55513-0954-XX Vectibix 100 MG/5ML SOLN (AMGEN)
55513-0956-XX Vectibix 400 MG/20ML SOLN (AMGEN)
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.
Panitumumab for the treatment of colorectal carcinoma is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Panitumumab for the treatment of other conditions/diseases is considered investigational.
Panitumumab is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Diagnosis of colorectal cancer if ALL of the following:
Tumors express KRAS and NRAS wild-type genes (without mutation) as determined by FDA-approved tests*
Will not be used as part of an adjuvant treatment regimen
Individual has not been treated previously with cetuximab or panitumumab
Disease is ANY ONE of the following:
Progressive, metastatic and panitumumab is used as single agent therapy after failure with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy
Metastatic or unresectable advanced and is used in combination with ANY ONE of the following:
Irinotecan- or oxaliplatin-based regimen
Vemurafenib and irinotecan with a BRAF V600E mutation if used as ANY ONE of the following:
Primary therapy after previous adjuvant FOLFOX or CapeOX within the past 12 months
Subsequent therapy for disease progression after previous treatment with fluoropyrimidine-, oxaliplatin-, or irinotecan-based therapy
Panitumumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., dermatologic/soft tissue toxicities, electrolyte depletion, severe infusion related reactions, acute renal failure, pulmonary fibrosis/interstitial lung disease (ILD), keratitis, etc.
DOSAGE & ADMINISTRATION
6mg/kg intravenously every 14 days
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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.
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).
Lexi-Comp Online. (2019). AHFS DI. Panitumumab. Retrieved February 6, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, August). Panitumumab. Retrieved February 6, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Panitumumab. Retrieved October 12, 2018 from National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Vectibix® (Panitumumab). Retrieved February 6, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125147s207lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/9/2007
MOST RECENT REVIEW DATE: 5/31/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10 mg