CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1432-4

Fabhalta (iptacopan) prior authorization

Prior authorization policy for Fabhalta (iptacopan) covering adults with PNH, primary IgA nephropathy (IgAN) at risk of rapid progression, and complement 3 glomerulopathy (C3G); defines initial and reauthorization clinical criteria, duration, and additional clinical rules.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyFabhalta (iptacopan) prior authorization

Policy CodePolicy 2025 P 1432-4

Change TypeAdded/Updated indications and criteria

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization; approvals are issued for 12 months and reauthorization requires documentation of positive clinical response (for C3G specify reduction in proteinuria).

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); included UPCR threshold example.

Simplified criteria language for converting to new complement inhibitor therapy.

3Covered Indications

12Authorization Duration (months)

≥1.5 g/gIgAN UPCR Threshold (example)

Coverage Summary & Scope

This policy is a prior authorization for Fabhalta (iptacopan) with a coverage stance of covered_with_criteria for adults with: paroxysmal nocturnal hemoglobinuria (PNH); primary immunoglobulin A nephropathy (IgAN) at risk of rapid progression; and complement 3 glomerulopathy (C3G). The policy defines both initial and reauthorization clinical criteria for each indication and specifies an authorization duration of 12 months for initial approvals and reauthorizations. State mandates, federal regulatory requirements, and member-specific benefit plans may affect coverage and how the criteria are applied.

Quick Policy Facts

Covered Indications3

Authorization Duration12 months

IgAN Risk Threshold (example)UPCR ≥1.5 g/g

Effective Date2025-08-01

Last Review2025-05

Initial Authorization Criteria (by indication)

Paroxysmal Nocturnal Hemoglobinuria (PNH) - Initial Authorization

Fabhalta will be approved based on both of the following criteria:

ALL of the following

Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
ONE of
- Patient will not be prescribed Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris)
- Patient is currently receiving another complement inhibitor (e.g., eculizumab, Empaveli, PiaSky, Ultomiris) which will be discontinued and Fabhalta will be initiated in accordance with the United States Food and Drug Administration approved labeling
  Conversion to Fabhalta permitted if prior complement inhibitor will be discontinued and initiation follows FDA labeling

Reauthorization Criteria (by indication)

Paroxysmal Nocturnal Hemoglobinuria (PNH) - Reauthorization

Fabhalta will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Fabhalta therapy
Patient is not receiving Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris)
Fabhalta must not be used in combination with another complement inhibitor for PNH unless prior therapy will be discontinued and conversion follows FDA labeling; claims in combination may be disallowed.

Complement 3 Glomerulopathy (C3G) - Reauthorization

Fabhalta will be approved based on the following criterion:

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization required

Fabhalta requires prior authorization; approvals are issued for 12 months for initial and reauthorization periods.

Documentation Required

Documentation of response for reauthorization

For reauthorization, providers must document positive clinical response to Fabhalta therapy. For C3G reauthorization this must be demonstrated by a reduction in proteinuria.

Codes Referenced in Policy

ICD-10 Diagnosis Examples in CriteriaICD-10

No codes listed

Examples of complement inhibitors (referenced but not billed codes)mixed

	eculizumab
	Empaveli
	PiaSky
	Ultomiris

Evidence & References

Key evidence and references cited in the policy include the Fabhalta package insert (Novartis; March 2025) and documented P&T approval/change history with dates: 2/2024, 4/2024, 10/2024, 5/2025. The brief does not present numeric trial metrics; supporting documentation and regulatory labeling are referenced for clinical details.

Clinical Background & Definitions

Background: Fabhalta (iptacopan) is a complement factor B inhibitor indicated for treatment of adults with PNH, for reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression (generally a UPCR ≥1.5 g/g), and for treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. Coverage may be impacted by state mandates, federal requirements, and member-specific benefit plan provisions; automated approvals based on claims/medication history and other utilization management programs may also apply.

Definitions

UPCR (term)Urine protein-to-creatinine ratio

Threshold (IgAN example)generally ≥ 1.5 g/g

ContextUsed to identify patients with IgAN at risk of rapid progression

Policy Changes & Timeline

2/2024P&T approval

Program created (Prior Authorization/Notification - Fabhalta).

4/2024policy change

Simplified criteria language for converting to new complement inhibitor therapy (clarification for conversion/initiation when prior complement inhibitor is discontinued per FDA labeling).

10/2024policy change

Updated background and added coverage criteria with additional indication for primary immunoglobulin A nephropathy (IgAN); updated list of examples for combination use requirement for PNH and updated reference (clarified UPCR threshold example: generally ≥1.5 g/g).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyFabhalta (iptacopan) prior authorization

Policy CodePolicy 2025 P 1432-4

Change TypeAdded/Updated indications and criteria

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization; approvals are issued for 12 months and reauthorization requires documentation of positive clinical response (for C3G specify reduction in proteinuria).

On This Page

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Primary Immunoglobulin A Nephropathy (IgAN) - Initial Authorization

Fabhalta will be approved based on all the following criteria:

Complement 3 Glomerulopathy (C3G) - Initial Authorization

Fabhalta will be approved based on both the following criteria:

ALL of the following

Diagnosis of complement 3 glomerulopathy (C3G)
Used to reduce proteinuria

Documentation of positive clinical response to Fabhalta therapy demonstrated by a reduction in proteinuria

This C3G indication and criteria were added as a material change to the policy.

Billing Rule

Combination therapy prohibition

Fabhalta must not be used in combination with another complement inhibitor for PNH unless the prior complement inhibitor will be discontinued and conversion to Fabhalta follows FDA-approved labeling; claims for concurrent combination use may be disallowed.

Documentation Required

Risk-based automated approvals

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic using automated approval processes.

5/2025policy changeLatest

Added new indication and criteria for complement 3 glomerulopathy (C3G); replaced Soliris with eculizumab in list of example complement inhibitors; updated background and references. (Flagged as material change.)

8/1/2025effective_dateLatest

Policy effective date.