This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims.
Opdivo may be considered medically necessary in patients 18 years of age or older for unresectable or metastatic melanoma, adjuvant treatment of melanoma, metastatic non-small cell lung cancer, renal cell carcinoma, relapsed or progressed classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma Head and Neck, locally advanced or metastatic urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)metastatic colorectal cancer, hepatocellular carcinoma, malignant pleural mesothelioma, small cell lung cancer, Not FDA approved indication for metastatic anal carcinoma or Merkel cell carcinoma; and if the conditions indicated below are met.
Nivolumab (Opdivo) is recommended by the NCCN Drugs and Biologics Compendium® for off-label use for the following indications:
• Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) – as initial therapy as a single agent or in combination with ibrutinib for either clonally related or unknown clonal status Richter’s transformation to diffuse large B-cell lymphoma in patients with del(17p)/TP53 mutations and who are chemotherapy refractory and unable to receive chemoimmunotherapy
• Classic Hodgkin lymphoma – as single agent, palliative therapy for individuals age 60 and older with relapsed or progressive disease following autologous HSCT without brentuximab vedotin, relapsed/refractory disease and transplant-ineligible based on comorbidity or failure of second-line therapy, or post-allogeneic transplant
• Classic Hodgkin lymphoma – as single agent, third-line or subsequent therapy for relapsed or progressive disease after autologous hematopoietic stem cell transplant without brentuximab vedotin, for relapsed/refractory disease and transplant-ineligible based on comorbidity or failure of second-line chemotherapy, or post-allogeneic transplant individuals age ≥ 18 and < 60
• CNS - Brain metastases (limited) – in combination with ipilimumab (preferred) or as a single agent for limited brain metastases in patients with melanoma as initial treatment in select patients, as treatment for recurrent brain metastases, or as treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options
• CNS Brain metastases (limited) - as a single agent for limited brain metastases in patients with PD-L1 positive non-small cell lung cancer as initial treatment in select patients, as treatment for recurrent brain metastases, or as treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options
• CNS - Brain metastases (extensive) - in combination with ipilimumab (preferred) or as a single agent for extensive brain metastases in patients with melanoma as primary treatment in select patients or as treatment for recurrent disease with stable systemic disease or reasonable systemic treatment options
• CNS Brain metastases (extensive) - as a single agent for extensive brain metastases in patients with PD-L1 positive non-small cell lung cancer as primary treatment in select patients or as treatment for recurrent disease with stable systemic disease or reasonable systemic treatment options
• Colon cancer - as primary treatment for locally unresectable or medically inoperable disease as a single agent or in combination with ipilimumab
• Colon cancer - adjuvant therapy for dMMR/MSI-H tumors as a single agent or in combination with ipilimumab following resection and/or local therapy for resectable metachronous metastases, unresectable metachronous metastases that converted to resectable disease after primary treatment, and following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment
• Colon cancer - primary neoadjuvant treatment for dMMR/MSI-H, resectable synchronous liver and/or lung metastases as a single agent or in combination with ipilimumab
• Colon cancer - as primary or initial therapy for unresectable or metastatic dMMR/MSI-H only disease as a single agent or in combination with ipilimumab for unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy, unresectable synchronous liver and/or lung metastases only, synchronous abdominal/peritoneal metastases, synchronous unresectable metastases of other sites, primary treatment for unresectable metachronous metastases, or unresectable metachronous metastases that remain unresectable after primary treatment
• Colon cancer - as single agent treatment for progression of dMMR/MSI-H unresectable advanced disease
• Extranodal NK/T-cell lymphoma, nasal type - as a single agent for relapsed or refractory disease following additional therapy with an alternate asparaginase-based combination chemotherapy regimen, not previously used and when a clinical trial is not available
• Melanoma (cutaneous) - as single agent, adjuvant therapy for resected stage III sentinel node-positive disease during nodal basin ultrasound surveillance or after completion lymph node dissection; stage III disease with clinically positive node(s) following wide excision of primary tumor and therapeutic lymph node dissection; stage III disease with clinical satellite/in-transit metastases if no evidence of disease after complete excision to clear margins; stage III disease with clinical satellite/in-transit metastases if no evidence of disease after initial local or regional therapy; local satellite/in-transit recurrence after complete excision to clear margins; local satellite/in-transit recurrence and no evidence of disease after initial local or regional therapy; or following therapeutic lymph node dissection and/or complete resection of nodal recurrence
• Melanoma (cutaneous) - as a single agent or in combination with ipilimumab as initial therapy for limited resectable stage III disease with clinical satellite/in-transit metastases or limited resectable local satellite/in-transit recurrence
• Melanoma (cutaneous) - reinduction therapy as a single agent or in combination with ipilimumab for metastatic or unresectable disease when prior anti PD-1 checkpoint inhibitor immunotherapy resulted in disease control with subsequent disease progression or relapse more than 3 months after treatment was discontinued and when there is no residual toxicity
• Vulvar cancer - as single agent, second-line therapy for HPV-related, locally advanced or metastatic disease
Opdivo is considered investigational in all other patients and for all other indications.
