CurrentUnitedHealthcarePolicy N/A

Authorization form and coverage criteria for exon 53–skipping antisense therapies (Vyvondys 53, Viltepso)

Form and criteria governing prior authorization requests (initial and reauthorization) for Vyvondys 53 or Viltepso for beneficiaries with Duchenne muscular dystrophy; intended for prescribers and UnitedHealthcare reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyAuthorization form and coverage criteria for exon 53–skipping antisense therapies (Vyvondys 53, Viltepso)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prescriber prior authorization form with required checklist items and attach genetic testing and baseline monitoring documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11initial checklist items

13reauth checklist items

30 mg/kgVyvondys 53 max weekly

80 mg/kgViltepso max weekly

Coverage Criteria

Initial Authorization

Covered when ALL of the following are met for initial authorization

Initial Authorization: 1) Beneficiary has a diagnosis of Duchenne muscular dystrophy; 2) Medical records confirm the DMD mutation is amenable to exon 53 skipping; 3) Vyvondys 53 or Viltepso is prescribed by or in consultation with a neurologist; 4) Beneficiary has meaningful voluntary motor function; 5) Beneficiary has been assessed for physical therapy and/or occupational therapy needs; 6) Baseline laboratory measurements obtained prior to start of therapy: serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio; 7) Prescriber attests that ongoing monitoring will occur: monthly urine dipstick with serum cystatin C and urine protein-to-creatinine ratio every 3 months; 8) Documentation of baseline movement/functional testing is provided; 9) Beneficiary is not taking any other RNA antisense agent or any other gene therapy; 10) Dose does not exceed 30 mg/kg once weekly for Vyvondys 53 or 80 mg/kg once weekly for Viltepso; 11) Beneficiary weight and drug dose/quantity/length of therapy are provided on the form.dose limits specified

All checklist items 1-11 on initial form must be completed

Reauthorization

Covered on reauthorization when ALL of the following are met

Policy Summary

PayerUnitedHealthcare

PolicyAuthorization form and coverage criteria for exon 53–skipping antisense therapies (Vyvondys 53, Viltepso)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prescriber prior authorization form with required checklist items and attach genetic testing and baseline monitoring documentation.

SourceLink

On This Page

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Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Form Completion

Prior authorization form must be completed by the prescriber. Provide beneficiary and prescriber information, drug name, strength, quantity per 30 days, and requested length of therapy (up to 30, 60, 90, 120, or 180 days). Prescriber signature and date are mandatory.

Include beneficiary weight
Drug name, strength, quantity per 30 days
Select length of therapy (30/60/90/120/180 days)
Prescriber signature and date (mandatory)

Documentation Required

Initial Authorization Requirements

Initial authorization will be considered only when all required baseline documentation and attestations are provided: confirmed DMD diagnosis with mutation amenable to exon 53 skipping, neurologist involvement (prescribed by or in consultation with a neurologist), documentation of meaningful voluntary motor function, baseline movement/functional testing, and baseline renal/protein testing.

Diagnosis of Duchenne Muscular Dystrophy (Yes/No)
Medical records confirming mutation amenable to exon 53 skipping (attach)
Prescribed by or in consultation with a neurologist (Yes/No)
Documentation of meaningful voluntary motor function (Yes/No)
Documentation of baseline movement/functional testing (Yes/No)
Baseline serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio measured prior to therapy (Yes/No)
Dose does not exceed 30 mg/kg once weekly (Vyvondys 53) or 80 mg/kg once weekly (Viltepso) (Yes/No)

Prior Authorization

Reauthorization Requirements

Reauthorization requires attached documentation demonstrating clinical response compared to pretreatment baseline and reporting of adverse effects. Prescribers must attest to ongoing monitoring and provide updated movement/functional testing and laboratory monitoring results as requested.

Attach documentation showing response to therapy vs pretreatment baseline
Report any treatment‑restricting adverse effects (Yes/No)
Provide on‑treatment movement/functional assessments
Provide ongoing renal/protein monitoring results as required

Denial Risk

Documentation‑Dependent Authorization

Authorization decisions are documentation‑dependent. Lack of required supporting records or incomplete attestations may result in denial or inability to authorize therapy. Ensure all requested records are attached before submission.

Missing documentation confirming exon 53 amenability may lead to denial
Incomplete baseline or on‑treatment testing documentation may prevent authorization
Prescriber attestation and signature required

Documentation Required

Required Supporting Documents

Required supporting documents must be attached with the PA request: medical records confirming the DMD mutation amenable to exon 53 skipping, baseline movement and functional testing, baseline laboratory tests (serum cystatin C, urine dipstick, urine protein‑to‑creatinine ratio), and subsequent on‑treatment assessments and labs.

Medical records confirming exon 53 amenable mutation (lab/genetic report)
Baseline movement/functional testing documentation
Baseline serum cystatin C, urine dipstick, and urine protein‑to‑creatinine ratio
On‑treatment movement/functional assessments and monitoring results

Prior Authorization

Concomitant Therapy Check

Prescriber must attest the beneficiary is not receiving another RNA antisense agent or any other gene therapy prior to initiating therapy.

Confirm beneficiary is not taking any other RNA antisense agent or any gene therapy (Yes/No)

Background

Duchenne muscular dystrophy (DMD) is an X‑linked neuromuscular disorder caused by mutations in the dystrophin gene. Exon‑skipping antisense oligonucleotide therapies, such as Vyvondys 53 and Viltepso, are designed to skip specific exons (here, exon 53) to restore the dystrophin reading frame for eligible mutations. Authorization for these therapies requires documented confirmation that the beneficiary’s mutation is amenable to exon 53 skipping, specialist involvement (prescribed by or in consultation with a neurologist), baseline and ongoing renal monitoring (serum cystatin C, urine dipstick, urine protein‑to‑creatinine ratio), and baseline/ongoing functional assessments to demonstrate response and safety.

OpenPayer

Authorization form and coverage criteria for exon 53–skipping antisense therapies (Vyvondys 53, Viltepso)

Coverage Criteria

Coding and Dosage

Provider Actions and Submission Requirements

Definitions

Background