DUVYZAT (givinostat) — Prior Authorization Criteria
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Prior authorization requirements and coverage criteria for DUVYZAT (givinostat) for treatment of Duchenne muscular dystrophy (DMD) in patients 6 years and older under Mississippi Division of Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria for DUVYZAT (givinostat)
Initial Therapy
Covered when ALL of the following are met for initial authorization (12 months):
Non-ambulatory patients do not meet initial authorization criteria.
Initial authorization duration: 12 months.
Initial Therapy — Initial authorization details and baseline assessments
Initial authorization details and baseline assessments:
Prior authorization is required for DUVYZAT; initial authorization period is 12 months when criteria are met.
Continuation Therapy / Re-Authorization
Covered upon re-authorization (12 months) when ALL of the following are documented:
Re-authorization duration: 12 months.
Re-Authorization
Re-authorization requirements for continued coverage (12 months):
Duration: 12 months.
Non-ambulatory patients do not meet the listed initial authorization criteria. Initial authorization requires that the patient be ambulatory (able to walk independently) as documented in the clinical record; requests for patients who are non-ambulatory should be considered not to meet initial coverage criteria.
Use of DUVYZAT (givinostat) is not supported when the patient's baseline platelet count is ≤150 x 10^9/L. In addition, requests will be denied if the patient does not meet the required age per the FDA label, does not have a documented diagnosis of Duchenne muscular dystrophy (DMD), is not ambulatory, or is not on a stable corticosteroid dose for a minimum of three months (unless a contraindication or intolerance to corticosteroids is documented).
Diagnosis, Lab Thresholds, and Dosing Codes
| Duchenne muscular dystrophy | Documented diagnosis required (ICD-10 code not specified in document) |
Provider Actions, Documentation, and Denial Triggers
Prior authorization required for DUVYZAT; initial approval 12 months
Prior authorization is required for DUVYZAT (givinostat). Initial authorization will be considered for 12 months when the coverage criteria are met; submit a Universal PA Form and supporting clinical documentation with the request.
No step therapy required
No step therapy requirements or prior medication failures are specified for DUVYZAT in this policy.
Required documentation to accompany PA request
Submit the Universal PA Form with supporting clinical documentation, including documented diagnosis, baseline labs (CBC and triglycerides; baseline platelet count), baseline timed 4‑stair climb if able, ECG when indicated, corticosteroid regimen documentation, and specialist consultation notes.
- Universal PA Form
- Documented diagnosis of Duchenne muscular dystrophy
- Baseline CBC and triglycerides
- Baseline platelet count
- Baseline timed 4‑stair climb (if patient is able)
- Baseline ECG if underlying cardiac disease or QT‑prolonging concomitant meds
- Documentation of corticosteroid regimen (stable dose ≥3 months or contraindication/intolerance)
- Prescribing or consult note from DMD specialist
Triggers for denial — eligibility and lab thresholds
Requests will be denied if the patient does not meet key eligibility requirements such as the FDA age requirement, documented diagnosis of Duchenne muscular dystrophy, ambulatory status when required, or baseline platelet count is not greater than 150 x 10^9/L.
- Does not meet age requirement per FDA label
- No documented diagnosis of Duchenne muscular dystrophy (DMD)
- Patient is non‑ambulatory when ambulatory status is required
- Baseline platelet count ≤150 x 10^9/L
- Not on stable corticosteroid regimen without documented contraindication/intolerance
Definitions and Clinical Terms
Background on DUVYZAT (givinostat)
DUVYZAT (givinostat) is a histone deacetylase inhibitor indicated for treatment of Duchenne muscular dystrophy (DMD) in patients aged 6 years and older per the FDA label. Treatment under this policy is intended for ambulatory patients and requires baseline safety and functional assessments prior to initiation.
Dosing and Quantity Limits
Site of Care and Administration
Home administration — oral medication taken with food
DUVYZAT is an oral suspension intended to be taken at home with food, dosed twice daily based on body weight per the package insert.
- Oral suspension (8.86 mg/mL) taken twice daily with food
- Dosing based on body weight per package insert
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