ModifiedCignaPOLICY: Complement Inhibitors - Fabhalta Prior Authorization Policy

Complement Inhibitors - Fabhalta Prior Authorization Policy

Cigna prior authorization policy governing medical necessity and coverage criteria for Fabhalta (iptacopan capsules) for C3 glomerulopathy, paroxysmal nocturnal hemoglobinuria (PNH), and primary IgA nephropathy (IgAN) for affected members and prescribing specialists.

Policy Summary

PayerCigna

PolicyComplement Inhibitors - Fabhalta Prior Authorization Policy

Policy CodePolicy POLICY: Complement Inhibitors - Fabhalta Prior Authorization Policy

Change TypeAnnual revision with material changes (added C3G, revised ACEi/ARB requirement, updated concomitant-use exclusions)

Effective DateN/A

Next Review DateMar 25, 2026

Key ActionObtain prior authorization with documentation of biopsy-confirmed diagnosis, UPCR/proteinuria, eGFR, evidence of ≥12 weeks of ACEi or ARB therapy where required, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

Complement 3 Glomerulopathy condition and criteria for approval were added to the policy.

C3G initial therapy requirements changed: removed prior kidney transplant exclusion, ACE/ARB requirement modified to 'at least ONE' agent and timeframe changed from ≥90 days to ≥12 weeks.

Conditions Not Covered: prohibition on concomitant use with other complement inhibitors was added and examples updated to include Soliris biosimilars.

Approval duration for Primary IgA Nephropathy changed to 1 year for both initial therapy and patients currently receiving Fabhalta.

3FDA indications covered

≥18Minimum age

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UPCR criteriaProteinuria thresholds

1 yearIgAN approval duration

≥12 wksACEi/ARB requirement

Coverage Criteria for Fabhalta (iptacopan)

Complement 3 Glomerulopathy (C3G)

Covered for Complement 3 Glomerulopathy when ONE of the following is met

C3G initial therapy: A) Initial therapy: Approve for 6 months if ALL of the following are met: (i) patient is ≥ 18 years of age; (ii) diagnosis confirmed by renal biopsy; (iii) urine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g; (iv) estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2; (v) patient has received the maximum or maximally tolerated dose of at least ONE agent (ACE inhibitor or ARB) for ≥ 12 weeks prior to starting Fabhalta; (vi) medication is prescribed by or in consultation with a nephrologist.all conditions required

Initial therapy duration = 6 months

C3G continuation: B) Patient is currently receiving Fabhalta: Approve for 1 year if ALL of the following are met: (i) patient is ≥ 18 years of age; (ii) diagnosis confirmed by renal biopsy; (iii) according to the prescriber, patient has had a response to Fabhalta (examples: reduction in UPCR or reduction in proteinuria); (iv) eGFR ≥ 30 mL/min/1.73 m2; (v) medication is prescribed by or in consultation with a nephrologist.all conditions required

Continuation duration = 1 year

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Covered for Paroxysmal Nocturnal Hemoglobinuria when ONE of the following is met

PNH initial therapy: A) Initial therapy: Approve for 6 months if ALL of the following are met: (i) patient is ≥ 18 years of age; (ii) diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of GPI-anchored proteins on at least two cell lineages; (iii) medication is prescribed by or in consultation with a hematologist.all conditions required

Initial therapy duration = 6 months

PNH continuation: B) Patient is currently receiving Fabhalta: Approve for 1 year if ALL of the following are met: (i) patient is ≥ 18 years of age; (ii) according to the prescriber, patient is continuing to derive benefit from Fabhalta (examples: increase in or stabilization of hemoglobin, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in FACIT‑Fatigue); (iii) medication is prescribed by or in consultation with a hematologist.all conditions required

Continuation duration = 1 year

Primary Immunoglobulin A Nephropathy (IgAN)

Covered for Primary Immunoglobulin A Nephropathy when ONE of the following is met

IgAN initial therapy: A) Initial therapy: Approve for 1 year if ALL of the following are met: (i) patient is ≥ 18 years of age; (ii) diagnosis confirmed by renal biopsy; (iii) patient is at high risk of disease progression defined by BOTH: (a) proteinuria ≥ 0.5 g/day OR UPCR ≥ 1.5 g/g; AND (b) patient has received the maximum or maximally tolerated dose of ONE agent (ACE inhibitor or ARB) for ≥ 12 weeks prior to starting Fabhalta; (iv) according to the prescriber, patient has received ≥ 3 months of optimized supportive care including blood pressure management, lifestyle modification, and cardiovascular risk modification; (v) eGFR ≥ 30 mL/min/1.73 m2; (vi) medication is prescribed by or in consultation with a nephrologist.all conditions required

Initial therapy duration = 1 year

IgAN continuation: B) Patient is currently receiving Fabhalta: Approve for 1 year if ALL of the following are met: (i) patient is ≥ 18 years of age; (ii) diagnosis confirmed by renal biopsy; (iii) according to the prescriber, patient has had a response to Fabhalta (examples: reduction in UPCR or reduction in proteinuria); (iv) eGFR ≥ 30 mL/min/1.73 m2; (v) medication is prescribed by or in consultation with a nephrologist.all conditions required

Indication-specific changes

Coverage includes indication-specific criteria; highlighted changes follow.

C3 glomerulopathy - initial therapy (summary of changes): Initial therapy revised: requirement that the patient has not received a kidney transplant was removed; ACEi/ARB requirement modified to 'at least ONE' agent and duration changed to ≥ 12 weeks.at least ONE ACEi/ARB ≥ 12 weeks

Full criteria are in the C3G criteria group.

Primary Immunoglobulin A Nephropathy (summary of changes): Authorization duration standardized: approval duration for Primary IgA Nephropathy changed to 1 year for both initial therapy and patients currently receiving Fabhalta.1 year authorization

Full criteria are in the IgAN criteria group.

Fabhalta (iptacopan) is covered only for the specified FDA-approved indications when the policy criteria are met. Requests for Fabhalta administered concurrently with another complement inhibitor or given in combination with medications specifically indicated for immunoglobulin A nephropathy (IgAN) will not be approved. Examples called out by the policy include other complement inhibitors (e.g., pegcetacoplan, eculizumab [Soliris and Soliris biosimilars], ravulizumab [Ultomiris], danicopan [Voydeya], crovalimab) and IgAN agents such as Filspari and Vanrafia; concomitant administration with these agents is considered not covered due to lack of supportive evidence.

Conditions not covered include use of Fabhalta in combination with another complement inhibitor; the policy explicitly lists examples (pegcetacoplan, eculizumab intravenous infusion including Soliris biosimilars, ravulizumab [Ultomiris], danicopan [Voydeya], crovalimab). The policy also prohibits concomitant use with medications indicated for IgAN (for example, Filspari and Vanrafia). These combinations are designated not medically necessary because there is no evidence to support additive efficacy or safety of such concomitant regimens.

Fabhalta is considered not medically necessary for any uses outside the specified indications in this policy. This includes combination regimens with other complement inhibitors or with agents indicated for IgAN, which are not supported by controlled clinical trial data and are therefore outside the scope of covered medical necessity.

Concomitant use of Fabhalta with another complement inhibitor or with certain medications indicated for IgAN is specifically excluded from coverage per the policy. Requests for concurrent therapy with listed complement inhibitors (including eculizumab and its biosimilars) or with IgAN-targeted agents will be denied as not covered.

Clinical Thresholds and Coding-related Criteria

Urine protein-to-creatinine ratio (UPCR) thresholds for C3G and IgAN

C3G UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g

IgAN UPCR thresholdUrine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g

IgAN alternative proteinuria thresholdProteinuria ≥ 0.5 g/day (alternative to UPCR ≥1.5 g/g)

Estimated glomerular filtration rate (eGFR) minimum requirement

Minimum eGFR requirementEstimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

Prior ACE inhibitor or ARB therapy duration requirement (≥ 12 weeks, at least ONE agent at maximally tolerated dose)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Fabhalta. Providers must submit documentation supporting the requested indication, required prior supportive therapy, and that Fabhalta will not be used concomitantly with excluded agents. Approvals are provided for the durations specified in the FDA‑Approved Indications criteria and require prescribing by or in consultation with a specialist for the treated condition.

All requests must include clinical documentation as described in the policy (biopsy reports, lab values, and prior therapy documentation).
Approvals are provided for the duration listed under each indication (see FDA‑Approved Indications).

Note

Approval Durations

Initial and continuation approval durations vary by indication. Typical durations: 6 months for initial therapy (where specified) and 1 year for patients currently receiving Fabhalta who meet continuation criteria. When an approval length is specified in months, 1 month = 30 days.

Complement 3 Glomerulopathy: Initial therapy — approve for 6 months; Current therapy — approve for 1 year.

Background and Rationale

Fabhalta (iptacopan) is an oral Factor B inhibitor indicated to reduce proteinuria in adults with Complement 3 glomerulopathy (C3G), for treatment of paroxysmal nocturnal hemoglobinuria (PNH), and to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). C3G and IgAN are complement-mediated glomerular diseases generally diagnosed by renal biopsy and managed with supportive care (including ACE inhibitor/ARB therapy and blood pressure control); Fabhalta use requires prior authorization and adherence to the indication-specific criteria in this policy. The policy history notes recent additions and revisions, including addition of C3G criteria and updates to concomitant use exclusions (e.g., adding Soliris biosimilars to examples).

Definitions and Key Terms

Definition — C3 glomerulopathy (C3G)

DefinitionAn ultra‑rare complement‑mediated kidney disease characterized by deregulation and overactivation of the alternative complement pathway with glomerular C3 deposition on renal biopsy; diagnosis requires renal biopsy

Clinical featuresTypically presents with proteinuria and hematuria; urine analysis is often the first diagnostic step

Standard managementSupportive care including blood pressure control with ACE inhibitors or ARBs to reduce proteinuria; immunosuppressants may be used for moderate to severe disease

Definition — Paroxysmal nocturnal hemoglobinuria (PNH)

DefinitionA rare, genetic hematopoietic stem cell disorder caused by PIGA mutations resulting in deficiency of GPI‑anchored proteins

Diagnosis

Policy Summary

PayerCigna

PolicyComplement Inhibitors - Fabhalta Prior Authorization Policy

Policy CodePolicy POLICY: Complement Inhibitors - Fabhalta Prior Authorization Policy

Change TypeAnnual revision with material changes (added C3G, revised ACEi/ARB requirement, updated concomitant-use exclusions)

Effective DateN/A

Next Review DateMar 25, 2026

SourceLink

On This Page

Continuation duration = 1 year

Duration requirementAt least 12 weeks of therapy with an ACE inhibitor or ARB prior to starting Fabhalta

Agent requirementMust have received the maximum or maximally tolerated dose of at least ONE ACE inhibitor or ARB

DocumentationDuration and agent(s) should be documented in prior authorization request

Minimum patient age for covered indications (≥ 18 years)

Minimum agePatient must be ≥ 18 years of age

ACEi/ARB therapy duration (redundant/confirmation of requirement)

Confirmed durationACEi/ARB therapy duration requirement: ≥ 12 weeks

ScopeRequirement applies to renal indications (C3G and IgAN) per policy criteria

Change notePolicy revised wording to require ‘at least ONE’ ACEi or ARB and changed duration from ≥90 days to ≥12 weeks

Paroxysmal Nocturnal Hemoglobinuria: Initial therapy — approve for 6 months; Current therapy — approve for 1 year.

Primary IgA Nephropathy: Approve for 1 year for both initial and current therapy when criteria met.

Denial Risk

Concomitant Use Exclusions

Fabhalta should not be prescribed in combination with other complement inhibitors or with other agents indicated for IgA nephropathy. Requests that propose concomitant use with excluded agents risk denial.

Concomitant use with another complement inhibitor is considered not medically necessary (examples include pegcetacoplan (subcutaneous injection), eculizumab IV infusion (Soliris and Soliris biosimilars), ravulizumab (Ultomiris), danicopan (Voydeya), crovalimab (PiaSky), and empaveli).
Concomitant use with other medications indicated for treatment of IgA nephropathy (e.g., Filspari, Vanrafia) is not recommended and may be denied due to lack of evidence supporting combination therapy.

Documentation Required

Prior Supportive Therapy Requirement

For renal indications (C3 glomerulopathy and primary IgA nephropathy), patients must have received an ACE inhibitor or an ARB at maximum or maximally tolerated dose for at least 12 weeks prior to starting Fabhalta, unless contraindicated or not tolerated. Documentation of the agent, dose, and duration must be provided.

Acceptable prior therapies: ACE inhibitor OR angiotensin receptor blocker.
Required duration: ≥ 12 weeks (document dose and tolerability).
If ACEi/ARB therapy is contraindicated or not tolerated, provide documentation supporting the contraindication or intolerance.

Documentation Required

Prior ACEi/ARB Requirement for C3 Glomerulopathy

For Complement 3 Glomerulopathy specifically, evidence that the patient received at least ONE of an ACE inhibitor or ARB at maximum or maximally tolerated dose for ≥ 12 weeks prior to initiation must be included with the prior authorization request. Provide medication name(s), dose(s), start and stop dates, and any documentation of intolerance or contraindication if ACEi/ARB were not used.

Biopsy confirmation and urine protein-to-creatinine ratio and eGFR values are also required per the C3G criteria.
Operational note: Requests lacking clear ACEi/ARB treatment documentation for C3G may be denied or pended for additional information.

Confirmed by peripheral blood flow cytometry showing absence or severe deficiency of GPI‑anchored proteins on at least two cell lineages

Clinical consequencesLeads to hemolysis, thrombosis risk, and cytopenias; supportive care and complement inhibitor therapy are management options

Definition — IgA nephropathy (IgAN)

DefinitionPrimary IgA nephropathy (IgAN) is defined by predominant or co‑dominant IgA deposits on kidney biopsy

Risk/progressionProteinuria and hypertension are major risk factors for CKD progression; proteinuria reduction to <0.5 g/day is a therapeutic target

Treatment contextManagement emphasizes supportive care; policy requires biopsy confirmation and proteinuria thresholds (UPCR ≥1.5 g/g or proteinuria ≥0.5 g/day) for Fabhalta coverage

Key clinical trial references and evidence citations

C3G phase 3 trialKavanagh D, Bomback AS, Vivarelli M, et al. Oral iptacopan therapy in patients with C3 glomerulopathy: a randomized, double‑blind, parallel group, multicentre, placebo‑controlled, phase 3 study. Lancet. 2025;406:1587‑1598.

IgAN NEJM trialPerkovic V, Barratt J, Rovin B, et al. Alternative complement pathway inhibition with iptacopan in IgA nephropathy. N Engl J Med. 2025;392(6):531‑543.

Regulatory contextFabhalta approved for C3G, PNH, and IgAN; IgAN approval was under accelerated approval based on reduction of proteinuria and requires confirmatory evidence