Viltolarsen (Viltepso)

Policy ID: I-232-004

Section: Injections

Effective Date: January 01, 2021

Revised Date: March 15, 2021

Revision Effective Date: April 01, 2021

Last Reviewed: March 23, 2023

Applies To: Commercial Only

Description

Viltolarsen (Viltepso^TM) is an antisense oligonucleotide which binds to exon 53 of dystrophin pre-mRNA resulting in exclusion of this exon during mRNA processing in individuals with genetic mutations that are amenable to exon 53 skipping. Exon 53 skipping intends to allow for production of an internally truncated dystrophin protein in individuals with genetic mutations 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.

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

Procedure Codes

J1427

Diagnosis Codes

Not Applicable for this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Adopt policy, was previously policy number I-9008

Internal Medical Policy Committee 1-19-2021 Added new code C9071 effective 1-1-2021

Internal Medical Policy Committee 3-17-2021 Added new code J1427 and removed code C9071 from policy effective 4-1-2021

Internal Medical Policy Committee 3-23-2022 Annual Review - no changes in criteria

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.

Policy ID: I-232-001

Section: Injections

Effective Date: January 01, 2021

Revised Date: October 27, 2020

Last Reviewed: November 19, 2020

Archived Date: March 31, 2021

Applies To: Commercial Only

Description

Criteria

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

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

Procedure Codes

J3590

Outpatient HCPCS (C Codes)

C9071

Diagnosis Codes

Not Applicable for this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Adopt policy, was previously policy number I-9008

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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