Dordaviprone (Modeyso) for diffuse midline glioma
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Defines medical necessity criteria, dosing, and prior authorization requirements for Modeyso (dordaviprone) for members across Commercial, HIM, and Medicaid lines of business, focused on treatment of diffuse midline glioma with H3 K27M mutation. Applies to providers submitting requests for initial and continuation therapy.
No material clinical or coverage changes in this revision.
Coverage Criteria for Modeyso (dordaviprone)
Continuation Therapy — Covered when ALL of the following are met for Continuation/Renewal (Diffuse Midline Glioma)
Covered when ALL of the following are met for Continuation/Renewal (Diffuse Midline Glioma):
Approval duration: 12 months
| Population / Weight Tier | Once-weekly Dose | Product Strength Available |
|---|---|---|
| Pediatrics/Adults: ≥52.5 kg | ||
| 625 mg once weekly | ||
| 125 mg capsule |
Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see referenced policies).
Requests for Modeyso (dordaviprone) to treat indications not listed in this policy will be considered not authorized if the provider does not submit adequate evidence per the referenced off‑label use policies; such uses are treated as not medically necessary when off‑label evidence is insufficient.
Coding and Dosing Summary
| No codes listed |
Prescriber / Prior Authorization Requirements
Prior authorization and required clinical information
Prior authorization is required. The provider must document: diagnosis of diffuse midline glioma, prescriber is or consulted with an oncologist, patient age ≥ 1 year, presence of H3 K27M mutation, disease progression following prior therapy (includes radiation and pharmacotherapies), and that the requested dose is within the policy's weekly dosing limits (adult or pediatric weight tiers) or supported by practice guidelines/peer‑reviewed literature. For continuation, documentation must show at least 30 days of prior Modeyso use and positive response to therapy.
- Diagnosis: diffuse midline glioma with H3 K27M mutation
- Prescribed by or in consultation with an oncologist
- Age ≥ 1 year
- Disease progressive following prior therapy (includes radiation; see Appendix B)
- Dose does not exceed policy weekly limits by adult/pediatric weight tiers OR prescriber submits supporting guidelines/literature
- Continuation: ≥30 days prior Modeyso use and evidence of positive response
Therapeutic alternatives and product preference
Therapeutic alternatives are listed in Appendix B (examples include temozolomide, PCV, lomustine, carmustine, bevacizumab, etoposide, carboplatin, cisplatin for adults; temozolomide and lomustine for H3 K27‑altered pediatric diffuse midline glioma). The policy specifies that Modeyso (dordaviprone) should be used only if dordaviprone is available and not contraindicated or causing clinically significant adverse effects.
- Appendix B lists preferred alternative pharmacotherapies and dosing varies by agent
- Modeyso use requires dordaviprone if available unless contraindicated or significant adverse effects occur
Required supporting documentation
Submit clinical documentation (e.g., office chart notes, laboratory results, or other clinical information) that demonstrates the member meets all approval criteria, including diagnosis, mutation status, prior therapies, oncologist involvement, dosing and response for continuation requests.
- Office chart notes confirming diagnosis and oncologist involvement
- Pathology/genetic testing showing H3 K27M mutation
- Records of prior therapies and evidence of disease progression
- For continuation: documentation of ≥30 days prior use and clinical response
Non‑covered indications risk denial
Requests for indications not listed in this policy (non‑FDA approved indications) will be denied unless sufficient documentation of efficacy and safety is provided per the referenced off‑label use policies.
- Off‑label requests must meet documentation requirements of CP.CPA.09 (Commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) or other evidence of coverage documents
Key Definitions and Regulatory Terms
Line of Therapy / Treatment Setting
Salvage
Accelerated approval based on response; confirmatory trials may be required for continued approval.
Required Biomarker for Coverage
Background and Clinical Context
Diffuse midline glioma with the H3 K27M mutation is an aggressive central nervous system tumor. Modeyso (dordaviprone) is indicated for treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma and progressive disease after prior therapy, and is provided under an accelerated approval pathway based on response rate and duration of response; continued approval may depend on confirmatory trials. The product is supplied as a 125 mg capsule and dosing is administered once weekly per policy weight tiers (maximum adult weekly dose 625 mg).
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