Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Ipilimumab (Yervoy) may be considered medically necessary in individuals 12 years of age or older for ANY of the following indications:
Food and Drug Administration (FDA) Indications
Colorectal Cancer
- As treatment in combination with nivolumab of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; or
Hepatocellular Carcinoma
- As treatment of individuals who have been previously treated with sorafenib, in combination with nivolumab; or
Malignant Pleural Mesothelioma
- As first-line treatment in combination with nivolumab for individuals 18 years of age and older with unresectable malignant pleural mesothelioma; or
Melanoma
- As treatment for individuals with unresectable or metastatic disease; or
- As adjuvant treatment for individuals with cutaneous melanoma with pathologic involvement of regional lymphoma nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy; or
- As treatment in combination with nivolumab for individuals 18 years of age and older with unresectable or metastatic melanoma; or
Non-Small Cell Lung Cancer (NSCLC)
- As first-line treatment in combination with nivolumab for individuals 18 years of age and older with metastatic disease expressing PD-L1 (1% or greater) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; or
- Treatment of individuals 18 years of age and older with metastatic or recurrent disease with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and two (2) cycles of platinum-doublet chemotherapy; or
Renal Cell Carcinoma
- As therapy in combination with nivolumab for the treatment of advanced disease in individuals with intermediate or poor-risk, previously untreated advanced renal cell carcinoma; or
National Comprehensive Cancer Network (NCCN) Recommendations
Central Nervous System (CNS) Lesions - Metastatic Melanoma
- As treatment for limited brain metastases as a single agent or in combination with nivolumab in individuals with melanoma for ANY of the following:
- As initial treatment in select individuals (e.g., with small asymptomatic brain metastases); or
- For recurrent brain metastases; or
- As treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options; or
- As treatment for recurrent extensive brain metastases in individuals with melanoma as primary treatment in select individuals (e.g., those with small asymptomatic brain metastases), stable systemic disease, or reasonable systemic treatment options for ANY of the following:
- In combination with nivolumab; or
- As a single agent; or
Colorectal Cancer
- As subsequent therapy in combination with nivolumab (if no previous treatment with a checkpoint inhibitor) for advanced or metastatic disease (dMMR/MSI-H only) following previous oxaliplatin-irinotecan-and/or fluoropyrimidine-based therapy; or
- As primary treatment in combination with nivolumab for unresectable metachronous metastases (dMMR/MSI-H only) and previous adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) within the past 12 months; or
- As therapy in combination with nivolumab in individuals dMMR/MSI-H only who are not appropriate for intensive therapy in EITHER of the following:
- As adjuvant treatment following resection and/or local therapy for resectable metachronous metastases in individuals who have received previous chemotherapy; or
- As adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment; or
- As therapy in combination with nivolumab (dMMR/MSI-H only) who are not appropriate for intensive therapy in ANY of the following:
- For unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy; or
- As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing of imminent obstruction; or
- For synchronous unresectable metastases of other sites; or
- As primary treatment for unresectable metachronous metastases in individuals who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy; or
- For unresectable metachronous metastases that remain unresectable after primary treatment; or
- For colon cancer ONLY:
- As primary treatment for locally unresectable or medically inoperable disease; or
- For rectal cancer ONLY:
- As primary treatment for T3, N Any; T1-2, N1-2;T4,N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant therapy; or
- Following palliative radiation therapy (RT) or chemo/RT for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable (with progression of primary tumor) after primary systemic therapy; or
Hepatocellular Carcinoma
- As subsequent treatment in combination with nivolumab (if Child-Pugh Class A only) for progressive disease in individuals who have not been previously treated with a checkpoint inhibitor and ANY of the following:
- Have unresectable disease and are not a transplant candidate; or
- Are inoperable by performance status or comorbidity, or have local disease or local disease with minimal extrahepatic disease only; or
- Have metastatic disease or extensive liver tumor burden; or
Malignant Pleural Mesothelioma
- As subsequent systemic therapy in combination with nivolumab; or
Melanoma, Cutaneous
- As adjuvant treatment for cutaneous melanoma as a high-dose single agent (if prior exposure to anti-PD-1 therapy) in ANY of the following:
- For local satellite/in-transit recurrence if no evidence of disease after complete excision to clear margins, or if no evidence of disease after initial treatment with local or regional therapy; or
- Following therapeutic lymph node dissection and/or complete resection of nodal recurrence; or
- Following complete resection of distant metastatic disease; or
- As first-line therapy in combination with nivolumab or at a low dose with pembrolizumab for metastatic or unresectable cutaneous melanoma; or
- As second-line or subsequent therapy for metastatic or unresectable cutaneous melanoma after disease progression or maximum clinical benefit from BRAF-targeted therapy in ANY of the following:
- As a single agent if checkpoint inhibitor immunotherapy was not previously used; or
- In combination with nivolumab if checkpoint inhibitor immunotherapy was not previously used or for individuals who progress on single agent checkpoint inhibitor immunotherapy; or
- In combination with intralesional injection of talimogene laherparepvec; or
- As re-induction therapy as a single agent or in combination with nivolumab if prior checkpoint inhibitor immunotherapy resulted in disease control and no residual toxicity, and disease progression/relapse occurred greater than three months after treatment discontinuation; or
Melanoma, Uveal
- As therapy for distant metastatic disease for ANY of the following:
- As single agent therapy; or
- In combination with nivolumab; or
Neuroendocrine and Adrenal Tumors
- As treatment in combination with nivolumab for non-pancreatic neuroendocrine tumors (poorly differentiated/high grade/large or small cell) if progression on first-line chemotherapy for metastatic disease; or
Non-Small Cell Lung Cancer (NSCLC)
- As treatment for recurrent, advanced, or metastatic disease as first-line therapy for PD-L1 expression positive (1% or greater) tumors that are EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET negative and no contraindications to PD-1 or PD-L1 inhibitors with performance status (PS) of 0-2 in ANY of the following:
- In combination with nivolumab; or
- In combination with nivolumab, pemetrexed, and either carboplatin or cisplatin for nonsquamous cell histology; or
- In combination with nivolumab, paclitaxel, and carboplatin for squamous cell histology; or
- As therapy for NSCLC with high tumor mutational burden (e.g., 10 or more mutations per megabase) in combination with nivolumab; or
- As treatment for recurrent, advanced, or metastatic disease in combination with nivolumab; nivolumab, pemetrexed, and either carboplatin or cisplatin for nonsquamous cell histology; or in combination with nivolumab, paclitaxel, and carboplatin for squamous cell histology for individuals with PS 0-1 and no contraindications to PD-1 or PD-L1 inhibitors as ANY of the following:
- As initial systemic therapy for EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET negative and PD-L1 less than 1%; or
- As first-line or subsequent therapy for BRAF V600E-mutation positive tumors; or
- As first-line or subsequent therapy for NTRK gene fusion positive tumors; or
- As first-line or subsequent therapy for MET exon 14 skipping mutation positive tumors; or
- As first-line or subsequent therapy for RET rearrangement positive tumors; or
- As subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib with or without ramucirumab or bevacizumab, afatinib, gefitinib, osimertinib, or dacomitinib therapy; or
- As subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, ceritinib, alectinib, or brigatinib therapy; or
- As subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib, entrectinib, or ceritinib therapy; or
Renal Cell Carcinoma
- Used in combination with nivolumab for four (4) cycles followed by single-agent nivolumab for relapsed or stage IV disease with clear cell histology in ANY of the following:
- As first-line therapy for favorable risk; or
- As first-line therapy for poor/intermediate risk; or
- As subsequent therapy; or
Small Bowel Adenocarcinoma and Advanced Ampullary Cancer
- In combination with nivolumab for advanced or metastatic disease (dMMR/MSI-H) for ANY of the following:
- As initial therapy with prior oxaliplatin exposure in the adjuvant setting or contraindication; or
- As subsequent therapy.
The use of ipilimumab (Yervoy) for any other indication is considered experimental/investigational. Scientific evidence does not support the use of ipilimumab (Yervoy) for any other indication.
