Medical Policy
Effective Date:10/01/2023 Title:Zynyz (retifanlimab-dlwr)
Revision Date: Document:BI726:00
CPT Code(s):
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Zynyz (retifanlimab-dlwr) requires prior authorization.

2)    Zynyx is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

3)    Zynyz is covered under the medical benefit.
Medical Statement

I. Initial Approval Criteria A. Merkel Cell Carcinoma (must meet all):

A. Diagnosis of MCC;

B. Prescribed by or in consultation with an oncologist;

C. Age ≥ 18 years;

D. Disease is metastatic or recurrent, locally advanced;

E. Disease is not amenable to surgery or radiation therapy;

F. Request meets one of the following (a or b):*

1. Dose does not exceed 500 mg (1 vial) every four weeks;

2. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

 

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months

 

 

II. Continued Therapy

A. Merkel Cell Carcinoma (must meet all):

 

1. Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Zynyz for a covered indication and has received this medication for at least 30 days;

 

2. Member is responding positively to therapy;

 

3. If request is for a dose increase, request meets one of the following (a or b):*

a. New dose does not exceed 500 mg (1 vial) every four weeks;

b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

 

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 12 months
Limits
Intentially left empty
Reference

1. Zynyz Prescribing Information. Wilmington, DE: Incyte Corporation.; March 2023. Available at: https://www.zynyz.com/. Accessed April 11, 2023.

 

2. National Comprehensive Cancer Network. Merkel Cell Carcinoma Version 1.2023. Available at https://www.nccn.org/guidelines/. Accessed April 20, 2023.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.