CurrentUnitedHealthcarePolicy 2024 P 2127-8

Emflaza (deflazacort) prior authorization / medical necessity

Defines UnitedHealthcare prior authorization and medical necessity stance for Emflaza (deflazacort) for treatment of Duchenne muscular dystrophy and describes approval logic and exclusions that may apply to members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyEmflaza (deflazacort) prior authorization / medical necessity

Policy CodePolicy 2024 P 2127-8

Change TypeNo material change

Effective DateJan 1, 2025

Next Review Date

Key ActionSubmit prior authorization with supporting documentation; plan-specific tried/failed criteria (e.g., trial of prednisone) may be required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10/2024P&T approval

2025-01-01Effective

≥2 yrsFDA age

EquivalentTherapeutic stance

Typically excludedCoverage stance

Coverage Determination

Not medically necessary / Typically excluded

Coverage determination summary

General coverage stance: Emflaza (deflazacort) is not medically necessary for treatment of Duchenne muscular dystrophy because published clinical evidence shows it is likely to produce equivalent therapeutic results as other available corticosteroids (e.g., prednisone).

Document states Emflaza is typically excluded; plan specifics and state mandates may modify coverage.

Emflaza (deflazacort) is typically excluded from UnitedHealthcare coverage for Duchenne muscular dystrophy. Coverage may vary by state mandate and by the member's specific benefit plan; other policies or utilization management programs may also apply. The policy record notes an added exclusion footnote in the 10/2024 update, and plan-specific details should be consulted to confirm the exclusion status for a given member.

Published clinical evidence indicates Emflaza is likely to produce equivalent therapeutic results to other available corticosteroids (for example, prednisone). Because of this therapeutic equivalence, the policy states Emflaza is not medically necessary for treatment of Duchenne muscular dystrophy when alternatives such as prednisone are available; tried/failed criteria may be required per plan specifics.

Policy Summary

PayerUnitedHealthcare

PolicyEmflaza (deflazacort) prior authorization / medical necessity

Policy CodePolicy 2024 P 2127-8

Change TypeNo material change

Effective DateJan 1, 2025

Next Review Date

Key ActionSubmit prior authorization with supporting documentation; plan-specific tried/failed criteria (e.g., trial of prednisone) may be required.

SourceLink

On This Page

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Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization/medical necessity program applies to Emflaza (deflazacort); coverage may be denied because Emflaza is typically excluded. Check plan-specific prior authorization requirements before submitting a request.

Program: Prior Authorization/Medical Necessity
Medication: Emflaza (deflazacort)
P&T Approval Date: 10/2024

Step Therapy

Step Therapy Possible

Step therapy possible — Tried/failed (step therapy) criteria may be required; Emflaza is considered therapeutically equivalent to other corticosteroids (e.g., prednisone), so plans may require a trial and failure of alternative corticosteroids prior to approval.

May require trial of alternative corticosteroids such as prednisone
Plan-specific tried/failed criteria apply

Documentation Required

Supporting Documentation Required

Supporting documentation note — Approvals and denials may be based on prior claim/medication history and diagnosis codes (ICD-10). Documentation requirements depend on the program and member benefit plan; state mandates and other utilization management programs may affect determinations.

UnitedHealthcare may approve initial or reauthorization based solely on previous claims/medication history and ICD-10 diagnosis codes
State mandates and member-specific benefit plans can alter coverage determination

Denial Risk

Coverage Exclusion Risk

Coverage exclusion risk — Emflaza is typically excluded from coverage; plan-specific tried/failed criteria and member benefit plan coverage or state mandates may change the exclusion status. Verify eligibility and coverage before prescribing.

Emflaza is typically excluded from coverage
Refer to plan specifics to determine exclusion status

Note

Automated Approval/Reauthorization Possible

Automated denial/approval processes — UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or other automated claim logic. Use of automated approval and re-approval processes varies by program and therapeutic class.

Approvals/reauthorizations may be automated based on claims and diagnosis codes
Automated processes vary by program/therapeutic class

Key Definitions

Duchenne Muscular Dystrophy — deflazacort (Emflaza) and relation to prednisone

DefinitionDuchenne muscular dystrophy (DMD): a neuromuscular disease for which corticosteroids such as deflazacort (Emflaza) and prednisone are used to improve motor and pulmonary outcomes.

FDA-indication (age)Emflaza (deflazacort) is indicated for treatment of Duchenne muscular dystrophy in patients 2 years of age and older.

Therapeutic equivalenceUnitedHealthcare P&T determined Emflaza (deflazacort) is therapeutically equivalent to prednisone for treatment of DMD; published evidence and AAN guidance state prednisone and deflazacort are possibly equally effective for motor, pulmonary, and cardiac outcomes.

Implication for corticosteroid therapy choiceBecause evidence supports likely equivalent therapeutic results between deflazacort and prednisone, coverage decisions may favor use of prednisone as an alternative to Emflaza depending on plan rules.

Clinical evidence summaryMultiple comparative studies (including three Class III trials) reported equivalent effects of deflazacort and prednisone on motor function, pulmonary function, scoliosis development, and cardiac outcomes over multi-year follow-up periods.

OpenPayer

Emflaza (deflazacort) prior authorization / medical necessity

Coverage Determination

Provider Requirements & Actions

Clinical Background

Key Definitions

Initial Therapy

Step Therapy / Tried and Failed Requirements