Medical Drug Clinical Criteria

Publish Date:

06/20/2023

Last Review Date:

05/19/2023

Overview

Coding

References

Clinical Criteria

Document History

Overview

This document addresses the use of Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)–blocking antibody indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Zynyz was approved by the FDA based on the single-arm Pod1um-201 trial in which 65 chemotherapy-naïve individuals with metastatic or recurrent locally advanced MCC and treated with Zynyz had complete and partial response rates of 18% and 34% respectively. Serious adverse reactions occurred in 22% of individuals with the most common being fatigue, arrhythmia, and pneumonitis.

Definitions and Measures

Merkel cell carcinoma: A rare, aggressive skin cancer.

Metastasis: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.

Programmed death (PD)-1: PD-1 proteins are found on T-cells and attach to PD ligands (PD-L1) found on normal (and cancer) cells (see immune checkpoint inhibitor above). Normally, this process keeps T-cells from attacking other cells in the body. Examples of FDA approved PD-1 inhibitors include Keytruda (pembrolizumab), Opdivo (nivolumab), and Libtayo (cemiplimab)

Programmed death ligand (PD-L)-1: The ligands found on normal (and cancer) cells to which the PD-1 proteins attach (see immune checkpoint inhibitor above). Cancer cells can have large amounts of PD-L1 on their surface, which helps them to avoid immune attacks. Examples of FDA approved PD-L1 inhibitors include Bavencio (avelumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab).

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Zynyz (retifanlimab-dlwr)

Requests for Zynyz (retifanlimab-dlwr) may be approved if the following criteria are met:

• Individual has a diagnosis of Merkel Cell Carcinoma; AND
• Individual has metastatic or recurrent locally advanced disease not amenable to surgery or radiation (NCCN 2A); AND
• Individual is using as monotherapy; AND
• Has not received treatment with an anti-PD-1 or PD-L1 agent.

Requests for Zynyz (retifanlimab-dlwr) may not be approved when the above criteria are not met and for all other indications.

Quantity Limits

Zynz (retifanlimab-dlwr) Quantity Limits

Drug Limit

1. Zynyz (retifanlimab-dlwr) 500 mg/ 20 mL vial
2. 500 mg every 28 days

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J9345

ICD-10 Diagnosis

C4A.0-C4A.9

Document History

New: 05/19/2023