CurrentUnitedHealthcarePolicy 1 = 2025 P 1444-2

Voydeya (danicopan) prior authorization

Prior authorization and reauthorization criteria for Voydeya (danicopan) as add-on therapy to complement protein C5 inhibitors for adults with PNH experiencing extravascular hemolysis; applies to UnitedHealthcare benefit administration.

Policy Summary

PayerUnitedHealthcare

PolicyVoydeya (danicopan) prior authorization

Policy CodePolicy 1 = 2025 P 1444-2

Change TypeNew prior authorization programadministrative annual review

Effective Date8/1/2025

Next Review Date

Key ActionSubmit prior authorization showing diagnosis of PNH, current C5 inhibitor therapy, and evidence of extravascular hemolysis while on a C5 inhibitor.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Voydeya (danicopan) was created (5/2024).

Annual review conducted (5/2025) and update made to list of C5 inhibitors by removing the trade name Soliris from eculizumab.

8/1/2025effective date

12 moauth duration (initial)

12 moauth duration (reauth)

5/2024, 5/2025P&T review

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization for Voydeya: a. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); b. Patient is currently receiving complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab); c. Patient is experiencing extravascular hemolysis (EVH) while on a C5 inhibitor; d. Patient will continue to receive the C5 inhibitor (eculizumab or ravulizumab); e. Patient is not receiving Voydeya in combination with a complement protein C3 inhibitor (e.g., pegcetacoplan) or a complement factor B inhibitor (e.g., iptacopan).

Authorization issued for 12 months.

inv-02: Continuation / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization for Voydeya: a. Documentation of positive clinical response to Voydeya (examples: decrease in extravascular hemolysis (EVH), increased or stabilization of hemoglobin levels, reduction in transfusions, improvement in hemolysis); b. Patient continues to receive Voydeya in combination with a complement protein C5 inhibitor (eculizumab or Ultomiris [ravulizumab]) for PNH; c. Patient is not receiving Voydeya in combination with a complement protein C3 inhibitor (e.g., pegcetacoplan) or a complement factor B inhibitor (e.g., iptacopan).

Authorization issued for 12 months.

Use of Voydeya (danicopan) in combination with a complement protein C3 inhibitor (for example, Empaveli / pegcetacoplan) or a complement factor B inhibitor (for example, Fabhalta / iptacopan) is excluded. Members receiving Voydeya must not be concurrently prescribed these C3 or factor B inhibitors when used for treatment of PNH.

Treatment with Voydeya (danicopan) is not supported when the patient is not on a complement protein C5 inhibitor (eculizumab or Ultomiris / ravulizumab) or when the patient is not experiencing extravascular hemolysis (EVH) while on a C5 inhibitor. Authorization requires evidence that the patient is receiving a C5 inhibitor and has ongoing EVH on that therapy.

Initial Therapy Criteria (detailed)

inv-11: Initial Therapy — detailed initial authorization criteria

Initial authorization requires all of the following

Detailed initial authorization criteria: a. Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH). b. Patient is currently receiving a complement protein C5 inhibitor: eculizumab or Ultomiris (ravulizumab). c. Patient is experiencing extravascular hemolysis (EVH) while on the C5 inhibitor. d. Plan for continued use of the C5 inhibitor concurrently with Voydeya. e. No concomitant use of Voydeya with a complement protein C3 inhibitor (e.g., pegcetacoplan) or a complement factor B inhibitor (e.g., iptacopan).

Authorization issued for 12 months.

Continuation / Reauthorization Criteria

inv-12: Reauthorization — requires evidence of continued benefit and continued use with C5 inhibitor

Reauthorization requires evidence of continued benefit and continued use with a C5 inhibitor

Reauthorization criteria: a. Documentation of positive clinical response to Voydeya (e.g., decreased EVH, increased or stabilized hemoglobin, reduced transfusion requirement, improvement in hemolysis); b. Continued concomitant use of Voydeya with a complement protein C5 inhibitor (eculizumab or Ultomiris [ravulizumab]); c. No concomitant use of Voydeya with a complement protein C3 inhibitor (pegcetacoplan) or a complement factor B inhibitor (iptacopan).

Authorization issued for 12 months.

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Initial Authorization Requirements

Initial authorization — provider must document diagnosis of PNH, current C5 inhibitor treatment, evidence of EVH while on C5 inhibitor, plan to continue C5 inhibitor, and that Voydeya will not be used with a C3 or factor B inhibitor. Authorization is issued for 12 months.

Diagnosis: paroxysmal nocturnal hemoglobinuria (PNH).
Current therapy: patient is currently receiving a complement protein C5 inhibitor (eculizumab or Ultomiris [ravulizumab]).
Clinical evidence: patient is experiencing extravascular hemolysis (EVH) while on a C5 inhibitor.
Plan of care: patient will continue to receive the C5 inhibitor (eculizumab or Ultomiris) in combination with Voydeya.
Concomitant therapy exclusion: patient is NOT receiving Voydeya in combination with a complement protein C3 inhibitor (e.g., Empaveli [pegcetacoplan]) or a complement factor B inhibitor (e.g., Fabhalta [iptacopan]).
Authorization duration: 12 months.

Documentation Required

Reauthorization Documentation and Automated Approval Note

Reauthorization — provider must document ongoing clinical benefit from Voydeya and continued combination with a C5 inhibitor; contraindicated combinations must be avoided. Approvals may also be issued automatically based on prior claim/medication history and claim logic.

Documentation of positive clinical response to Voydeya (examples: decreased EVH, increased or stabilized hemoglobin, reduced transfusion requirements, improvement in hemolysis).
Patient continues to receive Voydeya in combination with a complement protein C5 inhibitor (eculizumab or Ultomiris [ravulizumab]).
Patient is not receiving Voydeya with a complement protein C3 inhibitor (e.g., Empaveli [pegcetacoplan]) or a complement factor B inhibitor (e.g., Fabhalta [iptacopan]).
UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic; automated approval processes vary by program.
Supply limits may apply.

Denial Risk

Denial Triggers

Triggers that may lead to denial of authorization — ensure documentation addresses these risks before submission.

Patient does not have a documented diagnosis of PNH.
Patient is not currently receiving a complement protein C5 inhibitor (eculizumab or Ultomiris).
No evidence the patient is experiencing extravascular hemolysis (EVH) while on a C5 inhibitor.
Patient will not continue the C5 inhibitor in combination with Voydeya.
Patient is receiving Voydeya in combination with a complement protein C3 inhibitor (e.g., Empaveli [pegcetacoplan]) or a complement factor B inhibitor (e.g., Fabhalta [iptacopan]).
Insufficient documentation of positive clinical response at reauthorization (e.g., no data on hemoglobin, transfusion requirement, or hemolysis measures).

Definitions and Abbreviations

EVH — Extravascular hemolysis definition/term

TermExtravascular hemolysis (EVH)

DefinitionHemolysis occurring outside the blood vessels; in this policy context, EVH refers to ongoing red blood cell destruction that persists despite complement protein C5 inhibitor therapy in adults with paroxysmal nocturnal hemoglobinuria (PNH).

Clinical contextIndication for Voydeya (danicopan) as add‑on therapy to ravulizumab or eculizumab for treatment of EVH in adults with PNH.

Relevance to authorizationDocumentation of EVH while on a C5 inhibitor is required for initial authorization of Voydeya.

Exclusions related to EVHUse of Voydeya is not supported when the patient is not experiencing EVH while on a C5 inhibitor.

Policy Summary

PayerUnitedHealthcare

PolicyVoydeya (danicopan) prior authorization

Policy CodePolicy 1 = 2025 P 1444-2

Change TypeNew prior authorization programadministrative annual review

Effective Date8/1/2025

Next Review Date

Key ActionSubmit prior authorization showing diagnosis of PNH, current C5 inhibitor therapy, and evidence of extravascular hemolysis while on a C5 inhibitor.

SourceLink

On This Page

OpenPayer

Voydeya (danicopan) prior authorization

Coverage Criteria for Voydeya (danicopan)

Initial Therapy Criteria (detailed)

Continuation / Reauthorization Criteria

Provider Actions, Documentation, and Denial Triggers

Background and Indication

Definitions and Abbreviations

Policy Revision History