CurrentCignaPolicy IP0647

Complement Inhibitors - Voydeya

Defines Cigna's medical necessity criteria, prior authorization requirements, coverage duration, and exclusions for Voydeya (danicopan) as add-on therapy to eculizumab or Ultomiris in adults with PNH, including documentation requirements and prohibited concomitant therapies.

Policy Summary

PayerCigna

PolicyComplement Inhibitors - Voydeya

Policy CodePolicy IP0647

Change TypeCriteria additions and documentation updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit peripheral blood flow cytometry confirming absence or deficiency of GPI-anchored proteins on at least two lineages; include documentation of clinically significant extravascular hemolysis for initial approvals.

SourceLink

POLICY UPDATE CHANGES

Biosimilars to Soliris were added to the criteria.

Ultomiris was added to the criteria.

Documentation requirements for confirmation of diagnosis were added.

A subcutaneous injection route was removed from the criteria because the manufacturer decided not to market the product.

PiaSky was added to the list of medications that should not be used concomitantly with Voydeya.

New policy created (10/15/2024).

1Covered Indication (PNH extravascular hemolysis add-on)

3Not-recommended concomitant meds

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Approval durations (initial, continuation)

Coverage Summary

Scope: This policy defines Cigna’s medical necessity criteria, prior authorization requirements, coverage durations, documentation requirements, and exclusions for Voydeya (danicopan) as an add-on therapy to eculizumab (Soliris, including biosimilars) or Ultomiris (ravulizumab-cwvz) for treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH).

Coverage stance: Covered with criteria — Voydeya is medically necessary when specified criteria are met (see initial and continuation requirements); use for nonapproved indications or specified concomitant therapies is considered not medically necessary.

FDA indication and limitations: Voydeya is a complement Factor D inhibitor indicated as add-on therapy to eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion) for extravascular hemolysis in adults with PNH. Limitation of use: Voydeya has not been shown to be effective as monotherapy and should only be prescribed as an add-on to eculizumab or Ultomiris.

Boxed warning / REMS: Voydeya carries a Boxed Warning for serious infections caused by encapsulated bacteria and is available only through the Voydeya REMS program.

Approval durations and age threshold: For initial therapy approvals are for 3 months and for continuation approvals are for 1 year. Age requirement: ≥ 18 years.

Related products referenced: eculizumab (Soliris and biosimilars), Ultomiris (ravulizumab-cwvz); certain other complement inhibitors (Empaveli/pegcetacoplan, Fabhalta/iptacopan, PiaSky/crovalimab-akkz) are listed as not recommended for concomitant use.

Key Facts

Policy NumberIP0647

StatusCURRENT

Age threshold≥ 18 years

Approval durationsInitial: 3 months; Continuation: 1 year

Last review date2025-11-01

Has material changetrue

Medical Necessity Criteria

Medically Necessary - FDA-Approved Indication

Voydeya is considered medically necessary when the following are met:

Paroxysmal Nocturnal Hemoglobinuria

A) Initial therapy (Approve for 3 months)
- Patient is ≥ 18 years of ageAge ≥ 18 years
- 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]
- Medication is prescribed in combination with eculizumab intravenous infusion (Soliris, biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion)

Related Products and Codes

Related products referenced for combination therapymixed

Soliris	eculizumab intravenous infusion (includes biosimilars)
Ultomiris	ravulizumab-cwvz intravenous infusion
Empaveli	pegcetacoplan subcutaneous injection (listed as contraindicated concomitant use)
Fabhalta	iptacopan capsules (listed as contraindicated concomitant use)
PiaSky	crovalimab-akkz intravenous infusion or subcutaneous injection (listed as contraindicated concomitant use)

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Voydeya. Approvals are provided for the durations specified: initial approvals are for 3 months; continuation (patients currently receiving Voydeya) approvals are for 1 year.

Documentation Required

Documentation Required for Diagnosis Confirmation

Peripheral blood flow cytometry results showing the absence or deficiency of glycosylphosphatidylinositol (GPI)-anchored proteins on at least two cell lineages must be provided to confirm the diagnosis for initial therapy.

Documentation Required

Documentation of Extravascular Hemolysis

For initial therapy, the prescriber must document clinically significant extravascular hemolysis while the patient is receiving eculizumab or Ultomiris with objective laboratory findings.

Background

Voydeya (danicopan) is a complement Factor D inhibitor indicated as add-on therapy to eculizumab intravenous infusion (Soliris, including biosimilars) or Ultomiris (ravulizumab-cwvz intravenous infusion) for treatment of extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH).

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

Safety: Voydeya has a Boxed Warning for serious infections due to encapsulated bacteria and is available only through the Voydeya REMS program.

Diagnosis: PNH is a clinical diagnosis that should be confirmed with peripheral blood flow cytometry demonstrating absence or severe deficiency of GPI-anchored proteins on at least two cell lineages.

Clinically significant extravascular hemolysis: Evidence while receiving eculizumab or Ultomiris of reduced hemoglobin, elevated reticulocyte counts, increased transfusion requirements, or transfusion-dependence as documented by the prescriber.

Evidence & References

Prescribing information: Voydeya tablets [prescribing information], Alexion; March 2024.

Revision History

10/15/2024creation

New policy created.

08/15/2025annual_revision

Biosimilars to Soliris were added to the criteria where only Soliris was previously noted; Ultomiris was also added to the criteria.

08/15/2025revision

Subcutaneous injection route was removed from criteria because the manufacturer decided not to market the product.

Policy Summary

PayerCigna

PolicyComplement Inhibitors - Voydeya

Policy CodePolicy IP0647

Change TypeCriteria additions and documentation updates

Effective Date

Next Review Date

SourceLink

On This Page

According to the prescriber, patient has clinically significant extravascular hemolysis (while receiving eculizumab or Ultomiris), as evidenced by objective laboratory findings

Examples include reduction in hemoglobin levels, elevated reticulocyte counts, increased transfusion requirements, transfusion-dependence

Medication is prescribed by or in consultation with a hematologist

B) Currently receiving Voydeya (Approve for 1 year)

Patient is ≥ 18 years of ageAge ≥ 18 years
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 include increase in or stabilization of hemoglobin levels, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in FACIT-Fatigue score
Medication is prescribed by or in consultation with a hematologist

Not Medically Necessary / Exclusions

Voydeya is not medically necessary when used for nonapproved indications or specific concomitant uses:

Voydeya for any use other than the FDA-approved add-on indication for extravascular hemolysis in adults with PNH is not medically necessary
Concomitant use with Empaveli (pegcetacoplan subcutaneous injection) is not recommended/considered not medically necessary
Concomitant use with Fabhalta (iptacopan capsules) is not recommended/considered not medically necessary
Concomitant use with PiaSky (crovalimab-akkz intravenous infusion or subcutaneous injection) is not recommended/considered not medically necessary

Examples: reduced hemoglobin
Elevated reticulocyte counts
Increased transfusion requirements or transfusion-dependence

Documentation Required

Documentation of Clinical Benefit for Continuation

For continuation approvals, the prescriber must document that the patient is continuing to derive clinical benefit from Voydeya.

Hemoglobin stabilization or increase
Decreased transfusion requirements or transfusion independence
Reductions in hemolysis
Improvement in FACIT‑Fatigue score

Documentation Required

Specialist Prescribing Requirement

Voydeya must be prescribed by or in consultation with a hematologist; documentation of specialist prescribing or consultation is required.

Denial Risk

Concomitant Use with Certain Complement Inhibitors

Claims for concomitant use of Voydeya with Empaveli, Fabhalta, or PiaSky are considered not medically necessary and are likely to be denied.

Documentation Required

REMS and Infection Risk

Voydeya carries a Boxed Warning for serious infections caused by encapsulated bacteria and is available only through the Voydeya REMS program; providers must follow REMS requirements.

08/15/2025revision

Documentation requirements for confirmation of diagnosis were added (peripheral blood flow cytometry results showing absence or deficiency of GPI-anchored proteins on at least two cell lineages).

08/15/2025additionLatest

PiaSky (crovalimab-akkz) was added to the list of medications that should not be used concomitantly with Voydeya.