CurrentCignaPolicy N/A

Muscular Dystrophy - Duvyzat Prior Authorization Policy

Prior authorization policy for coverage of Duvyzat (givinostat oral suspension) for treatment of Duchenne muscular dystrophy in members of Cigna-administered health benefit plans; defines clinical criteria, documentation and prescribing requirements.

Policy Summary

PayerCigna

PolicyMuscular Dystrophy - Duvyzat Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document genetic confirmation of DMD, ambulatory status, and stable corticosteroid therapy as required for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6minimum patient age for approval

1 yrinitial approval duration

≥6 mostable corticosteroid duration (initial)

ambulatorypatient functional status required

specialistprescriber specialty

Coverage Criteria for Duvyzat (givinostat)

FDA-Approved Indication (Duchenne Muscular Dystrophy)

Covered when ONE of the following (A or B) is met for Duchenne Muscular Dystrophy; approvals for 1 year.

Overall approval pathways: Approve for 1 year if the patient meets ONE of the following (A or B)

A) Initial Therapy: Initial therapy pathway requires ALL of the following:

Initial Therapy details

Age: Patient is ≥ 6 years of age≥ 6 years
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Policy Summary

PayerCigna

PolicyMuscular Dystrophy - Duvyzat Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document genetic confirmation of DMD, ambulatory status, and stable corticosteroid therapy as required for approval.

SourceLink

On This Page

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Genetic confirmation: Diagnosis of DMD confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene [documentation required]

Ambulatory status: Patient is ambulatoryambulatory

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Corticosteroid therapy: Patient is on a stable systemic corticosteroid therapy for at least 6 months≥ 6 months

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Prescriber specialty: Medication is prescribed by or in consultation with a physician who specializes in treatment of Duchenne muscular dystrophy and/or neuromuscular disorders

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B) Currently Receiving Duvyzat (Continuation): Continuation therapy requires ALL of the following:

Continuation details

Age: Patient is ≥ 6 years of age≥ 6 years
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Ambulatory status: Patient is ambulatoryambulatory
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Corticosteroid therapy: Patient is continuing to receive stable systemic corticosteroid therapystable
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Clinical benefit: According to the prescriber, the patient continues to benefit from therapy, as demonstrated by stabilization or slowed decline on timed function tests (e.g., 4-stair climb, 6-minute walk test, time-to-rise) or in the North Star Ambulatory Assessment (NSAA) scoredocumented functional stabilization or slowed decline
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Prescriber specialty: Medication is prescribed by or in consultation with a physician who specializes in treatment of Duchenne muscular dystrophy and/or neuromuscular disorders
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Duvyzat (givinostat) is considered not medically necessary for any use(s) other than those specifically detailed in this policy for Duchenne muscular dystrophy. This policy will be revised as new published data become available to reflect any changes in approved indications or evidence supporting other uses.

Any request for Duvyzat that does not meet the specified coverage criteria for Duchenne muscular dystrophy as described in this policy is considered not medically necessary and will be denied.

Key Clinical & Coding Parameters

Minimum age

Minimum age≥ 6 years

Source contextPatient must be ≥ 6 years of age for initial or continuation therapy

Approval durationApprovals provided for 1 year when criteria are met

Stable corticosteroid duration (initial therapy)

Stable corticosteroid duration (initial therapy)≥ 6 months

Continuation requirementContinuation requires ongoing stable systemic corticosteroid therapy (no specific minimum duration)

DocumentationStability on corticosteroid therapy may need to be documented in chart notes per criteria

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for Duvyzat; approvals are provided for 1 year when criteria are met. Because of the specialized evaluation and monitoring required, Duvyzat must be prescribed by or in consultation with a physician who specializes in Duchenne muscular dystrophy or neuromuscular disorders.

Prior authorization recommended for prescription benefit coverage
Approvals provided for 1 year when initial or continuation criteria are met
Prescriber requirement: specialist or consultation with specialist

Documentation Required

Corticosteroid Requirement

Patients must be on stable systemic corticosteroid therapy as specified by the criteria: for initial therapy, systemic corticosteroid therapy must have been stable for at least 6 months prior to initiation; for continuation/maintenance therapy, the patient must be continuing on stable systemic corticosteroid therapy.

Initial therapy: stable systemic corticosteroid therapy for ≥ 6 months
Continuation therapy: continuing stable systemic corticosteroid therapy

Documentation Required

Documentation is required to support the clinical criteria and may include, but is not limited to, chart notes, genetic testing results confirming a pathogenic dystrophin (DMD) variant, prescription claims/receipts, prior authorization paperwork, and clinician assessments of functional status (timed function tests or NSAA scores) when applicable.

Genetic testing confirming a pathogenic dystrophin (DMD) variant [documentation required]
Chart notes and clinician assessment documenting ambulatory status and functional testing (e.g., 4-stair climb, 6-minute walk test, time-to-rise, NSAA)
Prescription claims records or receipts and prior authorization paperwork

Denial Risk

Not Covered Uses and Coding/Claims Risk

Requests for Duvyzat for any use not meeting the listed DMD criteria are considered not medically necessary and will be denied. Claims submitted without a covered diagnosis or appropriate supporting documentation will be denied as not covered.

Not covered: any indication other than the specified Duchenne muscular dystrophy criteria
Coding/claims risk: claims lacking covered diagnosis codes or required documentation will be denied as not covered

Clinical Background

Duchenne muscular dystrophy (DMD) is an X‑linked, progressive neuromuscular disorder caused by pathogenic variants in the dystrophin gene that lead to loss of functional dystrophin protein. It typically affects males and presents in childhood with progressive skeletal, respiratory, and cardiac muscle weakness. Duvyzat (givinostat) is an oral histone deacetylase (HDAC) inhibitor indicated for treatment of DMD in patients aged ≥ 6 years, and coverage under this policy is limited to the specific clinical criteria and documentation requirements outlined for that indication.

Drug and Functional Definitions

Duvyzat (givinostat)

DrugDuvyzat (givinostat)

MechanismOral histone deacetylase (HDAC) inhibitor

IndicationTreatment of Duchenne muscular dystrophy (DMD) in patients ≥ 6 years of age

Ambulatory / functional assessment

Ambulatory requirementPatient must be ambulatory for initial and continuation approval

Examples of functional assessments4‑stair climb, 6‑minute walk test, time‑to‑rise, North Star Ambulatory Assessment (NSAA)

PurposeAssess stabilization or slowed decline in function to support continuation therapy