JAYTHARI (deflazacort) prior authorization for Duchenne muscular dystrophy
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Defines prior authorization requirements, dosing, and renewal criteria for JAYTHARI (deflazacort) for treatment of Duchenne muscular dystrophy in beneficiaries age 5 and older under Mississippi Division of Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria for JAYTHARI (deflazacort)
Initial Therapy
Covered when ALL of the following are met
Initial authorization duration: 12 months
Continuation Therapy
Covered for re-authorization when ALL of the following are met
Re-authorization duration: 12 months
Initial Authorization — 12 Months
Use initial approval period of 12 months for JAYTHARI (deflazacort).
Re-Authorization — 12 Months
Renewal requires documentation of continued clinical benefit as specified in re-authorization criteria.
Provider Requirements and Prior Authorization
Prior authorization required for JAYTHARI
Prior authorization is required for JAYTHARI (deflazacort); approval will be considered when initial criteria are met, including patient age ≥5 years, confirmed diagnosis of DMD, required prior trials, and dosing within the allowed limit (≤ 0.9 mg/kg/day). Submit a Universal PA Form and supporting documentation with the request.
Step therapy: required prior trials of prednisone and EMFLAZA
Documented trials are required: at least a six-month trial with prednisone with inadequate response, allergy, or intolerable adverse effects (unless contraindicated) and at least a six-month trial with inadequate response to EMFLAZA prior to approval.
- Prednisone trial: ≥6 months with inadequate response, allergy, or intolerable adverse effects (examples listed in policy).
- EMFLAZA (deflazacort) trial: ≥6 months with inadequate response.
Required documentation to support PA
Include the Universal PA Form plus supporting clinical documentation: confirmation of DMD (genetic testing or muscle biopsy), records documenting prior 6‑month trials and inadequate response/intolerance to prednisone and EMFLAZA (unless contraindicated), current weight for dose calculation, and for re-authorization, evidence of positive clinical response.
- Genetic testing results showing dystrophin deletion or duplication mutation, or muscle biopsy demonstrating absence of dystrophin protein.
- Documentation of at least six-month trials and inadequate response, allergy, or intolerance to prednisone and of at least six-month trial and inadequate response to EMFLAZA (unless contraindicated).
- Current patient weight to verify dose ≤ 0.9 mg/kg/day.
- For re-authorization: documentation of stabilization, maintenance, or improvement in muscle strength/pulmonary function, or improvement in motor milestone scores, or slowing of decline versus natural history.
Triggers for denial
Requests may be denied if the requestor fails to document patient age ≥5 years, confirmatory genetic testing or muscle biopsy for DMD, required prior 6‑month trials with prednisone and EMFLAZA (with inadequate response/intolerance unless contraindicated), or if prescribed dose exceeds 0.9 mg/kg/day.
- Missing proof of age ≥5 years.
- No genetic testing or muscle biopsy confirming DMD.
- No documentation of required ≥6‑month trials and failure/intolerance to prednisone and to EMFLAZA (unless contraindicated).
- Prescribed dose greater than 0.9 mg/kg/day.
Dosing and Code-related Limits
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | Documented trial of prednisone for at least 6 months with inadequate response, allergy, or intolerable adverse effects (examples: cushingoid appearance, central (truncal) obesity, ≥10% body weight gain over 6 months, diabetes and/or hypertension difficult to manage, or severe behavioral/psychiatric effects requiring dose reduction), unless contraindicated |
| 2 | Documented trial of EMFLAZA (deflazacort) for at least 6 months with inadequate response, unless contraindicated |
Quantity and Dosing Limits
Definitions
Background
JAYTHARI (deflazacort) is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Prior authorization is required for JAYTHARI; approval will be considered when documentation meets the clinical criteria and required supporting materials are submitted with the Universal PA Form. [
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