Fabhalta (iptacopan) — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following: (A) Diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages demonstrating GPI-linked protein deficiency OR (B) Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND ALL of: (1) UPCR ≥ 1.5 g/g, (2) eGFR ≥ 30 mL/min/1.73 m^2, (3) ONE of: (A) Inadequate response after ≥3 months of maximally tolerated ACEI or ARB therapy OR (B) Intolerance/hypersensitivity to ACEI/ARB OR (C) FDA labeled contraindication to ALL ACEI/ARBs, (4) ONE of: (A) Inadequate response after a 6-month course of glucocorticoid therapy OR (B) Intolerance/hypersensitivity to glucocorticoid OR (C) FDA labeled contraindication to ALL glucocorticoid therapies OR (D) Glucocorticoid therapy not appropriate, (5) Will continue standard IgAN therapy (e.g., ACEI, ARB, SGLT2, aliskiren) OR (C) Other FDA labeled indication and route of administration
• If FDA labeled indication: ONE of following: (A) Patient's age within FDA labeling OR (B) Support for use for age for requested indication
• Prescriber is a specialist in hematology/nephrology or has consulted with one
• Not used in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz)
• No FDA labeled contraindications to requested agent
• Special case: For members residing in Ohio and plan is Fully Insured or HIM Shop (SG): No contraindications AND ONE of: (1) FDA labeled indication OR (2) Compendia-supported indication OR (3) Two peer-reviewed medical journal articles supporting safe/effective use; acceptable compendia: DrugDex level 1, 2A, 2B, AHFS-DI supportive; oncology compendia: NCCN 1, 2A, AHFS-DI supportive, DrugDex level 1, 2A, 2B, Clinical Pharmacology supportive, LexiDrugs evidence A, peer-reviewed literature

Reauthorization criteria

• Previously approved for requested agent through plan's PA process
• ONE of: (A) IgAN with improvement or stabilization as indicated by decrease from baseline in UPCR or proteinuria AND continuing standard IgAN therapy OR (B) PNH with improvement or stabilization (e.g., decreased RBC transfusions, improved hemoglobin, reduced LDH, or improved symptoms) OR (C) Other diagnosis with demonstrated clinical benefit
• Prescriber is specialist or has consulted with specialist
• Not used in combination with Empaveli, Soliris, Ultomiris, or Piasky
• No FDA labeled contraindications

Approval duration

Initial 6–12 months depending on plan and indication; Renewal 12 months