BlueCross BlueShield of Tennessee Medical Policy Manual
Retifanlimab-dlwr (Zynyz™)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Squamous Cell Carcinoma of the Anal Canal
Zynyz, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
Zynyz, as a single agent, is indicated for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
Merkel Cell Carcinoma
Zynyz is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
All other indications are considered experimental/investigational and not medically necessary.
Compendial Uses
Merkel cell carcinoma
Squamous cell carcinoma of the anal canal
Appendiceal neoplasms and cancers
Colorectal cancer
Small bowel adenocarcinoma
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Documentation of laboratory report confirming microsatellite instability-high (MSI-H), mismatch repair deficient (dMMR), or polymerase epsilon/delta (POLE/POLD1) tumor status with ultra-hypermutated tumor mutational burden [TMB] (greater than 50 mutations/megabase [mut/Mb]), where applicable.
EXCLUSIONS
Coverage will not be provided for members who have experienced disease progression while on PD-1 or PD-L1 inhibitor therapy.
COVERAGE CRITERIA
Merkel Cell Carcinoma (MCC)
Authorization of 6 months may be granted as a single agent for treatment of locally advanced, regional, or metastatic MCC.
Squamous Cell Carcinoma of the Anal Canal (SCAC)
Authorization of 6 months may be granted for treatment of SCAC when either of the following criteria is met:
Appendiceal Neoplasms and Cancers
Authorization of 6 months may be granted as a single agent for treatment of recurrent, progressive, or metastatic deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or polymerase epsilon/delta (POLE/POLD1) mutation with ultra-hypermutated phenotype (e.g., tumor mutational burden [TMB] greater than 50 mut/Mb) appendiceal neoplasms and cancers.
Colorectal Cancer
Authorization of 6 months may be granted as a single agent for treatment of locally unresectable, medically inoperable, advanced, recurrent, or metastatic deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or polymerase epsilon/delta (POLE/POLD1) mutation with ultra-hypermutated phenotype (e.g., tumor mutational burden [TMB] greater than 50 mut/Mb) colorectal cancer (including appendiceal adenocarcinoma).
Small Bowel Adenocarcinoma
Authorization of 6 months may be granted as a single agent for treatment of deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or polymerase epsilon/delta (POLE/POLD1) mutation with ultra-hypermutated phenotype (e.g., tumor mutational burden [TMB] greater than 50 mut/Mb) small bowel adenocarcinoma when either of the following criteria is met:
CONTINUATION OF THERAPY
Squamous Cell Carcinoma of the Anal Canal
Authorization of 6 months may be granted (up to 12 months total) for continued treatment in combination with carboplatin and paclitaxel in members requesting reauthorization for SCAC when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Authorization of 6 months may be granted (up to 24 months total) for continued treatment as a single agent in members requesting reauthorization for SCAC when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
All Other Indications
Authorization of 6 months may be granted (up to 24 months total) for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
ORIGINAL EFFECTIVE DATE: 6/30/2023
MOST RECENT REVIEW DATE: 7/31/2026
ID_CHS_2026a
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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