Viltolarsen (Viltepso) 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. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with viltolarsen (Viltepso). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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 for all indications, including but not limited to DMD, as there is a lack of conclusive evidence confirming clinical efficacy.
Not Applicable for this policy
Professional Statements and Societal Positions Guidelines
ND Committee Review
Internal Medical Policy Committee 9-21-2020 Adopted experimental/investigational policy effective 9-15-2020
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.