Policy. Medical Policy Manual Approved Revised: Do Not Implement until 6/30/2019. Nivolumab

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1 Medical Manual Approved Revised: Do Not Implement until 6/30/2019 Nivolumab NDC CODE(S) XX Opdivo 40 MG/4ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) XX Opdivo 100 MG/10ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) XX Opdivo 240 MG/24 ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) DESCRIPTION Nivolumab is a human monoclonal antibody classified as an IgG4 kappa immunoglobulin. It blocks the interaction with PD-1, programmed death receptor-1, and its ligands PD-L1 and PD-L2. When the PD-1 receptor found on T- cells binds with its ligands, T-cell proliferation and cytokine production is inhibited. Some tumors cause increased production of PD-1 ligands and can contribute to the inhibition of active T-cell immune surveillance of tumors. Nivolumab releases pathway-mediated inhibition of the immune response, including the anti-tumor immune response, which results in decreased tumor growth. POLICY Nivolumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.) o Anal Carcinoma o Central Nervous System Cancer o Gestational Trophoblastic Neoplasia o Hepatocellular Carcinoma (HCC) o Hodgkin lymphoma o Melanoma o Merkel Cell Carcinoma o Microsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dmmr) Colorectal Cancer (CRC) o Non-small cell lung cancer (NSCLC) o Renal cell carcinoma (i.e., kidney cancer) o Small cell lung cancer (SCLC) o Squamous cell carcinoma of the head and neck o Urothelial carcinoma (Bladder Cancer) Nivolumab for the treatment of other conditions/diseases is considered investigational. MEDICAL APPROPRIATENESS INITIAL APPROVAL Nivolumab is considered medically appropriate if ALL of the following criteria are met: o Individual must be 18 years of age or older (unless otherwise specified) o Individual has not received previous therapy with a programmed death ligand (PD-1/PD-L1)-directed therapy (e.g., cemiplimab, avelumab, pembrolizumab, atezolizumab, durvalumab, etc.) unless otherwise specified o Diagnosis of ANY ONE of the following: Anal Carcinoma if ALL of the following: Individual has metastatic squamous cell disease Used as a single agent for second-line therapy Central Nervous System Cancer if ALL of the following: Used for the treatment of melanoma brain metastases Nivolumab must have been is active against the primary melanoma tumor Used in combination with ipilimumab

2 Medical Manual Approved Revised: Do Not Implement until 6/30/2019 Gestational Trophoblastic Neoplasia used as a single agent for ANY ONE of the following: Recurrent or progressive disease and has intermediate placental or epithelioid trophoblastic tumor and was previously treated with a platinum/etoposide-containing regimen Individual has methotrexate-resistant high-risk disease Hepatocellular Carcinoma (HCC) if ALL of the following: Used as a single agent Individual progressed on or was intolerant to sorafenib Individual has a laboratory confirmed diagnosis of hepatocellular carcinoma Individual has Child-Pugh Class A or B7 disease Hodgkin lymphoma (chl) classified as classical disease(chl) and ALL of the following: Used as a single agent Disease is relapsed or progressive for ANY ONE of the following: o Individual had an autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin o Individual has received 3 or more lines of systemic therapy that includes autologous HSCT Melanoma if ANY ONE of the following: Disease is unresectable or metastatic for ANY ONE of the following: o Used as a single agent or in combination with ipilimumab o Used in combination with ipilimumab in individuals who previously progressed on single agent checkpoint inhibitor immunotherapy Individual has unresectable or metastatic uveal melanoma and used as single agent or in combination with ipilimumab Used as adjuvant treatment as a single agent and individual has lymph node involvement or metastatic disease and has undergone complete resection Used for retreatment of disease and ANY ONE of the following: o Used for retreatment in individuals who experienced disease control, (i.e, complete or partial response or stable disease), but subsequently have disease progression/relapse > 3 months after treatment discontinuation o Used as subsequent therapy in combination with ipilimumab in individuals who experience disease relapse and/or progression within 3 months after initial monotherapy with an immune checkpoint-inhibitor Merkel Cell Carcinoma if ALL of the following: Used as a single agent Individual has disseminated metastatic disease Microsatellite Instability-High (MSI-H)/Mismatch Repair Deficient (dmmr) Colorectal cancer (CRC) if ALL of the following: Individual must be at least 12 years of age or older Disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dmmr) Individuals must not have a diagnosis of MSI-H central nervous system metastases Individual has ANY ONE of the following: o Individual has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan based chemotherapy and ANY ONE of the following: Used as a single agent for unresectable advanced or metastatic disease Used in combination with ipilimumab for metastatic disease o Used as primary treatment for individuals who failed adjuvant treatment with FOLFOX (fluorouracil, leucovorin and oxaliplatin) or CapeOX (capecitabine-oxaliplatin) in the previous 12 months and ANY ONE of the following: Used as a single agent or in combination with ipilimumab for unresectable metastatic disease

3 Medical Manual Approved Revised: Do Not Implement until 6/30/2019 Used as initial therapy for individuals who are not candidates for intensive therapy as a single agent for unresectable advanced or metastatic disease Non-small cell lung cancer (NSCLC) if ANY ONE of the following: Individual has disease with high tumor mutational burden (TMB) (i.e., 10 mutations per megabase) as ANY ONE of the following: o Used as single agent o Used in combination with ipilimumab Used as subsequent therapy in individuals with metastatic disease and ALL of the following: o Used as a single agent o Disease has progressed during or following cytotoxic therapy o Individuals with genomic tumor aberrations must have progressed following systemic therapy for those aberrations (e.g., EGFR, ALK, etc.) Renal cell carcinoma (RCC) (i.e., kidney cancer) if ANY ONE of the following: Used in combination with ipilimumab and ANY ONE of the following: o Initial therapy in individuals with advanced or metastatic disease with intermediate or poor risk o Used as subsequent therapy in individuals with relapsed, unresectable metastatic disease with clear cell histology; Used as a single agent for ANY ONE of the following: o Individual has advanced disease with intermediate or poor risk o Disease is relapsed, unresectable metastatic disease and ANY ONE of the following: Used as subsequent therapy for clear cell histology Individual has non-clear cell histology Small cell lung cancer (SCLC) if ANY ONE of the following: Used as subsequent systemic therapy for ANY ONE of the following: o Single agent therapy for metastatic disease after previous platinum-based treatment and at least one other line of therapy o Treatment as single agent or in combination with ipilimumab in individual with an ECOG performance status of 0-2 for ANY ONE of the following: Relapse within 6 months following complete or partial response or stable disease with initial treatment Primary progressive disease Squamous cell carcinoma of the head and neck (SCCHN) if ALL of the following: Single agent therapy Recurrent, unresectable, persistent or metastatic disease Disease progression on or after platinum-based therapy Urothelial carcinoma (bladder cancer) if ALL of the following: Treatment must be as a single agent Must be used as subsequent systemic therapy after previous platinum treatment* Disease is ANY ONE of the following: o Locally advanced or metastatic o Post-cystectomy recurrence o Recurrent or metastatic Primary Carcinoma of the Urethra and individual does not have recurrent stage T3-4 disease or palpable inguinal lymph nodes o Metastatic Upper GU Tract Tumors o Metastatic Urothelial Carcinoma of the Prostate *If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum based therapy. Patients with comorbidities (e.g., hearing loss, neuropathy, poor PS, renal insufficiency, etc.) may not be eligible for cisplatin. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 ml/min or a PS of 2.

4 Medical Manual Approved Revised: Do Not Implement until 6/30/2019 RENEWAL CRITERIA Nivolumab is considered medically appropriate for renewal if ALL of the following criteria are met: o Individual continues to meet initial approval criteria o Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread o Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: severe infusion reactions, complications of allogeneic HSCT, severe immune mediated adverse reactions such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis/renal dysfunction, rash, encephalitis, etc. o Adjuvant treatment of melanoma has not exceeded a maximum of twelve (12) months of therapy: o Retreatment for Melanoma (metastatic or unresectable disease) for ANY ONE of the following: Used for retreatment in individuals who experienced disease control, (i.e, complete or partial response or stable disease), but subsequently have disease progression/relapse > 3 months after treatment discontinuation Used as subsequent therapy in combination with ipilimumab in individuals who experience disease relapse and/or progression within 3 months after initial monotherapy with an immune checkpointinhibitor INDICATION(S) Merkel Cell CRC Anal Cancer Melanoma NSCLC,MSI-H/dMMR chl, SCCHN, HCC and Urothelial Carcinoma SCLC Renal Cell Carcinoma DOSAGE & ADMINISTRATION 3 mg/kg every 2 weeks Single agent: 240 mg every 2 weeks, until disease progression or unacceptable toxicity. 3 mg/kg every 3 weeks for 4 doses, then 240 mg every 2 weeks until disease progression or unacceptable toxicity. 240 mg every 2 weeks or 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. Single agent: 240 mg every 2 weeks OR 480 mg every 4 weeks Adjuvant single-agent treatment: 240 mg every 2 weeks or 480 mg every 4 weeks, until disease recurrence or unacceptable toxicity for up to 1 year 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks 240 mg every 2 weeks or 480 mg every 4 weeks, until disease progression or unacceptable toxicity. Single agent: 240 mg every 2 weeks until disease progression or unacceptable toxicity 1 mg/kg to 3 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 doses, then 3 mg/kg every 2 weeks Single-agent: 240 mg every 2 weeks or 480 mg every 4 weeks, until disease progression or unacceptable toxicity. 3 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4

5 Medical Manual Approved Revised: Do Not Implement until 6/30/2019 doses, then follow single-agent regimen Gestational Trophoblastic Neoplasia 240 mg on days 1, 15, 29 (every 2 weeks) of a 42 day cycle repeated until (GTN) disease progression or unacceptable toxicity 1 mg/kg, followed by ipilimumab on the same day, every 3 weeks for 4 CNS Metastases doses, then 3 mg/kg every 2 weeks Dosing should be calculated using actual body weight and not flat dosing (as applicable) based on the following: Weight 74 kg : Standard dose 240 mg IV every 2 weeks OR 480 mg IV every 4 weeks Weight is 67 kg to 73 kg : Use 440 mg IV every 4 weeks Weight is 66 kg Use 400 mg IV every 4 weeks Note: This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account. LENGTH OF AUTHORIZATION Coverage will be provided for six months and may be renewed. Adjuvant use in the treatment of melanoma patients can be authorized up to a maximum of 12 months of therapy. Click here to view DOSAGE LIMITS APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS BlueCross BlueShield of Tennessee s Medical complies with Tennessee Code Annotated Section regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the offlabel use is recognized in one of the statutorily recognized standard reference compendia or in the published peerreviewed medical literature. IMPORTANT REMINDER We develop Medical Policies to provide guidance to Members and Providers. This Medical relates only to the services or supplies described in it. The existence of a Medical is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical and a health plan, the express terms of the health plan will govern. ADDITIONAL INFORMATION For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ) published by the National Comprehensive Cancer Network, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

6 Medical Manual Approved Revised: Do Not Implement until 6/30/2019 SOURCES Lexicomp Online. (2018). AHFS DI. Nivolumab. Retrieved February 11, 2019 from Lexicomp Online with AHFS. MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, February). Nivolumab. Retrieved February 11, 2019 from MICROMEDEX Healthcare Series. National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium. Nivolumab. Retrieved February 11, 2019 from the National Comprehensive Cancer Network. U. S. Food and Drug Administration. (2019, February). Center for Drug Evaluation and Research. Opdivo (nivolumab) injection, for intravenous use. Retrieved February 11, 2019 from EFFECTIVE DTE 6/30/2019 ID_MRx

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