Panitumumab (Vectibix)

Policy ID: I-117-008

Section: Injections

Effective Date: February 01, 2020

Revised Date: November 08, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Applies To: Commercial and Medicaid Expansion

Description

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 (Vectibix) may be considered medically necessary for the treatment of metastatic colorectal cancer (mCRC) when the following are met:

Individuals with wild-type RAS (defined as wild-type in both KRAS and NRAS) 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

Compendia Sources

Panitumumab (Vectibix) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of panitumumab (Vectibix) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

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.

Diagnosis Codes

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C78.00

C78.01

C78.02

C78.6

C78.7

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 New Policy

Internal Medical Policy Committee 1-19-2021 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2021 Updated NCCN recommendations and diagnosis codes

Internal Medical Policy Committee 7-21-2022 Annual review, no clinical content change

Internal Medical Policy Committee 11-29-2022

Removed NCCN recommendations; and
Added this statement "Panitumumab (Vectibix) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations."; and
Updated experimental/investigational statement; and
Removed diagnosis codes C17.0, C17.1, C17.2, C17.8, C17.9, Z85.038 and Z85.068

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-117-007

Section: Injections

Effective Date: February 01, 2020

Revised Date: July 10, 2021

Revision Effective Date: September 01, 2021

Last Reviewed: July 21, 2022

Archived Date: December 31, 2022

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

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.