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Ipilimumab (Yervoy)

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020

Description

Ipilimumab (Yervoy®) is a recombinant, human monoclonal antibody that binds to cytotoxic T-lymphocyte 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, resulting in an increase in antitumor responsiveness and allowing the body’s immune system to recognize, target, and attack cells in tumors.

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 patients 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

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

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 in individuals with melanoma for ANY of the following:
    • In combination with nivolumab for newly diagnosed brain metastases in select individuals (e.g., with small asymptomatic brain metastases) and stable systemic disease or reasonable systemic treatment options; or
    • In combination with nivolumab for recurrent brain metastases; or
    • As a single agent for recurrent brain metastases; or
  • As treatment for recurrent extensive brain metastases in individuals with melanoma and stable systemic disease or reasonable systemic treatment options for ANY of the following:
    • In combination with nivolumab; or
    • As a single agent; or

Colon Cancer

  • In combination with nivolumab for ANY of the following:
    • As subsequent therapy (if not previously treated with a checkpoint inhibitor) for unresectable advanced or metastatic disease (dMMR/MSI-H) following previous oxaliplatin-irinotecan-and/or fluoropyrimidine-based therapy; or
    • As initial therapy for individuals with unresectable advanced or metastatic disease (dMMR/MSI-H) who are not appropriate for intensive therapy; or
    • As primary treatment for unresectable metachronous metastases (dMMR/MSI-H) and previous adjuvant therapy with EITHER of the following:
      • Fluorouracil, leucovorin, and oxaliplatin (FOLFOX); or
      • Capecitabine and oxaliplatin (CapeOX); or

Malignant Pleural Mesothelioma

  • As subsequent systemic therapy in combination with nivolumab; or

Melanoma

  • As adjuvant treatment for cutaneous melanoma as a high-dose single agent (if prior exposure to nivolumab or pembrolizumab) in ANY of the following:
    • Following complete 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 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 metastatic or unresectable disease for ANY of the following:
    • As single agent therapy; or
    • In combination with nivolumab; or

Non-Small Cell Lung Cancer (NSCLC)

  • As therapy for tumor mutational burden in combination with nivolumab; or

Rectal Cancer

  • In combination with nivolumab for unresectable advanced or metastatic disease (dMMR/MSI-H) for ANY of the following:
    • As initial therapy for individuals who are not appropriate for intensive therapy; or
    • As subsequent therapy following previously oxaliplatin-irinotecan-and/or fluoropyrimidine-based therapy; or
    • As primary treatment for individuals with previous adjuvant FOLFOX or CapeOX therapy within the past 12 months; or

Renal Cell Carcinoma

  • Used in combination with nivolumab for 4 cycles followed by single-agent nivolumab for relapsed or stage IV disease in ANY of the following:
    • As first-line therapy for clear cell histology and favorable risk; or
    • As preferred first-line therapy for clear cell histology and poor/intermediate risk; or
    • As subsequent therapy for clear cell histology; or

Small Bowel Adenocarcinoma

  • 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; or

Small Cell Lung Cancer (SCLC)

  • Subsequent systemic therapy for patients with performance status 0-2 in combination with nivolumab for ANY of the following:
    • Relapse within six (6) months following complete or partial response or stable disease with initial treatment; or
    • Primary progressive disease.

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.

Procedure Codes

J9228

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes

C7A.1 C17.0 C17.1 C17.2 C17.3 C17.8 C17.9
C18.0 C18.2 C18.3 C18.4 C18.5 C18.6 C18.7
C18.8 C18.9 C19 C20 C21.0 C21.1 C21.8
C33 C34.00 C34.01 C34.02 C34.10 C34.11 C34.12
C34.2 C34.30 C34.31 C34.32 C34.80 C34.81 C34.82
C34.90 C34.91 C34.92 C38.4 C43.0 C43.10 C43.111
C43.112 C43.121 C43.122 C43.20 C43.21 C43.22 C43.30
C43.31 C43.39 C43.4 C43.51 C43.52 C43.59 C43.60
C43.61 C43.62 C43.70 C43.71 C43.72 C43.8 C43.9
C45.0 C64.1 C64.2 C64.9 C65.1 C65.2 C65.9
C69.30 C69.31 C69.32 C69.40 C69.41 C69.42 C69.60
C69.61 C69.62 C69.90 C69.91 C69.92 C78.00 C78.01
C78.02 C78.6 C78.7 C79.31 C79.51 C79.52 C80.0
C80.1 Z85.038 Z85.068 Z85.118 Z85.528 Z85.53 Z85.820

Professional Statements and Societal Positions Guidelines

NA

Links