CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Duvyzat (treatment for Duchenne muscular dystrophy) — Coverage Criteria

Policy governs coverage and authorization criteria for Duvyzat for treatment of Duchenne muscular dystrophy (DMD) in eligible members, including initial and continuation authorization requirements and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDuvyzat (treatment for Duchenne muscular dystrophy) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of confirmed DMD diagnosis, ambulatory status, baseline measures, and stable concomitant corticosteroid therapy for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moauthorization period

>=6minimum age

106.4 mg/dayquantity limit

ambulatoryambulatory requirement

Coverage Criteria for Duvyzat (Duchenne Muscular Dystrophy)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDuvyzat (treatment for Duchenne muscular dystrophy) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of confirmed DMD diagnosis, ambulatory status, baseline measures, and stable concomitant corticosteroid therapy for prior authorization.

SourceLink

On This Page

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Continuation authorization for Duvyzat: A. Member meets all initial authorization criteria.; B. Documentation that the member remains ambulatory (e.g., able to walk with or without assistance, not wheelchair dependent).; C. Documentation that the member is receiving a clinical benefit from Duvyzat therapy compared to pretreatment baseline in one or more of the following: increase in dystrophin level; stability, improvement, or slowed rate of decline in timed function tests (e.g., TTSTAND, 6MWT, TTRW, TTCLIMB/4SC); stability, improvement, or slowed rate of decline in upper limb function (ULM) test; stability, improvement, or slowed rate of decline in NSAA score; stability, improvement, or slowed rate of decline in FVC% predicted; improvement in quality of life.6 months authorization

Authorization may be granted for 6 months

Age, Authorization Duration, and Quantity Limits

inv-06: Age — minimum patient age for coverage

Minimum age for coverage6 years or older (member is 6 years of age or older)

Age requirement sourceFDA‑approved indication: Duvyzat is indicated for treatment of DMD in patients 6 years of age and older

ApplicabilityApplies to initial and continuation authorization criteria

inv-07: Authorization duration — initial and continuation period

Initial authorization duration6 months (authorization of 6 months may be granted)

Continuation authorization duration6 months (authorization of 6 months may be granted for continuation when criteria are met)

Requirement to qualifyBoth initial and continuation approvals require meeting specified clinical documentation and ambulatory status criteria

inv-08: Quantity limit — dosing limit per day

Daily quantity limit106.4 mg per 12 mL per day

ScopeApplies to all Duvyzat dosing for covered indications per policy

Policy sectionListed under IV. QUANTITY LIMIT

Prescriber and Documentation Requirements / Authorization Actions

Prior Authorization

Initial authorization — 6 months

Initial authorization for Duvyzat may be granted for 6 months when documentation requirements are met. Prescriber must be a neurologist who specializes in DMD or be in consultation with one. Requests must include diagnostic confirmation, baseline clinical data, ambulatory status, and concurrent stable systemic corticosteroid therapy unless contraindicated.

Authorization length: 6 months
Prescriber: neurologist specializing in DMD or consult with one
Age: member ≥ 6 years
Diagnostic confirmation: genetic testing showing a DMD gene mutation OR muscle biopsy showing absent dystrophin
Baseline clinical signs/symptoms of DMD (e.g., proximal muscle weakness, Gower's maneuver, elevated CK)
Ambulatory documentation (e.g., 4-stair climb ≤ 8 sec; time to rise from floor ≥3 and <10 sec)
Concurrent use with systemic corticosteroid on stable dose ≥ 6 months unless contraindicated or not tolerated
Baseline measures: dystrophin level, timed function tests (TTSTAND, 6MWT, TTRW, TTCLIMB/4SC), upper limb function (ULM), NSAA score, FVC% predicted

Prior Authorization

Continuation authorization — 6 months

Continuation authorization may be granted for 6 months when the member continues to meet the initial authorization criteria and demonstrates ongoing ambulatory status and clinical benefit compared to pretreatment baseline.

Authorization length: 6 months
Member must continue to meet all initial authorization criteria
Documentation that member remains ambulatory (able to walk with or without assistance; not wheelchair dependent)
Documentation of clinical benefit vs pretreatment baseline in one or more: increase in dystrophin level; stability, improvement, or slowed decline in timed function tests (TTSTAND, 6MWT, TTRW, TTCLIMB/4SC); stability/improvement/slowed decline in ULM; stability/improvement/slowed decline in NSAA score; stability/improvement/slowed decline in FVC% predicted; improvement in quality of life

Step Therapy

Step therapy

No step therapy requirements specified for Duvyzat in the treatment of DMD.

Denial Risk

Non‑FDA indications

Requests for indications other than the FDA‑approved DMD indication (patients ≥6 years) are considered experimental/investigational and not medically necessary.

Documentation Required

Required clinical documentation

Required clinical documentation for initial and continuation requests includes evidence of diagnosis and relevant clinical baseline and follow-up measures.

Diagnostic confirmation: genetic testing documenting DMD gene mutation OR muscle biopsy documenting absent dystrophin
Clinical signs/symptoms of DMD (e.g., proximal muscle weakness, Gower's maneuver, elevated CK)
Ambulatory status evidence
Baseline and follow-up measurements: dystrophin level; timed function tests (TTSTAND, 6MWT, TTRW, TTCLIMB/4SC); upper limb function (ULM); NSAA score; FVC% predicted
Documentation of concurrent systemic corticosteroid therapy and stability of dose for ≥6 months or documentation of contraindication/intolerance

Documentation Required

Continuation documentation

For continuation, include explicit comparison to pretreatment baseline to show clinical benefit (examples above) and documentation the member remains ambulatory.

Comparison of current measures to pretreatment baseline for at least one relevant outcome (dystrophin level, timed function tests, ULM, NSAA, FVC% predicted, quality of life)
Statement/evidence that member remains ambulatory (not wheelchair dependent)

OpenPayer

Duvyzat (treatment for Duchenne muscular dystrophy) — Coverage Criteria

Coverage Criteria for Duvyzat (Duchenne Muscular Dystrophy)

Age, Authorization Duration, and Quantity Limits

Prescriber and Documentation Requirements / Authorization Actions

Key Definitions

Background on Duchenne Muscular Dystrophy and Duvyzat