Tarpeyo (budesonide delayed-release capsules) — Cigna
Primary immunoglobulin A nephropathy (IgAN)
Initial criteria
- Patient is age ≥ 18 years; AND
- Diagnosis has been confirmed by biopsy; AND
- Patient is at high risk of disease progression, defined by meeting BOTH of the following (a and b):
- a) Patient meets ONE of the following [(1) or (2)]: (1) Proteinuria ≥ 0.5 g/day; OR (2) Urine protein-to-creatinine ratio ≥ 0.8 g/g; AND
- b) Patient has been receiving the maximum or maximally tolerated dose of ONE of the following for ≥ 90 days: (1) Angiotensin converting enzyme inhibitor; OR (2) Angiotensin receptor blocker; AND
- According to the prescriber, patient has received ≥ 90 days of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification; AND
- Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND
- Patient has not previously been treated with Tarpeyo; AND
- Medication is prescribed by or on consultation with a nephrologist.
Reauthorization criteria
- Patient is age ≥ 18 years; AND
- Diagnosis has been confirmed by biopsy; AND
- Patient has been receiving the maximum or maximally tolerated dose of ONE of the following for ≥ 90 days: (a) Angiotensin converting enzyme inhibitor; OR (b) Angiotensin receptor blocker; AND
- According to the prescriber, patient has received ≥ 90 days of optimized supportive care, including blood pressure management, lifestyle modification, and cardiovascular risk modification; AND
- Patient has an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AND
- Medication is prescribed by or on consultation with a nephrologist.
- Approval not to exceed total 10 consecutive months of therapy (subtracting previously received months).
Approval duration
10 months