ModifiedCignaPolicy N/A

Fabhalta (iptacopan) prior authorization — C3G, PNH, and IgAN

Prior authorization criteria and coverage policy for Fabhalta (iptacopan capsules) for C3 glomerulopathy, paroxysmal nocturnal hemoglobinuria (PNH), and primary immunoglobulin A nephropathy (IgAN) for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyFabhalta (iptacopan) prior authorization — C3G, PNH, and IgAN

Policy CodePolicy N/A

Change TypeCriteria added and revised for renal indicationsexclusions updated

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of biopsy or flow cytometry, evidence of required prior ACEi/ARB therapy, and specialist consultation.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered: Added new criterion regarding concomitant use with another complement inhibitor; examples of complement inhibitors were added as a Note.

Paroxysmal Nocturnal Hemoglobinuria: Initial approval duration was changed from 4 months to 6 months.

Primary Immunoglobulin A Nephropathy: This condition and criteria for approval was added to the policy.

High risk of disease progression urine protein threshold revised from proteinuria ≥ 1 g/day to proteinuria ≥ 0.5 g/day (or urine protein-creatinine ratio ≥ 1.5 g/g).

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

For Complement 3 Glomerulopathy initial therapy: removed requirement that patient has not received a kidney transplant; changed requirement from use of ACE inhibitor or ARB at maximum dose for ≥ 90 days to 'at least ONE' ACE inhibitor or ARB for ≥ 12 weeks.

3FDA-approved indications listed

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Coverage Criteria for Fabhalta (iptacopan)

C3 Glomerulopathy

Covered when ONE of the following is met (A or B):

C3G: Initial or Current Therapy

Initial therapy - C3G criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis confirmed by biopsy; AND iii. Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g; AND iv. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2; AND v. Patient has received the maximum or maximally tolerated dose of at least ONE of the following for ≥ 12 weeks prior to starting Fabhalta: (a) angiotensin converting enzyme inhibitor OR (b) angiotensin receptor blocker; AND vi. Medication is prescribed by or in consultation with a nephrologist.UPCR >= 1.0 g/g; eGFR >= 30 mL/min/1.73 m2
Initial approval duration: 6 months
Currently receiving - C3G criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis confirmed by biopsy; AND iii. According to the prescriber, patient has had a response to Fabhalta (examples: reduction in UPCR/proteinuria from baseline); AND iv. eGFR ≥ 30 mL/min/1.73 m2; AND v. Medication is prescribed by or in consultation with a nephrologist.eGFR >= 30 mL/min/1.73 m2
Continuation approval duration: 1 year

Paroxysmal Nocturnal Hemoglobinuria

Covered when ONE of the following is met (A or B):

PNH: Initial or Current Therapy

Initial therapy - PNH criteria: i. Patient is ≥ 18 years of age; AND ii. PNH diagnosis confirmed by peripheral blood flow cytometry showing absence or deficiency of glycosylphosphatidylinositol-anchored proteins on at least two cell lineages; AND iii. Medication is prescribed by or in consultation with a hematologist.
Initial approval duration: 6 months
Currently receiving - PNH criteria: i. Patient is ≥ 18 years of age; AND ii. According to the prescriber, patient is continuing to derive benefit from Fabhalta (examples: increase or stabilization of hemoglobin, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in FACIT-Fatigue score); AND iii. Medication is prescribed by or in consultation with a hematologist.
Continuation approval duration: 1 year

Primary Immunoglobulin A Nephropathy

Covered when ONE of the following is met (A or B):

IgAN: Initial or Current Therapy

Initial therapy - IgAN criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis confirmed by biopsy; AND iii. Patient is at high risk of disease progression, defined by BOTH: (a) meeting ONE of: proteinuria ≥ 0.5 g/day OR UPCR ≥ 1.5 g/g; AND (b) patient has received the maximum or maximally tolerated dose of ONE of the following for ≥ 12 weeks prior to starting Fabhalta: (1) angiotensin converting enzyme inhibitor OR (2) angiotensin receptor blocker; AND iv. According to the prescriber, patient has received ≥ 3 months of optimized supportive care including blood pressure management, lifestyle modification, and cardiovascular risk modification; AND v. eGFR ≥ 30 mL/min/1.73 m2; AND vi. Medication is prescribed by or in consultation with a nephrologist.Proteinuria >= 0.5 g/day OR UPCR >= 1.5 g/g; eGFR >= 30 mL/min/1.73 m2
Initial approval duration: 9 months
Currently receiving - IgAN criteria: i. Patient is ≥ 18 years of age; AND ii. Diagnosis confirmed by biopsy; AND iii. According to the prescriber, patient has had a response to Fabhalta (examples: reduction in UPCR/proteinuria from baseline); AND iv. eGFR ≥ 30 mL/min/1.73 m2; AND v. Medication is prescribed by or in consultation with a nephrologist.

Revised coverage criteria highlights

Policy includes coverage criteria for conditions such as Primary IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria, and Complement 3 Glomerulopathy; several numeric and prior-therapy criteria were revised as shown below.

High risk of disease progression: Patient meets ONE of: urine-to-protein-creatinine ratio >= 1.5 g/g OR proteinuria >= 0.5 g/dayUPCR >= 1.5 g/g OR proteinuria >= 0.5 g/day

Revised from prior proteinuria >= 1 g/day

Complement 3 Glomerulopathy initial therapy prior therapy requirements: Patient has received at least ONE of ACE inhibitor or ARB for >= 12 weeks; no requirement that patient has not received a kidney transplant (requirement removed)ACEi or ARB >= 12 weeks

Wording changed from 'ACEi or ARB at maximum or maximally tolerated dose for >= 90 days'

Concomitant administration of Fabhalta with another complement inhibitor is expressly excluded. The policy states there is no evidence to support concomitant use and lists this as a Condition Not Covered. Examples provided in the policy note include agents such as Empaveli (pegcetacoplan), PiaSky (crovalimab-akkz), eculizumab (Soliris and biosimilars), Ultomiris (ravulizumab-cwvz), and Voydeya (danicopan).

The policy further clarifies that concomitant use with another complement inhibitor is a formal exclusion and that the list of example agents has been updated over time. The history and note identify specific examples added or clarified (for example, PiaSky (crovalimab-akkz) and Voydeya (danicopan)), and indicate that Soliris biosimilars were later included as examples of complement inhibitors.

Fabhalta is considered not medically necessary for any use not listed in this policy. This includes concomitant use with another complement inhibitor and concomitant use with other medications indicated for treatment of immunoglobulin A nephropathy; such combination therapy is listed under Conditions Not Covered and may be denied.

In addition to excluding concomitant complement inhibitor therapy, the policy explicitly excludes combining Fabhalta with other agents indicated for IgA nephropathy (for example, Filspari and Vanrafia). The policy notes that combination therapy is generally not recommended because controlled clinical trial data supporting additive efficacy are lacking.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for new renal indications (Complement 3 Glomerulopathy and Primary Immunoglobulin A Nephropathy). Approvals are provided for the durations specified in the FDA‑Approved Indications criteria. Requests must document that initiation criteria for the specific renal indication are met.

Applies to initial therapy requests for C3G and Primary IgA Nephropathy
Approval durations: C3G initial therapy = 6 months; Primary IgAN initial therapy = 9 months

Step Therapy

Prior Supportive Therapy Required (ACEi/ARB)

For renal indications, the patient must have received at least one angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum or maximally tolerated dose for ≥ 12 weeks (≥ 3 months) prior to initiation of Fabhalta.

Applies to initial therapy for Complement 3 Glomerulopathy and Primary IgA Nephropathy
Documentation should specify the ACEi or ARB used, dose (or reason for maximal tolerance), and duration (≥ 12 weeks)

Clinical Thresholds and Coding-Related Values

Proteinuria thresholds — C3G and IgAN

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

IgAN high‑risk UPCR thresholdUrine protein-to-creatinine ratio ≥ 1.5 g/g

IgAN high‑risk proteinuria (daily)Proteinuria ≥ 0.5 g/day

eGFR — renal function threshold

Renal function threshold (all renal indications)Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

C3G eGFR requirement (initial & continuation)eGFR ≥ 30 mL/min/1.73 m2 (see C3G criteria)

IgAN eGFR requirement (initial & continuation)

Definitions and Key Terms

C3G definition

DefinitionComplement 3 glomerulopathy (C3G) is a rare, complement‑mediated kidney disease diagnosed by renal biopsy with predominant C3 deposits and minimal or absent immunoglobulin deposits

Diagnostic confirmationRenal biopsy demonstrating C3‑dominant deposits is required for diagnosis and for policy documentation

Clinical featuresTypically presents with proteinuria and hematuria; urine analysis is often an initial test

PNH definition

DefinitionParoxysmal nocturnal hemoglobinuria (PNH) is a rare hematopoietic stem cell disorder diagnosed by peripheral blood flow cytometry showing absence or severe deficiency of GPI‑anchored proteins on at least two lineages

Diagnostic confirmation for policy

Background

Fabhalta (iptacopan) is an oral factor B inhibitor approved for indications that include Complement 3 Glomerulopathy, Paroxysmal Nocturnal Hemoglobinuria, and Primary Immunoglobulin A Nephropathy (accelerated approval to reduce proteinuria). The policy emphasizes renal indications target reduction of proteinuria and includes safety considerations and programmatic controls; concomitant use with other complement inhibitors or with medications specifically indicated for IgAN is not supported and is listed as a Condition Not Covered.

Policy Summary

PayerCigna

PolicyFabhalta (iptacopan) prior authorization — C3G, PNH, and IgAN

Policy CodePolicy N/A

Change TypeCriteria added and revised for renal indicationsexclusions updated

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of biopsy or flow cytometry, evidence of required prior ACEi/ARB therapy, and specialist consultation.

SourceLink

On This Page

Denial Risk

Concomitant Complement Inhibitor / IgAN Agent Use — Not Recommended

Do not approve requests for Fabhalta in combination with another complement inhibitor or combined with other medications indicated for IgA nephropathy (e.g., Filspari, Vanrafia). There is no evidence to support concomitant use and combination therapy is generally not recommended.

Examples of complement inhibitors include: Empaveli (pegcetacoplan), PiaSky (crovalimab-akkz), eculizumab (Soliris and biosimilars), Ultomiris (ravulizumab-cwvz), Voydeya (danicopan)
Examples of other IgAN agents: Filspari, Vanrafia

Documentation Required

Required Documentation

Required documentation must be submitted with prior authorization requests for initiation and continuation of Fabhalta for renal indications. Because of the specialized management required, Fabhalta must be prescribed by or in consultation with a nephrologist.

Prescriber specialty: nephrologist or documentation of nephrology consultation
Diagnosis confirmation: renal biopsy report confirming C3G or IgA nephropathy
Baseline clinical data: urine protein-to-creatinine ratio (UPC or UPCR), proteinuria values, and estimated glomerular filtration rate (eGFR)
Supportive therapy documentation: record of ACEi or ARB use (agent, dose, duration ≥ 12 weeks) and note of optimized supportive care (≥ 3 months for Primary IgAN) including blood pressure and cardiovascular risk management
For continuation: documentation of clinical response or ongoing benefit per prescriber (e.g., reduction in proteinuria/UPCR, stabilization or improvement in eGFR)