sparsentan — Blue Cross Blue Shield of Montana
other FDA labeled or compendia-supported indications as described
Initial criteria
- Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy AND
- Requested agent used to slow kidney function decline in a patient at risk for disease progression AND
- ONE of the following: (A) urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g OR (B) proteinuria ≥ 0.5 g/day AND
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2 AND
- If the patient has an FDA labeled indication, ONE of: (A) patient’s age is within FDA labeling OR (B) support for use at that age exists AND
- ONE of the following: (A) Tried and had inadequate response after ≥ 3-month therapy with maximally tolerated angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), or combination containing ACEi or ARB OR (B) Intolerance or hypersensitivity to an ACEi or ARB or combination containing same OR (C) FDA labeled contraindication to ALL ACEi or ARB AND
- Patient will NOT use requested agent in combination with an ACEi, ARB, endothelin receptor antagonist (ERA, e.g., bosentan), or aliskiren AND
- Prescriber is a specialist (e.g., nephrologist) or has consulted with a specialist AND
- Patient has no FDA labeled contraindications to requested agent
Reauthorization criteria
- Patient previously approved for the requested agent through plan’s PA process AND
- Patient has had clinical benefit with requested agent AND
- Patient will NOT use in combination with ACEi, ARB, endothelin receptor antagonist (ERA, e.g., bosentan), or aliskiren AND
- Prescriber is a specialist (e.g., nephrologist) or has consulted with a specialist AND
- Patient has no FDA labeled contraindications to requested agent
Approval duration
12 months