Tarpeyo (budesonide delayed-release capsules) — Medica

Initial criteria

• age ≥ 18 years
• diagnosis confirmed by biopsy
• patient is at high risk of disease progression defined by meeting BOTH of the following: (a) proteinuria ≥ 0.5 g/day OR urine protein-to-creatinine ratio ≥ 0.8 g/g; AND (b) has been receiving the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor OR angiotensin receptor blocker for ≥ 90 days
• prescriber confirms patient has received ≥ 90 days of optimized supportive care including blood pressure management, lifestyle modification, and cardiovascular risk modification
• estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
• patient has not previously been treated with Tarpeyo
• prescribed by or in consultation with a nephrologist

Reauthorization criteria

• patient is currently receiving Tarpeyo
• age ≥ 18 years
• diagnosis confirmed by biopsy
• has been receiving the maximum or maximally tolerated dose of an angiotensin converting enzyme inhibitor OR angiotensin receptor blocker for ≥ 90 days
• prescriber confirms patient has received ≥ 90 days of optimized supportive care including blood pressure management, lifestyle modification, and cardiovascular risk modification
• estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
• prescribed by or in consultation with a nephrologist
• approval not to exceed 10 consecutive months in total

Approval duration

10 months