Currentmedical mutual - ohioPolicy N/A

Duvyzat

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.

Policy Summary

Payermedical mutual - ohio

PolicyDuvyzat

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for pharmacy benefit coverage of Duvyzat; provide required documentation including baseline function tests and baseline platelet and triglyceride values, and document specialist prescribing/consultation.

SourceLink

POLICY UPDATE CHANGES

No material changes

1Covered Indication (DMD)

2Approval Durations (initial/extended, years)

>=6Age Threshold (years)

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

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

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.

Documentation Required

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.

Documentation Required

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])

Documentation Required

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.

Denial Risk

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.

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.

Age>= 6 years

Stable systemic corticosteroid therapy (initial)>= 6 months

Established on medication (continuation)>= 1 year

Policy Summary

Payermedical mutual - ohio

PolicyDuvyzat

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Duvyzat

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Conditions Not Recommended for Approval

Provider Actions / Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Revision History