CurrentWest Virginia Bureau for Medical Services (Department of Human Services)Policy N/A

Amondys 45 (casimersen) prior authorization for Duchenne muscular dystrophy

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Defines prior authorization requirements and coverage criteria for Amondys 45 for patients with Duchenne muscular dystrophy who have a DMD gene mutation amenable to exon 45 skipping; applies to requests reviewed by West Virginia Bureau for Medical Services Pharmacy Prior Authorization.

Policy Summary

PayerWest Virginia Bureau for Medical Services (Department of Human Services)

PolicyAmondys 45 (casimersen) prior authorization for Duchenne muscular dystrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 26, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with mutation confirmation, baseline renal and functional tests, and documentation of ≥6 months corticosteroid therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval duration

>180m

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CurrentWest Virginia Bureau for Medical Services (Department of Human Services)Policy N/A

Amondys 45 (casimersen) prior authorization for Duchenne muscular dystrophy

Customize your policy alerts

Sign up for all West Virginia Bureau for Medical Services (Department of Human Services) policy alerts

Know when West Virginia Bureau for Medical Services (Department of Human Services) releases new policies or updates existing guidance.

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Policy Summary

PayerWest Virginia Bureau for Medical Services (Department of Human Services)

PolicyAmondys 45 (casimersen) prior authorization for Duchenne muscular dystrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 26, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with mutation confirmation, baseline renal and functional tests, and documentation of ≥6 months corticosteroid therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial approval duration

>180m

6MWT ambulatory threshold

weeklydosing frequency

05/26/2021effective since

Coverage Criteria for Amondys 45 (casimersen)

inv-01: Initial approval criteria

Covered when ALL of the following are met

Initial approval: Patient has a confirmed DMD gene mutation amenable to exon 45 skipping (chart notes provided); AND patient meets all FDA and manufacturer label requirements; AND baseline renal function has been evaluated and documentation provided with the request; AND request is from a neurologist or from a physician who has provided documentation of a formal neurologist consultation; AND patient has been stabilized on corticosteroid therapy for at least 6 months prior to the request (documentation of prescribed steroid therapy provided) — unless clinical justification for inability to take steroids is supplied; AND baseline validated functional test results obtained after ≥6 months of corticosteroid therapy are submitted (ambulatory: 6-minute walk test > 180 meters; non-ambulatory: Brooke Upper Extremity Function Scale score ≤ 5 AND Forced Vital Capacity ≥ 30% predicted).

All items required for approval

inv-02: Continuation of therapy

Covered when ALL of the following are met for renewal

Continuation approval: Follow-up functional test results demonstrate stabilization or improvement compared to baseline; AND results of regular renal function tests per manufacturer recommendations are supplied with each request; AND the patient maintains 100% compliance with scheduled Amondys 45 dosing (once weekly) and continues maintenance steroid therapy as prescribed — interruptions must be medically justified.

Approvals are renewed every 6 months

Requests for Amondys 45 will be immediately denied when the patient cannot take corticosteroid therapy and the ordering physician does not provide clinical justification for that inability. The policy requires patients to be stabilized on corticosteroid therapy for at least 6 months prior to the request and to continue maintenance steroid therapy while receiving Amondys 45; failure to meet this requirement without documented clinical rationale triggers an immediate denial of prior authorization.

Billing and Clinical Thresholds

Billing channelmixed

Pharmacy POS

Amondys 45 billed only as Pharmacy Point-of-Sale claim; contact RDTP for POS processing

6-minute walk test — ambulatory threshold

TestSix-minute walk test (6MWT)

Approval threshold> 180 meters (must achieve > 180 meters for approval)

Timing of testBaseline 6MWT must be obtained after at least 6 months of corticosteroid therapy

Use caseRequired for ambulatory patients as part of initial prior authorization documentation

Forced Vital Capacity (FVC) percent predicted — non-ambulatory threshold

MeasureForced Vital Capacity (FVC) — percent predicted

Approval threshold

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization review by Medical Director; approvals limited to 6 months

All prior authorization requests for Amondys 45 must be reviewed by the Medical Director. Approvals are issued for a maximum of 6 months and are contingent on meeting initial and continuation criteria (mutation confirmation, label requirements, baseline and ongoing functional and renal testing, and steroid therapy compliance).

Step Therapy

Require ≥6 months corticosteroid stabilization and ongoing maintenance therapy

The patient must have been stabilized on corticosteroid therapy for at least 6 months prior to the request and must continue maintenance steroid therapy while receiving Amondys 45. Documentation of the prescribed steroid therapy must be supplied with the request.

Background

Amondys 45 (casimersen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 45 skipping. Prior authorization for Amondys 45 requires review by the Medical Director and documentation that label requirements are met, baseline renal function has been evaluated, and the request originates from (or is supported by) a neurologist. Approval decisions are contingent on these program requirements and ongoing monitoring as specified by the manufacturer and the program.

Definitions and Key Terms

Amondys 45 (casimersen) — drug definition and approval context

DrugAmondys 45 (casimersen)

Mechanism/descriptionAn antisense oligonucleotide indicated for treatment of Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 45 skipping

Approval contextApproved under accelerated approval based on increased dystrophin production; clinical benefit has not been established and continued approval may depend on confirmatory trials

Billing channelBillable only as Pharmacy Point-of-Sale (POS) claim

6-minute walk test (6MWT) approval threshold — > 180 meters for ambulatory patients

TestSix-minute walk test (6MWT)

Policy Summary

PayerWest Virginia Bureau for Medical Services (Department of Human Services)

PolicyAmondys 45 (casimersen) prior authorization for Duchenne muscular dystrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 26, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with mutation confirmation, baseline renal and functional tests, and documentation of ≥6 months corticosteroid therapy.

SourceLink

On This Page

≥ 30% of predicted

ContextRequired for non-ambulatory patients along with Brooke Upper Extremity Function Scale ≤ 5

Baseline timingFVC must be obtained after the patient has received corticosteroid therapy for at least 6 months

Documentation Required

Documentation required with initial prior authorization request

Include chart notes confirming a DMD gene mutation amenable to exon 45 skipping, documentation that the patient meets all FDA/manufacturer label requirements, baseline renal function evaluation, documentation of corticosteroid therapy (type and duration), and baseline validated functional test results obtained after ≥6 months of corticosteroid therapy.

Chart documentation of confirmed DMD mutation amenable to exon 45 skipping
Evidence that label requirements are met
Baseline renal function evaluation/results
Details of corticosteroid therapy (agent and duration)
Baseline validated functional test results taken after ≥6 months of corticosteroid therapy

Documentation Required

Submit baseline and follow-up functional tests and renal monitoring

For ambulatory patients, submit a six-minute walk test (6MWT) result (must be taken after ≥6 months of corticosteroid therapy). For non-ambulatory patients, submit Brooke Upper Extremity Function Scale score (≤5) and Forced Vital Capacity percent predicted (≥30%). Also provide regular renal function monitoring per manufacturer recommendations with each request.

Ambulatory: 6MWT result (patient must achieve > 180 meters for approval)
Non-ambulatory: Brooke UE Function Scale score of 5 or less AND FVC ≥ 30% predicted
Renal monitoring per manufacturer: baseline GFR by 24‑hour urine, monthly urine dipstick for protein, serum cystatin C and UPCR every 3 months

Denial Risk

Immediate denial for lack of ≥6 months corticosteroid therapy without justification

If the patient is not on corticosteroid therapy for at least 6 months and the physician does not provide clinical justification for inability to take steroids, the prior authorization request will be immediately denied.

Approval threshold> 180 meters for ambulatory patients

Baseline requirement6MWT result must be taken after ≥ 6 months of corticosteroid therapy to be considered valid

PurposeSubmitted with initial request to demonstrate ambulatory function for prior authorization