Filspari® (Sparsentan) Approval Criteria:
- An FDA approved indication to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression; and
- The diagnosis of primary IgAN must be confirmed by the following:
- Kidney biopsy; and
- Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
- Member must be 18 years of age or older; and
- Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
- Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent), despite 3 months of maximal supportive care; and
- Member must be on a stable dose of a maximally tolerated angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months, unless contraindicated or intolerant; and
- Prescriber must verify the member will discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) prior to initiating treatment with Filspari®; and
- Member must not be taking strong CYP3A4 inhibitors (e.g., itraconazole) or strong CYP3A4 inducers (e.g., rifampin) concomitantly with Filspari®; and
- Member must not be taking H2 receptor blockers or proton pump inhibitors (PPIs) concomitantly with Filspari®; and
- If member is using antacids, they must agree to separate antacid and Filspari® administration by 2 hours; and
- Prescriber, pharmacy, and member must be enrolled in the Filspari® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- A quantity limit of 30 tablets per 30 days will apply.
Tarpeyo® [Budesonide Delayed Release (DR) Capsule] Approval Criteria:
- An FDA approved indication to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression; and
- The diagnosis of primary IgAN must be confirmed by the following:
- Kidney biopsy; and
- Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
- Member must be 18 years of age or older; and
- Must be prescribed by a nephrologist (or advanced care practitioner with a supervising physician who is a nephrologist); and
- Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent); and
- Member must be on a stable dose of a maximally-tolerated angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB), unless contraindicated or intolerant; and
- Approval duration will be for 9 months. The safety and efficacy of Tarpeyo® have not been established beyond 9 months of treatment. For continued authorization consideration after 9 months of treatment, a patient-specific, clinically significant reason why a longer treatment duration is medically necessary for the member must be provided; and
- A quantity limit of 120 capsules per 30 days will apply.
Vanrafia™ (Atrasentan) Approval Criteria:
- An FDA approved indication to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression; and
- The diagnosis of primary IgAN must be confirmed by the following:
- Kidney biopsy; and
- Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
- Member must be 18 years of age or older; and
- Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
- Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day (or equivalent), despite 3 months of maximal supportive care; and
- Member must be on a stable dose of a maximally tolerated angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months, unless contraindicated or intolerant; and
- Females of reproductive potential must have a negative pregnancy test prior to initiation of therapy and must agree to use effective contraception during treatment and for 2 weeks after the last dose of Vanrafia™; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.