Vyondys 53 (golodirsen) (ARCHIVED)

Policy ID: I-194-006

Section: Injections

Effective Date: December 13, 2019

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-194-006

Section: Injections

Effective Date: December 13, 2019

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Vyondys 53TM (golodirsen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Vyondys 53 (golodirsen) is considered experimental/investigational and therefore non-covered as there is a lack of conclusive evidence confirming clinical efficacy.

Procedure Code

J1429

Diagnosis Codes

Not Applicable to this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020- Effective December 13, 2019

Adopted new experimental/investigational policy

Internal Medical Policy Committee 7-22-2020

Removed not otherwise classified codes from policy,
Added procedure code J1429

Internal Medical Policy Committee 11-19-2020 Annual review, no clinical content change

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022 No clinical content change

Internal Medical Policy Committee 3-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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