CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zynyz (retifanlimab-dlwr) coverage criteria

Defines accepted indications, coverage criteria, exclusions, and coding for Zynyz (retifanlimab-dlwr) for members served by Evolent on behalf of Neighborhood Health Plan of Rhode Island; applies to medication request processing and authorization determinations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZynyz (retifanlimab-dlwr) coverage criteria

Policy CodePolicy N/A

Change TypeTemplate conversion with content updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization referencing HCPCS code J9345 for any Zynyz medication request.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC_1478; added new indication and updated exclusion criteria.

2FDA approved tumor indications listed

500 mgsingle dose maximum listed

24 monthsmaximum treatment duration

J9345HCPCS code

Coverage Criteria and Indications

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Covered Indications

Covered when ALL of the following are met for each indication

Merkel cell carcinoma (MCC): Zynyz may be used as monotherapy for metastatic or recurrent locally advanced MCC in members who are not candidates for surgery and/or radiation.

FDA-approved indication per policy

Anal carcinoma: Zynyz may be used as monotherapy for metastatic anal carcinoma in the second-line and subsequent therapy setting if no prior immunotherapy was received.

Second-line+ setting provided no prior immunotherapy in anal carcinoma

Exclusions for Zynyz (retifanlimab-dlwr) include members with disease progression on or after Zynyz or another checkpoint inhibitor (for example, pembrolizumab, avelumab, nivolumab). Coverage is also excluded for concurrent use with other anticancer therapies, prior immunotherapy use in the anal carcinoma setting, dosing that exceeds the single dose limit of 500 mg, and treatment that exceeds the maximum duration of 24 months. Requests for indications considered investigational or off-label without sufficient supporting evidence (see investigational criteria) are not covered.

Providers should also note that investigational or off‑label uses lacking adequate evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature—including concerns about representativeness of patient/cancer characteristics, regimen representation, clinically meaningful outcomes, study design, reliance on case reports, or abstracts without full articles—are excluded from coverage.

Uses of Zynyz (retifanlimab-dlwr) that are considered investigational or medically not necessary include off‑label indications that lack sufficient evidence or general acceptance in the medical community. Sufficient evidence is judged by whether published data adequately represent the patient and cancer characteristics, the specific regimen under study, and whether outcomes meet standards for clinical meaningfulness (for example, ASCO‑recommended thresholds such as a hazard ratio < 0.80 or an overall/progression‑free survival benefit of at least 3 months).

Case reports, meeting abstracts without a full peer‑reviewed publication, or other uncontrolled anecdotal reports are insufficient to establish coverage for investigational/off‑label uses.

Indication	Regimen	Coverage status
Merkel cell carcinoma (metastatic or recurrent locally advanced)	Zynyz (retifanlimab-dlwr) monotherapy	Covered when criteria met (used as monotherapy for members who are not candidates for surgery and/or radiation)
Anal carcinoma (metastatic; second-line and subsequent)	Zynyz (retifanlimab-dlwr) monotherapy	Covered when criteria met (second-line+ setting provided no prior immunotherapy)

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required. All requests for Zynyz (retifanlimab-dlwr) must be submitted to Evolent for review prior to initiation of therapy.

Prior authorization required
HCPCS code: J9345

Note

Continuation Request Exemption

Continuation (re-authorization) requests may be exempt from this policy when all conditions are met. Providers should confirm eligibility for the exemption before submitting a new prior authorization request.

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse > 30 days of having an active authorization
No additional medications are being added to the continuation request

Documentation Required

Required Supporting Documentation

Requests must include supporting clinical evidence drawn from acceptable sources. Use the strongest available source(s) to justify use, especially for off‑label indications.

Acceptable documentation: FDA product labeling
CMS‑recognized compendia
NCCN or ASCO clinical guidelines
Peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Triggers for Denial

Requests may be denied if any exclusion criteria are met or if dosing, duration, or concurrent therapy limits are exceeded.

Concurrent use with other anticancer therapies is not allowed
Prior use with immunotherapy in the anal carcinoma setting may trigger denial
Dosing exceeds single‑dose limit of 500 mg
Treatment duration exceeds maximum of 24 months
Off‑label or investigational use lacking support from CMS compendia or acceptable peer‑reviewed evidence may be denied

Background and Drug Information

Zynyz (retifanlimab-dlwr) is an anti‑PD‑1 immune checkpoint inhibitor indicated in this policy for certain advanced malignancies. The policy references FDA labeling and the clinical evidence base (including clinical trials and oncology compendia) when determining appropriate use and required supporting documentation. Clinically meaningful outcome benchmarks referenced in the policy follow ASCO guidance (for example, a hazard ratio < 0.80 or a survival benefit of at least 3 months) when evaluating the strength of evidence for off‑label or investigational uses.

OpenPayer

Zynyz (retifanlimab-dlwr) coverage criteria

Coverage Criteria and Indications

Billing, Dosing Limits, and Coding

Prior Authorization, Documentation, and Denial Triggers

Line of Therapy Specifications

Clinical Definitions and Outcome Thresholds

Background and Drug Information