CurrentColorado Rocky Mountain Health PlansPolicy N/A

Fabhalta (iptacopan) prior authorization

Prior authorization and reauthorization requirements for Fabhalta (iptacopan) for adults with PNH, primary IgA nephropathy (IgAN) at risk of rapid progression, and complement 3 glomerulopathy (C3G); applies to Colorado Rocky Mountain Health Plans clinical pharmacy programs and providers seeking coverage for these indications.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyFabhalta (iptacopan) prior authorization

Policy CodePolicy N/A

Change TypeAdded C3Gupdated IgAN criteria

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Fabhalta for initial or continued use with documentation of diagnosis and, for reauthorization, evidence of positive clinical response.

SourceLink

POLICY UPDATE CHANGES

Added new indication and criteria for C3 glomerulopathy (C3G).

Updated background and added coverage criteria with additional indication for primary immunoglobulin A nephropathy (IgAN).

Simplified criteria language for converting to new complement inhibitor therapy and updated examples of complement inhibitors (replaced Soliris with eculizumab).

3indications covered

12 monthsauthorization period

UPCR ≥1.5 g/gIgAN threshold

Prior Auth

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Coverage Criteria by Indication

inv-01: PNH — Fabhalta is covered for PNH when ALL of the following are met

Fabhalta is covered for PNH when ALL of the following are met

PNH Initial Authorization: (1) Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); AND (2) One of the following: (a) Patient will not be prescribed Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris); OR (b) Patient is currently receiving another complement inhibitor which will be discontinued and Fabhalta will be initiated in accordance with FDA-approved labeling.

Authorization issued for 12 months

inv-02: PNH Reauthorization — For reauthorization for PNH the following must be met

For reauthorization for PNH the following must be met

PNH Reauthorization: (1) Documentation of positive clinical response to Fabhalta therapy; AND (2) Patient is not receiving Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris).

Authorization issued for 12 months

inv-03: IgAN — Fabhalta is covered for IgAN when ALL of the following are met

Fabhalta is covered for IgAN when ALL of the following are met

IgAN Initial Authorization: (1) Diagnosis of primary immunoglobulin A nephropathy (IgAN); AND (2) Patient is at risk of rapid disease progression (e.g., generally a urine protein-to-creatinine ratio [UPCR] greater than or equal to 1.5 g/g); AND (3) Intended use is to reduce proteinuria.UPCR >= 1.5 g/g

Authorization issued for 12 months

IgAN Reauthorization: (1) Documentation of positive clinical response to Fabhalta therapy.

Authorization issued for 12 months

inv-04: C3G — Fabhalta is covered for C3G when ALL of the following are met

Fabhalta is covered for C3G when ALL of the following are met

C3G Initial Authorization: (1) Diagnosis of complement 3 glomerulopathy (C3G); AND (2) Intended use is to reduce proteinuria.

Authorization issued for 12 months

C3G Reauthorization: (1) Documentation of positive clinical response to Fabhalta therapy demonstrated by a reduction in proteinuria.

Authorization issued for 12 months

Requests for treatment of paroxysmal nocturnal hemoglobinuria (PNH) with Fabhalta (iptacopan) will not be approved if the patient is to receive Fabhalta concurrently with another complement inhibitor for PNH (examples include eculizumab, Empaveli, PiaSky, Ultomiris), unless the existing complement inhibitor will be discontinued and conversion to Fabhalta will occur in accordance with FDA‑approved labeling. Authorization for conversion or initiation under these conditions will be issued for 12 months.

For reauthorization of Fabhalta for PNH, the policy requires documentation of a positive clinical response to Fabhalta and confirmation that the patient is not receiving Fabhalta in combination with another complement inhibitor for PNH; concurrent combination use without planned discontinuation and appropriate conversion per labeling will not meet approval.

Initial Therapy Requirements

inv-14: Initial Therapy — Initial authorization requirements by indication

Initial authorization requirements by indication

PNH Initial: Diagnosis of PNH AND not used in combination with another complement inhibitor for PNH unless converting from that inhibitor per FDA labeling.

Authorization issued for 12 months

IgAN Initial: Diagnosis of IgAN AND at risk of rapid progression (generally UPCR >= 1.5 g/g) AND use to reduce proteinuria.UPCR >= 1.5 g/g

Authorization issued for 12 months

C3G Initial: Diagnosis of C3G AND use to reduce proteinuria.

Authorization issued for 12 months

Reauthorization / Continuation Criteria

inv-15: Reauthorization — Reauthorization rules require evidence of positive clinical response; for C3G this is reduction in proteinuria.

Reauthorization rules require evidence of positive clinical response; for C3G this is reduction in proteinuria.

Continuation/Reauthorization: Documentation of positive clinical response to Fabhalta therapy (for C3G demonstrated by reduction in proteinuria).

Authorization issued for 12 months

Required Provider Actions and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization required for Fabhalta for initial use in PNH, IgAN, and C3G. When criteria are met, approval will be issued for 12 months.

Initial authorization: approval issued for 12 months when required diagnosis and criteria met (PNH, IgAN, C3G).
Reauthorization: documentation of positive clinical response required; approvals issued for 12 months.

Note

Automated processes and supply limits

Automated approval and re-approval processes may be used based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits may be applied.

Automated processes may permit initial and reauthorization without additional documentation depending on program/therapeutic class.
Supply limits may be enforced.

Billing and Measurement Codes

Referenced billing codesNDC

NDC	Drug billing codes referenced generically; specific NDCs not listed in document

Urine protein-to-creatinine ratio (UPCR)

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

ContextReferenced for adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression

UseServes as the proteinuria threshold to determine eligibility for Fabhalta for IgAN

Key Definitions

Rapid disease progression (IgAN)

DefinitionRapid disease progression in IgAN is generally referenced as UPCR ≥ 1.5 g/g

Associated indicationPrimary immunoglobulin A nephropathy (IgAN) — used to identify patients at risk of rapid progression

Policy applicationUsed in initial authorization criteria where patient must be at risk of rapid progression (generally UPCR ≥1.5 g/g)

Background and Drug Description

Iptacopan (Fabhalta) is a complement factor B inhibitor indicated for adults with paroxysmal nocturnal hemoglobinuria (PNH), for reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid progression (policy references UPCR ≥1.5 g/g as the threshold for risk), and to reduce proteinuria in adults with complement 3 glomerulopathy (C3G).

Prior authorization is required for Fabhalta across these indications; when criteria are met, approvals are issued for 12 months.

Step Therapy and Conversion Rules

Step	Requirement
1	Conversion from other complement inhibitors must follow FDA labeling; automated prior-authorization and re-approval processes may be used based on prior claim/medication history and diagnosis codes. Supply limits may be applied.
Notes	Use of automated approval and re-approval processes varies by program and/or therapeutic class; state mandates may apply.

Site-of-Care and Supply Limits

Billing Rule

Supply limits may apply at infusion centers

Supply limits may be in place for administration at infusion centers; the policy does not specify additional site‑of‑care rules.