CurrentCignaPolicy IP0647

Voydeya

Defines Cigna prior authorization and medical coverage criteria for Voydeya (danicopan tablets) as add-on therapy to eculizumab (Soliris, biosimilars) or Ultomiris for treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH). Includes FDA-approved indications, documentation requirements, duration of approval, and non-covered concomitant uses.

Policy Summary

PayerCigna

PolicyVoydeya

Policy CodePolicy IP0647

Change TypeAnnual revision (08/15/2025)

Effective Date08/15/2025

Next Review Date

Key ActionSubmit prior authorization with required documentation (peripheral blood flow cytometry and objective lab evidence) and ensure prescription is by or in consultation with a hematologist.

POLICY UPDATE CHANGES

Annual Revision: Biosimilars to Soliris were added to the criteria where only Soliris was previously noted.

Annual Revision: Ultomiris subcutaneous injection was removed from criteria.

Added documentation requirements for confirmation of diagnosis (flow cytometry) and for objective laboratory findings.

Conditions Not Recommended for Approval: PiaSky was added to the list of medications that should not be used concomitantly with Voydeya.

New policy created on 10/15/2024.

1FDA-Approved Indications

3Medications not recommended for concomitant use

2Approval duration options (initial/continuation)

Coverage Summary

FDA-Approved Indication — Paroxysmal Nocturnal Hemoglobinuria (PNH): Voydeya (danicopan) is covered with criteria as an add-on therapy to terminal complement inhibitors (eculizumab intravenous infusion [Soliris, biosimilars] or Ultomiris [ravulizumab-cwvz]) for the treatment of extravascular hemolysis in adults (≥ 18 years) with PNH. The product carries a Boxed Warning for serious infections caused by encapsulated bacteria and is available only through the Voydeya REMS restricted access program.

FDA-Approved Indication - Paroxysmal Nocturnal Hemoglobinuria

Approve if the patient meets ONE of the following (A or B):

A) Initial therapy

Patient is ≥ 18 years of age
[documentation required]
Diagnosis was confirmed by peripheral blood flow cytometry results showing the absence or deficiency of glycosylphosphatidylinositol-anchored proteins on at least two cell lineages
[documentation required]
The medication is prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion)
According to the prescriber, patient has clinically significant extravascular hemolysis (while receiving eculizumab or Ultomiris), as evidenced by objective laboratory findings
Examples of objective laboratory findings include reduction in hemoglobin levels, elevated reticulocyte counts, increased transfusion requirements, transfusion-dependence.
The medication is prescribed by or in consultation with a hematologist

B) Patient is Currently Receiving Voydeya

Patient is ≥ 18 years of age
The medication is prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion)
According to the prescriber, patient is continuing to derive benefit from Voydeya
Examples of benefit include increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in FACIT-Fatigue score.
The medication is prescribed by or in consultation with a hematologist

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Voydeya; approvals provided for the durations specified.

Initial: 3 months
Continuation/current user: 1 year

Documentation Required

Documentation of diagnosis required

Documentation of peripheral blood flow cytometry demonstrating absence/deficiency of GPI-anchored proteins on at least two cell lineages is required for initial approval.

Flow cytometry must show absence or severe deficiency of GPI‑anchored proteins on at least two cell lineages

Applicable Codes and Referenced Therapies

Referenced companion therapies required in criteriamixed

eculizumab (Soliris)	Intravenous infusion; Soliris or biosimilars
ravulizumab-cwvz (Ultomiris)	Intravenous infusion

Clinical Context & Evidence Notes

Limitation of use: Not effective as monotherapy — Voydeya has not been shown to be effective when used alone and should only be prescribed as an add-on to eculizumab or Ultomiris.

Diagnostic confirmation: Peripheral blood flow cytometry is required to confirm PNH by demonstrating absence or severe deficiency of GPI-anchored proteins on at least two cell lineages (documentation required).

Clinically significant extravascular hemolysis: Prescriber-documented extravascular hemolysis while receiving eculizumab or Ultomiris, evidenced by objective laboratory findings such as reduced hemoglobin, elevated reticulocyte counts, increased transfusion requirements, or transfusion-dependence.

Background & Safety

Background: Voydeya is a complement Factor D inhibitor indicated as an add-on therapy to eculizumab (Soliris, including biosimilars) or Ultomiris for treatment of extravascular hemolysis in adults with PNH. The drug has a Boxed Warning for serious infections with encapsulated bacteria and is available only through the Voydeya REMS program. Cigna prior authorization and documentation requirements apply, including confirmation of diagnosis and objective laboratory evidence as specified in the coverage criteria.

Not Recommended / Exclusions

Not medically necessary for other uses: Voydeya is considered not medically necessary for indications outside the FDA-approved add-on use for extravascular hemolysis in PNH.

Concomitant therapies not recommended: Concomitant use with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or PiaSky (crovalimab) is explicitly not recommended and may be denied.

Prior authorization and documentation: Prior authorization is required (initial approvals generally for 3 months, continuation for 1 year), and documentation such as peripheral blood flow cytometry and objective laboratory findings or evidence of benefit must be provided.

Revision History

08/15/2025revision (material)Latest

Annual Revision: Biosimilars to Soliris were added to the criteria where only Soliris was previously noted.

08/15/2025revision (material)Latest

Annual Revision: Ultomiris subcutaneous injection was removed from criteria (manufacturer decided not to market the product).

08/15/2025revision (material)