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Last Review Date: 03/05/2024

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, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 12/2023, 03/2024

1. Length of Authorization

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

2. Dosing Limits

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

• Vectibix 100 mg/5 mL solution for injection single-dose vial: 3 vials every 14 days
• Vectibix 400 mg/20 mL solution for injection single-dose vial: 2 vial every 14 days

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

• 70 billable units every 14 days  

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Colorectal Cancer † ‡ ^1,2,6,11-12

• Patient has not been previously treated with cetuximab or panitumumab; AND
• Will not be used as part of an adjuvant treatment regimen; AND
  • Patient has both KRAS and NRAS mutation negative (wild-type) and BRAF V600E negative (wild-type) disease as determined by an FDA or CLIA-compliant testv; AND

• Used as primary treatment for metastatic or unresectable (or medically inoperable) disease; AND

• Used in combination with FOLFOX †; OR
• Used in combination with CapeOX or FOLFIRI §; AND
  • Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
  • Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
    1. Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR

• Used in combination with irinotecan §; AND
  • Patient previously received FOLFOX or CapeOX within the past 12 months; AND
  • Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR

• Used as primary treatment for T3, N Any; T1-2, N1-2; T4, N Any rectal cancer; AND
• Used in combination with CapeOX, FOLFOX, or FOLFIRI; AND
  • Used if resection is contraindicated following total neoadjuvant therapy; AND
    1. Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
    5. Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND

• • Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
• Used if resection is contraindicated following neoadjuvant/definitive immunotherapy; AND
  1. Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease; OR

• Used as subsequent therapy for advanced or metastatic disease; AND
• Used as a single agent; AND
  • Patient has fluoropyrimidine-, oxaliplatin-, and irinotecan-refractory disease †; OR
  • Patient has irinotecan-intolerant disease §; AND
    1. Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
    5. Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND

• • • Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
• Used in combination with irinotecan §; AND
  • Patient has oxaliplatin-refractory disease, irinotecan-refractory disease, or oxaliplatin- and irinotecan-refractory disease; AND
    1. Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
    5. Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND

• • • Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
• Used in combination with FOLFIRI §; AND
  • Patient has oxaliplatin-refractory disease**; AND
    1. Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
    5. Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND

• • • Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR
• Used in combination with FOLFOX or CapeOx §; AND
  • Patient has irinotecan-refractory disease**; AND
    1. Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
    5. Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND

• • • Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR

• Patient has BRAF V600E mutation positive disease as determined by an FDA or CLIA-compliant testv ‡; AND

• Used in combination with encorafenib; AND
• Used as initial treatment for unresectable metastatic disease after previous FOLFOX or CapeOX within the past 12 months; AND
  • Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
• 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; AND
  • Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
  • Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
    1. Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy; OR

• Patient has KRAS G12C mutation positive disease as determined by an FDA-approved or CLIA-compliant testv ‡; AND

• Used in combination with sotorasib or adagrasib; AND
• Used as initial treatment for unresectable metastatic disease after previous FOLFOX or CapeOx within the past 12 months; AND
  • Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
• 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; AND
  • Patient has proficient mismatch repair/microsatellite-stable (pMMR/MSS) disease; OR
  • Patient has deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) disease or polymerase epsilon/delta (POLE/POLD1) mutation; AND
    1. Patient is not a candidate for or has progressed on checkpoint inhibitor immunotherapy

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

**May also be used for progression on non-intensive therapy in patients with improvement in functional status (except if received previous fluoropyrimidine).

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

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,6,11

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the 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.

5. Dosage/Administration ^1,6,11-12

6. 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

7. References

1. Vectibix [package insert]. Thousand Oaks, CA; Amgen, Inc.; August 2021. Accessed January 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) panitumumab. National Comprehensive Cancer Network, 2024. 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 2024.
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 1.2024. National Comprehensive Cancer Network, 2024. 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 2024.

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 1.2024. National Comprehensive Cancer Network, 2024. 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 2024.
12. Kuboki Y, Yaeger R, Fakih MG, et al. Sotorasib in combination with panitumumab in refractory KRAS G12C-mutated colorectal cancer: Safety and efficacy for phase Ib full expansion cohort. Ann Oncol 2022;33:S136-S196.

Appendix 1 – Covered Diagnosis Codes

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

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

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