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 reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether Fabhalta slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

• 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) as confirmed by a kidney biopsy [A]
AND
• 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, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool] [B]
AND
• Used to reduce proteinuria
AND
• Patient has an estimated glomerular filtration rate (eGFR) of greater than or equal to 20 mL/min/1.73 m2
AND
• Patient has been on a minimum 90-day trial of a maximally tolerated dose 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)
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 [C]
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 [C]

P & T Revisions

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) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.

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End Notes

1. IgAN can only be diagnosed with a kidney biopsy [2]
2. 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]
3. Safety and effectiveness of FABHALTA in patients with recurrent C3G following kidney transplant have not been established. [1]

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Revision History

• 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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