TARPEYO (budesonide capsule, delayed release)

TARPEYO (budesonide capsule, delayed release)

Self-Administration - oral

Diagnosis considered for coverage: 

• 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.

Coverage Criteria:

For diagnosis of primary immunoglobulin A nephropathy (IgAN):

• Dose does not exceed 16 mg once daily (recommended duration of therapy is 9 months), AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a nephrologist, AND
• Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy, AND
• Patient is at risk of rapid disease progression [as shown by a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/g], AND
• Estimated glomerular filtration rate (eGFR) greater than or equal to 35 mL/min/1.73 m², AND
• One of the following (a OR b):
  • a) Patient has been on a minimum 90-day trial of a maximally tolerated dose and will continue to receive therapy with one of the following (i OR ii):
    • i) An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
    • ii) An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan) 
  • b) Patient has a contraindication or intolerance to both ACE inhibitors and ARBs, AND
• Trial and failure, contraindication, or intolerance to TWO alternative systemic glucocorticoids (e.g., methylprednisolone, prednisone)

Coverage Duration: 

• 9 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosing: The recommended duration of therapy is 9 months, with a dosage of 16 mg administered orally once daily. When discontinuing therapy, reduce the dosage to 8 mg once daily for the last 2 weeks of therapy.
• Safety and efficacy of treatment with subsequent courses of Tarpeyo have not been established.
• The International IgAN Prediction Tool may be accessed here: https://qxmd.com/calculate/calculator_499/international-igan-prediction-tool-at-biopsy-adults

Policy Updates:

• 5/17/2022 – New policy approved by P&T.

References:

• Tarpeyo Prescribing Information. Calliditas Therapeutics AB. Stockholm, Sweden. December 2021. 
• Kidney Disease Improving Global Outcomes. KDIGO 2021 clinical practice guideline for the management of glomerular diseases. 2021. https://kdigo.org/guidelines/gd/. Accessed February 1, 2022.