CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Duvyzat (treatment for Duchenne muscular dystrophy) — Coverage Criteria

This policy governs prior authorization, coverage criteria, continuation, and quantity limits for Duvyzat for treatment of Duchenne muscular dystrophy (DMD) for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDuvyzat (treatment for Duchenne muscular dystrophy) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for 6 months with documentation confirming DMD diagnosis, ambulatory status, baseline measures, and neurologist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization interval

≥6 yrsminimum age

106.4 mg/dayquantity limit

requiredambulatory requirement

Coverage Criteria for Duvyzat (Duchenne Muscular Dystrophy)

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Initial Authorization Criteria: A. Medication is prescribed by or in consultation with a neurologist who specializes in the treatment of Duchenne muscular dystrophy (DMD).

Initial Authorization Criteria: B. Member is 6 years of age or older.

Initial Authorization Criteria: C. Documentation that the diagnosis of DMD was confirmed by either: 1) genetic testing documenting a mutation in the DMD gene, or 2) muscle biopsy documenting absent dystrophin.

Initial Authorization Criteria: D. Documentation of clinical signs and symptoms of DMD (e.g., proximal muscle weakness, Gower's maneuver, elevated serum creatine kinase level).

Initial Authorization Criteria: E. Documentation that the member is ambulatory (examples: 4-stair climb ≤ 8 seconds and time to rise from floor between ≥ 3 and < 10 seconds).

Initial Authorization Criteria: F. Medication will be used in combination with a systemic corticosteroid (e.g., prednisone, prednisolone) and must be on a stable dose for a minimum of 6 months unless contraindicated or not tolerated.

Initial Authorization Criteria: G. Baseline documentation of one or more of the following: a) dystrophin level; b) timed function tests (e.g., TTSTAND, 6MWT, TTRW, TTCLIMB/4SC); c) upper limb function (ULM) test; d) North Star Ambulatory Assessment (NSAA) score; or e) Forced Vital Capacity (FVC) percent predicted.

Continuation Therapy (DMD)

Covered when ALL of the following are met for continuation authorization (6 months):

Continuation Authorization Criteria: A. The member meets all initial authorization criteria.

Continuation Authorization Criteria: B. Documentation that the member remains ambulatory (e.g., able to walk with or without assistance, not wheelchair dependent).

Continuation Authorization Criteria: C. Documentation that the member is receiving clinical benefit from Duvyzat compared to pretreatment baseline in one or more of the following: 1) increase in dystrophin level; 2) stability, improvement, or slowed rate of decline in timed function tests (e.g., TTSTAND, 6MWT, TTRW, TTCLIMB/4SC); 3) stability, improvement, or slowed rate of decline in upper limb function (ULM) test; 4) stability, improvement, or slowed rate of decline in NSAA score; 5) stability, improvement, or slowed rate of decline in FVC% predicted; or 6) improvement in quality of life.

Provider Actions and Authorization Requirements

Prior Authorization

Initial authorization — 6 months

Prior authorization for 6 months is required for initiation of Duvyzat (for DMD) when all listed criteria are met.

Authorization duration: 6 months
Applies to FDA‑approved indication: DMD in patients ≥6 years

Prior Authorization

Continuation authorization — 6 months

Prior authorization for 6 months is required for continuation of Duvyzat and may be granted when continued ambulatory status and documented clinical benefit compared to pretreatment baseline are met.

Authorization duration: 6 months
Member must remain ambulatory (e.g., able to walk with or without assistance, not wheelchair dependent)
Documented clinical benefit in one or more measures (e.g., dystrophin level, timed function tests, ULM, NSAA, FVC% predicted, or quality of life)

Documentation Required

Specialist prescriber and concomitant steroid documentation

Provider attestation is required that Duvyzat is prescribed by or in consultation with a neurologist who specializes in DMD, and that therapy will be used in combination with a systemic corticosteroid at a stable dose for a minimum of 6 months unless contraindicated or not tolerated.

Prescriber: neurologist who specializes in DMD, or documented consultation with such a specialist
Concomitant therapy: systemic corticosteroid (e.g., prednisone, prednisolone) on a stable dose for ≥6 months unless contraindicated or not tolerated
Baseline documentation required: dystrophin level and/or timed function tests (TTSTAND, 6MWT, TTRW, TTCLIMB/4SC), upper limb function (ULM), NSAA score, and/or FVC% predicted
Diagnosis confirmation: genetic testing documenting DMD gene mutation or muscle biopsy documenting absent dystrophin
Clinical signs: documentation of DMD signs/symptoms (e.g., proximal muscle weakness, Gower's maneuver, elevated CK)
Ambulatory status at baseline: documentation (e.g., 4SC ≤ 8 sec and time to rise from floor between ≥3 and <10 sec)

Background

Duchenne muscular dystrophy (DMD) is an X‑linked neuromuscular disorder caused by mutations in the DMD gene that result in absent or deficient dystrophin, leading to progressive proximal muscle weakness, elevated creatine kinase, loss of ambulation, and respiratory decline. Duvyzat is FDA‑approved for treatment of DMD in patients 6 years of age and older and is intended to be used with a systemic corticosteroid as part of the management of eligible patients.

Definitions and Clinical Terms

Ambulatory

DefinitionMember is able to walk with or without assistance and is not wheelchair dependent.

Examples (timed function tests)4‑stair climb (4SC) ≤ 8 seconds; time to rise from floor between ≥ 3 and < 10 seconds.

Context for useAmbulatory status is required for both initial authorization and continuation of Duvyzat therapy.

Clinical benefit on continuation

Definition of clinical benefitImprovement, stability, or slowed rate of decline in dystrophin levels, timed function tests, upper limb function, NSAA score, FVC% predicted, or quality of life.

Timed function tests (examples)TTSTAND, 6MWT, TTRW (10 m), TTCLIMB/4SC — stability, improvement, or slowed decline on these measures supports continuation.

Most actionable continuation evidenceDocumentation of clinical benefit compared to pretreatment baseline in one or more measures (e.g., increased dystrophin level or improved/stable timed function test).

Requirement tie-inClinical benefit must be documented for 6‑month continuation authorization, in addition to continued ambulatory status and meeting initial criteria.