CurrentCentenePolicy N/A

Retifanlimab-dlwr (Zynyz)

Defines Centene medical necessity criteria, authorization durations, dosing limits, and coding for retifanlimab-dlwr (Zynyz) across Commercial, HIM, and Medicaid lines of business for FDA-approved and selected NCCN-recommended off-label indications (MCC, SCAC, small bowel/colon/rectal cancers).

Policy Summary

PayerCentene

PolicyRetifanlimab-dlwr (Zynyz)

Policy CodePolicy N/A

Change TypeAnnual reviews (2024, 2025) and initial creation

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member has met all approval criteria and documents response for continued therapy.

SourceLink

POLICY UPDATE CHANGES

2Q 2024 annual review: for MCC, added pathways for primary locally advanced disease and recurrent regional disease per NCCN 2A recommendation and added requirement that Zynyz be prescribed as a single agent; added criteria for anal carcinoma per NCCN 2A recommendation; added Zynyz HCPCS code and removed inactive codes; references reviewed and updated.

2Q 2025 annual review: added criteria for small bowel adenocarcinoma, colon cancer, and rectal cancer per NCCN 2A recommendation; for anal carcinoma, added option to be prescribed in combination with carboplatin and paclitaxel; references reviewed and updated.

Policy created 04.13.23; initial P&T Approval Date 05.23.23.

3FDA approved indications mentioned

3NCCN off-label pathways added (2025)

500 mgPer-dose limit (mg)

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Coverage Summary

Coverage stance: covered_with_criteria for FDA-approved and select NCCN 2A off-label indications. Scope: defines Centene medical necessity criteria, authorization durations, dosing limits, and coding for retifanlimab-dlwr (Zynyz) across Commercial, HIM, and Medicaid lines of business for FDA-approved indications and selected NCCN-recommended off-label uses including Merkel cell carcinoma (MCC), squamous cell carcinoma of the anal canal (SCAC / anal carcinoma), and the NCCN 2A–recommended off-label tumor types added in 2025 (small bowel adenocarcinoma, colon cancer, rectal cancer). Coverage is limited to the specified diagnoses and criteria (including oncologist involvement, age ≥ 18, and dosing limits).

Thresholds

Maximum dose per administration500 mg (1 vial) every 4 weeks

Minimum prior exposure for continuationReceived medication for at least 30 days

Effective date06.01.23

Last review date05.25

Initial Therapy Criteria (by indication)

Continuation Therapy Criteria

Other Diagnoses / Off‑label Pathways

Applicable Codes

HCPCS - Retifanlimab-dlwrHCPCSCovered

J9345

Injection, retifanlimab-dlwr; mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Authorization required and approval limited to indicated diagnoses and criteria; prescriber must provide evidence when dose exceeds standard limit or for off-label regimen support.

Codes: J9345

Billing Rule

Dose limit billing

Dose billed must not exceed 500 mg (1 vial) every 4 weeks unless supported by practice guidelines or peer-reviewed literature; prescriber must submit supporting evidence for doses above this limit.

Code: J9345
Dose limit: 500 mg (1 vial) every 4 weeks

Clinical Evidence & References

Evidence sources include the Zynyz Prescribing Information (Incyte), accessed May 2025 and NCCN Drugs & Biologics Compendium and disease-specific guidelines (2025). The policy and references note that the Merkel cell carcinoma indication was approved under accelerated approval based on tumor response and duration of response, with continued approval contingent on confirmatory trials.

Background

Background: Retifanlimab-dlwr (Zynyz) is FDA-approved for first-line treatment of inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (in combination with carboplatin and paclitaxel), and as a single-agent for locally recurrent/metastatic SCAC after platinum progression or intolerance. Zynyz is also FDA-approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) under accelerated approval based on tumor response and duration of response. The policy incorporates NCCN 2A recommendations to authorize additional off-label tumor types (added in 2025), including small bowel adenocarcinoma, colon cancer, and rectal cancer, with specified biomarker criteria and dosing limits. The dosing regimen for MCC and SCAC per the policy is 500 mg IV every 4 weeks; the product is supplied as a single-dose 500 mg vial.

Definitions

SCACSquamous cell carcinoma of the anal canal

MCCMerkel cell carcinoma

NCCNNational Comprehensive Cancer Network

MSI-HMicrosatellite instability-high

dMMRDeficient mismatch repair

TMBTumor mutation burden

Revision History

05.25 / P&T Approval Date = 05.25 (document Date = 03.06.25)2Q 2025 annual reviewLatest

05.24 / P&T Approval Date = 05.242Q 2024 annual review