Pharmacy Prior Authorization Criteria

Tarpeyo (budesonide) - PA, NF

Indications for Prior Authorization

Tarpeyo (budesonide)

• For diagnosis of Primary Immunoglobulin A Nephropathy (IgAN)
  Indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Criteria

Tarpeyo

Prior Authorization

Length of Approval: 9 Month(s)

• Diagnosis of primary immunoglobulin A nephropathy (IgAN)
AND
• Patient is at risk for disease progression (e.g., proteinuria of at least 0.5 g/day, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool) [A]
AND
• Used to reduce the loss of kidney function
AND
• ONE of the following:
• Patient is receiving concomitant therapy with one of the following at a maximally tolerated dose: [2]
• An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
• An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
OR
• Patient has a contraindication or intolerance to both ACE inhibitors and ARBs
AND
• Prescribed by or in consultation with a nephrologist

Tarpeyo

Non Formulary

Length of Approval: 9 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of primary immunoglobulin A nephropathy (IgAN)
AND
• Patient is at risk for disease progression (e.g., proteinuria of at least 0.5 g/day, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool) [A]
AND
• Used to reduce the loss of kidney function
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Patient is receiving concomitant therapy with one of the following at a maximally tolerated dose: [2]
• An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
• An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
OR
• Patient has a contraindication or intolerance to both ACE inhibitors and ARBs
AND
• Prescribed by or in consultation with a nephrologist

P & T Revisions

2026-02-20, 2025-12-18, 2025-12-18, 2025-03-20, 2024-03-22, 2023-03-16, 2022-08-02, 2022-05-18, 2022-03-04

References

1. Tarpeyo Prescribing Information. Calliditas Therapeutics AB. Stockholm, Sweden. June 2024.
2. Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4S):S1–S71.

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End Notes

1. The International IgAN Prediction Tool incorporates clinical information at the time of biopsy and is a valuable resource to quantify risk of progression and inform shared decision-making with patients. [2]

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Revision History

• 2026-02-20: 2026 annual review: updated criteria and background.
• 2025-12-18: No criteria changes
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-03-20: 2025 annual review: no criteria changes. Background updates.
• 2024-03-22: 2024 annual review: updated criteria to align with expanded FDA-approved indication.
• 2023-03-16: Annual review: no criteria changes.
• 2022-08-02: Update Guideline
• 2022-05-18: Update Guideline
• 2022-03-04: New progam

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