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) as confirmed by a kidney biopsy [A]
AND
• Patient is at risk for disease progression
AND
• Used to reduce the loss of kidney function
AND
• Estimated glomerular filtration rate (eGFR) greater than or equal to 35 mL/min/1.73 m2
AND
• ONE of the following:
• 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: [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
• Trial and failure, contraindication, or intolerance to another glucocorticoid (e.g., methylprednisolone, prednisone)
AND
• Prescribed by or in consultation with a nephrologist

Tarpeyo

Non Formulary

Length of Approval: 9 Month(s)

• Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy [A]
AND
• Patient is at risk for disease progression
AND
• Used to reduce the loss of kidney function
AND
• Submission of medical records (e.g., chart notes) confirming estimated glomerular filtration rate (eGFR) greater than or equal to 35 mL/min/1.73 m2
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• 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: [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
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to another glucocorticoid (e.g., methylprednisolone, prednisone)
AND
• Prescribed by or in consultation with a nephrologist

P & T Revisions

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. December 2023.
2. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.

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End Notes

1. IgAN can only be diagnosed with a kidney biopsy. [2]

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Revision History

• 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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