CurrentMass General Brigham Health PlanPolicy N/A

Fabhalta (iptacopan)

Pharmacy benefit prior authorization policy for Fabhalta (iptacopan) including specialty dispensing, indication-specific initial and continuation criteria, quantity/authorization limits, and contact information for prior authorization.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFabhalta (iptacopan)

Policy CodePolicy N/A

Change TypeAdded indications/criteria

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization is required for Fabhalta; specialty-designated medication must be filled at a contracted specialty pharmacy. Contact numbers and fax provided for prior authorization submission.

SourceLink

POLICY UPDATE CHANGES

Added supplemental indication of C3G.

Added criteria for supplemental indication of IgAN.

Reviewed and updated for December and August P&T meetings.

3Covered Indications

12 moAuthorization Duration

Coverage Summary

Fabhalta (iptacopan) is covered with criteria for specific indications under the pharmacy benefit prior authorization policy. It is indicated and may be authorized for adults with primary IgA nephropathy (IgAN) at risk of rapid progression, adults with paroxysmal nocturnal hemoglobinuria (PNH), and adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. The medication is designated as a specialty product and must be filled at a contracted specialty pharmacy. Initial and reauthorization approvals are granted for 12 months.

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Initial Therapy Criteria

General Authorization Pathways

Authorization may be granted for members new to the plan within the previous 90 days who are currently receiving treatment with the requested medication (excludes samples/PAP) OR if member meets all of the diagnosis-specific criteria below.

ANY of the following

ALL of the following
- Member is new to the plan within the previous 90 days and is currently receiving treatment with the requested medication
Diagnosis-specific criteria: Member meets all criteria for the specific diagnosis (see relevant diagnosis node)

Initial Therapy — Paroxysmal Nocturnal Hemoglobinuria (PNH)

Authorization granted when ALL of the following are met:

ALL of the following

Member has a diagnosis of paroxysmal nocturnal hemoglobinuria confirmed by flow cytometry

Initial Therapy — Primary Immunoglobulin A Nephropathy (IgAN)

Authorization granted when ALL of the following are met:

ALL of the following

Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy
Member is at risk of rapid disease progressionUPCR >= 1.5 g/g
e.g., generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool
Member has an estimated glomerular filtration rate (eGFR) greater than or equal to 20 mL/min/1.73 m2eGFR >= 20 mL/min/1.73 m2
Member has had intolerance, adverse effect or contraindication to maximally tolerated renin angiotensin system (RAS) inhibitor (e.g., ACEI or ARB) for at least 3 months

Initial Therapy — Complement 3 Glomerulopathy (C3G)

Authorization granted when ALL of the following are met:

ALL of the following

Diagnosis of complement 3 glomerulopathy (C3G)
Requested medication is being used to reduce proteinuria
Member is on a maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., benazepril, lisinopril, losartan, valsartan)
Member has not had a kidney transplant
Requested medication is prescribed by or in consultation with a nephrologist

Continuation Therapy Criteria

Continuation of Therapy — Paroxysmal Nocturnal Hemoglobinuria (PNH)

Reauthorization will be approved when the following are met:

ALL of the following

Prescriber submits documentation of a positive response to therapy
e.g., normalization of lactate dehydrogenase (LDH) levels, hemoglobin stabilization, decreased number of red blood cell transfusions

Continuation of Therapy — Complement 3 Glomerulopathy (C3G)

Reauthorization will be approved when ALL of the following are met:

ALL of the following

Documentation member has had a positive clinical response to therapy
e.g., reduction in 24-hour UPCR, stable or improved eGFR compared to baseline
Member is on a maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., benazepril, lisinopril, losartan, valsartan)
Member has not had a kidney transplant

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Fabhalta (iptacopan). This medication has been designated specialty and must be filled at a contracted specialty pharmacy. Contact phone and fax numbers are provided for prior authorization submission.

Specialty dispensing required: must be filled at a contracted specialty pharmacy
Prior authorization contact: Phone: 877-519-1908; Fax: 855-540-3693

Documentation Required

Diagnosis confirmation and supporting documentation

Providers must submit diagnostic confirmation and supporting clinical documentation. Required documentation includes: flow cytometry confirmation for PNH; kidney biopsy confirmation for IgAN; urine protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) for IgAN; evidence of intolerance, adverse effect, or contraindication to a maximally tolerated RAS inhibitor (e.g., ACEI or ARB) for at least 3 months for IgAN; documentation of nephrologist prescription or consultation for C3G. For continuation, submit evidence of positive response to therapy: for PNH, normalization of LDH and hemoglobin stabilization (or decreased RBC transfusions); for C3G, reduction in 24-hour UPCR or stable/improved eGFR compared to baseline.

PNH: flow cytometry confirmation; for continuation provide LDH normalization, hemoglobin stabilization, or fewer RBC transfusions
IgAN: kidney biopsy confirmation; UPCR (>= 1.5 g/g indicates risk), eGFR (>= 20 mL/min/1.73 m2); evidence of RAS inhibitor intolerance/adverse effect/contraindication after >= 3 months
C3G: diagnosis and use to reduce proteinuria; member on maximally tolerated RAS inhibitor and prescribed by/with nephrologist; for continuation provide reduction in 24-hour UPCR or stable/improved eGFR

Billing Rule

Authorization duration

Authorization approvals (initial and reauthorization) are granted for 12 months.

Initial approval duration: 12 months
Reauthorization approval duration: 12 months

Background

Background: Fabhalta (iptacopan) is a complement factor B inhibitor indicated for reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid progression, for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), and for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria.

Definitions

Maximally tolerated RAS inhibitorUse of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) at the highest tolerated dose

Positive clinical response (C3G)Reduction in 24-hour UPCR or stable/improved eGFR compared to baseline

Revision History

2025-10-01material_changeLatest

Added supplemental indication of C3G (per July P&T review effective 10/01/2025).

2025-03-01material_change

Added criteria for supplemental indication of IgAN (per December P&T review effective 3/01/2025).

2024-10-01non_material_revision

Policy revised (reviewed at August P&T; effective 10/01/2024).

2024-12-11non_material_revision

Reviewed and updated for December P&T (noted in review history).

2024-08-14non_material_revision

Reviewed at August P&T (noted in review history).

Policy Summary

PayerMass General Brigham Health Plan

PolicyFabhalta (iptacopan)

Policy CodePolicy N/A

Change TypeAdded indications/criteria

Effective DateOct 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Fabhalta (iptacopan)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History