CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1500

Voydeya (danicopan) — Coverage Criteria

Defines accepted indications, inclusion/exclusion, and utilization management requirements for Voydeya (danicopan) for members — primarily addressing add-on therapy in adults with PNH and continuation requests. Applies to Medicaid/commercial lines managed by Neighborhood Health Plan of Rhode Island via Evolent/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVoydeya (danicopan) — Coverage Criteria

Policy CodePolicy UM ONC_1500

Change TypeRoutine review — no material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent Utilization Management with supporting FDA labeling or accepted compendia/guideline evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2024-05-31effective date

May 08, 2024committee approval

200 mgsingle dose max

PNH (EVH)covered indication

Coverage Criteria

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inv-01: Coverage Criteria

Covered when ALL of the following are met

Continuation request exemptions: For continuation requests exemption from this policy: member has not experienced disease progression on the requested medication; medication was used within the last year without a lapse of more than 30 days of having an active authorization; no additional medications are being added to the continuation request.

Section II.A

PNH add-on indication: Voydeya (danicopan) may be used as an add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adult members with paroxysmal nocturnal hemoglobinuria (PNH).adult members

Section II.B

Requests for Voydeya (danicopan) will be excluded when any of the following apply: disease progression while taking danicopan, or dosing that exceeds a single dose of 200 mg. Additionally, use that is investigational for an off‑label indication that lacks sufficient supporting evidence (as defined in policy) is excluded from coverage.

Use of Voydeya (danicopan) for investigational or off‑label indications will not be approved unless the indication is supported by sufficient evidence. Sufficient evidence is defined in the policy and requires that published data adequately represent the patient and disease characteristics and the therapy regimen, report clinically meaningful outcomes (e.g., ASCO‑recommended thresholds), and be based on appropriate study design. Case reports and meeting abstracts without full peer‑reviewed publications generally do not meet the evidence sufficiency criteria.

Provider Actions / Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Voydeya (danicopan) medication requests. Evolent Utilization Management processes all medication requests from network ordering providers; final approval authority resides with the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent Utilization Management reviews and makes coverage recommendations.
Final approval: Utilization Management Committee.

Documentation Required

Supporting Documentation Required

Supporting documentation must demonstrate that use of Voydeya (danicopan) is consistent with FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements. Documentation should include relevant clinical records, prior authorization history, treatment regimen details, and literature or compendia references that justify the requested use.

Acceptable evidence sources: FDA labeling, CMS compendia, NCCN, ASCO, or peer-reviewed literature meeting CMS Chapter 15 standards.
Provide clinical notes showing diagnosis, prior therapies, and rationale for danicopan.
Include citations or excerpts from guideline/compendia/literature when requesting off-label use.

Step Therapy

Continuation and Add-on Therapy Rules

Continuation and add-on therapy requests follow specific rules. Continuation requests for medications deemed not-approvable under this policy are exempt from re-review only when all continuation criteria are met. Voydeya may be approved as an add-on to ravulizumab or eculizumab for adult members with PNH and extravascular hemolysis when criteria are met.

Continuation criteria: member has not experienced disease progression on the requested medication; medication was used within the last year without a lapse >30 days of an active authorization; no additional medications are being added to the continuation request.
Add-on use: danicopan may be used as add-on therapy to ravulizumab or eculizumab for treatment of EVH in adult PNH patients (must be supported by required documentation).

Background

Danicopan (Voydeya) is an oral complement factor D inhibitor indicated as an add‑on to terminal complement inhibitors (ravulizumab or eculizumab) for treatment of clinically significant extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH). As an add‑on therapy, coverage is contingent on meeting the policy’s clinical criteria and not meeting any exclusion criteria such as progression on therapy, exceeding the single‑dose limit, or investigational/off‑label use without sufficient evidence.

Definitions

inv-10: Extravascular hemolysis (EVH) definition and relation to PNH and danicopan indication

DefinitionExtravascular hemolysis (EVH): hemolysis occurring outside the bloodstream associated with PNH

Related indicationVoydeya (danicopan) is indicated as an add-on therapy to ravulizumab or eculizumab for treatment of EVH in adult members with paroxysmal nocturnal hemoglobinuria (PNH)

Supporting evidencePolicy references Voydeya prescribing information and pivotal phase 3 ALPHA trial supporting use for clinically significant EVH

Continuation Therapy Criteria

inv-11: Continuation Therapy

Continuation requests may be exempt from this policy if all conditions are met

Continuation conditions: Member has not experienced disease progression on the requested medication; medication used within the last year without a lapse of more than 30 days of having an active authorization; no additional medications are being added to the continuation request.