Pharmacy Prior Authorization Criteria

Filspari (sparsentan)

Indications for Prior Authorization

Filspari (sparsentan)

• For diagnosis of Primary immunoglobulin A nephropathy (IgAN)
  Indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Criteria

Filspari

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of primary immunoglobulin A nephropathy (IgAN) as confirmed by a kidney biopsy [A]
AND
• Patient is at risk of rapid disease progression [e.g., proteinuria greater than 0.75 - 1 g/day, or by other criteria such as clinical risk scoring using the International IgAN Prediction Tool] [B,C]
AND
• Used to slow kidney function decline
AND
• Patient has an estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m2
AND
• Patient has been on a minimum 90-day trial of a maximally tolerated dose of one of the following:
• An angiotensin-converting enzyme (ACE) inhibitor (e.g., benazepril, lisinopril)
• An angiotensin II receptor blocker (ARB) (e.g., losartan, valsartan)
AND
• Medication will not be used in combination with any of the following:
• Angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitor (ARNI) [e.g., Entresto (sacubitril/valsartan)]
• Endothelin receptor antagonists (ERAs) [e.g., Letairis (ambrisentan), Tracleer (bosentan), Opsumit (macitentan)]
• Tekturna (aliskiren)
AND
• Prescribed by or in consultation with a nephrologist

Filspari

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates a positive clinical response to therapy as demonstrated by a decrease in urine protein-to-creatinine ratio (UPCR) from baseline
AND
• Medication is not taken in combination with any of the following:
• Angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitor (ARNI) [e.g., Entresto (sacubitril/valsartan)]
• Endothelin receptor antagonists (ERAs) [e.g., Letairis (ambrisentan), Tracleer (bosentan), Opsumit (macitentan)]
• Tekturna (aliskiren)

P & T Revisions

2024-09-26, 2024-03-21, 2023-08-22, 2023-06-22, 2023-05-23, 2023-04-25, 2023-04-03

References

1. Filspari Package Insert. Travere Therapeutics, Inc. San Diego, CA. August 2024.
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]
2. 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]
3. High risk of progression in IgAN is currently defined as proteinuria >0.75–1 g/d despite ‡90 days of optimized supportive care [2]

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Revision History

• 2024-09-26: Updates to criteria based on full FDA approval and updated indication
• 2024-03-21: 2024 annual review: Added Entresto as an example for angiotensin receptor-neprilysin inhibitor (ARNI). Background and formatting updates.
• 2023-08-22: P&T dates clean up
• 2023-06-22: Update to include medication should not be used in combination with ARNi
• 2023-05-23: Addition of brand and generic drug names of examples provided
• 2023-04-25: Added generic name of Filspari to indication section
• 2023-04-03: New program for Filspari

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