Last Review Date: 06/06/2022

Date of Origin:  12/22/2009

Dates Reviewed: 12/2009, 03/2010, 07/2010, 09/2010, 12/2010, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020, 03/2021, 06/2021, 09/2021, 12/2021, 03/2022, 06/2022

I. Length of Authorization

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

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Vectibix 100 mg/5 mL solution for injection: 3 vials every 14 days
• Vectibix 400 mg/20 mL solution for injection: 1 vial every 14 days

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

• 70 units every 14 days   

III. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ^1,2

• Patient is both KRAS and NRAS mutation negative (wild-type) as determined by an FDA or CLIA-compliant testv; AND
• Patient has not been previously treated with cetuximab or panitumumab; AND
• Will not be used as part of an adjuvant treatment regimen; AND

Colorectal Cancer † ^1,2,6,11

• Patient has metastatic, unresectable (or medically inoperable), or advanced disease that is BRAF mutation negative (wild-type); AND
  • Used as primary treatment; AND

• Used in combination with FOLFOX †; OR
• Used in combination with FOLFIRI §; OR
• Used in combination with an irinotecan-based regimen after previous adjuvant FOLFOX or CapeOX within the past 12 months §; OR

• • Used as subsequent therapy; AND
• Used as a single agent for oxaliplatin- and/or irinotecan-refractory disease OR irinotecan-intolerant disease; OR
• Used in combination with irinotecan for oxaliplatin- and/or irinotecan-refractory disease §; OR
• Used in combination with FOLFIRI for oxaliplatin-refractory disease §**; OR
• Used in combination with FOLFOX for irinotecan-refractory disease §**; OR

• Patient has BRAF V600E mutation positive disease ‡; AND
  • Used in combination with encorafenib; AND

• Used as subsequent therapy for progression of advanced or metastatic disease after at least one prior line of treatment in the advanced or metastatic disease setting; OR
• Used as primary treatment for unresectable metastatic disease after previous adjuvant FOLFOX or CapeOX within the past 12 months

Appendiceal Adenocarcinoma – Colon Cancer ‡ ^2,6

• Patient has BRAF V600E mutation positive disease; AND
• Used in combination with encorafenib; AND
• Used as subsequent therapy for progression of advanced or metastatic disease after at least one prior line of treatment in the advanced or metastatic disease setting

§Colon cancer patients must have left-sided tumors only.

**May also be used for progression on non-intensive therapy, except if received previous fluoropyrimidine with improvement in functional status (Note: Colon cancer patients must have left-sided tumors only).

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

† FDA-labeled indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria ^1,6,11

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by a stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: dermatologic/soft-tissue toxicity, electrolyte depletion, severe infusion-related reactions, acute renal failure, pulmonary fibrosis/interstitial lung disease (ILD), photosensitivity, ocular toxicities (i.e., keratitis, corneal perforation), etc.

V. Dosage/Administration ^1,6,11

VI. Billing Code/Availability Information

HCPCS Code:

• J9303 – Injection, panitumumab, 10 mg; 1 billable unit = 10 mg

NDC(s):

• Vectibix 100 mg/5 mL single-dose vial; solution for injection: 55513-0954-xx
• Vectibix 400 mg/20 mL single-dose vial; solution for injection: 55513-0956-xx

VII. References

1. Vectibix [package insert]. Thousand Oaks, CA; Amgen, Inc; August 2021. Accessed May 2022.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) panitumumab. National Comprehensive Cancer Network, 2022. 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 May 2022.
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 1.2022. National Comprehensive Cancer Network, 2022. 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 May 2022.

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 1.2022. National Comprehensive Cancer Network, 2022. 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 May 2022.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Articles (LCAs), and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A