Necitumumab (Portrazza) Notification

Necitumumab (Portrazza) is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. Necitumumab is a recombinant human IgG1 monoclonal antibody that blocks activity of EGFR, a protein commonly found on squamous NSCLC tumors.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 221, 200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).

BCBSNC will provide coverage for Necitumumab (Portrazza) when it is determined to be medically necessary because the medical criteria and guidelines noted below are met.

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. 

Necitumumab (Portrazza) is considered medically necessary for the treatment of metastatic squamous non-small cell lung cancer in patients: 

• When used in combination with gemcitabine and cisplatin; AND
• When used for first-line treatment.

Use of Necitumumab (Portrazza) may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either:

• In accordance with FDA label (when clinical benefit has been established, see Policy Guidelines); OR 
• In accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached.

Necitumumab (Portrazza) is considered not medically necessary and therefore not covered when above criteria are not met.

Necitumumab (Portrazza) is considered investigational when used for:

1. Non-cancer indications; OR
2. When criteria are not met regarding FDA labeling OR strong endorsement/support by nationally recognized compendia, as stated under “When Necitumumab (Portrazza) is covered.” 

Portrazza is not indicated for treatment of non-squamous non-small cell lung cancer.

The recommended dose is 800mg administered as an intravenous infusion over 60 minutes on days 1 and 8 of each 3-week cycle prior to the gemcitabine and cisplatin infusion.

Drugs prescribed for treatment of cancer in accordance with FDA label may be considered medically necessary when clinical benefit has been established, and should not be determined to be investigational as defined in Corporate Medical Policy (CMP), “Investigational (Experimental) Services.”

Please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia. 

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: J9295, S0353, S0354 

US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Available at:

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm474131.htm Accessed February 4, 2016.

US Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf Accessed February 4, 2016.

Senior Medical Director review 2/2016.

Specialty Matched Consultant Advisory Panel 8/2016

Medical Director review 8/2016

Medical Director review 2/2017

2/29/16 New policy issued. Necitumumab (Portrazza) is considered medically necessary, when used in combination with gemcitabine and cisplatin, for first- line treatment of patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Notification given 2/29/2016 for effective date 4/29/2016. Senior medical director review 2/2016. (lpr)

4/29/16 Added HCPCS code C9475 to Billing/Coding section. (lpr)

9/30/16 Specialty Matched Consultant Advisory Panel review 8/31/2016. Medical Director review 8/2016. No change to policy statement. (lpr)

12/30/16 Deleted the following HCPCS codes C9475, C9399, J9999, J3490, J3590 and added HCPCS codes J9295, S0353, S0354 to Billing/Coding section. Notification given 12/30/16 for effective date 4/1/17. (lpr)

2/24/17 Added the following statement to “When Covered” section: “Use of Necitumumab (Portrazza) may be considered medically necessary for clinical indications not listed above when the drug is prescribed for the treatment of cancer either: In accordance with FDA label (when clinical benefit has been established, see Policy Guidelines); OR In accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached”. Under “When Not Covered” section, added the statement “Necitumymab (Portrazza) is considered investigational when used for: 1)Noncancer indications; OR 2) When criteria are not met regarding FDA labeling OR strong endorsement/ support by nationally recognized compendia, as stated under “When Necitumymab (Portrazza) is covered.” Added the following statements under “Policy Guidelines” section: 1)Drugs prescribed for treatment of cancer in accordance with FDA label may be considered medically necessary when clinical benefit has been established, and should not be determined to be investigational as defined in Corporate Medical Policy, Investigational (Experimental) Services.” 2) Please refer to CMP “Investigational (Experimental) Services” for a summary of evidence standards from nationally recognized compendia. Medical Director review 2/2017. Remains on notice. Effective date. 4/1/17. (lpr)