BlueCross BlueShield of Tennessee Medical Policy Manual

Panitumumab (Vectibix®)

NDC CODE(S)

55513-0954-XX VECTIBIX 100MG/5ML Solution (AMGEN)

55513-0956-XX VECTIBIX 400MG/20ML Solution (AMGEN)

DESCRIPTION

Panitumumab is a recombinant human IgG2 kappa monoclonal antibody which binds specifically to the human epidermal growth factor receptor (EGFR).  EGFR is expressed in multiple cell lines including epithelial tissues and is over-expressed in certain cancers.  EGFR functions in a complex cascade system that affects gene transcription involved with cellular growth, motility and proliferation.  By binding to EGFR, panitumumab interrupts the cascade which ultimately leads to the development of cancer. This results in inhibition of excessive cell growth, induction of apoptosis, and decreased proinflammatory cytokine and vascular growth factor production.

In the EGFR cascade, certain proteins including the RAS proteins normally function as switches in the kinase pathway activated between cell surface EGFR and downstream signaling.  The gene mapping normal, non-mutated gene is referred to as a wild-type gene.  Mutations in one specific RAS protein, the KRAS gene, occur in 30% to 50% of colorectal cancers as well as other tumor types.  These mutations in KRAS cause activation of the EGFR pathway beyond the point at which panitumumab would bind with EGFR and interrupt the cascade.  This renders panitumumab and other anti-EGFR agents ineffective against those tumors expressing RAS mutations such as KRAS and, found more recently, those in another of the RAS proteins, NRAS.

Another common mutation is found in the BRAF gene, a serine/threonine kinase.  BRAF encodes a component downstream of the RAS proteins in the EGFR cascade. The BRAF gene is important for transducing mitogenic signals from the cell surface.  BRAF mutations have been found in thyroid, colorectal and lung cancers as well as in a majority of malignant melanomas, however specific targeting and treatment of BRAF-dependent tumors remains under investigation.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Universal Criteria

Colorectal Cancer

*If confirmed using an FDA approved assay - http://www.fda.gov/companiondiagnostics

RENEWAL CRITERIA

DOSAGE/ADMINISTRATION

INDICATION

DOSE

Colorectal Cancer

Administer 6 mg/kg intravenously every 14 days until disease progression or unacceptable toxicity.

LENGTH OF AUTHORIZATION

Coverage will be provided for 6 months and may be renewed.

DOSING LIMITS

Max Units (per dose and over time) [HCPCS Unit]:

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

1.     Vectibix [package insert]. Thousand Oaks, CA; Amgen, Inc; June 2017. Accessed January 2021.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) panitumumab. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

3.     Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.

4.     Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf

5.     Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.

6.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Colon Cancer. Version 1.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

7.     Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol. 2007 May 1;25(13):1658-64.

8.     Price TJ, Peeters M, Kim TW, et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14.

9.     Kim TW, Elme A, Kusic Z, et al. A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer. Br J Cancer. 2016 Nov 8;115(10):1206-1214. doi: 10.1038/bjc.2016.309. Epub 2016 Oct 13.

10.  Douillard JY, Siena S, Cassidy J, et al. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jul;25(7):1346-55. doi: 10.1093/annonc/mdu141. Epub 2014 Apr 8.

11.  Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Rectal Cancer. Version 1.2021. National Comprehensive Cancer Network, 20201. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed January 2021.

12.  Lexi-Comp Online. (2021, February). AHFS DI. Panitumumab. Retrieved March 24, 2021 from Lexi-Comp Online with AHFS.

13.  MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2020, December). Panitumumab. Retrieved March 24, 2021 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE:  6/9/2007

MOST RECENT REVIEW DATE:   7/31/2021

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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