Duvyzat
Customize your policy alerts
Sign up for all medical mutual - ohio policy alerts
Know when medical mutual - ohio releases new policies or updates existing guidance.
Monitor payer policy activity
Policy governing prior-authorization recommended pharmacy benefit coverage of Duvyzat (givinostat) for treatment of Duchenne muscular dystrophy (DMD) in patients aged 6 years and older, including initial and continuing therapy clinical criteria, approval durations, documentation and conditions not recommended for approval.
No material changes
Coverage Summary
Coverage stance: covered_with_criteria. Scope: prior-authorization recommended pharmacy benefit coverage of Duvyzat (givinostat) for Duchenne muscular dystrophy (DMD) in patients aged >= 6 years, describing initial and continuing therapy criteria, documentation requirements, approval durations, and conditions not recommended for approval. Subject: Duvyzat (givinostat) for Duchenne muscular dystrophy. Key thresholds: age >= 6 years; stable systemic corticosteroid therapy for initial approval >= 6 months; established on medication for continuation >= 1 year. Approval durations: initial approval 1 year, extended approval 1 year.
Initial Therapy Criteria
Duchenne Muscular Dystrophy (DMD) - Initial Therapy
Covered when ALL of the following are met:
ALL of the following
- A: The patient is 6 years and older>= 6 years
- B: Patient's diagnosis of Duchenne Muscular Dystrophy is confirmed by genetic testing with a confirmed pathogenic variant in the dystrophin gene
- C: The patient has completed baseline function tests (e.g. time to wheelchair assistance, required respiratory assistance/pulmonary function tests, four-stair climb [4SC], 6-minute walk test [6MWT], time to walk/run 10 meters [10MWT], or North Star Ambulatory Assessment [NSAA])
Examples provided; documentation of baseline function tests required
- D: The patient is ambulatory
- E: The patient has been a stable on a systemic corticosteroid therapy for at least 6 months>= 6 months
- F: The medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne Muscular Dystrophy (DMD) and/or neuromuscular disorders
Initial approval requires specialist prescribing or consultation
- G: The prescribing physician has obtained and evaluated baseline platelet counts and triglycerides levels prior to initiation
Baseline labs required
Baseline function tests: Examples include time to wheelchair assistance, required respiratory assistance/pulmonary function tests, 4-stair climb (4SC), 6-minute walk test (6MWT), 10-meter walk/run (10MWT), and North Star Ambulatory Assessment (NSAA).
Continuation Therapy Criteria
Duchenne Muscular Dystrophy (DMD) - Continuing Therapy
Covered when ALL of the following are met:
ALL of the following
- A: The patient has been established on the medication for at least 1 year>= 1 year
- B: The patient is 6 years and older>= 6 years
- C: The patient is ambulatory
- D: The patient continues to be stable on a systemic corticosteroid therapy
- E: The medication is prescribed by or in consultation with a physician who specializes in the treatment of Duchenne Muscular Dystrophy (DMD) and/or neuromuscular disorders
- F: According to the prescriber, the patient continues to benefit from therapy, as demonstrated by a 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) score
Prescriber attestation of clinical benefit required
Conditions Not Recommended for Approval
Conditions Not Recommended for Approval
Not recommended when ANY of the following apply:
ANY of the following
- 1: Treatment in patients who have previously received gene therapy for DMD (safety/efficacy not studied)
- 2: Concomitant treatment with exon-skipping therapies for DMD (examples: Amondys/casimersen, Exondys 51/eteplirsen, Viltepso/viltolarsen, Vyondys 53/golodirsen)
- 3: Use for circumstances not listed in the Recommended Authorization Criteria (requests for other uses will be reviewed case-by-case)
Provider Actions / Prior Authorization
Prior authorization recommended
Prior authorization is recommended for pharmacy benefit coverage of Duvyzat; requests for non-listed uses will be reviewed for medical necessity on a case-by-case basis.
Specialist prescribing/consultation requirement
Initial therapy must be prescribed by or in consultation with a physician who specializes in DMD and/or neuromuscular disorders; documentation of specialist involvement should be provided.
Baseline testing required
Obtain and evaluate baseline platelet counts and triglyceride levels prior to initiation; complete baseline function tests (examples provided) must be documented.
- Platelet counts prior to initiation
- Triglyceride levels prior to initiation
- Baseline function tests (examples: time to wheelchair assistance, required respiratory assistance/pulmonary function tests, four-stair climb [4SC], 6-minute walk test [6MWT], time to walk/run 10 meters [10MWT], North Star Ambulatory Assessment [NSAA])
Ongoing benefit attestation for continuation
For reauthorization, prescriber must attest the patient continues to benefit, demonstrated by stabilization or slowed decline on timed function tests or NSAA score.
Coverage denial for non-medically necessary or investigational uses
The Company may deny reimbursement if the drug or services are not medically necessary, investigational/experimental, not within member benefits, or if requested documentation is not provided.
Applicable Codes
No specific billing codes (NDC, CPT, HCPCS) are listed in this policy. Code lookup and submission should follow the payer's billing guidance and pharmacy benefit billing procedures.
Clinical Evidence & References
Evidence: EPIDYS phase 3 randomized placebo-controlled trial (Lancet Neurol. 2024); Duvyzat oral suspension prescribing information, March 2024.
Background
Background: Duvyzat (givinostat) is an oral histone deacetylase (HDAC) inhibitor indicated for treatment of Duchenne muscular dystrophy in patients 6 years and older. It is intended to improve muscle function and reduce inflammation, and is the first nonsteroidal treatment approved for patients with all genetic variants of DMD.
Revision History
Policy reviewed on 03/19/2026 (annual review date and last revised date).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.