ZYNYZ (retifanlimab-dlwr)

ZYNYZ (retifanlimab-dlwr)

Office-Administration – intravenous infusion

Diagnosis considered for coverage:

• Merkel Cell Carcinoma (MCC): Indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Coverage Criteria:

For diagnosis of Merkel cell carcinoma (MCC) in adults:

• Diagnosis of Merkel cell carcinoma; AND
• Disease is one of the following:
  • Metastatic
  • Recurrent locally advanced; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with an oncologist; AND
• Treatment duration of therapy has not exceeded a total of 24 months

Reauthorization Criteria:

For diagnosis of MCC:

• Patient does not show evidence of progressive disease while on therapy; AND
• Treatment duration of therapy has not exceeded a total of 24 months

Dosing:

• 500 mg IV infusion over 30 minutes every 4 weeks until disease progression, unacceptable toxicity, or for up to 24 months
  • Premedication: consider premedication with an antipyretic and/or an antihistamine for patients who have had previous systemic reactions to infusions of therapeutic proteins

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• NCCN guidelines recommend Zynyz as an “Other Recommended Regimen” for N0, N+, and M1 disease, often after pembrolizumab.
• Zynyz is the third PD-1/PD-L1 inhibitor FDA-approved for the treatment of adults with metastatic or recurrent locally advanced MCC. Avelumab and pembrolizumab are also FDA-approved in pediatric patients.
• No evidence of additional benefit beyond 24 months has been established. 

Policy Updates:

• 12/01/2023 – New policy for Zynyz approved by WHA P&T Committee. (P&T, 11/14/2023)

References:

1. Zynyz Prescribing Information. Incyte Corporation. Wilmington, DE. March 2023. 
2. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Merkel cell carcinoma. v1.2023 – April 10, 2023. NCCN Web site. https://www.nccn.org/. Accessed April 24, 2023. 
3. Per clinical consult with oncologist, May 9, 2023.