CurrentCignaPolicy N/A

Modeyso (dordaviprone) prior authorization

Defines prior authorization requirements for Modeyso (dordaviprone capsules) for treatment of high-grade glioma with H3 K27M mutation under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyModeyso (dordaviprone) prior authorization

Policy CodePolicy N/A

Change TypeClinical scope expansionrecurrent disease added

Effective DateAug 13, 2025

Next Review DateAug 13, 2025

Key ActionObtain prior authorization and document H3 K27M mutation, recurrent/progressive high-grade glioma, prior therapy, and patient age.

SourceLink

POLICY UPDATE CHANGES

The condition of approval wording was broadened from 'Diffuse Midline Glioma' to 'High-Grade Glioma' with examples provided.

An option for approval was added for patients with recurrent disease.

1 yearstandard approval duration

H3 K27Mrequired tumor biomarker

≥1 yrage indication (FDA)

recurrent/progressivedisease status required

Coverage Criteria for Modeyso (dordaviprone)

COVERAGE CRITERIA — Covered when ALL of the following are met

Covered when ALL of the following are met:

ALL of the following

Diagnosis of high-grade glioma (examples include World Health Organization Grade 3 or 4 gliomas, such as diffuse midline glioma or glioblastoma).
Tumor harbors a histone 3 (H3) K27M mutation.
Patient has recurrent or progressive disease following prior therapy.
Patient has received at least one prior therapy (examples include radiation, procarbazine, lomustine, or vincristine).

Modeyso (dordaviprone) is considered not medically necessary for any uses other than the FDA‑approved indication described above. Coverage criteria will be updated as new published clinical evidence becomes available.

Policy Summary

PayerCigna

PolicyModeyso (dordaviprone) prior authorization

Policy CodePolicy N/A

Change TypeClinical scope expansionrecurrent disease added

Effective DateAug 13, 2025

Next Review DateAug 13, 2025

Key ActionObtain prior authorization and document H3 K27M mutation, recurrent/progressive high-grade glioma, prior therapy, and patient age.

SourceLink

On This Page

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Uses of Modeyso outside the FDA‑approved indication (off‑label uses) are considered not medically necessary and are not covered unless there is supportive evidence and an applicable coverage pathway documented and approved.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization required — 1 year approvals

Prior authorization is required for Modeyso; approvals are issued for a one-year duration when all coverage criteria are met.

Step Therapy

Prior therapy required (≥1 prior therapy)

Patient must have received at least one prior therapy to meet approval criteria; examples of prior therapies include radiation, procarbazine, lomustine, or vincristine.

Examples: radiation, procarbazine, lomustine, or vincristine

Documentation Required

Required clinical documentation

Documentation must demonstrate presence of a histone 3 (H3) K27M mutation, evidence of recurrent or progressive high-grade glioma, and that the patient has received prior therapy; patient age consistent with the FDA indication (≥ 1 year) should also be documented.

H3 K27M mutation documented
Recurrent or progressive high-grade glioma documented
Record of prior therapy(ies) received
Patient age ≥ 1 year

Denial Risk

Not medically necessary for other uses — denials possible

Requests for Modeyso for any uses outside the specified indication(s) are considered not medically necessary and may be denied.

Use limited to FDA‑approved indication (H3 K27M high‑grade glioma with recurrent/progressive disease after prior therapy)

Covered Regimens and Dosing

Regimen	Indication	Coverage
Modeyso (dordaviprone) capsules	Treatment of high-grade glioma (examples include diffuse midline glioma or glioblastoma) harboring histone 3 (H3) K27M mutation with recurrent or progressive disease after prior therapy	Covered with criteria: approve for 1 year when ALL criteria are met (A) H3 K27M mutation documented; (B) recurrent or progressive high-grade glioma; (C) at least one prior therapy received; (D) patient age meets FDA indication (≥ 1 year)

Biomarker Requirements

H3 K27M — required biomarker (operational details and testing evidence)

Required biomarkerHistone 3 (H3) K27M mutation must be documented

Evidence requiredDocumentation must support presence of H3 K27M mutation (e.g., pathology report or molecular testing)

Role in coverageH3 K27M is required for approval of Modeyso for high-grade glioma

Age considerationPatient age must meet FDA indication (≥ 1 year) when H3 K27M is documented

Source indication textPolicy aligns with FDA-approved indication: Modeyso indicated for diffuse midline glioma harboring H3 K27M mutation; coverage requires H3 K27M

Line of Therapy / Usage

second-line

Line of therapy: Indicated as second-line therapy: patient has recurrent or progressive disease following prior therapy (at least one prior systemic or local therapy).

Examples of prior therapy include radiation, procarbazine, lomustine, or vincristine

Definitions

High-grade glioma — examples and policy note

DefinitionHigh-grade glioma: examples include World Health Organization (WHO) Grade 3 or 4 gliomas

ExamplesDiffuse midline glioma

ExamplesGlioblastoma

Policy change noteCondition of approval broadened from 'Diffuse Midline Glioma' to 'High-Grade Glioma' with examples added

Background

Modeyso is a protease activator approved for the treatment of high‑grade glioma harboring a histone 3 (H3) K27M mutation. The FDA indication and policy focus on patients with recurrent or progressive disease following prior therapy; approvals under the prior authorization process are provided for 1 year when the coverage criteria are met. Requests for indications beyond those specified in this policy are considered not medically necessary.