Fabhalta (iptacopan) — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. Diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) as confirmed by flow cytometry with at least 2 independent reagents on at least 2 cell lineages demonstrating deficiency of GPI-linked proteins (lab tests required) OR
• B. Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND ALL of the following:
• 1. Urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g AND
• 2. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 AND
• 3. ONE of the following:
• A. Tried and had inadequate response after ≥ 3 months of maximally tolerated ACE inhibitor (ACEI) or angiotensin II receptor blocker (ARB), or combination medication containing an ACEI or ARB OR
• B. Has intolerance or hypersensitivity to an ACEI or ARB OR
• C. Has an FDA labeled contraindication to ALL ACEI or ARB agents AND
• 4. ONE of the following:
• A. Tried and had inadequate response after a 6‑month course of glucocorticoid therapy (e.g., methylprednisolone, prednisolone, prednisone) OR
• B. Has intolerance or hypersensitivity to glucocorticoid therapy OR
• C. Has an FDA labeled contraindication to ALL glucocorticoid therapies OR
• D. There is support that glucocorticoid therapy is NOT appropriate AND
• 5. Will continue on standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2 inhibitor, aliskiren) OR
• C. Has another FDA labeled indication for the requested agent and route of administration AND
• If the patient has an FDA labeled indication, then ONE of the following:
• A. Patient’s age is within FDA labeling for the requested indication OR
• B. There is support for using the requested agent for the patient’s age for the requested indication AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, nephrologist) or has consulted with a specialist AND
• The patient will NOT use Fabhalta in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz) AND
• The patient does NOT have any FDA labeled contraindications to Fabhalta.
• For Ohio members in Fully Insured or HIM Shop plans, approval also allowed when BOTH:
• A. The patient has no FDA labeled contraindications AND
• B. ONE of the following:
• 1. Has another FDA labeled indication for Fabhalta OR
• 2. Has another indication supported in compendia OR
• 3. Prescriber submitted two peer‑reviewed professional medical journal articles supporting use as generally safe and effective.

Reauthorization criteria

• Patient was previously approved for the requested agent through the plan’s Prior Authorization process AND
• ONE of the following:
• A. Diagnosis of IgAN AND BOTH:
• 1. Demonstrated improvement or stabilization with Fabhalta by one of:
• – Decrease from baseline in UPCR ratio OR
• – Decrease from baseline in proteinuria AND
• 2. Will continue standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2 inhibitor, aliskiren) OR
• B. Diagnosis of PNH AND has had improvements or stabilization (e.g., decreased RBC transfusion requirement, stabilization/improvement of hemoglobin, reduction of LDH, stabilization of symptoms) (medical records required) OR
• C. Diagnosis other than IgAN or PNH AND has had clinical benefit with Fabhalta AND
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, nephrologist) or has consulted a specialist AND
• Fabhalta will NOT be used in combination with Empaveli, Soliris, Ultomiris, or Piasky AND
• The patient does NOT have any FDA labeled contraindications to Fabhalta.

Approval duration

6–12 months (initial 6 months for PNH, 9 months for IgAN, 12 months for other indications; renewal 12 months)