CurrentCignaPolicy IP0651

Duvyzat

Cigna's coverage policy for the use of Duvyzat (givinostat oral suspension) to treat Duchenne muscular dystrophy (DMD) in eligible patients, including prior authorization and documentation requirements for prescribers and payers.

Policy Summary

PayerCigna

PolicyDuvyzat

Policy CodePolicy IP0651

Change TypeNew policy

Effective Date07/01/2025

Next Review Date

Key ActionSubmit prior authorization with required documentation and specialist consultation for approvals of Duvyzat.

SourceLink

POLICY UPDATE CHANGES

New policy created for Duvyzat (givinostat) with coverage criteria and prior authorization requirements.

≥6Minimum age for approval

1 yrApproval duration

IP0651Policy number

YesNew policy

Coverage Criteria for Duvyzat (givinostat)

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Overall: Either A (Initial Therapy) OR B (Currently Receiving Duvyzat)

A) Initial Therapy: Approve if ALL of the following are met

A.i: Patient is ≥ 6 years of age

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A.ii: Diagnosis of Duchenne Muscular Dystrophy confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene (documentation required)

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A.iii: Patient is ambulatory

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A.iv: Patient is on a stable systemic corticosteroid therapy for at least 6 months>= 6 months

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A.v: Medication 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: Approve if ALL of the following are met

B.i: Patient is ≥ 6 years of age

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B.ii: Patient is ambulatory

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B.iii: Patient is continuing to receive stable systemic corticosteroid therapy

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B.iv: Per prescriber, patient continues to benefit from therapy demonstrated by stabilization or slowed decline on timed function tests (e.g., 4-stair climb, 6-minute walk test, time-to-rise) or North Star Ambulatory Assessment (NSAA) score

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B.v: Medication prescribed by or in consultation with a physician who specializes in treatment of Duchenne muscular dystrophy and/or neuromuscular disorders

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Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of Duvyzat; approvals are provided for the durations noted (typically 1 year) and require the medication to be prescribed by or in consultation with a physician who specializes in Duchenne muscular dystrophy and/or neuromuscular disorders.

Approvals are provided for 1 year when criteria are met.
Prescription must be by or in consultation with a DMD/neuromuscular specialist.

Step Therapy

Concurrent corticosteroid therapy requirement

The policy requires patients to be on stable systemic corticosteroid therapy for at least 6 months prior to initiation (initial therapy) and to continue stable corticosteroid therapy for continuation criteria.

Initial therapy: patient must be on stable systemic corticosteroid therapy for at least 6 months (FDA-Approved Indication A.iv).
Continuation: patient must be continuing to receive stable systemic corticosteroid therapy (FDA-Approved Indication B.iii).

Documentation Required

Required documentation

Documentation is required as noted in the criteria and may include chart notes, prescription claims/receipts, genetic testing confirming a pathogenic dystrophin variant, and evidence of specialist involvement.

Genetic testing confirming a pathogenic dystrophin variant is required for initial therapy (FDA-Approved Indication A.ii).
Documentation may include chart notes, prescription records, and evidence of prescription by or consultation with a DMD/neuromuscular specialist.

Billing Rule

Coding and claims denial risk

Claims submitted without covered diagnosis or procedure codes, or for services billed for conditions not covered under this policy, will be denied as not covered.

When billing, providers must use the most appropriate codes as of the submission date; absence of covered codes will result in denial.

Denial Risk

Indication-based denials

Use of Duvyzat for any indication other than Duchenne muscular dystrophy is considered not medically necessary and may be denied.

Duvyzat for any other use is explicitly listed in the policy as not medically necessary.

Definitions

Duvyzat (givinostat)

Generic nameGivinostat (brand name: Duvyzat)

Formulation / classOral suspension; histone deacetylase (HDAC) inhibitor

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

Prescriber requirementMedication must be prescribed by or in consultation with a physician who specializes in DMD and/or neuromuscular disorders (per coverage criteria)

Duchenne muscular dystrophy (DMD)

DefinitionDuchenne muscular dystrophy (DMD) is a rare, progressive X-linked disease caused by mutation(s) of the DMD (dystrophin) gene leading to absent or minimal dystrophin production and progressive muscle weakness.

Typical presentationUsually diagnosed in the second or third year of life; almost exclusively affects young boys

Affected systems and prognosisProgressive involvement of skeletal, respiratory, and cardiac muscles with mortality often in the third to fourth decade of life

EpidemiologyIncidence in the U.S. approximately 1 in 5,000 live male births

Background

Duchenne muscular dystrophy (DMD) is a rare, progressive, X-linked neuromuscular disorder caused by pathogenic variants in the dystrophin (DMD) gene leading to absent or markedly reduced dystrophin. It typically affects boys and results in progressive skeletal, respiratory, and cardiac muscle weakness, with clinical decline over childhood and adulthood. Duvyzat (givinostat) is an oral histone deacetylase (HDAC) inhibitor indicated for treatment of DMD in patients aged ≥ 6 years and is considered for coverage under the criteria in this policy.

Revision History and Policy Changes

2025-07-01policy_effective_dateLatest

New policy for Duvyzat (givinostat) becomes effective; establishes coverage criteria, prior authorization requirements, and a 1-year approval duration for eligible patients with Duchenne muscular dystrophy.

2024-11-01policy_creation

Policy created and documented as new (Revision note: New policy).

Policy Summary

PayerCigna

PolicyDuvyzat

Policy CodePolicy IP0651

Change TypeNew policy

Effective Date07/01/2025

Next Review Date

Key ActionSubmit prior authorization with required documentation and specialist consultation for approvals of Duvyzat.

SourceLink

On This Page

OpenPayer

Duvyzat

Coverage Criteria for Duvyzat (givinostat)

Coding and Age Requirements

Prior Authorization, Documentation, and Billing Guidance

Definitions

Background

Revision History and Policy Changes