Currentmedical mutual - ohioPolicy N/A

Deflazacort (Pyquvi; Jaythari; Kymbee)

Pharmacy benefit prior authorization policy for deflazacort products (Pyquvi, Jaythari, Kymbee, and generics) for treatment of Duchenne muscular dystrophy (DMD) in eligible patients, including initial and continuation approval criteria, documentation requirements, and approval durations.

Policy Summary

Payermedical mutual - ohio

PolicyDeflazacort (Pyquvi; Jaythari; Kymbee)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective Date

Next Review DateNov 20, 2025

Key ActionPrior authorization is recommended; approve only patients meeting the documented criteria and required supporting documentation.

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

2Minimum age (generics/Kymbee)

5Label age for Jaythari/Pyquvi/Kymbee

1 yrInitial approval duration

1 yrExtended approval duration

Coverage Summary

This policy is a pharmacy benefit prior authorization for deflazacort products (Pyquvi, Jaythari, Kymbee, and generics) for treatment of Duchenne muscular dystrophy (DMD). It establishes initial and continuation approval criteria (diagnosis confirmation, age requirements, prior prednisone/prednisolone trial and intolerance or severe behavioral adverse effects, specialist prescribing or consultation, and formulation-specific documentation when suspension is used), the documentation requirements needed to support approval (genetic testing or muscle biopsy, details of prior steroid trial and specific adverse effects), and the approval durations applied for initial and extended therapy. Prior authorization is recommended and approval is limited to patients meeting the stated criteria.

Continuation Therapy Criteria — Patients Currently Receiving Deflazacort

Recommended Authorization Criteria - 2. Duchenne Muscular Dystrophy (DMD), patient is currently receiving deflazacort

Criteria for continued therapy

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Initial approvals are issued for 1 year. Reauthorization (extended approval) is also issued for 1 year and requires documentation from the prescriber that the patient continues to have improvement or benefit from deflazacort therapy to support continued coverage.

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of deflazacort; approval is recommended only for those meeting the policy criteria.

Documentation Required

Documentation of diagnosis and prior steroid trial

Document the diagnosis and prior steroid trial. Required documentation includes confirmation of DMD and details of prior prednisone/prednisolone therapy and any intolerable adverse effects.

Genetic testing showing a confirmed pathogenic dystrophin variant OR muscle biopsy showing absence of or marked decrease in dystrophin protein
Documentation that the patient tried prednisone or prednisolone for 6 months or longer
Documentation of intolerable adverse effects (one or more): Cushingoid appearance; central (truncal) obesity; undesirable weight gain > 10% of body weight over 6 months; diabetes and/or hypertension difficult to manage
Alternatively, documentation that the patient experienced a severe behavioral adverse effect on prednisone/prednisolone that required or would require dose reduction

Documentation Required

Specialist prescribing requirement

Initial approval requires the medication be prescribed by or in consultation with a physician who specializes in Duchenne muscular dystrophy (DMD) and/or neuromuscular disorders.

Documentation Required

Formulation substitution documentation

If a suspension formulation is prescribed, document that the patient is unable to take tablet formulations.

Applies to deflazacort, Pyquvi, and Jaythari suspension when tablets (deflazacort, Jaythari or Kymbee/Pyquvi/Jaythari tablets) cannot be taken

Billing Rule

Approval durations

Initial approval: 1 year; Extended (reauthorization) approval: 1 year, with documented continued benefit required.

Background

Deflazacort is a corticosteroid indicated for treatment of Duchenne muscular dystrophy (DMD). DMD is an X-linked progressive disease caused by mutations in the DMD (dystrophin) gene that result in absent or minimal dystrophin production, leading to progressive muscle weakness affecting skeletal, respiratory, and cardiac muscles and premature mortality from cardiac or respiratory complications. DMD is defined here as: Duchenne muscular dystrophy, an X-linked disease from DMD gene mutations causing absent or minimal dystrophin.

Policy Summary

Payermedical mutual - ohio

PolicyDeflazacort (Pyquvi; Jaythari; Kymbee)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective Date

Next Review DateNov 20, 2025

Key ActionPrior authorization is recommended; approve only patients meeting the documented criteria and required supporting documentation.

On This Page

OpenPayer

Deflazacort (Pyquvi; Jaythari; Kymbee)

Coverage Summary

Initial Therapy Criteria — Duchenne Muscular Dystrophy (DMD)

Continuation Therapy Criteria — Patients Currently Receiving Deflazacort

Provider Actions & Administrative Requirements

Applicable Codes

Background

Clinical Evidence & Rationale

Revision History