Vyondys 53 (golodirsen)

Policy ID: I-194-004

Section: Injections

Effective Date: December 13, 2019

Revised Date: October 19, 2020

Revision Effective Date: January 01, 2021

Last Reviewed: March 23, 2023

Applies To: Commercial Only

Description

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

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 Codes

J1429

Diagnosis Codes

Not Applicable with 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

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.

Section: Injections

Effective Date: December 13, 2019

Revised Date: June 18, 2020

Revision Effective Date: July 01, 2020

Last Reviewed: July 22, 2020

Archived Date: December 31, 2020

Applies To: Commercial Only

Description

Criteria

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

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

Procedure Codes

J1429

Diagnosis Codes

Not Applicable with this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date: December 13, 2019

Internal Medical Policy Committee 7-22-2020 Removed not otherwise classified codes from policy, added J1429

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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