CurrentMass General Brigham Health PlanPolicy N/A

Fabhalta (iptacopan) — Coverage Criteria (PNH, IgAN, C3G)

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Policy governs prior authorization, coverage criteria, and quantity limits for Fabhalta (iptacopan) under the pharmacy benefit for Mass General Brigham Health Plan Commercial/Exchange members, including indications in PNH, IgAN, and C3G and specialty pharmacy dispensing requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFabhalta (iptacopan) — Coverage Criteria (PNH, IgAN, C3G)

Policy CodePolicy N/A

Change TypeMaterial clinical updates

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required medical records and specialty pharmacy dispensing; document diagnosis confirmation and prior ACEi/ARB therapy where applicable.

SourceLink

POLICY UPDATE CHANGES

Added indication-specific criteria for complement 3 glomerulopathy (C3G) as a supplemental indication.

Updated criteria for IgAN to require that the requested medication is being used to reduce proteinuria.

Added a quantity limitation of 2 capsules per day for Fabhalta.

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CurrentMass General Brigham Health PlanPolicy N/A

Fabhalta (iptacopan) — Coverage Criteria (PNH, IgAN, C3G)

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Policy Summary

PayerMass General Brigham Health Plan

PolicyFabhalta (iptacopan) — Coverage Criteria (PNH, IgAN, C3G)

Policy CodePolicy N/A

Change TypeMaterial clinical updates

Effective DateMay 1, 2026

Last ReviewMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required medical records and specialty pharmacy dispensing; document diagnosis confirmation and prior ACEi/ARB therapy where applicable.

SourceLink

POLICY UPDATE CHANGES

Added indication-specific criteria for complement 3 glomerulopathy (C3G) as a supplemental indication.

Updated criteria for IgAN to require that the requested medication is being used to reduce proteinuria.

Added a quantity limitation of 2 capsules per day for Fabhalta.

Coverage Criteria for Fabhalta (iptacopan)

PNH Initial Therapy

Covered when ALL of the following are met for PNH:

PNH initial: 1. Diagnosis of paroxysmal nocturnal hemoglobinuria confirmed by flow cytometry

IgAN Initial Therapy

Covered when ALL of the following are met for primary IgA nephropathy (IgAN):

IgAN initial - biopsy: 1. Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy

IgAN initial - intent: 4. Requested medication is being used to reduce proteinuria

C3G Initial Therapy

Covered when ALL of the following are met for complement 3 glomerulopathy (C3G):

C3G initial - diagnosis: 1. Diagnosis of complement 3 glomerulopathy (C3G)

C3G initial - intent: 2. Requested medication is being used to reduce proteinuria

C3G initial - transplant: 4. Member has not had a kidney transplant

C3G initial - prescriber: 5. Requested medication is prescribed by or in consultation with a nephrologist

PNH Continuation

Reauthorization for PNH when ALL of the following are met:

PNH continuation: 1. Submission of medical records (e.g., chart notes) documenting a positive response to therapy (e.g., normalization of lactate dehydrogenase [LDH] levels, hemoglobin stabilization, decreased number of red blood cell transfusions)

IgAN Continuation

Reauthorization for IgAN when ALL of the following are met:

IgAN continuation: 1. Submission of medical records (e.g., chart notes) documenting member has had a positive clinical response to therapy as evidenced by ONE of the following: a) decreased levels of proteinuria from baseline on a 24-hour urine collection, or b) decrease in UPCR from baseline based on 24-hour urine collection

C3G Continuation

Reauthorization for C3G when ALL of the following are met:

C3G continuation - response: 1. Submission of medical records (e.g., chart notes) documenting member has had a positive clinical response to therapy (e.g., reduction in 24-hour UPCR, stable or improved eGFR compared to baseline)

C3G continuation - ACEi/ARB: 2. Member continues to be treated with a maximally tolerated dose of one of the following: ACEi or ARB

Examples listed: benazepril, lisinopril, losartan, valsartan

C3G continuation - transplant: 3. Member has not had a kidney transplant

Exclusion: Members with a prior kidney transplant are not eligible for C3G coverage with Fabhalta. Documentation must show the member has not had a kidney transplant to meet C3G coverage criteria.

Diagnostic confirmation requirements: For IgAN, the diagnosis must be confirmed by a kidney biopsy. For C3G, the diagnosis must be documented as complement 3 glomerulopathy per the medical record.

Prior therapy requirements: For renal indications (IgAN and C3G), the member must have trialed and remained on a maximally tolerated dose of a renin-angiotensin system inhibitor. For IgAN this is a minimum trial of 3 months (unless intolerance, adverse effect, or contraindication). For C3G the member must be on a maximally tolerated dose of an ACE inhibitor or ARB for at least 12 weeks prior to initiating therapy.

Coding and Clinical Thresholds

Drug codesNDC

NDC	Not specified in document

UPCR threshold for IgAN

UPCR threshold>= 1.5 g/g

ContextUsed to define 'at risk of rapid disease progression' in IgAN initial criteria

MeasurementUrine protein-to-creatinine ratio (UPCR)

eGFR threshold for IgAN

eGFR threshold>= 20 mL/min/1.73 m2

ContextMinimum renal function required for IgAN initial therapy

UnitsmL/min/1.73 m2

Provider Actions, Documentation, and Authorization Rules

Prior Authorization

Prior Authorization and Specialty Fill Required

Prior authorization is required for Fabhalta (iptacopan). This medication is designated as specialty and must be dispensed through a contracted specialty pharmacy.

Program Type: Prior Authorization required
Benefit: Pharmacy Benefit
Specialty dispensing required — must fill at contracted specialty pharmacy

Step Therapy

ACEi/ARB Required Prior Therapy for IgAN and C3G

For members with IgAN or C3G, a trial of a renin-angiotensin system (RAS) inhibitor is required prior to approval unless contraindicated or not tolerated.

IgAN: At least a 3-month trial of an ACE inhibitor or ARB at maximally tolerated dose, unless intolerance/adverse effect/contraindication documented
C3G: Currently being treated with a maximally tolerated dose of an ACE inhibitor or ARB for at least 12 weeks prior to initiating requested therapy

Key Definitions and Diagnostic Methods

At-risk IgAN (general UPCR threshold)

General at-risk UPCRUPCR >= 1.5 g/g

IndicationDefines patients with primary IgA nephropathy at risk of rapid progression

Source statementGenerally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g

Flow cytometry (PNH diagnosis confirmation)

Diagnostic methodFlow cytometry confirmation of paroxysmal nocturnal hemoglobinuria (PNH)

PurposeRequired to confirm diagnosis of PNH for coverage

Documentation

Background on Fabhalta (iptacopan)

Background: Fabhalta (iptacopan) is a complement pathway inhibitor used in hematologic and renal indications. In nephrology, it is intended to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid progression and to treat adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Coverage for these renal indications requires documentation of diagnosis and evidence that the medication is being used with the intent to reduce proteinuria.

Mechanism and general use: The agent acts on the complement cascade and is prescribed or managed in coordination with nephrology for C3G. For IgAN, eligibility focuses on biopsy confirmation, markers of risk such as UPCR and eGFR thresholds, and prior optimized renin-angiotensin system therapy to reduce proteinuria.

Policy Revision History

2026-05-01material change - criteria and limitsLatest

Reviewed 02/11/2026 and effective 05/01/2026: updated IgAN criteria to require use to reduce proteinuria, clarified C3G ACEi/ARB trial duration (≥3 months), and added a quantity limitation for Fabhalta (2 capsules/day).

2026-01-01terminology update

Effective 01/01/2026: updated ACEI/ARB trial verbiage for the diagnosis IgAN following 10/08/2025 review.

2025-10-01