CurrentUnitedHealthcarePolicy 2025 P 2346-3

Duvyzat (givinostat) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for coverage of Duvyzat (givinostat) oral suspension for treatment of Duchenne muscular dystrophy (DMD) in patients aged 6 years and older.

Policy Summary

PayerUnitedHealthcare

PolicyDuvyzat (givinostat) prior authorization and medical necessity

Policy CodePolicy 2025 P 2346-3

Change TypeCriteria added and removed (gene therapy language)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit supporting medical records and physician attestation demonstrating all initial or reauthorization criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added criterion for initial authorization addressing previous treatment with gene therapy for DMD.

Removed criterion from reauthorization addressing previous treatment with gene therapy for DMD.

Annual review with updated references; clarified initial authorization and reauthorization criteria.

1Program number

2Policy items with material change

YesReferences updated

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Medically Necessary Criteria for Duvyzat (givinostat)

Initial Authorization — Medically Necessary

Duvyzat will be approved based upon all of the following criteria:

ALL of the following

Diagnosis of Duchenne muscular dystrophy (DMD)
Diagnosis confirmed by the presence of a mutation in the DMD gene
Patient is 6 years of age or older
Age criterion per FDA indication
Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
Patient has been or will be established on a stable corticosteroid regimen
Prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD
Gene therapy status (one of)
- Patient has not received gene therapy (e.g., Elevidys [delandistrogene moxparvovec-rokl]) for the treatment of DMD
- If patient has previously received gene therapy
  - Patient has previously received gene therapy (e.g., Elevidys [delandistrogene moxparvovec-rokl]) for the treatment of DMD
  - Submission of medical records (e.g., chart notes, laboratory values) documenting a clinically meaningful functional decline resulting from loss of muscle strength/motor ability (e.g., loss of a motor milestone) since receiving gene replacement therapy
Patient will not receive Duvyzat in combination with exon-skipping therapies for DMD (e.g., Amondys [casimersen], Exondys 51 [eteplirsen], Viltepso [viltolarsen], Vyondys 53 [golodirsen])
Concomitant use with exon-skipping therapies is excluded

Reauthorization — Continued Medical Necessity

Duvyzat will be approved for reauthorization based on all of the following:

ALL of the following

Physician attestation that patient would benefit from continued administration
Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.)
Patient continues to receive concomitant corticosteroid regimen
Prescribed by, or in consultation with, a pediatric neuromuscular specialist with expertise in the treatment of DMD
Patient will not receive Duvyzat in combination with exon-skipping therapies for DMD (e.g., Amondys [casimersen], Exondys 51 [eteplirsen], Viltepso [viltolarsen], Vyondys 53 [golodirsen])

Exceptions / Administrative Notes

Other rules that may affect coverage decisions:

ANY of the following

State mandates, federal regulatory requirements, and the member specific benefit plan may impact coverage criteria
UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic
Supply limits may be in place

ref

What Providers Must Do

Prior Authorization

Obtain prior authorization for Duvyzat

Providers must obtain prior authorization demonstrating that all applicable initial authorization or reauthorization criteria are met. The PA submission must include supporting medical records and a physician attestation as specified in the policy.

PA must document each required initial or reauthorization criterion (diagnosis, genetic confirmation, age, ambulatory status, corticosteroid regimen, specialist involvement, and gene therapy status when applicable).
Include physician attestation for reauthorization requests per policy.
Attach relevant chart notes, laboratory values, and other supporting medical records.

Documentation Required

Submit documentation of ambulatory status

Submit medical records (e.g., chart notes) confirming the patient is ambulatory without needing an assistive device for both initial authorization and reauthorization requests.

Document absence of side-by-side assist, cane, walker, wheelchair, or similar devices in the chart notes.
Include these notes with the PA packet for initial and continued coverage reviews.

Documentation Required

If prior gene therapy, document functional decline

For patients previously treated with gene therapy, submit medical records documenting a clinically meaningful functional decline (e.g., loss of a motor milestone) since receiving gene replacement therapy to meet initial authorization criteria.

Provide chart notes, laboratory values, or other records demonstrating loss of muscle strength/motor ability after gene therapy.
This documentation is required only for initial authorization when the patient has previously received gene therapy.

Documentation Required

Specialist involvement required

Prescriptions must be written by, or in consultation with, a pediatric neuromuscular specialist with expertise in DMD; include documentation of specialist involvement in the medical record.

Include a note or attestation showing the prescribing clinician is a pediatric neuromuscular specialist or that the specialist was consulted regarding treatment.
Specialist involvement is required for both initial authorization and reauthorization.

Policy Identifiers and Referenced Products

Policy identifiermixed

2025 P 2346-3

UnitedHealthcare program/policy number for Duvyzat prior authorization/medical necessity

Example referenced gene therapy and exon-skipping products (not coverage codes)mixed

Elevidys	delandistrogene moxparvovec-rokl (gene therapy) — referenced as prior therapy example
Amondys	casimersen (exon-skipping) — referenced as excluded concomitant therapy example
Exondys 51	eteplirsen (exon-skipping) — referenced as excluded concomitant therapy example
Viltepso	viltolarsen (exon-skipping) — referenced as excluded concomitant therapy example
Vyondys 53	golodirsen (exon-skipping) — referenced as excluded concomitant therapy example

Clinical and Program Background

Duvyzat (givinostat) is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. The indication and clinical program are based on the product labeling and clinical trial evidence, including the phase 3 EPIDYS trial evaluating the safety and efficacy of givinostat in boys with DMD, and are reflected in the program references and package insert.

The policy requires that patients be established on a stable corticosteroid regimen consistent with guideline literature supporting corticosteroid use in DMD. The clinical rationale and references include the American Academy of Neurology practice guideline update on corticosteroid treatment of DMD and the Duvyzat package insert and clinical trial publications cited in the policy.

Policy Changes

2024-07program_creation

Program created as a new prior authorization/medical necessity policy for Duvyzat (givinostat) (P&T approval recorded 7/2024).

2025-07annual_review

Annual review performed with no changes to criteria; references updated.

2025-11criteria_revision (added)Latest

Added initial-authorization criterion allowing patients previously treated with gene therapy only if documentation shows a clinically meaningful functional decline since gene replacement therapy.

2025-11criteria_revision (removed)

Removed prior-treatment-with-gene-therapy language from the reauthorization criteria.

2026-02-01effective_date

Policy effective date established.

OpenPayer

Duvyzat (givinostat) prior authorization and medical necessity

Medically Necessary Criteria for Duvyzat (givinostat)

What Providers Must Do

Policy Identifiers and Referenced Products

Clinical and Program Background

Key Definitions

Policy Changes