CurrentUnitedHealthcarePolicy N/A

Prior Authorization/Authorization Form for Vyondys 53 (golodirsen) and Viltepso (viltolarsen)

A pharmacy prior-authorization questionnaire and authorization form used by UnitedHealthcare to evaluate initial and reauthorization requests for Vyondys 53 (golodirsen) and Viltepso (viltolarsen) for beneficiaries with Duchenne muscular dystrophy, capturing clinical eligibility, monitoring, dosing, and documentation requirements.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization/Authorization Form for Vyondys 53 (golodirsen) and Viltepso (viltolarsen)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must complete the form answering initial (questions 1-11) or reauthorization (questions 12-13) items and attach required medical records to support mutation confirmation, baseline testing, and response to therapy.

POLICY UPDATE CHANGES

No material clinical/coverage changes

2Drugs covered by form

11Initial authorization questions

2Reauthorization questions

Coverage Summary

UnitedHealthcare covers Vyondys 53 (golodirsen) and Viltepso (viltolarsen) with criteria as specified on the UnitedHealthcare pharmacy prior-authorization form. The form is used to evaluate initial and reauthorization requests for these exon-skipping therapies for beneficiaries with Duchenne muscular dystrophy and captures clinical eligibility, monitoring, dosing limits, and required documentation.

Initial Authorization Criteria

Covered when ALL of the following are met:

Prescriber is a neurologist or therapy is prescribed in consultation with a neurologist
Prescriber signature mandatory
Diagnosis: Beneficiary has a diagnosis of Duchenne muscular dystrophy
Must confirm mutation of the Duchenne muscular dystrophy gene via attached medical records
Motor function: Beneficiary has meaningful voluntary motor function
Therapy assessment: Assessment for physical therapy and/or occupational therapy needs has been performed
Baseline functional testing: Baseline movement/functional testing documentation is attached
Concomitant therapies exclusion: Beneficiary is not taking any other RNA antisense agent or any other gene therapy
Request may be denied if beneficiary is receiving another RNA antisense agent or any other gene therapy
Dosing limits: Prescribed dose does not exceed 30 mg/kg once per week for Vyondys 53 OR 80 mg/kg once per week for Viltepso<= 30 mg/kg weekly (Vyondys 53) OR <= 80 mg/kg weekly (Viltepso)
Baseline labs: Baseline laboratory monitoring (serum cystatin C, urine dipstick, urine protein-to-creatinine ratio) has been measured prior to initiation
Monitoring plan: Prescriber attests that serum cystatin C, urine dipstick (monthly), and urine protein-to-creatinine ratio will be measured during treatmenturine dipstick monthly

Reauthorization (Continuation) Criteria

Reauthorization Criteria

Covered when ALL of the following are met:

Response documentation: Documentation attached demonstrating response to therapy compared to pretreatment baseline
Adverse effects: No treatment-restricting adverse effects have occurred due to therapy
Prescriber signature certifying accuracy of information
Prescriber signature mandatory

Provider Actions & Submission Requirements

Prior Authorization

Prior authorization submission

Providers must complete the form answering initial (questions 1-11) or reauthorization (questions 12-13) and attach required medical records to support mutation confirmation, baseline testing, and response to therapy.

Mutation confirmation medical records
Baseline laboratory testing (serum cystatin C, urine dipstick, urine protein-to-creatinine ratio)
Baseline functional/movement testing
Documentation of response to therapy for reauthorization

Documentation Required

Mutation confirmation documentation

Attach medical records that confirm the mutation of the Duchenne muscular dystrophy gene for initial authorization.

Documentation Required

Baseline and ongoing monitoring

Measure and document baseline serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio prior to initiation and attest that these will be measured during treatment, with monthly urine dipstick monitoring and periodic serum cystatin C and urine protein-to-creatinine ratio.

Urine dipstick: monthly

Documentation Required

Functional status documentation

Provide baseline movement/functional testing at initiation. For reauthorization, attach documentation showing the beneficiary has demonstrated a response to therapy compared to the pretreatment baseline.

Denial Risk

Concomitant therapy exclusion

Request may be denied if the beneficiary is receiving another RNA antisense agent or any other gene therapy.

Billing Rule

Prescriber signature requirement

Prescriber signature is mandatory on the form for processing; the form includes a prescriber signature and date to certify accuracy.

Background

The form is intended to capture the clinical and administrative information needed for UnitedHealthcare pharmacy prior-authorization for exon-skipping therapies Vyondys 53 and Viltepso used in Duchenne muscular dystrophy. It gathers baseline testing (serum cystatin C, urine dipstick, urine protein-to-creatinine ratio), documents baseline movement/functional testing, enforces dosing limits, and records monitoring plans and documentation of response for reauthorization.

Meaningful voluntary motor function: Not explicitly defined on the form; the prescriber must indicate Yes/No as part of the initial authorization questions.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization/Authorization Form for Vyondys 53 (golodirsen) and Viltepso (viltolarsen)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Prior Authorization/Authorization Form for Vyondys 53 (golodirsen) and Viltepso (viltolarsen)

Coverage Summary

Initial Authorization Criteria

Reauthorization (Continuation) Criteria

Exclusions / Denial Conditions

Provider Actions & Submission Requirements

Applicable Codes / Drugs Referenced

Background

Clinical Evidence

Revision History

Vyondys 53	golodirsen (brand name listed)
Viltepso	viltolarsen (brand name listed)