CurrentUnitedHealthcarePolicy N/A

Vyondys 53, Viltepso (North Carolina) Prior Authorization Form - Community Planopen_in_new

A UnitedHealthcare prior authorization form used by prescribers to request initial or renewal coverage for exon-skipping therapies Vyondys 53 (golodirsen) and Viltepso (viltolarsen) for beneficiaries with Duchenne muscular dystrophy in the Community Plan (North Carolina). It captures required clinical attestation, baseline testing, monitoring, dosing limits, and documentation of response/adverse effects.

Policy Summary

PayerUnitedHealthcare

PolicyVyondys 53, Viltepso (North Carolina) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the form, provide beneficiary weight, documentation of amenable exon 53 mutation, baseline functional testing and labs for initial requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

2Drugs covered by form

53Genetic target (exon)

3Required baseline/monitoring labs

Coverage Summary

Coverage stance: covered with criteria for Vyondys 53 (golodirsen) and Viltepso (viltolarsen) per the UnitedHealthcare prior authorization form for exon 53-skipping therapies in the Community Plan (North Carolina). The form requires prescriber completion and signature and captures: clinical attestation (diagnosis of Duchenne muscular dystrophy and mutation amenable to exon 53 skipping), specialist involvement (prescribed by or in consultation with a neurologist), functional status (meaningful voluntary motor function), baseline testing (serum cystatin C, urine dipstick, urine protein-to-creatinine ratio prior to therapy), monitoring (monthly urine dipstick; serum cystatin C and urine protein-to-creatinine ratio every 3 months), dosing limits (Vyvondys 53 ≤ 30 mg/kg once weekly; Viltepso ≤ 80 mg/kg once weekly), and required documentation (weight, documentation of amenable exon 53 mutation, baseline functional testing, and baseline labs).

Provider Actions & Prior Authorization Requirements

Prior Authorization

Submit completed prior authorization form

Prescriber must complete and sign the prior authorization form. For initial requests, the signed form must include beneficiary weight, confirmation of Duchenne muscular dystrophy diagnosis, documentation that the DMD gene mutation is amenable to exon 53 skipping, baseline functional/movement testing, and baseline laboratory measurements (serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio).

Prior Authorization

Reauthorization documentation

For reauthorization, attach documentation demonstrating the beneficiary has shown a clinical response to therapy compared with the pretreatment baseline and report whether the beneficiary has experienced any treatment‑restricting adverse effects.

Documentation Required

Baseline and ongoing renal/protein monitoring

Obtain baseline renal/protein tests prior to initiating therapy: serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio. During treatment, monitor urine dipstick monthly and measure serum cystatin C and urine protein-to-creatinine ratio every 3 months.

Documentation Required

Specialist involvement required

Therapy must be prescribed by or in consultation with a neurologist. Document the neurologist prescription or consultation on the request form.

Billing Rule

Dosing limit verification

Prescriber must attest on the form that the requested weekly dose does not exceed the specified mg/kg limits: ≤30 mg/kg once per week for Vyvondys 53 and ≤80 mg/kg once per week for Viltepso. Requests exceeding these limits may be denied.

Background & Definitions

Background: This prior authorization form operationalizes requirements for exon 53-skipping therapies Vyondys 53 and Viltepso for beneficiaries with Duchenne muscular dystrophy. For initial requests it requires molecular confirmation that the beneficiary's DMD mutation is amenable to exon 53 skipping, prescriber attestation that the drug is prescribed by or in consultation with a neurologist, documentation that the beneficiary has meaningful voluntary motor function and has been assessed for PT/OT needs, baseline measurement of serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio, a monitoring plan (monthly urine dipstick; serum cystatin C and urine protein-to-creatinine ratio every 3 months), documentation of baseline movement/functional testing, verification of beneficiary weight, and prescriber attestation that the weekly dose does not exceed the specified mg/kg limits. For reauthorization the form requires attached documentation showing response to therapy compared to pretreatment baseline and reporting of any treatment-restricting adverse effects. Prescriber signature is mandatory and required documentation must be attached for review.

Term	Definition
Meaningful voluntary motor function
Not defined on form; prescriber must attest presence of meaningful voluntary motor function.
Amenable to exon 53 skipping
Molecular confirmation that the beneficiary's DMD gene mutation is responsive to exon 53 skipping therapy; documentation must be attached.

Policy Summary

PayerUnitedHealthcare

PolicyVyondys 53, Viltepso (North Carolina) Prior Authorization Form - Community Planopen_in_new

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the form, provide beneficiary weight, documentation of amenable exon 53 mutation, baseline functional testing and labs for initial requests.

SourceLink

On This Page

OpenPayer

Vyondys 53, Viltepso (North Carolina) Prior Authorization Form - Community Planopen_in_new

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Exclusions / Conflicts

Provider Actions & Prior Authorization Requirements

Applicable Codes

Background & Definitions

Clinical Evidence

Revision History