CurrentMass General Brigham Health PlanPolicy N/A

Voydeya (danicopan) prior authorization and coverage

Defines prior authorization, quantity limits, and clinical criteria for coverage of Voydeya (danicopan) as add-on therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH) under the pharmacy/specialty benefit of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVoydeya (danicopan) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date08/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document PNH confirmed by flow cytometry and that Voydeya will be prescribed with eculizumab or ravulizumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration

180quantity limit

add-on onlyuse restriction

PNHdiagnosis required

Coverage Criteria for Voydeya (danicopan)

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Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial Authorization - All required: Member has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) confirmed by flow cytometry.

Initial Authorization - All required: Voydeya will be prescribed in combination with either eculizumab OR ravulizumab.

Alternatively, authorization may be granted for members new to the plan within the last 90 days who are currently receiving the medication (excluding product obtained as samples or via manufacturer patient assistance programs).

Continuation Therapy

Reauthorization will be granted when ALL of the following are met:

Reauthorization - All required: Prescriber submits documentation of a positive response to therapy (e.g., normalization of lactate dehydrogenase [LDH], improvement in hemoglobin, decreased number of red blood cell transfusions).

Reauthorization - All required: Voydeya will continue to be used in combination with either eculizumab OR ravulizumab.

Approvals (initial and reauthorization) will be granted for 12 months.

Initial Therapy

Initial therapy

Initial coverage conditions

Initial: PNH confirmed by flow cytometry.

Initial: Voydeya will be prescribed in combination with either eculizumab OR ravulizumab.

Members new to the plan within the last 90 days who are currently receiving the medication may be authorized (excluding product obtained as samples or via manufacturer patient assistance programs).

Continuation / Reauthorization

Reauthorization

Reauthorization criteria and duration

Reauthorization: Prescriber documents a positive response to therapy (e.g., normalization of LDH, improvement in hemoglobin, decreased RBC transfusions).

Reauthorization: Voydeya will continue to be used in combination with either eculizumab OR ravulizumab.

Reauthorizations granted for 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required under the specialty pharmacy benefit. Approvals are limited to members meeting the clinical criteria below and when the medication is dispensed through a contracted specialty pharmacy.

Benefit: Pharmacy Benefit (Specialty)
Prior Authorization: Required
Specialty dispensing required: Contracted specialty pharmacy

Step Therapy

Step therapy header is present for this policy. No specific step-through medications or required trials are defined in the source guidance.

Documentation Required

Initial Authorization Documentation

For initial authorization, submit documentation confirming the diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) by flow cytometry and documentation that Voydeya will be prescribed in combination with either eculizumab or ravulizumab.

PNH confirmation: flow cytometry result required
Combination therapy required: concurrent use with eculizumab OR ravulizumab

Documentation Required

Continuation Documentation

For continuation (reauthorization), the prescriber must submit documentation of a positive clinical response to therapy (examples: normalization of LDH, improved hemoglobin, decreased red blood cell transfusions). Reauthorization requires that Voydeya continue to be used in combination with either eculizumab or ravulizumab; lack of documented response or absence of required combination therapy may result in denial.

Documented positive response to therapy (e.g., LDH normalization, hemoglobin improvement, fewer transfusions)
Ongoing combination with eculizumab OR ravulizumab required for reauthorization

Step Therapy	Details
Step therapy	Step therapy is designated in the policy header, but the document does not specify any step sequencing or required prior agents; no specific step requirements are provided.

Background

Voydeya (danicopan) is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). The agent targets proximal complement activation and should be used only in combination with a terminal complement inhibitor, as it has not been shown to be effective as monotherapy.

Definitions

Extravascular hemolysis (EVH)

DefinitionExtravascular hemolysis (EVH) is hemolysis occurring outside the vascular compartment that contributes to anemia in paroxysmal nocturnal hemoglobinuria (PNH).

Clinical relevanceEVH in PNH is the target indication for adding proximal complement inhibitor danicopan to terminal complement inhibitors (eculizumab or ravulizumab).

Therapeutic implicationVoydeya (danicopan) is indicated as add-on therapy to address EVH and has not been shown to be effective as monotherapy; it should be prescribed with eculizumab or ravulizumab.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVoydeya (danicopan) prior authorization and coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date08/01/2025

Next Review DateN/A

Key ActionObtain prior authorization and document PNH confirmed by flow cytometry and that Voydeya will be prescribed with eculizumab or ravulizumab.

SourceLink

On This Page

OpenPayer

Voydeya (danicopan) prior authorization and coverage

Coverage Criteria for Voydeya (danicopan)

Initial Therapy

Continuation / Reauthorization

Provider Actions and Documentation Requirements

Step Therapy

Quantity Limits

Site of Care and Dispensing

Background

Definitions