Pharmacy Prior Authorization Criteria

Fabhalta (iptacopan)

Indications for Prior Authorization

Fabhalta (iptacopan)

• For diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH)
  Indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

• For diagnosis of Immunoglobulin A nephropathy (IgAN)
  Indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.

• For diagnosis of Complement 3 Glomerulopathy
  Indicated for the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria.

Criteria

Fabhalta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Paroxysmal nocturnal hemoglobinuria (PNH)

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
AND
• Hemoglobin level of less than 10 g/dL
AND
• Prescribed by or in consultation with a hematologist/oncologist

Fabhalta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)

• Patient demonstrates positive clinical response to therapy (e.g., hemoglobin stabilization, decrease in the number of red blood cell transfusions)

Fabhalta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Immunoglobulin A nephropathy (IgAN)

• Diagnosis of primary immunoglobulin A nephropathy (IgAN)
AND
• Patient is at risk for disease progression (e.g., proteinuria of at least 0.5 g/day, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool) [A]
AND
• Used to slow kidney function decline
AND
• One of the following:
• Patient has been on a minimum 90-day trial of a maximally tolerated dose and will continue to receive therapy with one of one of the following:
• An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
• An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
OR
• Patient has a contraindication or intolerance to both ACE inhibitors and ARBs
AND
• Prescribed by or in consultation with a nephrologist

Fabhalta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Immunoglobulin A nephropathy (IgAN)

• Patient demonstrates a positive clinical response to therapy as demonstrated by a decrease in urine protein-to-creatinine ratio (UPCR) from baseline

Fabhalta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Complement 3 Glomerulopathy

• Diagnosis of kidney complement 3 glomerulopathy (C3G)
AND
• Used to reduce proteinuria
AND
• Patient is on a maximally tolerated renin-angiotensin system (RAS) inhibitor (e.g., benazepril, lisinopril, losartan, valsartan)
AND
• Patient has not had a kidney transplant [B]
AND
• Prescribed by or in consultation with a nephrologist

Fabhalta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Complement 3 Glomerulopathy

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

P & T Revisions

2026-07-28, 2026-02-02, 2025-12-18, 2025-04-29, 2025-01-10, 2024-09-20, 2024-04-23, 2024-01-30

References

1. Fabhalta Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey. March 2025.
2. Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A

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End Notes

1. The International IgAN Prediction Tool incorporates clinical information at the time of biopsy and is a valuable resource to quantify risk of progression and inform shared decision-making with patients [2]
2. Safety and effectiveness of FABHALTA in patients with recurrent C3G following kidney transplant have not been established. [1]

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Revision History

• 2026-07-28: Updated criteria for IgAN - Fabhalta granted traditional (full) approval to slow kidney function decline in adults with primary IgAN at risk of disease progression
• 2026-02-02: 2026 UM Annual Review: For IgAN criteria: remove requirement for kidney biopsy and eGFR greater than 20 mL/min/1.73m2. Update “e.g., generally a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g“ to “e.g., proteinuria of at least 0.5 g/day" due to updated KDIGO guidelines. For t/f requirement for ACE/ARB, add in that patient will continue to receive therapy with an ACE or ARB unless they have a contraindication or intolerance to ACE and ARBs.
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-04-29: New indication of complement 3 glomerulopathy (C3G)
• 2025-01-10: 2025 UM Annual Review. No changes
• 2024-09-20: New indication for primary immunoglobulin A nephropathy
• 2024-04-23: Removal of embedded step through Soliris, Ultomiris or Empaveli
• 2024-01-30: New Program for Fabhalta

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