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AetnaCommercial · Prior Auth · Medical Policy · Oncology, DermatologyMedium impact

Retifanlimab-dlwr (Zynyz) (CPB 1030, reviewed 2026-04-27)

Effective date
Not stated in the notice
Identified
Aug 16, 2026

Summary

Aetna considers retifanlimab-dlwr (Zynyz) medically necessary for commercial medical plans in these indications: Merkel cell carcinoma as a single agent; squamous cell carcinoma of the anal canal (SCAC) in combination with carboplatin and paclitaxel, or as a single agent after progression on or intolerance to platinum-based chemotherapy; dMMR/MSI-H or POLE/POLD1 ultra-hypermutated colorectal cancer, small bowel adenocarcinoma, and appendiceal neoplasms and cancers, each as a single agent. Aetna considers all other indications experimental, investigational, or unproven, and considers members not eligible when they have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy. Continuation is considered medically necessary for up to 12 months with carboplatin and paclitaxel or up to 24 months as a single agent for SCAC, and up to 24 months for the other listed indications, when there is no evidence of unacceptable toxicity or disease progression on the current regimen.

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What to do

Action · 8 steps
01Billing team: Precertification of retifanlimab-dlwr (Zynyz) is required of all Aetna participating providers and members in applicable plan designs.
02Call (866) 752-7021 or fax (888) 267-3277 for precertification.
03Statement of Medical Necessity precertification forms are on the Specialty Pharmacy Precertification page.
04Providers: Confirm the member meets the selection criteria for one of the listed indications and has not experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.
05Confirm the site of service follows the Utilization Management Policy on Site of Care for Specialty Drug Infusions.
06Bill HCPCS J9345 (retifanlimab-dlwr, 1 mg) when the selection criteria are met, with the covered ICD-10 codes listed in the policy.
07Reauthorization requests for continued treatment are considered when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
08For Medicare criteria, see the Medicare Part B criteria referenced in the policy.

Codes mentioned

J9345C17.0C17.9C18.0C18.9C19C20C21.0C21.8D37.3

Original notice

Retifanlimab-dlwr (Zynyz) (CPB 1030, reviewed 2026-04-27)
aetna.com · Always check the source before changing claims.
View original ↗

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Related policy hubs

Aetna policiesOncologyDermatologyCode J9345Code C17.0Code C17.9Code C18.0Code C18.9Code C19Code C20Code C21.0Code C21.8Code D37.3

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