CurrentUnitedHealthcarePolicy CSPA2026D0105H

Amondys 45 (Casimersen) (for Pennsylvania Only)

Policy governs medical benefit drug coverage of Amondys 45 (casimersen) for treatment of Duchenne muscular dystrophy in Pennsylvania members; specifies initial and continuation authorization criteria and coding. Applies to prescribers and UnitedHealthcare reviewers in PA.

Policy Summary

PayerUnitedHealthcare

PolicyAmondys 45 (Casimersen) (for Pennsylvania Only)

Policy CodePolicy CSPA2026D0105H

Change TypeRevised coverage criteria

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit medical records confirming DMD diagnosis amenable to exon 45 skipping, baseline motor assessment, and documentation of continued benefit for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria; added criterion requiring Amondys 45 will not be used concomitantly with Duvyzat (givinostat).

Up to 12 momaximum authorization period

J1426HCPCS code

G71.01Diagnosis code

PAstate-specific

Coverage Criteria for Amondys 45 (casimersen)

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Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a neurologist with expertise in the diagnosis of DMD

Initial Therapy: Submission of medical records confirming the mutation of the DMD gene is amenable to exon 45 skipping

Initial Therapy: Submission of medical records documenting a baseline evaluation, including a standardized assessment of motor function by a neurologist experienced in treating Duchenne muscular dystrophy, prior to beginning Amondys 45 therapy

Prior Gene Therapy Status: One of the following

Prior Gene Therapy Option 1: Patient has not previously received gene therapy (e.g., Elevidys [delandistrogene moxparvovec-rokl]) for the treatment of DMD

Prior Gene Therapy Option 2: Patient has previously received gene therapy for DMD AND submission of medical records documenting a clinically meaningful functional decline resulting from loss of muscle strength/motor ability (e.g., loss of a motor milestone) since receiving gene replacement therapy

Concomitant Therapy Exclusion: Amondys 45 will not be used concomitantly with Duvyzat (givinostat) or other exon skipping therapies for DMD (e.g., Exondys 51 [eteplirsen], Viltepso [viltolarsen], Vyondys 53 [golodirsen])

Prescriber and Dosing: Prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD and dosing in accordance with the United States Food and Drug Administration approved labeling

Initial authorization up to 12 months

Continuation Therapy

Reauthorization covered when ALL of the following are met:

Continuation Therapy: Documentation of continued clinical benefit based on prescriber's assessment, including an evaluation with a standardized assessment of motor function ability by a neurologist with experience in treating Duchenne muscular dystrophy

Reauthorization up to 12 months

Unproven / Not Medically Necessary

Unproven Indications: Use of Amondys 45 for other forms of muscular dystrophy (e.g., Becker muscular dystrophy) or for DMD that is not amenable to exon 45 skipping

Not medically necessary/unproven

Use of Amondys 45 (casimersen) outside its specified indication is considered unproven and not medically necessary. Specifically, Amondys 45 has not been studied in and is not covered for treatment of other forms of muscular dystrophy (for example, Becker muscular dystrophy) or for Duchenne muscular dystrophy that is not amenable to exon 45 skipping. Providers should not submit requests for these indications because the evidence does not support clinical benefit.

Treatment of other forms of muscular dystrophy (e.g., Becker muscular dystrophy) with Amondys 45 is considered unproven and not medically necessary because casimersen has not been studied in these conditions and clinical benefit has not been demonstrated.

Prescriber, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations will be for up to 12 months; reauthorizations (continuation therapy) may also be approved for up to 12 months.

Prior authorization is required before initiating Amondys 45 therapy.
Initial authorization: up to 12 months.
Reauthorization/continuation: up to 12 months per approval.

Note

Prescriber and Dosing Requirements

Prescriber and dosing requirements. Therapy must be prescribed by, or in consultation with, a neurologist with expertise in treating Duchenne muscular dystrophy. Dosing must follow the FDA‑approved labeling.

Prescriber: Neurologist with expertise in DMD or treatment in consultation with such a neurologist.
Dosing: In accordance with the FDA approved labeling for Amondys 45.
Amondys 45 must not be used concomitantly with Duvyzat (givinostat) or other exon skipping therapies (e.g., eteplirsen, viltolarsen, golodirsen).

Documentation Required

Documentation Requirements

Required documentation must be submitted with the authorization request. Provide medical records confirming diagnosis, mutation amenability, baseline assessments, and monitoring documentation.

Diagnostic confirmation of Duchenne muscular dystrophy by, or in consultation with, a neurologist experienced in DMD.
Medical records confirming the DMD gene mutation is amenable to exon 45 skipping.
Baseline evaluation documentation, including a standardized assessment of motor function performed by a neurologist experienced in DMD, prior to initiating therapy.
For patients previously treated with gene therapy (e.g., Elevidys), medical records documenting a clinically meaningful functional decline (loss of muscle strength/motor ability or loss of a motor milestone) since gene replacement therapy.
Documentation of continued clinical benefit on reauthorization including a standardized motor function assessment by a neurologist experienced in treating DMD.

Denial Risk

Denial Conditions / Risk

Denial may be triggered if required criteria or documentation are not met. Requests lacking evidence of an amenable exon 45 mutation, missing baseline or follow‑up standardized motor assessments, absence of neurologist involvement, use with excluded concomitant therapies, or requests for unproven indications may be denied.

No documentation confirming the DMD mutation is amenable to exon 45 skipping.
Missing baseline standardized motor function assessment prior to initiation.
Missing documentation of continued clinical benefit or required follow‑up assessments on reauthorization.
Prescriber not a neurologist experienced in DMD and no documented consultation with such a specialist.
Concomitant use with excluded agents (e.g., Duvyzat/givinostat or other exon skipping therapies).
Request for treatment of unproven indications (e.g., other forms of muscular dystrophy such as Becker muscular dystrophy).

Background

Duchenne muscular dystrophy (DMD) is an X-linked recessive degenerative neuromuscular disease characterized by progressive skeletal and cardiac muscle weakness that can lead to respiratory and/or cardiac failure. Casimersen is an antisense oligonucleotide therapy indicated for patients with DMD who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. The drug works by inducing exon skipping to enable production of a truncated but functional dystrophin protein; clinical trials have shown increases in dystrophin levels in patients with exon 45–amenable mutations. Use of casimersen should be limited to patients meeting the policy’s diagnostic and documentation requirements and should not be used concomitantly with other exon-skipping therapies or investigational agents such as givinostat.

OpenPayer

Amondys 45 (Casimersen) (for Pennsylvania Only)

Coverage Criteria for Amondys 45 (casimersen)

Coding and Clinical Measures

Prescriber, Authorization, and Documentation Requirements

Definitions and Mutation Eligibility

Background

Policy History / Revision Information