Fabhalta (iptacopan) prior authorization — Coverage Criteria
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Defines prior authorization and reauthorization criteria 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 pharmacy benefits.
No material clinical or coverage changes in this revision.
Coverage Criteria
PNH
Initial and reauthorization criteria for PNH
Initial Authorization for PNH
- Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
Combination therapy rule
- No concomitant complement inhibitor: Patient will not be prescribed Fabhalta in combination with another complement inhibitor used for the treatment of PNH
- Switching from another complement inhibitor: Patient is currently receiving another complement inhibitor which will be discontinued and Fabhalta will be initiated in accordance with FDA labeling
Reauthorization for PNH
- Clinical response: Documentation of positive clinical response to Fabhalta therapy
- No combination therapy: Patient is not receiving Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris)
IgA Nephropathy (IgAN)
Initial and reauthorization criteria for IgAN
Initial Authorization for IgAN
- Diagnosis of primary immunoglobulin A nephropathy (IgAN)
- Risk of progression: Patient is at risk of rapid disease progression (e.g., generally a urine protein-to-creatinine ratio (UPCR) >= 1.5 g/g)UPCR >= 1.5 g/g
- Indication: Use of Fabhalta to reduce proteinuria
Complement 3 Glomerulopathy (C3G)
Initial and reauthorization criteria for C3G
Initial Authorization for C3G
- Diagnosis of complement 3 glomerulopathy (C3G)
- Indication: Use of Fabhalta to reduce proteinuria
Fabhalta must not be prescribed in combination with another complement inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) unless the patient is switching from that other complement inhibitor and the prior agent will be discontinued with Fabhalta initiated in accordance with United States Food and Drug Administration labeling. This includes agents such as eculizumab, Empaveli, PiaSky, and Ultomiris as listed in the policy. Authorization for initial therapy is issued for 12 months when criteria are met.
Initial Therapy
Initial Therapy
Initial authorization requirements per indication (authorization for 12 months).
Authorization issued for 12 months
Authorization issued for 12 months
Authorization issued for 12 months
| Step | Requirement / Rule | Notes |
|---|---|---|
| 1 | Fabhalta must not be prescribed in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris). | Initial authorization requires diagnosis of PNH; authorization issued for 12 months. |
| 1 (switching exception) | Patient currently receiving another complement inhibitor may switch to Fabhalta only if the prior agent will be discontinued and Fabhalta is initiated per FDA‑approved labeling. | Applies to planned transitions from agents such as eculizumab, Empaveli, PiaSky, Ultomiris; authorization issued for 12 months. |
Reauthorization / Continuation
Reauthorization/Continuation
Reauthorization requires documentation of positive clinical response; authorizations issued for 12 months.
Authorization issued for 12 months
Authorization issued for 12 months
Authorization issued for 12 months
Provider Actions & Prior Authorization
Prior authorization required
Prior authorization is required for Fabhalta. When the coverage criteria are met, initial and reauthorization approvals are issued for 12 months.
Do not combine with other complement inhibitors for PNH
For PNH, Fabhalta must not be used in combination with another complement inhibitor for PNH unless the patient is switching from that therapy and the other agent will be discontinued per FDA labeling.
- Examples of complement inhibitors listed: eculizumab, Empaveli, PiaSky, Ultomiris.
Automated approval may vary; missing history/diagnosis can cause denial
Automated approval and re-approval processes vary by program; lack of required previous claim/medication history or diagnosis codes (ICD-10) can trigger denial or require manual review.
- UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.
- Use of automated approval and re-approval processes varies by program and/or therapeutic class.
Provide prior claims, ICD‑10 codes, and be aware of supply limits
Previous claim/medication history, diagnosis codes (ICD-10), and claim logic may be used to approve initial or reauthorization requests; supply limits may apply.
- Approvals may be granted based solely on prior claims/medication history and diagnosis codes.
- Supply limits may be in place and could affect authorization quantity.
Coding & Thresholds
Definitions
Background
Fabhalta (iptacopan) is a complement factor B inhibitor with an FDA-approved indication for adults with paroxysmal nocturnal hemoglobinuria (PNH). For PNH, Fabhalta is covered when the member has a diagnosis of PNH and either will not be prescribed Fabhalta in combination with another complement inhibitor for PNH or is switching from another complement inhibitor which will be discontinued and Fabhalta will be started per FDA labeling. When the initial authorization criteria are met, authorization will be issued for 12 months.
Quantity Limits
Revision History
UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program and therapeutic class.
Supply limits may be in place for Fabhalta (iptacopan) as an additional clinical rule affecting approvals and dispensing.
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