CurrentUnitedHealthcarePolicy N/A

Deflazacort prior authorization (Emflaza, Jaythari, Kymbee, Pyquvi)

Defines UnitedHealthcare Pharmacy prior authorization and medical necessity rules for deflazacort products used to treat Duchenne muscular dystrophy (DMD); applies to members whose benefits require pharmacy program review.

Policy Summary

PayerUnitedHealthcare

PolicyDeflazacort prior authorization (Emflaza, Jaythari, Kymbee, Pyquvi)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization/medical necessity review for Emflaza, Jaythari, Kymbee, or Pyquvi before coverage is approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4deflazacort products listed

>=2 yrslowest indicated age (Emflaza)

>=5 yrsindicated age (others)

ProgramPrior Auth

Coverage criteria for deflazacort products

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Primary coverage determination: Published clinical evidence shows Emflaza, Jaythari, Kymbee, and Pyquvi are likely to produce equivalent therapeutic results as other available corticosteroids (e.g., prednisone); therefore these products are not medically necessary for treatment of Duchenne muscular dystrophy.

Products are typically excluded; plan-specific tried/failed criteria may apply.

UnitedHealthcare generally treats Emflaza (deflazacort), Jaythari (deflazacort), Kymbee (deflazacort), and Pyquvi (deflazacort) as excluded or limited formulary options for treatment of Duchenne muscular dystrophy (DMD). Published program language states these products are "typically excluded from coverage," and coverage may be impacted by state mandates, federal regulatory requirements, and the member-specific benefit plan. Refer to the member’s plan documents to determine whether an exclusion, prior authorization requirement, or other utilization management program applies.

The clinical rationale for limiting coverage is that published evidence indicates Emflaza, Jaythari, Kymbee, and Pyquvi are likely to produce equivalent therapeutic results compared with other available corticosteroids (for example, prednisone). Because no clear efficacy or overall safety advantage is demonstrated, these deflazacort products are considered not medically necessary for DMD in the general population; plan-specific tried/failed criteria may still apply.

Provider requirements and actions

Prior Authorization

Prior Authorization Required

Prior authorization / medical necessity review is required for listed deflazacort products prior to coverage. Providers should obtain plan-specific prior authorization where applicable and confirm any state mandates or member benefit limitations that may affect coverage.

Affected products: Emflaza (deflazacort), Jaythari (deflazacort), Kymbee (deflazacort), Pyquvi (deflazacort)
Effective Date: 2026-03-01
Program: UnitedHealthcare Prior Authorization/Medical Necessity

Step Therapy

Tried/Failed May Be Required

Tried-and-failed or step-therapy requirements may apply. Evidence and plan rules indicate these deflazacort products are typically excluded and coverage may require failure or intolerance to alternative corticosteroids (e.g., prednisone) per the member's benefit plan.

Step-therapy: May require prior trial and inadequate response or intolerance to other corticosteroids (e.g., prednisone)
Check member-specific plan documents for explicit tried/failed requirements and exclusions

Note

Approval Based on Claim History

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

Approvals may be granted based on previous claims and ICD-10 diagnosis codes without additional documentation
Use of automated claim logic varies by program; verify program-specific operations

Denial Risk

Medical Necessity Rationale for Denial

Denials or coverage limitations will be based on medical necessity and the evidence-based determination that these deflazacort products are not medically necessary for Duchenne muscular dystrophy when equivalent, less costly corticosteroids are appropriate. Document clinical rationale, prior therapies, and relevant member-specific plan coverage to support appeals.

Medical necessity rationale for denial: Published evidence indicates equivalence to other corticosteroids; therefore deflazacort products may be considered not medically necessary
Include documentation of prior trials, reasons for intolerance or failure, and any state or plan-mandated exceptions when submitting for authorization or appeal

Background on deflazacort and indications

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD). Emflaza is indicated for patients 2 years of age and older; Jaythari, Kymbee, and Pyquvi are indicated for patients 5 years of age and older. Despite these indications, UnitedHealthcare’s clinical review concluded that deflazacort products do not provide demonstrated superiority over other corticosteroids for DMD, and authorization decisions will follow the medical necessity and plan-specific rules described elsewhere in this document.

Key definitions

Duchenne muscular dystrophy (DMD) and deflazacort

DefinitionDuchenne muscular dystrophy (DMD) is a genetic neuromuscular disorder treated with corticosteroids; deflazacort is one glucocorticoid option used for DMD.

Deflazacort products listedIncludes Emflaza, Jaythari, Kymbee, and Pyquvi — all formulations of deflazacort used to treat DMD.

Age indicationsEmflaza is indicated for patients 2 years of age and older; Jaythari, Kymbee, and Pyquvi are indicated for patients 5 years of age and older.

Therapeutic equivalenceUnitedHealthcare P&T determined Emflaza is therapeutically equivalent to prednisone for DMD; deflazacort does not show a clear efficacy or overall safety advantage over other glucocorticoids.

Clinical implicationBecause deflazacort is considered therapeutically equivalent to other corticosteroids, coverage may be limited or subject to prior authorization and plan-specific requirements.

Criteria for initial therapy coverage

Initial therapy coverage

Coverage determination for initial therapy

Initial coverage logic: Even though indicated for DMD, deflazacort products are generally not considered medically necessary because they are therapeutically equivalent to other corticosteroids; approval may be limited or require prior therapies per plan.

Refer to member-specific benefits and state mandates.

Step	Required prior therapy / failure	Notes
1	Tried and failed other corticosteroids (e.g., prednisone) per member-specific plan	Tried/failed criteria may be required; Emflaza, Jaythari, Kymbee, and Pyquvi are typically excluded—refer to plan specifics and state mandates