Compendium is a derivative work of the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med Aug 19;363(8): Wilgenhof S, Du Four S, Vandenbroucke F, et al. Single-center experience with ipilimumab in an expanded access program for patients with pretreated advanced melanoma. J Immunother Apr;36(3): Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD) for Chemotherapy Drugs and their Adjuncts (L28576). Centers for Medicare & Medicaid Services, Inc. Updated on 02/19/2014 with effective date 03/01/2014. Accessed March XI. Appendix: Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E CA,HI, NV, AS, GU, CNMI Noridian Administrative Services (NAS) Page 4 of 5

5 F AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Administrative Services (NAS) 5 KS, NE, IA, MO Wisconsin Physicians Service (WPS) 6 MN, WI, IL National Government Services (NGS) H LA, AR, MS, TX, OK, CO, NM Novitas Solutions 8 MI, IN Wisconsin Physicians Service (WPS) 9 (N) FL, PR, VI First Coast Service Options 10 (J) TN, GA, AL Cahaba Government Benefit Administrators 11 (M) NC, SC, VA, WV Palmetto GBA 12 (L) DE, MD, PA, NJ, DC Novitas Solutions K NY, CT, MA, RI, VT, ME, NH National Government Services (NGS) 15 KY, OH CGS Administrators, LLC Page 5 of 5