Tarpeyo™
Drug - Tarpeyo™ (budesonide delayed release capsules) [Calliditas Therapeutics AB]
October 2022
Therapeutic area - Glucocorticoids, oral
Approval criteria
- Patient is at least 18 years of age AND
- Patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN), confirmed by biopsy AND
- IgAN is not due to IgA vasculitis or IgAN due to viral causes, inflammatory bowel disease, autoimmune disease, cirrhosis, or IgA-dominant postinfectious glomerulonephritis AND
- Patient is on a stable and maximally tolerated dose of a reninangiotensin system (RAS) inhibitor (angiotensin converting enzyme [ACE] inhibitor or angiotensin receptor blocker [ARB]), unless contraindicated, and has been for ≥ 3 months AND
- Patient continues to have proteinuria ≥ 1 g/24 hour AND
- Prescriber attestation and documentation that patient is at risk of rapid disease progression AND
- Patient has an estimated glomerular filtration filter (eGFR) ≥ 35 mL/min/1.73 m2 AND
- Patient does not have severe hepatic impairment (Child-Pugh class C) AND
- Prescriber attestation that a benefits and harms discussion has occurred with the patient AND
- Prescriber attestation that risks due to immunosuppression will be monitored and appropriate prophylaxis will be initiated
- Approval is for the equivalent of 9.5 months in days and is not renewable
Quantity limits
Background
Tarpeyo is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
Questions?
MHCP Provider Resource Center 651-431-2700 or 800-366-5411
