CurrentBlue Cross Blue Shield - IowaPolicy 05.05.48

Voydeya (danicopan) for extravascular hemolysis in PNH

Defines prior authorization, coverage criteria, dosing/quantity limits, documentation, prescriber specialty, and billing guidance for Voydeya (danicopan) as add-on therapy to ravulizumab or eculizumab for extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH).

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyVoydeya (danicopan) for extravascular hemolysis in PNH

Policy CodePolicy 05.05.48

Change TypeRevised (Oct 2025)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with flow cytometry confirming GPI-AP deficiency and labs showing hemoglobin ≤ 9.5 g/dL and absolute reticulocyte count ≥ 120 x10^9/L for initial approval; provide clinical documentation for continuation.

POLICY UPDATE CHANGES

Policy reviewed and revised October 2025 with current effective date January 1, 2026.

1Covered Indication (PNH EVH)

18+Age requirement (years)

4Standard quantity limit

Coverage Summary

Coverage stance: covered with criteria for Voydeya (danicopan) as an add-on to ravulizumab (Ultomiris) or eculizumab for treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Voydeya has not been shown to be effective as monotherapy and the policy requires diagnostic confirmation of PNH by flow cytometry demonstrating deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs).

Reauthorization / Continued Treatment Criteria (12 months)

Reauthorization / Continued Treatment (12 months)

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

No evidence of unacceptable toxicity or disease progression while on the current regimen
Patient demonstrates a positive response to therapy (e.g., improvement in hemoglobin levels, normalization of lactate dehydrogenase [LDH] levels)
Requested medication will be used concomitantly with Ultomiris (ravulizumab) or eculizumab
Requested medication will NOT be used concomitantly with Empaveli (pegcetacoplan) or Fabhalta (Iptacopan)

Not Medically Necessary / Exclusions

Not Medically Necessary

Denial condition

Voydeya (danicopan) considered not medically necessary for members who do not meet the criteria set forth above

Exclusion: Voydeya is not effective as monotherapy and requests will be denied when used as monotherapy. The policy also excludes use of Voydeya concomitantly with Empaveli (pegcetacoplan) or Fabhalta (iptacopan); claims may be denied if used with those agents.

Provider Actions

Prior Authorization

Prior authorization required

Submission of required documentation is necessary to initiate prior authorization for initial and continuation requests; initial requests require flow cytometry demonstrating GPI-AP deficiency and hemoglobin and absolute reticulocyte count showing clinically significant EVH; continuation requires chart notes or medical record documentation supporting positive clinical response.

Documentation Required

Required laboratory documentation

Provide flow cytometry results showing GPI-AP deficiency and labs demonstrating hemoglobin ≤ 9.5 g/dL and absolute reticulocyte count ≥ 120 x10^9/L for initial approval; provide clinical notes or medical record documentation showing positive response for continuation.

Prior Authorization

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a hematologist.

Billing Rule

Quantity limits

Standard limit = 4 blister cards per 28 days. FDA-recommended dosing: initial 150 mg orally three times daily; may increase to 200 mg orally three times daily if hemoglobin has not increased by >2 g/dL after 4 weeks and the patient required a transfusion.

Denial Risk

Concomitant therapy exclusions

Claims may be denied if Voydeya (danicopan) is used as monotherapy or used concomitantly with Empaveli (pegcetacoplan) or Fabhalta (iptacopan).

Clinical Evidence

Evidence and alignment: Coverage is informed by the listed evidence, including the FDA package insert: Voydeya [package insert], April 2024, and the policy intent to provide coverage consistent with product labeling and FDA guidance. Definitions: GPI-APs = glycosylphosphatidylinositol-anchored proteins; deficiency demonstrated by flow cytometry for PNH diagnosis. EVH = extravascular hemolysis.

Background

Background: Voydeya (danicopan) is indicated as an add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with PNH. It has not been shown to be effective as monotherapy. The policy requires diagnostic confirmation of PNH by flow cytometry demonstrating GPI-AP deficiency (examples include ≥ 5% PNH cells or ≥ 51% GPI-AP deficient polymorphonuclear cells) and documents laboratory thresholds for clinically significant EVH when used as add-on therapy.

Revision History

2024-08-24original_effective_date

Original Effective Date August 24, 2024

2025-10-01reviewed_and_revised

Policy reviewed and revised October 2025

2026-01-01policy_effective_dateLatest

Policy effective date January 1, 2026