CurrentUnitedHealthcarePolicy N/A

Emflaza (deflazacort) prior authorization for Duchenne muscular dystrophy

Form and criteria governing prior authorization requests for Emflaza (deflazacort) for beneficiaries with Duchenne muscular dystrophy; affects prescribing providers and reviewers within UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyEmflaza (deflazacort) prior authorization for Duchenne muscular dystrophy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with genetic test confirming Duchenne, beneficiary age ≥2, baseline motor assessment, prednisone history, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age ≥ 2 yearsminimum beneficiary age for initial request

requiredbaseline motor milestone documentation

prednisone trialprednisone trial queried

no live vaccinesvaccination caution

Coverage Criteria for Emflaza (deflazacort)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization Criteria: 1) Beneficiary is age 2 years or older; 2) Diagnosis of Duchenne muscular dystrophy confirmed by genetic testing (documentation required); 3) Documentation of prior prednisone use: either prednisone not tried, or if tried, documentation of inadequate response or documentation of unmanageable/clinically significant side effects (e.g., significant weight gain/obesity, persistent psychiatric/behavioral issues, diabetes, hypertension, or Cushingoid appearance); 4) Baseline motor milestone assessment performed with documentation (one or more of: 6-minute walk test [6MWT], North Star Ambulatory Assessment [NSAA], Motor Function Measure [MFM], Hammersmith Functional Motor Scale [HFMS], or other); 5) Medication prescribed by or in consultation with a neurologist; 6) Provider confirms Emflaza will not be given concurrently with live vaccinations; 7) Emflaza dosing is in accordance with US FDA–approved labeling.

These items correspond to the initial authorization form and must be documented for approval.

Reauthorization / Continued Therapy

Covered on reauthorization when ALL of the following are met

Reauthorization Criteria:

Policy Summary

PayerUnitedHealthcare

PolicyEmflaza (deflazacort) prior authorization for Duchenne muscular dystrophy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with genetic test confirming Duchenne, beneficiary age ≥2, baseline motor assessment, prednisone history, and dosing per FDA labeling.

SourceLink

On This Page

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Provider Submission, Documentation, and Denial Triggers

Prior Authorization

Prior authorization submission requirements

Prior authorization is required for initiation and reauthorization of therapy. Submit a complete prior authorization request that includes beneficiary and prescriber information, the drug name, strength, quantity per 30 days, and requested length of therapy. Include documentation confirming the Duchenne Muscular Dystrophy diagnosis by genetic testing and the baseline motor milestone assessment results.

Beneficiary name, date of birth, and insurance ID
Prescriber name, NPI, contact information, and specialty
Drug name, strength, quantity per 30 days, and length of therapy (specify days requested)
Initial vs reauthorization request indication
Attachments: genetic testing results confirming DMD, baseline motor milestone assessment(s), and prior treatment documentation

Step Therapy

Prednisone trial / step therapy

Before approving therapy, the payer requires documentation that the beneficiary has tried prednisone unless there is documented intolerance or unacceptable adverse effects. If prednisone was tried, submit documentation of inadequate clinical response OR clinically significant, unmanageable side effects.

Indicate whether beneficiary has tried prednisone: Yes / No
If Yes: submit documentation of inadequate response to adequate prednisone trial
If Yes: OR submit documentation of unacceptable/clinically significant side effects (examples: significant weight gain/obesity, persistent psychiatric/behavioral issues, new-onset diabetes, hypertension, or Cushingoid features)
If No trial of prednisone, provide rationale if relevant (e.g., contraindication)

Documentation Required

Required documentation

Required clinical documentation must be submitted with the prior authorization request. Failure to provide these records may delay review or result in denial.

Genetic testing confirming diagnosis of Duchenne Muscular Dystrophy (required)
Baseline motor milestone assessment results — select and submit at least one: 6-minute walk test (6MWT), North Star Ambulatory Assessment (NSAA), Motor Function Measure (MFM), Hammersmith Functional Motor Scale (HFMS), or other validated motor assessment with explanation
Documentation of prescriber specialty or consultation with a neurologist
For reauthorization: documentation of clinical benefit (stabilization, maintenance or improvement in muscle strength or pulmonary function, improvement in motor milestone scores, or motor function better than expected natural history)
Treatment history including prior corticosteroid use and any adverse effects

Denial Risk

Triggers for denial

Requests lacking required information or documentation are at high risk for denial. Verify all items before submission to avoid processing delays.

Missing genetic testing confirming DMD — denial trigger
Age under 2 years at time of request — not eligible (denial trigger)
Absence of baseline motor milestone assessment documentation — denial trigger
No documentation of prior prednisone trial or documentation of contraindication/intolerance when applicable
Incomplete prescriber information or lack of neurologist involvement/consultation when required

Definitions and Assessment Examples

Baseline motor milestone assessment — examples listed on form (6MWT, NSAA, MFM, HFMS)

6-minute walk test (6MWT)Listed as an acceptable baseline motor milestone assessment on the authorization form; providers must select and submit documentation.

North Star Ambulatory Assessment (NSAA)Included on the form as an accepted baseline motor milestone assessment option requiring documentation.

Motor Function Measure (MFM)Specified on the form as an acceptable baseline motor milestone assessment; submit corresponding documentation.

Hammersmith Functional Motor Scale (HFMS)Listed among required baseline motor milestone assessments on the form; provider must submit documentation.

Other (specified by provider)Form allows selection of 'Other' with explanation; providers may submit an alternative validated motor assessment with explanation and documentation.

OpenPayer

Emflaza (deflazacort) prior authorization for Duchenne muscular dystrophy

Coverage Criteria for Emflaza (deflazacort)

Provider Submission, Documentation, and Denial Triggers

Background

Definitions and Assessment Examples