Modeyso (dordaviprone)
Indications for Prior Authorization
Modeyso (dordaviprone)
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For diagnosis of Diffuse Midline Glioma
Indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Criteria
Modeyso
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Diffuse Midline Glioma
- Diagnosis of diffuse midline glioma AND
- Patient is 1 year of age or older AND
- Disease is confirmed by the presence of H3 K27M mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND
- Disease has progressed following prior therapy (e.g., chemotherapy)
Modeyso
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Diffuse Midline Glioma
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2025-10-01
References
- Modeyso Prescribing Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. August 2025.
Revision History
- 2025-10-01: New Program
HEALTHY LIVING