Filspari – NC Standard

Restricted Product(s)

• Filspari (sparsentan)

FDA Approved Use

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

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) (medical record documentation required); AND 
3. The patient’s urine protein-to-creatinine ratio (UPCR) is ≥ 0.8 g/g and eGFR is ≥ 30 mL/min/1.73 m2 (medical record documentation required); AND 
4. The patient has been receiving at least 3 months of optimized supportive care (e.g., treatment of dyslipidemia, dietary sodium and protein restriction, smoking cessation, weight control); AND 
5. The patient has been receiving a stable dose of a renin-angiotensin system (RAS) inhibitor (e.g., ACE inhibitor or ARB) at a maximally tolerated dose for at least 3 months; AND 
6. The patient will discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitor, endothelin receptor antagonists (ERAs), and aliskiren prior to initiating treatment with Filspari; AND 
7. The medication is prescribed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., nephrologist); AND 
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

February 2025: Criteria change: Updated FDA approved use section due to label update and changed UPCR requirement from 1.5 g/g to 0.8 g/g. Added P&T statement.          

March 2023: Original utilization management policy issued.