Fabhalta (iptacopan hcl) — Blue Cross Blue Shield of Texas

Initial criteria

• 1. ONE of the following: A. Diagnosis of PNH confirmed by flow cytometry showing deficiency of GPI-linked proteins on ≥2 cell lineages OR B. Diagnosis of primary IgAN confirmed by kidney biopsy AND ALL of the following: 1. Urine protein-to-creatinine ratio ≥ 1.5 g/g 2. eGFR ≥ 30 mL/min/1.73 m² 3. ONE of the following: A. Tried and inadequate response after ≥3 months of maximally tolerated ACEI or ARB (or combination product) OR B. Intolerance or hypersensitivity to an ACEI or ARB OR C. FDA labeled contraindication to all ACEI or ARB agents 4. ONE of the following: A. Tried and inadequate response after ≥6 months of glucocorticoid therapy OR B. Intolerance or hypersensitivity to glucocorticoids OR C. FDA labeled contraindication to all glucocorticoids OR D. Support that glucocorticoid therapy is not appropriate 5. Will continue standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2, aliskiren) C. Patient has another FDA labeled indication for the requested agent and route of administration
• 2. If the patient has an FDA-labeled indication, then ONE of the following: A. Age within FDA labeling for the indication OR B. Support for use at patient's age for the indication
• 3. Prescriber is a specialist in the diagnosis area (e.g., hematologist, nephrologist) or has consulted with one
• 4. The agent will NOT be used in combination with Empaveli (pegcetacoplan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz)
• 5. Patient does NOT have any FDA labeled contraindications to the requested agent
• Additional coverage (Ohio fully insured/HIM Shop): - Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH: A. No labeled contraindications AND B. ONE of the following: 1. Has another FDA labeled indication for the requested agent and route OR 2. Has another indication supported in compendia (DrugDex level 1, 2A, 2B; AHFS-DI) OR, for oncology uses, NCCN 1 or 2A, AHFS-DI supportive text, DrugDex level 1, 2A, 2B, Clinical Pharmacology, or LexiDrugs evidence level A OR 3. Prescriber has submitted two major peer-reviewed journal articles (randomized, double-blind, placebo controlled acceptable; case studies not acceptable) supporting use as generally safe and effective

Reauthorization criteria

• 1. Patient previously approved for the requested agent through plan PA process
• 2. ONE of the following: A. Diagnosis of IgAN AND BOTH: 1. Improvement or stabilization as shown by decrease from baseline in UPCR ratio or proteinuria 2. Will continue standard of care IgAN therapy (e.g., ACEI, ARB, SGLT2, aliskiren) B. Diagnosis of PNH AND improvement or stabilization (decreased RBC transfusion requirement, improved/stable hemoglobin, reduced LDH, improved/stable symptoms) C. Other diagnosis AND clinical benefit demonstrated
• 3. Prescriber is specialist in area of diagnosis (e.g., hematologist, nephrologist) or has consulted with specialist
• 4. Agent not used with Empaveli (pegcetacoplan), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz), or Piasky (crovalimab-akkz)
• 5. No FDA labeled contraindications

Approval duration

Initial: 6–12 months (plan dependent); Renewal: 12 months