Medical Policy
Effective Date:12/02/2009 Title:Vectibix (Panitumumab)
Revision Date: Document:BI257:00
CPT Code(s):J9303
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Vectibix (Panitumumab) requires preauthorization.

2)    Vectibix is an intravenous medication used to treat advanced colon cancers.

3)    It has been shown that individuals with a certain gene mutation in colon cancers do not respond to Vectibix.
Medical Statement

1)    Vectibix (panitumumab) is eligible for coverage through the specialty pharmacy program under the following criteria:

a)    Colo-rectal Cancer

i)      Metastatic disease and;

ii)    Failed standard chemotherapy (e.g., fluoropyrimidine-, irinotecan-, and oxaliplatin-containing chemotherapy regimens) and;

iii)    Documented presence of the wild-type KRAS gene. See BI129 Tumor Markers.

 

 

Codes Used In This BI:

J9303 - Panitumumab injection
Limits

1)    Vectibx is not eligible for benefits in members who have shown colon cancer progression after a course of therapy with Erbitux (cetuximab).

2)    Vectibix is considered experimental/investigational for other tumors.
Reference
  1. American Cancer Society (ACS). Overview: Colon and rectum cancer. Cancer Reference Information. Atlanta, GA: ACS; 2007. Available at: http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=10. Accessed January 2, 2008.
  2. National Horizon Scanning Centre (NHSC). Panitumumab for advanced colorectal cancer - horizon scanning review. Birmingham, UK: NHSC; 2005.
  3. Zhang W, Gordon M, Lenz HJ. Novel approaches to treatment of advanced colorectal cancer with anti-EGFR monoclonal antibodies. Ann Med. 2006;38(8):545-551.
  4. Chua YJ, Cunningham D. Panitumumab. Drugs Today (Barc). 2006;42(11):711-719.
  5. National Cancer Institute (NCI). Colon and rectal cancer. Cancer Topics. Bethesda, MD: NCI; 2007. Available at: http://www.cancer.gov/cancertopics/types/colon-and-rectal. Accessed January 2, 2008.
  6. U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Oncology Drug Products (OODP). FDA approves Vectibix (panitumumab) to treat metastatic colorectal carcinoma.
  7. Burtness B. Clinical use of monoclonal antibodies to the epidermal growth factor receptor in colorectal cancer. Oncology (Williston Park). 2007;21(8):964-970; discussion 970, 974, 976-977.
  8. Saadeh CE, Lee HS. Panitumumab: A fully human monoclonal antibody with activity in metastatic colorectal cancer. Ann Pharmacother. 2007;41(4):606-613.
  9. Berlin J, Posey J, Tchekmedyian S, et al. Panitumumab with irinotecan/leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2007;6(6):427-432.
  10. Hecht JR, Patnaik A, Berlin J, et al. Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer. 2007;110(5):980-988.
  11. Giusti RM, Shastri KA, Cohen MH, et al. FDA drug approval summary: Panitumumab (Vectibix). Oncologist. 2007;12(5):577-583.
  12. 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;25(13):1658-1664.
  13. Grothey A. Biological therapy and other novel therapies in early-stage disease: Are they appropriate? Clin Cancer Res. 2007;13(22 Pt 2):6909s-6912s.
  14. Cohenuram M, Saif MW. Panitumumab the first fully human monoclonal antibody: From the bench to the clinic. Anticancer Drugs. 2007;18(1):7-15.
  15. Moehler M, Galle PR, Gockel I, et al. Multimodal treatment of gastric cancer. Best Pract Res Clin Gastroenterol. 2007;21(6):965-981.
  16. Harari PM. Stepwise progress in epidermal growth factor receptor/radiation studies for head and neck cancer. Int J Radiat Oncol Biol Phys. 2007;69(2 Suppl):S25-S27.
  17. Socinski MA. Antibodies to the epidermal growth factor receptor in non small cell lung cancer: Current status of matuzumab and panitumumab. Clin Cancer Res. 2007;13(15 Pt 2):s4597-s4601.
  18. Freeman DJ, Juan T, Reiner M, et al. Association of K-ras mutational status and clinical outcomes in patients with metastatic colorectal cancer receiving panitumumab alone. Clin Colorectal Cancer. 2008;7(3):184-190.
  19. Amado RG, Wolf M, Peeters M, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(10):1626-1634.
  20. Baselga J, Rosen N. Determinants of RASistance to anti-epidermal growth factor receptor agents. J Clin Oncol. 2008;26(10):1582-1584.
  21. Blue Cross Blue Shield Association (BCBSA), Technology Evaluation Center (TEC). KRAS mutations and epidermal growth factor receptor inhibitor therapy in metastatic colorectal cancer. Actions Taken by the Medical Advisory Panel. TEC Assessment Program. Chicago, IL: BCBSA; September 2008.
  22. Hecht JR, Mitchell E, Chidiac T, et al. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009;27(5):672-680.
  23. Peeters M, Siena S, Van Cutsem E, et al. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer. 2009;115(7):1544-1554.
  24. National Comprehensive Cancer Network (NCCN). Colon Cancer. NCCN Clinical Practice Guidelines in Oncology, v.3.2009. Fort Washington, PA: NCCN; 2009
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.