KYMBEE (deflazacort) prior authorization for Duchenne muscular dystrophy
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Defines prior authorization requirements for KYMBEE (deflazacort) for treatment of Duchenne muscular dystrophy (DMD) and applies to providers seeking Medicaid coverage from the Mississippi Division of Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria for KYMBEE (deflazacort)
Initial Authorization
Covered when ALL of the following are met:
Examples of intolerable adverse effects include cushingoid appearance, central (truncal) obesity, ≥10% body weight gain over 6 months, difficult-to-manage diabetes or hypertension, or severe behavioral/psychiatric effects requiring dose reduction.
Initial approval duration: 12 months.
Re-Authorization
Covered when ALL of the following are met:
Re-authorization duration: 12 months.
- ONE of: Stabilization, maintenance, or improvement of muscle strength or pulmonary function.
- ONE of: Improvement in motor milestone assessment scores from baseline testing.
- ONE of: Improvement of motor function superior to the projected natural course of DMD (slowing of decline or progression).
Requests for KYMBEE (deflazacort) will be evaluated against the specific coverage criteria listed for initial authorization and re-authorization. There are no additional blanket exclusions beyond the criteria; however, requests that do not meet the required elements — for example, those lacking documentation of a confirmed Duchenne muscular dystrophy diagnosis, missing required prior therapy trials, or prescribing doses above the allowed limit — do not meet medical necessity per this policy and may be denied. The policy requires that, for initial approval, all of the following be met: the patient is ≥ 5 years of age; DMD is confirmed by genetic testing or positive muscle biopsy; documented ≥ 6‑month trial with inadequate response/intolerance to prednisone (unless contraindicated); documented ≥ 6‑month trial with inadequate response to EMFLAZA® (deflazacort); and the prescribed dose does not exceed 0.9 mg/kg/day.
Use of KYMBEE outside the policy parameters will not meet medical necessity. Specifically, therapy initiated in patients younger than 5 years, without documentation confirming DMD by genetic testing or muscle biopsy, or without the required prior trials of prednisone and EMFLAZA (each of at least 6 months unless contraindicated) does not satisfy the coverage criteria. Additionally, dosing above the maximum of 0.9 mg/kg/day is not permitted; re‑authorization also requires documentation of a positive clinical response (for example, stabilization or improvement in muscle strength or pulmonary function, improved motor milestone scores, or slowing of decline compared with the natural history).
Drug and Dosing Identifiers
| No codes listed |
Provider Requirements and Prior Authorization
Prior authorization required for KYMBEE (initial and re‑auth)
Prior authorization is required for KYMBEE (deflazacort). Providers must obtain PA for both initial starts and re‑authorizations; approvals are considered only when the policy criteria are met and supporting documentation is submitted with the Universal PA Form.
Required prior trials: prednisone (≥6 months) and EMFLAZA
Before initial approval, the patient must have had a minimum six‑month trial of prednisone with inadequate response, intolerance, or allergy unless contraindicated; a minimum six‑month trial with inadequate response to EMFLAZA (deflazacort) is also required.
- Prednisone trial: at least six months with inadequate response, allergy, or intolerable adverse effects unless contraindicated.
- EMFLAZA (deflazacort) trial: at least six months with inadequate response.
Required documentation to support PA
Submit the Universal PA Form plus supporting clinical documentation confirming DMD and prior therapy history; include genetic testing or muscle biopsy results and clinical notes documenting prior trials and any adverse effects or treatment response.
- Universal PA Form (required).
- Genetic testing showing dystrophin deletion/duplication OR positive muscle biopsy (absence of dystrophin).
- Clinical notes documenting prior prednisone and EMFLAZA trials, responses, intolerances, and baseline/follow‑up assessments for re‑authorization.
Denial triggers: dosing, missing documentation, or absent prior trials/benefit
Requests may be denied if the prescribed dose exceeds 0.9 mg/kg/day or when required documentation or prior trials are missing; other denial reasons include lack of confirmed DMD diagnosis or failure to demonstrate clinical benefit for re‑authorization.
- Prescribed dose > 0.9 mg/kg/day (exceeds policy maximum).
- Missing Universal PA Form or supporting clinical documentation (genetic testing or muscle biopsy, prior trial records).
- No documented six‑month prednisone trial or six‑month EMFLAZA trial when required.
- For re‑authorization: absence of documentation showing stabilization, improvement, or slowed decline in muscle strength, pulmonary function, or motor milestones.
Definitions
Background
KYMBEE (deflazacort) is a corticosteroid formulation indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 5 years and older. The dosing specified in the policy is 0.9 mg/kg once daily, with available tablet strengths of 6 mg, 18 mg, 30 mg, and 36 mg; initial and re‑authorization approvals are issued for 12 months when criteria are met.
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