Fabhalta (iptacopan) — Prior authorization and medical necessity criteria
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Prior authorization and medical necessity 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 benefit.
Added new indication and criteria for C3 glomerulopathy (C3G).
Authorization issued for 12 months for initial and reauthorization.
Updated examples for glucocorticoids to include budesonide.
Coverage Criteria
Initial Therapy (PNH)
Covered when ALL of the following are met:
Authorization will be issued for 12 months.
Continuation Therapy (PNH)
Covered for continued therapy when ALL of the following are met:
Authorization will be issued for 12 months.
Initial Therapy (IgAN)
Covered when ALL of the following are met:
Examples of ACEi/ARB provided in policy (e.g., captopril, enalapril, candesartan, valsartan).
Example SGLT2: empagliflozin.
Authorization will be issued for 12 months.
Continuation Therapy (IgAN)
Covered for continued therapy when the following is met:
Authorization will be issued for 12 months.
Initial Authorization
Fabhalta will be approved based on all the following criteria:
Reauthorization
Fabhalta will be approved for reauthorization when the following is met:
Authorization will be issued for 12 months.
Concomitant use of Fabhalta with another complement inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) is not permitted. Coverage requires that Fabhalta not be prescribed in combination with another PNH complement inhibitor (e.g., Empaveli/PiaSky, eculizumab, Ultomiris), or that the member is currently receiving another complement inhibitor which will be discontinued and Fabhalta initiated per FDA labeling.
Patients who have undergone a prior solid-organ or cell transplant, including kidney transplant, are excluded from coverage for Fabhalta. This exclusion applies regardless of indication and must be confirmed in the member’s medical record prior to authorization.
Initial Therapy — Drug-specific and Indication-based Requirements
Initial Therapy (drug-specific)
Initial authorization requirements by indication.
Authorization issued for 12 months.
Authorization issued for 12 months.
Initial Therapy (C3G)
Initial authorization criteria for Fabhalta in C3G
Reauthorization / Continuation Criteria
Reauthorization/Continuation
Reauthorization criteria require documented clinical benefit.
Authorization issued for 12 months.
Authorization issued for 12 months.
Reauthorization
Reauthorization requirements
Authorization will be issued for 12 months.
Provider Actions & Documentation Requirements
Prior authorization required with diagnostic confirmation and specialty prescriber
Submit a prior authorization request for Fabhalta; for initial approvals include medical records confirming diagnosis and note specialty prescriber. Initial authorization requires documentation confirming the diagnosis (e.g., flow cytometry for PNH) and that the drug is prescribed by or in consultation with the appropriate specialist (hematologist/oncologist for PNH; nephrologist for IgAN/C3G).
- For PNH: include flow cytometry analysis confirming presence of PNH clones and supporting lab results/signs/symptoms.
- For IgAN and C3G: include renal/kidney biopsy reports and prescriber specialty (nephrologist) documentation.
Prior authorization required; 12‑month authorization length
Obtain prior authorization for both initial and reauthorization requests; when criteria are met, approvals are issued for 12 months.
- Authorization will be issued for 12 months for initial approvals and for reauthorization when criteria are met.
Document supportive/adjunct therapy (ACEi/ARB and SGLT2) for IgAN
For IgAN requests, document that the patient is on (or has documented intolerance/allergy/contraindication to) supportive therapy including a maximally tolerated ACE inhibitor or ARB and a maximally tolerated SGLT2 inhibitor.
- Show stabilization on a maximally tolerated ACE inhibitor (e.g., captopril, enalapril) or ARB (e.g., candesartan, valsartan) or document intolerance/contraindication.
- Show stabilization on a maximally tolerated SGLT2 inhibitor (e.g., empagliflozin) or document intolerance/contraindication.
Require trial/failure or intolerance to a glucocorticoid before approval
Document a history of failure, contraindication, or intolerance to a glucocorticoid (after a 30‑day trial) prior to approval.
- Examples of glucocorticoids include budesonide, methylprednisolone, prednisone.
- For C3G and IgAN, prior steroid failure/intolerance is required in the initial authorization criteria.
Submit medical records, biopsy reports, and labs to support diagnosis
Submit complete medical records and laboratory data to support the diagnosis and indication requested. For PNH include flow cytometry confirming PNH clones; for IgAN and C3G include renal/kidney biopsy reports and relevant labs.
- PNH: flow cytometry analysis confirming PNH clones plus signs/symptoms or labs attributable to PNH.
- IgAN: renal biopsy confirming primary IgA nephropathy and documentation of UPCR/eGFR as applicable.
- C3G: kidney biopsy demonstrating characteristic C3G findings, duration of glomerulonephritis ≥ 3 months, and complement testing (e.g., serum C3).
- Include documentation excluding MGUS for C3G (serum free light chains or other tests) when applicable.
Provide kidney biopsy and ≥3‑month duration evidence for C3G
Provide kidney biopsy report showing characteristic C3G findings and documentation that glomerulonephritis has persisted ≥ 3 months; include complement testing and exclusion of MGUS as required.
- Include kidney biopsy demonstrating characteristic findings of C3G.
- Document glomerulonephritis duration ≥ 3 months and one or more complement abnormalities (e.g., serum C3 < 77 mg/dL or other complement markers).
- Provide serum free light chain testing or other means to exclude MGUS when indicated.
Denial risk if required diagnostic or therapy documentation is missing
Missing or incomplete required documentation may result in denial. Examples include absence of flow cytometry confirming PNH clones, missing renal biopsy confirming primary IgAN, not meeting UPCR/eGFR thresholds, or lack of documentation of supportive therapies or steroid trial.
- PNH denials: no flow cytometry confirming PNH clones or lacking lab/signs/symptoms attributable to PNH.
- IgAN denials: no renal biopsy confirming primary IgAN, missing UPCR ≥1.5 g/g or eGFR ≥30 documentation, or missing documentation of ACEi/ARB or SGLT2 stabilization or steroid trial.
Denial risk for C3G when diagnostic or exclusion data are missing
For C3G, lack of required diagnostic documentation may trigger denial. Missing kidney biopsy showing C3G, glomerulonephritis duration < 3 months, absent complement abnormalities (e.g., low C3) or failure to exclude MGUS are specific denial risks.
- Denials may occur if kidney biopsy does not demonstrate C3G or if GN duration is under 3 months.
- Absence of complement testing showing low C3 or other abnormalities, or no documentation excluding MGUS, increases risk of denial.
- Requests from prescribers not by or in consultation with a nephrologist may be denied; prior solid‑organ or cell transplant is an exclusion.
Clinical Thresholds & Key Clinical Values
Required Prior Treatments / Step Edges
| Requirement | Details |
|---|---|
| Prior stabilization on RAAS inhibitor | |
| Patient is on a stabilized dose and receiving concomitant therapy with a maximally tolerated angiotensin‑converting enzyme (ACE) inhibitor or a maximally tolerated angiotensin II receptor blocker (ARB) unless the patient has an allergy, contraindication, or intolerance |
| Requirement | Details |
|---|---|
| Prior glucocorticoid trial | |
| History of failure, contraindication, or intolerance to a glucocorticoid (e.g., methylprednisolone, prednisone) prior to approval |
Definitions & Disease Concepts
Background
Fabhalta (iptacopan) is a complement factor B inhibitor indicated for adults with paroxysmal nocturnal hemoglobinuria (PNH), for reducing proteinuria in adults with primary IgA nephropathy at risk of rapid progression, and for treatment of complement 3 glomerulopathy (C3G). Prior authorization is required and approvals are contingent on documented diagnostic confirmation and specialty prescribing. For PNH, authorization requires flow cytometry confirmation of PNH clones and that Fabhalta is not used concomitantly with another PNH complement inhibitor unless that agent will be discontinued and Fabhalta started per FDA labeling; prescribing must be by or in consultation with a hematologist/oncologist.
Revision History
Annual review conducted; no changes to clinical coverage criteria but budesonide was added to examples of glucocorticoids.
New indication and coverage criteria for complement 3 glomerulopathy (C3G) were added to the policy.
Background updated and coverage criteria for primary immunoglobulin A nephropathy (IgAN) were added; list of examples for combination use requirement for PNH updated and references refreshed.
Criteria language simplified for converting to new complement inhibitor therapy.
Program created (prior authorization/medical necessity for Fabhalta); initial change control and new program established.
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