Pharmacy Prior Authorization Criteria

Zynyz (retifanlimab-dlwr)

Indications for Prior Authorization

Zynyz (retifanlimab-dlwr)

• For diagnosis of 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.

Criteria

Zynyz

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Merkel cell carcinoma (MCC)
AND
• Disease is one of the following:
• metastatic
• recurrent locally advanced
AND
• Treatment duration of therapy has not exceeded a total of 24 months [A]

Zynyz

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-06-05, 2023-07-31, 2023-05-26

References

1. Zynyz Prescribing Information. Incyte Corporation. Wilmington, DE. April 2024.
2. Per clinical consult with oncologist, May 9, 2023.

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End Notes

1. Zynyz is recommended to be administered until disease progression, unacceptable toxicity, or up to 24 months. There is no evidence of additional benefit beyond 24 months and a higher risk of adverse events. [1,2]

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Revision History

• 2024-06-05: 2024 Annual Review. No criteria changes. Updated references.
• 2023-07-31: Removed specialist requirement
• 2023-05-26: New program for Zynyz.

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