CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Elevidys (delandistrogene moxeparvovec-rokl) Coverage Criteria

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This policy governs prior authorization and coverage of Elevidys for New Hampshire Medicaid Fee-for-Service beneficiaries with Duchenne muscular dystrophy. Coverage requires all specified clinical, laboratory, treatment, and monitoring criteria.

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyElevidys (delandistrogene moxeparvovec-rokl) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all eleven approval criteria are satisfied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4+Minimum age

Exons 18-58DMD mutation

<1:400Antibody titer

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CurrentNew Hampshire Department of Health and Human ServicesPolicy N/A

Elevidys (delandistrogene moxeparvovec-rokl) Coverage Criteria

Customize your policy alerts

Sign up for all New Hampshire Department of Health and Human Services policy alerts

Know when New Hampshire Department of Health and Human Services releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyElevidys (delandistrogene moxeparvovec-rokl) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all eleven approval criteria are satisfied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4+Minimum age

Exons 18-58DMD mutation

<1:400Antibody titer

1 doseLifetime limit

Elevidys Coverage Criteria

Initial Elevidys Coverage

Coverage is provided when ALL of the following criteria are met:

ALL of the following

Patient is at least 4 years of age or older.
Patient has been diagnosed with Duchenne muscular dystrophy (DMD).
Patient has a confirmed mutation of the DMD gene between exons 18 to 58.
Patient has a baseline anti-AAVrh74 total binding antibody titer of < 1:400 as measured by ELISA.
Patient is ambulatory as confirmed by the North Star Ambulatory Assessment (NSAA) scale.NSAA score ≥ 1
Patient has been on a stable dose of a corticosteroid prior to the start of therapy, unless corticosteroids are contraindicated or not tolerated, and will use a corticosteroid regimen concomitantly before and after infusion. Refer to the package insert for recommended corticosteroid dosing during therapy.
Patient's troponin-I levels will be monitored at baseline and subsequently as clinically indicated.
Patient will have liver function assessed prior to and following therapy for at least 3 months and as clinically indicated.

Elevidys is not covered when the patient is receiving concomitant therapy with DMD-directed antisense oligonucleotides, including golodirsen, casimersen, viltolarsen, or eteplirsen, or has received a DMD-directed antisense oligonucleotide within the past 7 days.

Elevidys is not covered when the patient has an active infection, including clinically important localized infections.

Clinical and Coding Parameters

Eligibility threshold

Minimum age4 years or older

Genetic eligibility

DMD gene mutationConfirmed mutation between exons 18 and 58

Antibody threshold

Baseline anti-AArh74 total binding antibody titerLess than 1:400 by ELISA

Ambulatory status threshold

North Star Ambulatory Assessment

Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required before Elevidys (delandistrogene moxeparvovec-rokl) is administered. Approval requires that all eleven criteria are satisfied; coverage is limited to a single dose per lifetime and one kit based on the patient’s weight.

Submit documentation demonstrating compliance with each approval criterion.
Quantity limitation: one dose per lifetime; one kit based on patient weight.

Documentation Required

Clinical Eligibility Documentation

Document the patient’s clinical eligibility for Elevidys, including age, diagnosis, genetic confirmation, antibody titer, ambulatory status, concurrent or recent antisense oligonucleotide therapy, and infection status.

Patient is at least 4 years of age.
Confirmed diagnosis of Duchenne muscular dystrophy (DMD).

Elevidys and Duchenne Muscular Dystrophy

Elevidys (delandistrogene moxeparvovec-rokl) is indicated for ambulatory patients with Duchenne muscular dystrophy (DMD) who are 4 years of age or older and have a confirmed mutation in the DMD gene. Coverage is subject to the policy’s genetic, immunologic, functional, infection, concomitant-therapy, corticosteroid, and monitoring requirements.

Initial Therapy

Initial therapy is covered when ALL approval criteria are met:

Initial Elevidys therapy approval criteria

Age: Patient is at least 4 years of age.>= 4 years
Diagnosis: Patient has been diagnosed with Duchenne muscular dystrophy (DMD).
Genetic confirmation: Patient has a confirmed mutation of the DMD gene between exons 18 and 58.Exons 18-58

Lifetime and Weight-Based Quantity Limits

Quantity limits

Elevidys lifetime limitSingle dose per lifetime

Quantity limits

Elevidys course limit1 kit based on patient weight

Policy Summary

PayerNew Hampshire Department of Health and Human Services

PolicyElevidys (delandistrogene moxeparvovec-rokl) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that all eleven approval criteria are satisfied.

SourceLink

On This Page

Score of 1 or greater

Confirmed DMD gene mutation between exons 18 and 58.

Baseline anti-AAVrh74 total binding antibody titer is < 1:400, measured by ELISA.

Ambulatory status confirmed by the North Star Ambulatory Assessment (NSAA), with a score of ≥ 1.

Patient is not receiving concomitant DMD-directed antisense oligonucleotide therapy, including golodirsen, casimersen, viltolarsen, or eteplirsen, and has not received such therapy within the past 7 days.

Patient does not have an active infection, including a clinically important localized infection.

Documentation Required

Corticosteroid Documentation

Document that the patient has received a stable corticosteroid dose before therapy, unless corticosteroids are contraindicated or not tolerated, and will receive the planned corticosteroid regimen before and after infusion.

Record any corticosteroid contraindication or intolerance.
Document the planned pre- and postinfusion corticosteroid regimen; refer to the package insert for recommended corticosteroid dosing during therapy.

Documentation Required

Required Laboratory Monitoring

Required laboratory monitoring must be documented as part of the Elevidys treatment plan, including troponin-I and liver function monitoring.

Monitor troponin-I at baseline and subsequently as clinically indicated.
Assess liver function before and after therapy for at least 3 months, and thereafter as clinically indicated.

Denial Risk

Failure to Meet Approval Criteria

Coverage will be denied when the approval criteria are not met.

Denial condition: any of the eleven approval criteria is not satisfied.

Antibody titer: Patient has a baseline anti-AArh74 total binding antibody titer of less than 1:400, as measured by ELISA.< 1:400 by ELISA

Ambulatory status: Patient is ambulatory as confirmed by the North Star Ambulatory Assessment (NSAA) scale.NSAA score >= 1

Concomitant antisense therapy: Patient is not receiving concomitant therapy with DMD-directed antisense oligonucleotides, including golodirsen, casimersen, viltolarsen, or eteplirsen.

Recent antisense therapy: Patient has not received a DMD-directed antisense oligonucleotide within the past 7 days.No treatment within the past 7 days

Infection status: Patient does not have an active infection, including a clinically important localized infection.No active infection

Corticosteroid therapy: Patient has been receiving a stable dose of a corticosteroid before starting therapy, unless corticosteroids are contraindicated or not tolerated, and will receive a corticosteroid regimen before and after infusion.Stable corticosteroid dose; pre- and postinfusion regimen

Refer to the package insert for recommended corticosteroid dosing during therapy.

Troponin-I monitoring: The patient's troponin-I levels will be monitored at baseline and subsequently as clinically indicated.Baseline and as clinically indicated

Liver function monitoring: The patient's liver function will be assessed before and after therapy for at least 3 months and thereafter as indicated.Before and after therapy for at least 3 months