CurrentCignaPolicy IP0137

Muscular Dystrophy - Amondys 45

Defines Cigna's prior-authorization, coverage criteria, dosing, and documentation requirements for Amondys 45 when used to treat patients with Duchenne muscular dystrophy amenable to exon 45 skipping.

Policy Summary

PayerCigna

PolicyMuscular Dystrophy - Amondys 45

Policy CodePolicy IP0137

Change TypeTitle and dosing updateddocumentation clarified

Effective DateAug 15, 2024

Next Review DateJun 6, 2026

Key ActionObtain prior authorization; approvals are provided for 6 months and require prescription by or consultation with a neurologist, neuromuscular specialist, or MDA clinic.

SourceLink

POLICY UPDATE CHANGES

Updated policy title from 'Casimersen' to 'Muscular Dystrophy - Amondys 45' and added dosing to the policy.

Clarified documentation language to state 'Documentation is required where noted in the criteria.'

6 monthsapproval duration

30 mg/kgrecommended dosing

>=300 m6MWT requirement

>=50%FVC requirement

J1426covered code

Policy Summary

PayerCigna

PolicyMuscular Dystrophy - Amondys 45

Policy CodePolicy IP0137

Change TypeTitle and dosing updateddocumentation clarified

Effective DateAug 15, 2024

Next Review DateJun 6, 2026

Key ActionObtain prior authorization; approvals are provided for 6 months and require prescription by or consultation with a neurologist, neuromuscular specialist, or MDA clinic.

SourceLink

On This Page

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Coverage Criteria for Amondys 45 (casimersen)

Initial Therapy

Approve for 6 months if the patient meets ALL of the following (Initial Therapy):

Initial Therapy: Patient is less than 14 years of age at start of therapy.age <14

Initial Therapy: Documentation of Duchenne muscular dystrophy confirmed by a pathogenic or likely pathogenic DMD gene variant that is amenable to exon 45 skipping.

Initial Therapy: Able to walk a distance of at least 300 meters independently over 6 minutes (6‑minute walk test >= 300 meters).>= 300 meters

Initial Therapy: Forced vital capacity (FVC) is at least 50%.>= 50%

Initial Therapy: Medication is prescribed by, or in consultation with, a neurologist, neuromuscular specialist, or a Muscular Dystrophy Association clinic.

Approval duration = 6 months

Patient is Currently Receiving Amondys 45

Approve for 6 months if the patient is currently receiving Amondys 45 and ALL of the following are met:

Continuation Therapy: The above initiation criteria were met prior to initiation of Amondys 45.

Continuation Therapy: Patient has experienced a beneficial clinical response, including the continued ability to walk.continued clinical benefit

Continuation Therapy: Medication continues to be prescribed by, or in consultation with, a neurologist, neuromuscular specialist, or a Muscular Dystrophy Association clinic.

Approval duration = 6 months

Amondys 45 (casimersen) is approved by Cigna only for the FDA‑approved indication in Duchenne muscular dystrophy patients with DMD gene mutations amenable to exon 45 skipping and when the specific coverage criteria are met. Amondys 45 for any other use is considered not medically necessary. Prior authorization is required for Amondys 45 and approvals are issued for 6 months when criteria are satisfied.

Concurrent administration of Amondys 45 with other exon‑skipping DMD agents is not supported by available clinical evidence and is explicitly excluded from coverage. Claims for uses outside the stated indication or for concurrent exon‑skipping therapy will be considered not medically necessary.

Concurrent use of Amondys 45 with other exon‑skipping agents for the treatment of Duchenne muscular dystrophy is considered not medically necessary due to lack of clinical evidence supporting combined exon‑skipping therapy.

Because no clinical data demonstrate safety or additive benefit of simultaneous exon skipping with multiple agents, concurrent administration is excluded from coverage and prior authorization will not be granted for overlapping exon‑skipping treatments.

Coding and Clinical Thresholds

Considered Medically Necessary when criteria metHCPCSCovered

J1426

Injection, casimersen, 10 mg

inv-06: 6-Minute Walk Test — threshold requirement (>= 300 meters)

6-Minute Walk Test (6MWT) thresholdPatient must be able to walk at least 300 meters independently over 6 minutes (>= 300 meters)

ApplicabilityRequired for Initial Therapy approval (one of the criteria that must ALL be met for a 6-month approval)

MeasurementDistance measured as independent ambulation over a 6-minute period

Related requirementCombined with FVC >= 50% and genetic confirmation of exon 45‑amenable DMD variant for initiation

inv-07: Forced vital capacity (FVC) — threshold requirement (>= 50%)

Forced vital capacity (FVC) thresholdForced vital capacity must be at least 50% (>= 50%)

Provider Actions, Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for prescription benefit coverage of Amondys 45. All approvals are provided for 6 months. Because of the specialized skills required for evaluation and diagnosis of patients treated with Amondys 45 as well as the monitoring required for adverse events and long-term efficacy, Amondys 45 must be prescribed by, or in consultation with, a physician who specializes in the condition being treated (e.g., neurologist, neuromuscular specialist, or Muscular Dystrophy Association clinic). Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Prior authorization required for Amondys 45 — approvals provided for 6 months
Prescriber requirement: must be prescribed by or in consultation with a neurologist, neuromuscular specialist, or Muscular Dystrophy Association clinic

Documentation Required

Required Documentation

Documentation is required where noted in the criteria. Documentation may include, but is not limited to, chart notes, laboratory tests, medical test results (including genetic testing confirming a DMD gene variant amenable to exon 45 skipping), and claims records. Receipt of sample product does not satisfy any documentation or criteria requirements for coverage.

Background

Amondys 45 (casimersen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy in patients with a pathogenic or likely pathogenic DMD variant that is amenable to exon 45 skipping. The policy requires documentation of the genetic diagnosis and, for initiation, that patients be younger than 14 years, able to walk at least 300 meters on the 6‑minute walk test, and have a forced vital capacity of at least 50%. The recommended dosing under the policy is 30 mg/kg once weekly administered as an intravenous infusion.

Definitions

inv-13: Amenable to exon 45 skipping — definition of a confirmed pathogenic/likely pathogenic DMD variant making patient eligible

DefinitionA confirmed pathogenic or likely pathogenic variant in the DMD gene for which exon 45 skipping would restore the dystrophin reading frame, as documented by genetic testing.

DocumentationGenetic testing documentation confirming a pathogenic or likely pathogenic DMD variant amenable to exon 45 skipping is required for coverage consideration.

Policy contextThis is a required criterion for Initial Therapy approval and for patients currently receiving Amondys 45 (must have met this prior to initiation).

Indication linkAmondys 45 is indicated for DMD in patients with a confirmed DMD gene mutation amenable to exon 45 skipping (FDA‑approved indication).