ModifiedCountycarePolicy 5008.CC

Duchenne Muscular Dystrophy Drug Therapies

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This guideline governs prior authorization under the Health Plan medical benefit for Amondys 45, Vyondys 53, and Elevidys used to treat Duchenne muscular dystrophy. It applies to practitioners involved in providing the requested drugs.

Policy Summary

PayerCountycare

PolicyDuchenne Muscular Dystrophy Drug Therapies

Policy CodePolicy 5008.CC

Change TypeModified

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Elevidys, Amondys 45, and Vyondys 53 and submit all applicable drug-specific criteria.

SourceLink

POLICY UPDATE CHANGES

The Elevidys initial authorization duration was updated to up to 6 months.

The guideline includes updated Elevidys approval and eligibility requirements.

3Drug therapies covered

6 monthsInitial Elevidys authorization

1 yearAmondys 45/Vyondys 53 authorization

60 days

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ModifiedCountycarePolicy 5008.CC

Duchenne Muscular Dystrophy Drug Therapies

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Policy Summary

PayerCountycare

PolicyDuchenne Muscular Dystrophy Drug Therapies

Policy CodePolicy 5008.CC

Change TypeModified

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Elevidys, Amondys 45, and Vyondys 53 and submit all applicable drug-specific criteria.

SourceLink

POLICY UPDATE CHANGES

The Elevidys initial authorization duration was updated to up to 6 months.

The guideline includes updated Elevidys approval and eligibility requirements.

3Drug therapies covered

6 monthsInitial Elevidys authorization

1 yearAmondys 45/Vyondys 53 authorization

60 days

Post-infusion corticosteroids

1 lifetimeElevidys treatment limit

Drug-Specific Coverage Criteria

Initial Amondys 45 and Vyondys 53 therapy

Covered when ALL of the following are met for Amondys 45 or Vyondys 53.

Amondys 45 and Vyondys 53 initial therapy

Disease and drug match: The member has a diagnosis of Duchenne muscular dystrophy with a confirmed DMD gene mutation amenable to the requested exon skipping.
The mutation must be amenable to exon 45 skipping for Amondys 45 or exon 53 skipping for Vyondys 53.
Prescribing and dose requirements: The requested drug is prescribed at a dose within the manufacturer's dosing guidelines in FDA-approved labeling by, or in consultation with, a provider board certified in neurology, orthopedics, physical medicine and rehabilitation, neuromuscular medicine, or neurodevelopmental disabilities.
Required clinical documentation: Documentation includes current weight; a 6-Minute Walk Test if the member is ambulatory; Brooke Upper Extremity Function score; stable pulmonary function; urinalysis showing absence of proteinuria; blood urea nitrogen; and serum creatinine.BUE Function ≤5; FVC ≥30% predicted
Corticosteroid prerequisite
- The member has tried and been adherent to standard corticosteroid therapy for a minimum of 6 months.Minimum 6 months
- The provider has documented justification for discontinuation of standard corticosteroid therapy.
Treatment planning: The goals of therapy are documented.

Initial Elevidys therapy

Covered when ALL of the following are met for Elevidys.

Elevidys initial therapy

Age and diagnosis: The member is at least 4 years of age and has a diagnosis of Duchenne muscular dystrophy with documentation of a DMD gene mutation.At least 4 years
Mutation requirement: The documented DMD gene mutation is not a deletion in exon 8 or exon 9.
Prescribing and dose requirements: Elevidys is prescribed at a dose within the manufacturer's dosing guidelines in FDA-approved labeling by, or in consultation with, a provider board certified in neurology, orthopedics, physical medicine and rehabilitation, neuromuscular medicine, or neurodevelopmental disabilities.

Annual continuation therapy

Covered for annual continuation when ALL of the following are met for Amondys 45 or Vyondys 53.

Annual continuation of Amondys 45 or Vyondys 53

Adherence and clinical response: The member continues to be adherent to the requested medication, supported by infusion records, and the prescriber documents a clinical response to therapy.
Current clinical and laboratory documentation: Current weight, 6-Minute Walk Test if the member is ambulatory, Brooke Upper Extremity Function score, Forced Vital Capacity, urinalysis showing absence of proteinuria, blood urea nitrogen, and serum creatinine are submitted.BUE Function ≤5; FVC ≥30% predicted
Standard therapy continuation: Previously initiated standard therapy has continued when appropriate and tolerated.

Elevidys is excluded when the member’s DMD mutation is a deletion in exon 8 or exon 9, the baseline anti-AAVrh74 total binding antibody titer is 1:400 or higher, the member has previously received Elevidys, or the member will receive exon-skipping therapy concomitantly or after Elevidys treatment.

Elevidys reauthorization is not eligible because only one treatment course per member’s lifetime is allowed.

Covered Drug Codes and Clinical Thresholds

ElevidysHCPCSCovered

J1413

Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose

Amondys 45HCPCSCovered

J1426

Injection, casimersen, 10mg

Vyondys 53HCPCSCovered

J1429

Injection, golodirsen, 10mg

Brooke Upper Extremity Function score

Required score≤5

Applies toInitial and annual continuation therapy for Amondys 45 and Vyondys 53

DocumentationThe Brooke Upper Extremity (BUE) Function score must be submitted with the request

Forced Vital Capacity

Required pulmonary functionForced Vital Capacity (FVC) ≥30% predicted

Applies toInitial and annual continuation therapy for Amondys 45 and Vyondys 53

Authorization, Documentation, and Denial Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Amondys 45 (casimersen), Elevidys (delandistrogene moxeparvovec-rokl), and Vyondys 53 (golodirsen). Requests are reviewed using FDA criteria to determine Medical Necessity.

Applies to Amondys 45, Elevidys, and Vyondys 53.

Documentation Required

Qualified Specialist Prescriber

The medication must be prescribed by, or prescribed in consultation with, a provider board certified in an appropriate specialty.

Neurology
Orthopedics
Physical medicine and rehabilitation
Neuromuscular medicine
Neurodevelopmental disabilities

Disease and Therapy Background

Duchenne muscular dystrophy (DMD) is a rare, X-linked recessive, life-threatening, degenerative neuromuscular disease caused by mutations in the DMD gene. Dystrophin deficiency leads to progressive muscle degeneration, loss of independent ambulation, and respiratory and cardiac complications.

Defined Clinical Terms

Duchenne muscular dystrophy (DMD)

DiseaseA rare, X-linked, recessive, life-threatening, degenerative neuromuscular disease affecting males

Genetic characteristicCaused by mutations in the DMD gene on chromosome Xp21

Protein affectedThe DMD gene produces dystrophin, which provides mechanical stability to muscle fibers during contraction

Clinical consequencesAbsence of or defects in dystrophin lead to progressive muscle degeneration, loss of independent ambulation, and respiratory and cardiac complications

Initial Therapy Decision Trees

Amondys 45 and Vyondys 53 initial therapy

Initial therapy requires ALL of the following criteria for Amondys 45 or Vyondys 53.

Amondys 45 or Vyondys 53 initial therapy

Disease and drug match: The member has a diagnosis of Duchenne muscular dystrophy with a confirmed DMD gene mutation amenable to the requested exon skipping.
The mutation must be amenable to exon 45 skipping for Amondys 45 or exon 53 skipping for Vyondys 53.
Prescribing and dose requirements: The requested drug is prescribed at a dose within the manufacturer's dosing guidelines in FDA-approved labeling by, or in consultation with, a provider board certified in neurology, orthopedics, physical medicine and rehabilitation, neuromuscular medicine, or neurodevelopmental disabilities.
Required clinical documentation: Documentation includes current weight; a 6-Minute Walk Test if the member is ambulatory; Brooke Upper Extremity Function score; stable pulmonary function; urinalysis showing absence of proteinuria; blood urea nitrogen; and serum creatinine.

Annual Continuation Decision Tree

Amondys 45 and Vyondys 53 continuation

Annual reauthorization requires ALL of the following criteria for Amondys 45 or Vyondys 53.

Adherence and clinical response: The member continues to be adherent to the requested medication, supported by infusion records, and the prescriber documents a clinical response to therapy.
Current clinical and laboratory documentation: Current weight, 6-Minute Walk Test if the member is ambulatory, Brooke Upper Extremity Function score, Forced Vital Capacity, urinalysis showing absence of proteinuria, blood urea nitrogen, and serum creatinine are submitted.BUE Function ≤5; FVC ≥30% predicted
Standard therapy continuation: Previously initiated standard therapy has continued when appropriate and tolerated.

Required Prior Therapy

Step	Therapy requirement	Duration or exception
1	Try standard corticosteroid therapy and remain adherent before starting Amondys 45 or Vyondys 53.	Minimum 6 months; provider justification for discontinuation may be submitted instead.

Step	Therapy requirement	Duration
1	Initiate corticosteroid therapy before Elevidys infusion and continue treatment after infusion.	Continue for a minimum of 60 days after infusion.

Policy Summary

PayerCountycare

PolicyDuchenne Muscular Dystrophy Drug Therapies

Policy CodePolicy 5008.CC

Change TypeModified

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Elevidys, Amondys 45, and Vyondys 53 and submit all applicable drug-specific criteria.

SourceLink

On This Page

Antibody requirement:

The baseline anti-AAVrh74 total binding antibody titer is below 1:400.

Provider attestations: The provider attests that the member will initiate a corticosteroid regimen before infusion and continue treatment for a minimum of 60 days after infusion; will not receive exon-skipping therapies concomitantly or following Elevidys treatment; and has not previously received Elevidys.Corticosteroids for at least 60 days after infusion

DocumentationStable pulmonary function and the current FVC must be submitted with the request

Baseline anti-AAVrh74 total binding antibody titer

Required baseline titer<1:400

Applies toInitial Elevidys therapy

Exclusion thresholdElevidys is not eligible when the titer is 1:400 or higher

Minimum age for Elevidys

Minimum ageAt least 4 years

Applies toInitial Elevidys therapy

Required documentationThe member’s age must be submitted with the Elevidys request

Standard corticosteroid therapy trial

Minimum duration6 months

Applies toInitial Amondys 45 and Vyondys 53 therapy

AlternativeThe provider may submit justification for discontinuation of standard corticosteroid therapy

Billing Rule

FDA-Labeled Dosing Required

The requested medication must be prescribed at a dose within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.

Applies to Amondys 45, Vyondys 53, and Elevidys.

Step Therapy

Standard Corticosteroid Therapy

For Amondys 45 or Vyondys 53, the member must have tried and remained adherent to standard corticosteroid therapy for at least 6 months, or the request must include justification for discontinuing standard therapy.

Document adherence and duration of prior standard corticosteroid therapy.
A clinical justification is required when standard therapy was discontinued.

Documentation Required

Elevidys Corticosteroid Regimen

For Elevidys, the provider must attest that the member will initiate a corticosteroid regimen before infusion and continue treatment for at least 60 days after infusion.

Corticosteroids must begin before the Elevidys infusion.
Treatment must continue for a minimum of 60 days after infusion.

Documentation Required

Initial Exon-Skipping Therapy Documentation

Initial Amondys 45 and Vyondys 53 requests must include documentation supporting the diagnosis, mutation-specific exon-skipping indication, clinical status, safety requirements, prior therapy, and goals of therapy.

Confirmed Duchenne muscular dystrophy (DMD) diagnosis and a DMD gene mutation amenable to exon 45 skipping for Amondys 45 or exon 53 skipping for Vyondys 53.
Current weight.
6-Minute Walk Test (6MWT), if ambulatory.
Brooke Upper Extremity (BUE) Function score of ≤5.
Stable pulmonary function with Forced Vital Capacity (FVC) ≥30% predicted.
Urinalysis showing absence of proteinuria.
Blood Urea Nitrogen (BUN) and serum creatinine (SCr).
Documentation of adherence to standard corticosteroid therapy for at least 6 months, or justification for discontinuation.
Documentation of the goals of therapy.

Documentation Required

Initial Elevidys Documentation

Initial Elevidys requests must document that the member meets the age, diagnosis, genetic, antibody, dosing, and treatment-eligibility requirements.

Member is at least 4 years of age.
DMD diagnosis with a documented DMD gene mutation.
The mutation is not a deletion in exon 8 or exon 9.
Baseline anti-AAVrh74 total binding antibody titer is <1:400.
FDA-labeled dosing is prescribed.
Provider attests that the member will not receive exon-skipping therapy, such as Amondys 45 or Exondys 51, concomitantly or following Elevidys treatment.
Provider attests that the member has not previously received Elevidys.

Documentation Required

Continuation Therapy Documentation

Annual continuation requests for Amondys 45 or Vyondys 53 must document ongoing adherence, clinical response, current clinical measures, and continued standard therapy when appropriate and tolerated.

Infusion records supporting adherence to the requested medication.
Prescriber's assessment documenting clinical response to therapy.
Current weight.
6MWT, if ambulatory.
BUE Function score of ≤5.
FVC ≥30% predicted.
Urinalysis showing absence of proteinuria.
BUN and SCr.
Continued standard therapy previously initiated, if appropriate and tolerated.
All prior authorization renewals are reviewed annually for Medical Necessity.

Denial Risk

Criteria Not Met

The request must meet all criteria in the applicable drug-specific section. If established criteria are not met, the request may be referred to a Medical Director for review, as required by the plan and request level, and may be denied.

Failure to satisfy drug-specific Medical Necessity criteria may result in denial.

Denial Risk

Elevidys Exclusion Risks

Elevidys is not appropriate when specified exclusion risks are present, including prior Elevidys treatment or concurrent or planned exon-skipping therapy.

The member has received Elevidys previously.
The member will receive exon-skipping therapy, such as Amondys 45 or Exondys 51, concomitantly or following Elevidys treatment.
The DMD mutation is a deletion in exon 8 or exon 9.
The baseline anti-AAVrh74 total binding antibody titer is not <1:400.

Denial Risk

No Elevidys Reauthorization

Elevidys is not eligible for reauthorization because only one treatment course is permitted per member's lifetime.

No repeat Elevidys course or lifetime reauthorization is allowed.

BUE Function ≤5; FVC ≥30% predicted

Corticosteroid prerequisite

The member has tried and been adherent to standard corticosteroid therapy for a minimum of 6 months.Minimum 6 months
The provider has documented justification for discontinuation of standard corticosteroid therapy.

Treatment planning: The goals of therapy are documented.

Elevidys initial therapy

Initial therapy requires ALL of the following criteria for Elevidys.

Age and diagnosis: The member is at least 4 years of age and has a diagnosis of Duchenne muscular dystrophy with documentation of a DMD gene mutation.At least 4 years
Mutation requirement: The documented DMD gene mutation is not a deletion in exon 8 or exon 9.
Prescribing and dose requirements: Elevidys is prescribed at a dose within the manufacturer's dosing guidelines in FDA-approved labeling by, or in consultation with, a provider board certified in neurology, orthopedics, physical medicine and rehabilitation, neuromuscular medicine, or neurodevelopmental disabilities.
Antibody requirement: The baseline anti-AAVrh74 total binding antibody titer is below 1:400.<1:400
Provider attestations: The provider attests that the member will initiate a corticosteroid regimen before infusion and continue treatment for a minimum of 60 days after infusion; will not receive exon-skipping therapies concomitantly or following Elevidys treatment; and has not previously received Elevidys.Corticosteroids for at least 60 days after infusion