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09-J0000-94

Original Effective Date: 04/15/09

Reviewed: 07/13/16

Revised: 10/15/16

Next Review: 07/12/17

Subject: Human EGFR Inhibitors (Cetuximab [Erbitux®], Panitumumab [Vectibix®])

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Cetuximab (Erbitux®) and panitumumab (Vectibix®) are human monoclonal antibodies that target the epidermal growth factor receptor (EGFR, also known as HER-1). EGFR is expressed in many normal epithelial tissues, including the skin and hair follicle. Over expression of EGFR has been detected in many human cancers including those of the head and neck, colon and rectum. Excessive activation of EGFR is associated with advanced stages of cancer and a poor prognosis. In contrast to small molecule tyrosine kinase inhibitors (e.g., imatinib [Gleevec®]) that inhibit EGFR by interfering with ATP binding, cetuximab and panitumumab block the EGFR receptor on both normal and cancerous cells. This binding blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased survival of tumor cells that express the EGFR. Panitumumab differs from cetuximab in that it has a higher affinity for the receptor and it produces less hypersensitivity reactions.

The FDA approved cetuximab with irinotecan for EGFR-expressing metastatic colorectal cancer (mCRC) refractory to irinotecan-based chemotherapy and as a single agent for EGFR-expressing mCRC in patients who are intolerant of irinotecan-based chemotherapy in February 2004. In March 2006, it was approved for unresectable squamous cell head and neck cancer with radiation therapy and as a single agent for metastatic head and neck cancer. In November 2011, the indication was expanded to include use with other drugs for head and neck cancer. It was approved as monotherapy in October 2007 for EGFR-expressing mCRC after failure of both irinotecan- and oxaliplatin-based regimens, and approved as first-line therapy for KRAS mutation negative (wild type), EGFR-expressing mCRC in combination with the FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) regimen in July 2012.

The FDA approved panitumumab in September 2006 for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC) as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. The indication was expanded in July 2012 to include use in combination with FOLFOX for first-line treatment wild-type KRAS mCRC.

Current National Comprehensive Cancer Network (NCCN) guidelines support the use of cetuximab in colorectal cancer, squamous cell carcinoma of the head and neck, non-melanoma carcinoma of the skin, non-small cell lung cancer, and penile cancer. NCCN guidelines support the use of panitumumab in colorectal cancer.

POSITION STATEMENT:

Initiation of cetuximab (Erbitux®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Cetuximab is used to treat any of the indications listed in table 1.

2. All of the indication-specific criteria are met.

3. The member has not previously failed treatment with panitumumab (Vectibix®)

4. Cetuximab is NOT used in combination with ANY of the following:

a. Bevacizumab (Avastin®)

b. Erlotinib (Tarceva®)

c. Gefitinib (Iressa®)

d. Panitumumab (Vectibix®)

5. The dose of cetuximab does not exceed either of the following:

• 400 mg/m2 initially, then 250 mg/m2 every 7 days

• 500 mg/m2 every 14 days

Table 1:

Indications and Specific Criteria

Indication

Criteria

Colorectal cancer

KRAS/NRAS gene is normal (i.e., without mutation, also known as wild type)

Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Cetuximab will be used in one of the following settings

1. Treatment of locally or regionally advanced disease in combination with radiotherapy

2. Treatment of recurrent disease, unresectable disease, persistent disease, or metastatic disease

Non-melanoma carcinoma of the skin

Member has squamous cell skin cancer that is recurrent or metastatic

Non-small cell lung cancer (NSCLC)

When used in combination with afatinib for metastatic disease AND member’s disease has progressed on EGFR tyrosine kinase inhibitor therapy (e.g., erlotinib, gefitinib)

Penile cancer

When ALL of the following apply:

1. Disease is metastatic

2. Member has failed previous treatment

3. Used as single-agent therapy

Approval duration: 6 months

Continuation of cetuximab (Erbitux®) meets the definition of medical necessity when ALL of the following criteria are met:

1. An authorization/reauthorization for cetuximab has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment any indication in Table 1, OR the member previously met all indication-specific initiation criteria.

2. The member has not experienced disease progression during treatment with cetuximab.

3. Cetuximab is NOT used in combination with ANY of the following:

a. Bevacizumab (Avastin®)

b. Erlotinib (Tarceva®)

c. Gefitinib (Iressa®)

d. Panitumumab (Vectibix®)

4. The dose does not exceed 250 mg/m2 every 7 days or 500 mg/m2 every 14 days.

Approval duration: 1 year

Initiation of panitumumab (Vectibix®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Treatment is for colorectal cancer and the KRAS/NRAS gene is normal (i.e., without mutation, also known as wild type).

2. The member has not previously failed treatment with cetuximab (Erbitux®)

3. Panitumumab is NOT used in combination with ANY of the following:

a. Bevacizumab (Avastin®)

b. Cetuximab (Erbitux®)

c. Erlotinib (Tarceva®)

d. Gefitinib (Iressa®)

4. 4. The dosage does not exceed 6 mg/kg every 14 days.

Approval duration: 6 months

Continuation of panitumumab (Vectibix®) meets the definition of medical necessity when ALL of the following criteria are met:

1. An authorization/reauthorization for panitumumab has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of colorectal cancer, OR the member previously met all indication-specific initiation criteria.

2. The member has not experienced disease progression during treatment with panitumumab

3. Panitumumab is NOT used in combination with ANY of the following:

a. Bevacizumab (Avastin®)

b. Cetuximab (Erbitux®)

c. Erlotinib (Tarceva®)

d. Gefitinib (Iressa®)

4. The dosage does not exceed 6 mg/kg every 14 days.

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approval:

• Cetuximab: cetuximab is FDA-approved for treatment of head and neck cancer and colorectal cancer in the following settings

o Head and Neck Cancer

− Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy.

− Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU.

− Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy as monotherapy.

o Colorectal Cancer: KRAS mutation-negative (wild-type), EGFR-expressing, metastatic colorectal cancer as determined by FDA-approved tests

− in combination with FOLFIRI for first-line treatment,

− in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,

− as a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan

o Prior to cetuximab therapy, members should be pre-medicated with a histamine-receptor antagonist. The recommended dose is 400 mg/m2 initially as an intravenous (IV) infusion over 120 minutes followed by 250 mg/m2 weekly IV over 60 minutes.

o Cetuximab should be initiated one week prior to initiation of radiation therapy

o Cetuximab administration should be completed 1 hour prior to platinum-based therapy with 5-FU and FOLFIRI.

o Cetuximab is not indicated for treatment of persons with RAS mutation-positive mCRC

• Panitumumab: indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:

o As first-line therapy in combination with FOLFOX

o As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. Panitumumab is not indicated for treatment of persons with RAS mutation-positive mCRC or for persons who RAS mCRC status is unknown.

o The recommended dose is 6 mg/kg every 14 days. Panitumumab should be administered as an IV infusion over 60 minutes (doses of 1000 mg or less) or 90 minutes (doses greater than 1000 mg).

o Infusion reactions may occur; appropriate medical resources for the treatment of infusion reactions should be available.

Drug Availability

• Cetuximab is supplied as 100 mg/50 mL and 200 mg/100 mL single-use vials. Store vials under refrigeration at 2° C to 8° C (36° F to 46° F).

• Panitumumab is supplied as 100 mg/5 mL, 200 mg/10 mL, and 400 mg/20 mL single-use vials. Store vials in the original carton under refrigeration at 2º to 8ºC (36º to 46ºF) until time of use. Protect from direct sunlight.

PRECAUTIONS:

Boxed Warning

• Cetuximab

o Serious infusion reactions may occur. Immediately stop and permanently discontinue cetuximab if a serious reaction occurs.

o Cardiopulmonary arrest and/or sudden death have been reported by persons administered cetuximab. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after cetuximab administration

• Panitumumab

o Dermatologic toxicities may occur. Withhold or discontinue panitumumab if severe or life-threatening complications occur. Limit sun exposure

Warnings and Precautions

• Cetuximab

o Pulmonary Toxicity: Interrupt therapy for acute onset or worsening of pulmonary symptoms.

o Dermatologic Toxicity: Limit sun exposure. Monitor for inflammatory or infectious sequelae.

o Hypomagnesemia: Periodically monitor during and for at least 8 weeks following the completion of cetuximab. Replete electrolytes as necessary.

• Panitumumab

o Increased Mortality or Toxicity when panitumumab is used in combination with chemotherapy

o Pulmonary Fibrosis/Interstitial Lung Disease (ILD): Permanently discontinue panitumumab in persons developing ILD.

o Electrolyte Depletion/Monitoring: Monitor electrolytes during and for 8 weeks after completion of panitumumab therapy and institute appropriate treatment.

o Infusion reactions: Immediately stop and permanently discontinue if serious infusion reaction occurs.

o Ocular Toxicities: Monitor for evidence of keratitis or ulcerative keratitis. Interrupt or discontinue panitumumab for acute or worsening keratitis

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9055

Injection, cetuximab,10 mg

J9303

Injection, panitumumab,10 mg

ICD-10 Diagnoses Codes That Support Medical Necessity for J9055 (cetuximab): (Effective 10/01/15)

C00.0 – C08.9

Malignant neoplasm of lip, base of tongue, of other and unspecified parts of tongue, gum, floor of mouth, palate, of other and unspecified parts of mouth, parotid and salivary gland.

C09 – C10.9

Malignant neoplasm of tonsil and oropharynx

C11.0 – C11.9

Malignant neoplasm of nasopharynx

C12.0 – C14.8

Malignant neoplasm of piriform sinus, hypopharynx and other and ill-defined sites in the lip, oral cavity and pharynx.

C17.0 – 17.2

Malignant neoplasm of duodenum, jejunum, ileum

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C18.0 – C21.8

Malignant neoplasm of colon, rectosigmoid junction, rectum and anus and anal canal

C31.0 – C31.9

Malignant neoplasm of accessory sinuses

C32.0 – C34.92

Malignant neoplasm of larynx, trachea, bronchus and lung

C44.00

Malignant neoplasm of skin of lip

C44.02

Squamous cell carcinoma of skin of lip

C44.09

Other specified malignant neoplasm of skin of lip

C44.121 – C44.129

Squamous cell carcinoma of skin of unspecified eyelid, including canthus

C44.221 – C44.229

Squamous cell carcinoma of skin of unspecified ear and external auricular

C44.320

Squamous cell carcinoma of skin of unspecified parts of face

C44.321

Squamous cell carcinoma of skin of nose

C44.329

Squamous cell carcinoma of skin of other parts of face

C44.42

Squamous cell carcinoma of skin of scalp and neck

C44.520

Squamous cell carcinoma of anal skin

C44.521

Squamous cell carcinoma of skin of breast

C44.529

Squamous cell carcinoma of skin of other part of trunk

C44.621 – C44.629

Squamous cell carcinoma of skin of unspecified upper limb, including shoulder

C44.721 – C44.729

Squamous cell carcinoma of skin of unspecified lower limb, including hip

C44.82

Squamous cell carcinoma of overlapping sites of skin

C44.92

Squamous cell carcinoma of skin, unspecified

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C60.0 – C60.9

Malignant neoplasm of penis

C63.7

Malignant neoplasm of other specified male genital organs

C63.8

Malignant neoplasm of overlapping sites of male genital organs

C72.1

Malignant neoplasm of cauda equina

C76.0

Malignant neoplasm of head, face and neck

C77.0

Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

C78.00 – C78.02

Secondary malignant neoplasm of unspecified lung

C78.6

Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

D37.01

Neoplasm of uncertain behavior of lip

D37.02

Neoplasm of uncertain behavior of tongue

D37.04

Neoplasm of uncertain behavior of the minor salivary glands

D37.05

Neoplasm of uncertain behavior of pharynx

D37.09

Neoplasm of uncertain behavior of other specified sites of the oral cavity

D38.0

Neoplasm of uncertain behavior of larynx

D38.5

Neoplasm of uncertain behavior of other respiratory organs

D38.6

Neoplasm of uncertain behavior of respiratory organ, unspecified

ICD-10 Diagnoses Codes That Support Medical Necessity for J9303 (panitumumab): (Effective 10/01/15)

C17.0 – 17.2

Malignant neoplasm of duodenum, jejunum, ileum

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C18.0 – C21.8

Malignant neoplasm of colon, rectosigmoid junction, rectum, anus and anal canal

C78.00 – C78.89

Secondary malignant neoplasm of respiratory and digestive organs

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Cetuximab (Erbitux), (L33278) located at fcso.com.

DEFINITIONS:

Apoptosis: A state in which a cell has ceased replication and is in the process of programmed cell death.

EGFR: The epidermal growth factor receptor (EGFR; ErbB-1; HER1 in humans) is the cell-surface receptor for members of the epidermal growth factor family (EGF-family) of extracellular protein ligands. The epidermal growth factor receptor is a member of the ErbB family of receptors, a subfamily of four closely related receptor tyrosine kinases: EGFR (ErbB-1), HER2/c-neu (ErbB-2), Her 3 (ErB-3) and Her 4 (ErB-4). Mutations affecting EGFR expression or activity could result in cancer.

FOLFOX: combination chemotherapy consisting of the following agents; leucovorin, fluorouracil, oxaliplatin.

FOLFIRI: combination chemotherapy consisting of the following agents; leucovorin, fluorouracil, irinotecan.

RELATED GUIDELINES:

Analysis of Human DNA in Stool Samples as a Technique for Colorectal Cancer Screening, 05-82000-27
Bevacizumab (Avastin®) Injection, 09-J0000-66

Carboplatin (Paraplatin®) IV, 09-J0000-93

Docetaxel (Taxotere®s) IV, 09-J0000-95

Gemcitabine (Gemzar®), 09-J0000-96

KRAS Mutation Analysis, 05-86000-28

Oxaliplatin (Eloxatin®) IV, 09-J1000-00

Paclitaxel and Paclitaxel (protein-bound) IV, 09-J1000-05

Topotecan HCl (Hycamtin®) IV, 09-J1000-02

Vinorelbine Tartrate (Navelbine®) IV, 09-J1000-03

OTHER:

TABLE 1

ECOG PERFORMANCE STATUS

Grade

ECOG

0

Fully active, able to carry on all pre-disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2

Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair

5

Dead

REFERENCES:

  1. Bouchahda M, Macarulla G, Lledo F, et al. Efficacy and safety of cetuximab (C) given with a simplified, every other week (q2w), schedule in patients (pts) with advanced colorectal cancer (aCRC): a multicenter, retrospective study. J Clin Oncol. 2008;26(15S):Abstract 15118. Presented at: The 44th American Society of Clinical Oncology Annual Meeting (ASCO). May 30–June 3, 2008. Chicago, Illinois.
  2. Cetuximab. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 June 16 ].
  3. Clinical Pharmacology. [database online]. Tampa, FL: Gold Standard, Inc.; 2015. URL. www.Clinicalpharamcology-ip.com. Accessed 06/18/16.
  4. Erbitux (cetuximab) [package insert]. Bristol-Myers Squibb Co. Princeton (NJ): April 2016.
  5. Micromedex ® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 6/18/16.
  6. Mrabti H, La Fouchardiere C, Desseigne F, et al. Irinotecan associated with cetuximab given every 2 weeks versus cetuximab weekly in metastatic colorectal cancer. J Can Res Ther. 2009;5:272-6.
  7. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 06/21/16..
  8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Colon Cancer. Available at: http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed 6/28/16.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016. Squamous Cell Skin Cancer. Available at: http://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed 6/28/16.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2016. Head and Neck Cancers. Available at: http://www.nccn.org/professionals/physician_gls/PDF/head-and-neck.pdf. Accessed 6/28/16.
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 4.2016. . Non-Small Cell Lung Cancer. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed 6/28/16
  12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Penile Cancer. Accessed 6/28/16. Available at: http://www.nccn.org/professionals/physician_gls/pdf/penile.pdf
  13. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2016. Rectal Cancer. Available at: http://www.nccn.org/professionals/physician_gls/pdf/rectal.pdf. Accessed 6/28/16.
  14. Panitumumab. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 June 16].
  15. Pfeiffer P, Bjerregarrd JK, Qvortrup C, et al, “Simplification of Cetuximab (Cet) Administration: Double Dose Every Second Week as a 60 Minute Infusion,” J Clin Oncol, 2007, 25(18S):4133 [abstract 4133 from 2007 ASCO Annual Meeting Proceedings, Part I].
  16. Vectibix (panitumumab) [package insert]. Amgen Inc. Thousand Oaks (CA): March 2015.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 07/13/16.

GUIDELINE UPDATE INFORMATION:

04/15/09

New Medical Coverage Guideline.

05/15/09

Revision to guideline; consisting of adding panitumumab coverage criteria, updating ICD-9 codes for cetuximab, changing name and updating references.

10/15/09

Revision to guideline; consisting of clarifying dosage.

04/15/10

Revision to guideline; consisting of updating codes.

08/01/10

Revision to guideline; consisting of updating codes.

09/15/10

Review and revision to guideline; consisting of updating coding and references.

09/15/11

Review and revision to guideline; consisting of updating coding and references.

10/01/11

Revision to guideline; consisting of updating codes.

09/15/12

Review and revision to guideline; consisting of updating position statement, precautions, coding and references.

12/15/12

Revision to guideline; consisting of updating coding.

09/15/13

Review and revision to guideline; consisting of revising and reformatting position statement; revising description, dosage/administration and precautions sections; updating references, program exceptions, and coding.

02/15/14

Revision to guideline; consisting of removing chordoma indication.

08/15/14

Review and revision to guideline; consisting of reformatting position statement, updating dosage/administration and references.

08/15/15

Review and revision to guideline; consisting of description, position statement, and references.

09/15/15

Revision to guideline consisting of revised dosage in position statement and references.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

08/15/16

Review and revision to guideline; consisting of updating description, position statement, coding and references.

10/15/16

Revision to guideline consisting of updating position statement and references.

Date Printed: June 23, 2017: 06:30 PM