ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 1444-2

Voydeya (danicopan) - Prior Authorization/Notification - UniteedHealthcare Commercial Plansopen_in_new

Prior authorization policy for Voydeya (danicopan) as add-on therapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH) experiencing extravascular hemolysis (EVH) while on a complement protein C5 inhibitor. Includes initial and reauthorization criteria, therapy duration, and combination exclusions.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVoydeya (danicopan) - Prior Authorization/Notification - UniteedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 1444-2

Change TypeNew program (5/2024) and annual review update (5/2025)

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization is required and will be granted for 12 months if initial criteria are met; reauthorization requires documentation of positive clinical response and continued combination with a C5 inhibitor.

SourceLink

POLICY UPDATE CHANGES

New program created for Prior Authorization/Notification - Voydeya (danicopan) with P&T approval in 5/2024.

Annual review 5/2025 updated list of C5 inhibitors by removing trade name of Soliris from eculizumab.

12 monthsAuthorization duration

2P&T Approval Years

Coverage Summary

Scope: Prior authorization policy for Voydeya (danicopan) as add-on therapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH) experiencing extravascular hemolysis (EVH) while on a complement protein C5 inhibitor. Includes initial and reauthorization criteria, therapy duration, and combination exclusions. Policy Number: 2025 P 1444-2. Program effective date: 8/1/2025. Last review: 05/01/2025.

Indication summary: Voydeya (danicopan) is indicated as an add-on to C5 inhibitors (ravulizumab or eculizumab) for treatment of extravascular hemolysis (EVH) in adults with PNH. Coverage stance: covered_with_criteria. Authorization duration: 12 months when initial criteria are met.

Initial Therapy Criteria

Initial Authorization

Voydeya will be approved based on all of the following criteria:

Initial Authorization criteria

Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
Current C5 inhibitor: Patient is currently receiving complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
EVH on C5 inhibitor: Patient is experiencing extravascular hemolysis (EVH) while on complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
Will continue C5 inhibitor: Patient will continue to receive complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab)
Combination 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)) used for the treatment of PNH

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Reauthorization / Continuation Therapy Criteria

Reauthorization

Voydeya will be approved based on all of the following criteria:

Reauthorization criteria

Documentation of response: Documentation of positive clinical response to Voydeya therapy (e.g., decrease in extravascular hemolysis (EVH), increased or stabilization of hemoglobin levels, reduction in transfusions, improvement in hemolysis, etc.)
Continued C5 inhibitor: Patient continues to receive Voydeya in combination with complement protein C5 inhibitor eculizumab or Ultomiris (ravulizumab) for PNH
Combination 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)) used for the treatment of PNH

Typical authorization period is 12 months for both initial approval and reauthorization. Reauthorization requires documentation of clinical response to Voydeya; acceptable evidence includes examples such as decreased extravascular hemolysis (EVH), stabilized or increased hemoglobin, or reduction in transfusion requirements.

Exclusions / Not Allowed Combinations

Combination therapy exclusion

Combination therapy exclusion for PNH: Do not use Voydeya (danicopan) in combination with complement protein C3 inhibitors (e.g., Empaveli / pegcetacoplan) or complement factor B inhibitors (e.g., Fabhalta / iptacopan) for the treatment of PNH.

Sourced from initial and reauthorization criteria and provider actions.

Operational note: The policy explicitly states that Voydeya should not be approved when used in combination with a complement protein C3 inhibitor (e.g., pegcetacoplan) or a complement factor B inhibitor (e.g., iptacopan), and this combination exclusion is enforced as a billing rule. UnitedHealthcare may also approve or deny based on claim/medication history and claim logic per the policy.

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required for Voydeya

Prior authorization is required for Voydeya (danicopan) as add-on therapy for PNH. If the initial criteria are met, authorization will be issued for 12 months. Reauthorization also requires meeting the program’s reauthorization criteria (including documented clinical response and continued use with a C5 inhibitor).

Authorization duration: 12 months
Typical evidence required: diagnosis of PNH, current use of a C5 inhibitor (eculizumab or ravulizumab), evidence of EVH while on C5 inhibitor

Documentation Required

Document clinical response for reauthorization

For reauthorization, document examples of positive clinical response to Voydeya such as decreased extravascular hemolysis (EVH), increased or stabilized hemoglobin levels, reduction in transfusion requirements, or other improvement in hemolysis.

Billing Rule

Combination therapy exclusion

Do not approve Voydeya when it is used in combination with a complement protein C3 inhibitor (for example, pegcetacoplan/Empaveli) or a complement factor B inhibitor (for example, iptacopan/Fabhalta) for the treatment of PNH.

Prior Authorization

Automated approvals may apply

UnitedHealthcare may grant initial approval or reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Automated approval and re-approval processes may be used, and supply limits may apply.

Approvals may be based on claims/medication history and diagnosis codes
Supply limits may apply

Background & Definitions

Background: Voydeya (danicopan) is a complement factor D inhibitor indicated as add-on therapy to Ultomiris (ravulizumab) or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Primary reference: Voydeya [package insert], Alexion Pharmaceuticals, Inc.; March 2024.

Definitions:

EVH: Extravascular hemolysis.

C5 inhibitor: Complement protein C5 inhibitors eculizumab or ravulizumab (Ultomiris).

Revision History

5/2024program_created