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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

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.


Background

On September 27, 2006, panitumumab (Vectibix) received an accelerated approval from the Food and Drug Administration (FDA) for use as a single agent for the treatment of patients with EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens (Giusti et al, 2007). There are no data to support the combination of panitumumab with chemotherapy in the treatment of colorectal cancer (NCCN, 2009). In addition, according to the FDA-approved labeling of Vectibix, panitumumab should not be used in combination with other monoclonal antibodies.

The FDA`s approval of Vectibix was based on the findings of a phase III, randomized, controlled, clinical trial of 463 patients with metastatic colorectal cancer (Van Cutsem et al, 2007).  Subjects with 1 % or more EGFR tumor cell membrane staining, measurable disease, and radiological documentation of disease progression during or within 6 months of most recent chemotherapy were randomly assigned to one of the 2 groups: (i) panitumumab 6 mg/kg of body weight every 2 weeks plus best supportive care (BSC; n = 231); or (ii) BSC alone (n = 232).  Tumor assessments by blinded central review were scheduled from week 8 until disease progression.  The primary end point was PFS.  Secondary end points included objective response, OS, and safety.  Patients in the second group (BSC alone) who progressed could receive panitumumab in a cross-over study.  Panitumumab significantly prolonged PFS (hazard ratio [HR], 0.54; 95 % CI, 0.44 to 0.66, [p < 0.0001]).  Median PFS time was 8 weeks (95 % CI, 7.9 to 8.4 weeks) for panitumumab and 7.3 weeks (95 % CI, 7.1 to 7.7 weeks) for BSC.  Mean PFS time was 13.8 (0.8) weeks for panitumumab and 8.5 (0.5) weeks for BSC.  Objective response rates also favored panitumumab over BSC; after a 12-month minimum follow-up, response rates were 10 % for panitumumab and 0 % for BSC (p < 0.0001).  No difference was observed in OS (HR, 1.00; 95 % CI, 0.82 to 1.22), which was confounded by similar activity of panitumumab after 76 % of BSC patients entered the cross-over study.  Panitumumab was well-tolerated.  Skin toxicities, hypomagnesemia, and diarrhea were the most common adverse events observed.  No patients had grade 3/4 infusion reactions.  The authors concluded that panitumumab significantly improved PFS with manageable toxicity in patients with chemo-refractory colorectal cancer.

Grothey (2007) stated that in the past 20 years adjuvant chemotherapy has been the standard of care in patients with early-stage colon cancer at high risk of recurrence.  Until now, treatment entails the use of cytotoxic drugs that have well-demonstrated effectiveness in advanced colorectal cancer.  Most recently, targeted biological agents (i.e., antibodies against the EGFR and vascular endothelial growth factor [VEGF]) have become essential components of the palliative medical treatment of colorectal cancer.  Proof of effectivenss of these agents in advanced disease has led to the initiation of several trials testing EGFR and VEGF antibodies in the adjuvant setting.  Although definitive results of ongoing adjuvant studies will not be available for several years, some oncologists might already inappropriately consider the use of these targeted agents as a component of adjuvant therapy in selected patients.  Whether the results obtained in advanced colorectal cancer can be readily translated into a projected effectiveness in early-stage colon cancer, however, is unclear.  Furthermore, the long-term safety of biological agents in potentially surgically cured patients has yet to be established.

According to guidelines from the NCCN (2009), EGFR testing of colorectal tumor cells has no demonstrated predictive value in determining likelihood of response to panitumumab or cetuximab. Therefore, NCCN colorectal cancer guidelines do not recommend routine EGFR testing, and states that no patient should be either considered or excluded from cetuximab or panitumumab therapy on the basis of EGFR test results. The guidelines state: "In contrast to the results for KRAS genetic testing, the testing of colon cancer tissue for EGFR has demonstrated no predictive value in determining the likelihood of response with cetuximab and panitumumab. Hence, routine EGFR testing is not recommended, and no patients should be excluded from therapy with either of these drugs on the basis of such testing."

There are no data or compelling rationale to show that panitumumab would be effective after disease progression with cetuximab (Erbitux). NCCN guidelines on colorectal cancer (2009) state: "If cetuximab is used as initial therapy, then neither cetuximab nor panitumumab should be used in second or subsequent lines of therapy. There are no data, nor is there compelling rationale, to support the use of panitumumab after clinical failure on cetuximab, or cetuximab after clinical failure on panitumumab. As such, the use of one of these agents after therapeutic failure on the other is not recommended."


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.
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