Tarpeyo – NC Standard

Restricted Product(s)

• Tarpeyo (budesonide DR)

FDA Approved Use

• Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g

Criteria for Approval of Restricted Product(s)

Initial Coverage Criteria

1. The patient has a diagnosis of primary immunoglobulin A nephropathy (IgAN) (medical record documentation required); AND 
2. The patient’s urine protein-to-creatinine ratio (UPCR) is ≥ 1.5 g/g and eGFR is ≥ 35 mL/min/1.73 m2 (medical record documentation required); AND 
3. 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 
4. The patient has been receiving a stable dose of a renin-angiotensin system (RAS) inhibitor therapy (e.g., ACE inhibitor or ARB) at a maximally tolerated dose; AND 
5. The patient has tried and failed or has a clinical intolerance/contraindication to an oral glucocorticoid (e.g., prednisone or methylprednisolone) (medical record documentation required); AND 
6. The patient has tried and failed generic oral budesonide (medical record documentation required); OR
   1. The patient has a clinical contraindication to the inactive ingredients of generic oral budesonide (medical documentation required); AND 
7. The medication is prescribed by or in consultation with a specialist in the area of the patient’s diagnosis (i.e., nephrologist); AND 
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 270 days (9 months)

Continuation Coverage Criteria

1. The patient was previously approved through BlueCross NC criteria or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has shown improvement through a reduction in proteinuria (UPCR) (medical record documentation required); AND 
3. The patient’s eGFR remains ≥ 35 mL/min/1.73 m2 (medical record documentation required); AND
4. The patient remains on a stable dose of maximally tolerated RAS inhibitor therapy.
   
   Duration of Approval: 365 days (12 months)

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: Initial coverage: 270 days, Continuation coverage: 365 days

References

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

Policy Implementation/Update Information

July 2023: Criteria change: Updated t/f to a glucocorticoid (e.g., prednisone or methylprednisolone) and added requirement for t/f generic oral budesonide.
March 2023: Criteria update: Separated lab results which required medical records from supportive care. Clarified with examples for supportive care.
January 2022: Original utilization management policy issued.