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Panitumumab (Vectibix)

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

Panitumumab (Vectibix®) is a human, IgG2 kappa recombinant, monoclonal antibody that binds specifically to the human epidermal growth factor receptor (EGFR). It is an injectable drug that may be used in the treatment of colorectal cancer.

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.

Panitumumab may be considered medically necessary for the following indications:

Food and Drug Administration (FDA) Indications

  • FDA approved indication for the treatment of individuals with wild-type RAS (defined as wild-type in both KRAS and NRAS)  metastatic colorectal cancer (mCRC) as determined by an FDA-approved test as ANY of the following:
    • First-line therapy in conjunction with FOLFOX (fluorouracil, leucovorin, and oxaliplatin); or
    • Monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy; or

 

National Comprehensive Cancer Network (NCCN) Indications

Colon Cancer

  • Therapy for KRAS/NRAS/BRAF wild-type gene and left-sided only tumors in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, or as a single agent in individuals not appropriate for intensive therapy
    • As primary treatment for locally unresectable or medically inoperable disease; or
    • 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 or 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
  • Primary treatment for unresectable synchronous liver and/or lung metastases (KRAS/NRAS/BRAF wild-type gene and left-sided tumors only) in combination with
    • FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen;  or
    • FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen; or
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin and irinotecan) regimen; or
  • Therapy for KRAS/NRAS/BRAF wild-type gene and left-sided only tumors in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, or as a single agent in individuals not appropriate for intensive therapy
    • As adjuvant treatment following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment, or
    • As adjuvant treatment following resection and/or local therapy for resectable metachronous metastases in individuals who have received previous chemotherapy or had growth on neoadjuvant chemotherapy; or
    • As adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment; or
  • Primary treatment for individuals with unresectable metachronous metastases (KRAS/NRAS/BRAF wild-type gene and left-sided tumors only) and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months:
    • In combination with irinotecan; or
    • In combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen; or
  • Primary treatment in combination with irinotecan and vemurafenib for individuals with unresectable metachronous metastases (BRAF V600E mutation positive) and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months.
  • Subsequent therapy for progression of unresectable advanced or metastatic disease (KRAS/NRAS/BRAF wild-type only) not previously treated with cetuximab or panitumumab:
    • In combination with irinotecan or with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen if previously treated with oxaliplatin-based therapy without irinotecan; or
    • In combination with irinotecan or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen if previously treated with irinotecan-based therapy without oxaliplatin; or
    • In combination with irinotecan if previously treated with FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
    • In combination with irinotecan if previously treated with a fluoropyrimidine without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabin, and oxaliplatin) with or without bevacizumab; or
  • Subsequent therapy in combination with irinotecan and vemurafenib for progression of unresectable advanced or metastatic disease (BRAF V600E mutation positive) not previously treated with cetuximab or panitumumab, in individuals previously treated with:
    • Oxaliplatin-based therapy without irinotecan Irinotecan-based therapy without oxaliplatin; or
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
    • A fluoropyrimidine without irinotecan or oxaliplatin followed by; or
    • FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab; or
  • Subsequent therapy in combination with dabrafenib and trametinib or with encorafenib and binimetinib for progression of unresectable advanced or metastatic disease (BRAF V600E mutation positive) not previously treated with cetuximab or panitumumab, in individuals previously treated with:
    • Oxaliplatin-based therapy without irinotecan; or
    • Irinotecan-based therapy without oxaliplatin; or
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
    • A fluoropyrimidine without irinotecan or oxaliplatin followed by; or
    • FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab; or

Rectal Cancer

  • Therapy for KRAS/NRAS/BRAF wild-type gene tumors in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, or as a single agent in individuals not appropriate for intensive therapy:
    • 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
    • For synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable (with no progression of primary tumor) after primary systemic therapy; or
    • Following short-course 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
    • As primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for individuals with existing or imminent obstruction; or
    • As primary treatment 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
  • Primary treatment for synchronous liver only and/or lung only metastases (KRAS/NRAS/BRAF wild-type gene only) that are unresectable or medically inoperable in combination with:
    • FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen; or
    • FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen; or
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin and irinotecan) regimen; or
  • Therapy for KRAS/NRAS/BRAF wild-type gene tumors in combination with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, or as a single agent in individuals not appropriate for intensive therapy:
    • As adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases in individuals who have received previous chemotherapy or had growth on neoadjuvant chemotherapy; or
    • As adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment; or
  • Primary treatment for individuals with unresectable metachronous metastases (KRAS/NRAS/BRAF wild-type gene only) and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months
    • In combination with irinotecan; or
    • In combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen; or
  • Primary treatment in combination with irinotecan and vemurafenib for individuals with unresectable metachronous metastases (BRAF V600Emutation positive) and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months; or
  • Subsequent therapy for progression of unresectable advanced or metastatic disease (KRAS/NRAS/BRAF wild-type gene only) not previously treated with cetuximab or panitumumab:
    • In combination with irinotecan or with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen if previously treated with oxaliplatin-based therapy without irinotecan; or
    • In combination with irinotecan or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen if previously treated with irinotecan-based therapy without oxaliplatin; or
    • In combination with irinotecan if previously treated with FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
    • In combination with irinotecan if previously treated with a fluoropyrimidine without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab; or
  • Subsequent therapy in combination with irinotecan and vemurafenib for progression of unresectable advanced or metastatic disease (BRAF V600E mutation positive) not previously treated with cetuximab or panitumumab, in individuals previously treated with:
    • Oxaliplatin-based therapy without irinotecan; or
    • Irinotecan-based therapy without oxaliplatin; or
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
    • A fluoropyrimidine without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab; or
  • Subsequent therapy in combination with dabrafenib and trametinib or with encorafenib and binimetinib for progression of unresectable advanced or metastatic disease (BRAF V600E mutation positive) not previously treated with cetuximab or panitumumab, in individuals previously treated with:
    • Oxaliplatin-based therapy without irinotecan; or
    • Irinotecan-based therapy without oxaliplatin; or
    • FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
    • A fluoropyrimidine without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab.

 

Panitumumab is considered experimental/investigational and, therefore, non-covered any other indications. Peer reviewed literature does not support the use of panitumumab for any indications other than those listed on this medical policy.

Procedure Codes

J9303

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

C17.0 C17.1 C17.2 C17.8 C17.9 C18.0 C18.1
C18.2 C18.3 C18.4 C18.5 C18.6 C18.7 C18.8
C18.9 C19 C20 C21.8 C78.6 C78.7 C78.00
C78.01 C78.02 C78.5 Z85.038 Z85.048

Professional Statements and Societal Positions Guidelines

NA

Links