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 (Vectibix) may be considered medically necessary for the following indications:
Food and Drug Administration (FDA) Indications
- 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 in individuals 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
- An individual has progressed on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status; or
- Therapy for KRAS/NRAS/BRAF wild-type gene and left-sided only tumors as a single agent in patients 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 patients with existing or imminent obstruction; or
- For synchronous unresectable metastases of other sites; or
- As primary treatment for unresectable metachronous metastases in patients 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 in individuals appropriate for intensive therapy or as a single agent in individuals not appropriate for intensive therapy when used:
- 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
- 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 encorabenib 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; or
- Adjuvant treatment in combination with FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, irinotecan) regimen for KRAS/NRAS/BRAF wild-type and left-sided only tumors following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment; or
- Adjuvant treatment in combination with irinotecan for unresectable metachronous metastases (KRAS/NRAS/BRAF wild-type gene only) that converted to resectable disease after primary treatment; or
- Adjuvant treatment in combination with encorafenib for unresectable metachronous metastases (BRAF V600E mutation positive) that converted to resectable disease after primary treatment; or
- Subsequent therapy for progression of advanced or metastatic disease (KRAS/NRAS/BRAF wild-type only):
- In combination with irinotecan, with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, or as a single agent for individuals who cannot tolerate irinotecan, if previously treated with oxaliplatin-based therapy without irinotecan; or
- In combination with irinotecan, FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen, or as a single agent for individuals who cannot tolerate irinotecan if previously treated with irinotecan-based therapy without oxaliplatin; or
- In combination with irinotecan or as a single agent for individuals who cannot tolerate irinotecan if previously treated with oxaliplatin and irinotecan; or
- In combination with irinotecan or as a single agent for individuals who cannot tolerate irinotecan if previously treated 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 encorafenib for progression of advanced or metastatic disease (BRAF V600E mutation positive) in individuals previously treated:
- With oxaliplatin-based therapy without irinotecan; or
- With Irinotecan-based therapy without oxaliplatin; or
- Treatment with oxaliplatin and irinotecan; or
- FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen; or
- Without irinotecan or oxaliplatin; or
- Without irinotecan or oxaliplatin followed by 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 in individuals 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 total 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 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
- 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 isolated pelvic/anastomotic recurrence; 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
- And who have progressed on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status; or
- Therapy for KRAS/NRAS/BRAF wild-type gene tumors 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 or total 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 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
- 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 isolated pelvic/anastomotic recurrence; 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 in individuals 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
- And who have progressed on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status; or
- Therapy for KRAS/NRAS/BRAF wild-type gene tumors 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 patients who have received previous 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 encorafenib 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 advanced or metastatic disease (KRAS/NRAS/BRAF wild-type gene only):
- In combination with irinotecan, FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen, or as a single agent for individuals who cannot tolerate irinotecan if previously treated with oxaliplatin-based therapy without irinotecan; or
- In combination with irinotecan, FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen, or as a single agent for individuals who cannot tolerate irinotecan if previously treated with irinotecan-based therapy without oxaliplatin; or
- In combination with irinotecan or as a single agent for individuals who cannot tolerate irinotecan if previously treated with oxaliplatin and irinotecan; or
- In combination with irinotecan or as a single agent for individuals who cannot tolerate irinotecan if previously treated 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 encorafenib for progression of advanced or metastatic disease (BRAF V600E mutation positive), in individuals previously treated:
- With oxaliplatin-based therapy without irinotecan; or
- With irinotecan-based therapy without oxaliplatin; or
- With oxaliplatin and irinotecan; or
- Without irinotecan or oxaliplatin; or
- Without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab; or
- Adjuvant treatment in combination with irinotecan for unresectable metachronous metastases (KRAS/NRAS/BRAF wild-type gene only) that converted to resectable disease after primary treatment; or
- Adjuvant treatment in combination with encorafenib for unresectable metachronous metastases (BRAF V600E mutation positive) that converted to resectable disease after primary treatment.
Panitumumab (Vectibix) is considered experimental/investigational and, therefore, non-covered any other indications. Peer reviewed literature does not support the use of panitumumab (Vectibix) for any indications other than those listed on this medical policy.
Procedure Codes