CurrentMass General Brigham Health PlanPolicy N/A

Amondys 45 (casimersen)

Defines prior authorization criteria, dosing, initial and continuation approval durations, and documentation requirements for Amondys 45 (casimersen) for treatment of Duchenne muscular dystrophy patients amenable to exon 45 skipping under the pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAmondys 45 (casimersen)

Policy CodePolicy N/A

Change TypePolicy created

Effective DateNov 1, 2021

Next Review Date

Key ActionPrior authorization required; submit documentation of DMD mutation amenable to exon 45 skipping, baseline and interim 6MWT results, timed function test results, and prescribing clinician specialty.

SourceLink

POLICY UPDATE CHANGES

Policy created and reviewed 09/22/2021 for P&T; effective 11/01/2021.

1Covered Indication (DMD amenable to exon 45 skipping)

200 m6MWT ambulatory threshold

6 moInitial approval duration

12 moReauthorization duration

Coverage Summary

Amondys 45 (casimersen) is covered with prior authorization for treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed DMD gene mutation that is amenable to exon 45 skipping. This indication was approved under accelerated approval based on an increase in dystrophin production in skeletal muscle (see Amondys 45 package insert).

Refer to the Amondys 45 package insert (Sarepta Therapeutics; February 2021) for prescribing and safety information.

Definitions

Amenable to exon 45 skipping: examples of DMD gene exon deletions amenable to exon 45 skipping include deletions such as exon 44; deletions of exons 46-47, 46-48, 46-49, 46-51, 46-53, and 46-55 (appendix examples).

Ambulatory (policy): defined as a current six-minute walk test (6MWT) distance of ≥ 200 meters; the 6MWT must have been observed or completed by the treating provider, or ordered by the treating provider and completed by a qualified medical practitioner.

Provider Actions / Prior Authorization Requirements

Prior Authorization

Obtain prior authorization

Prior authorization required. Submit documentation showing a DMD gene mutation amenable to exon 45 skipping, pretreatment baseline and interim six-minute walk test (6MWT) results, results of timed function tests, and the prescribing clinician's specialty.

Documentation Required

Baseline and ongoing functional testing documentation

Include a pretreatment baseline and all interim six-minute walk test (6MWT) results for initial and continuation requests. For reauthorization, provide documentation of a stable or improving pattern of 6MWTs (pretreatment baseline plus all interim results) and include results (with dates) for timed function tests demonstrating stable or improving performance (at least two of the five specified tests). Tests must be observed or completed by the treating provider or ordered by the treating provider and completed by a qualified medical practitioner.

Billing Rule

Dosing requirement

Authorization is conditioned on appropriate dosing: 30 mg/kg administered intravenously once weekly.

Prior Authorization

Specialist prescriber requirement

The prescribing physician must be a neurologist or a provider who specializes in the treatment of Duchenne muscular dystrophy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAmondys 45 (casimersen)

Policy CodePolicy N/A

Change TypePolicy created

Effective DateNov 1, 2021

Next Review Date

SourceLink

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Amondys 45 (casimersen)

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Definitions

Provider Actions / Prior Authorization Requirements

Applicable Codes

Clinical Evidence / Approval Basis

Revision History