budesonide delayed release capsule 4 mg — Blue Cross Blue Shield of Montana
other FDA labeled or compendia-supported indications (for Ohio Fully Insured or HIM Shop members)
Initial criteria
- Diagnosis of primary immunoglobulin A nephropathy (IgAN) confirmed by kidney biopsy
- Used to reduce the loss of kidney function in a patient at risk for disease progression
- Urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g OR proteinuria ≥ 0.5 g/day
- eGFR ≥ 30 mL/min/1.73 m^2
- Age is within FDA labeling for the requested indication OR there is support for use at patient's age
- Tried and had inadequate response after ≥ 3 months with a maximally tolerated ACE inhibitor or ARB OR intolerance/hypersensitivity/contraindication to all ACEi or ARB
- Currently stable on requested agent OR tried and failed one oral generic glucocorticoid OR glucocorticoid discontinued due to lack of efficacy/adverse event/intolerance/hypersensitivity/contraindication OR glucocorticoid expected to be ineffective or not in best interest based on patient characteristics OR tried another drug in same class and discontinued due to lack of efficacy/adverse event [chart notes required]
- Not previously treated with Tarpeyo course (9 months) OR prior course completed with support for another course
- Prescriber is a specialist in nephrology or has consulted with one
- No FDA labeled contraindications to Tarpeyo
Approval duration
BCBSIL & BCBSMT: 12 months; Others: 10 months