Rivfloza– NC Standard

Restricted Product(s)

• Rivfloza® (nedosiran)

FDA Approved Use

• For treatment of children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of primary hyperoxaluria type 1 (PH1) [medical record documentation required]; AND 
2. The diagnosis has been confirmed by at least one of the following [medical record documentation required]:
   1. Molecular genetic testing demonstrating AGXT gene mutation; OR
   2. Liver biopsy demonstrating alanine-glyoxylate aminotransferase (AGT) deficiency; AND 
3. The requested agent will be used to lower urinary oxalate levels [medical record documentation required]; AND 
4. The patient has an eGFR greater than or equal to 30 mL/minute/1.73 m2 [medical record documentation required]; AND 
5. The patient has NOT had a previous liver transplant [medical record documentation required]; AND 
6. The patient will NOT be using the requested agent in combination with Oxlumo; AND 
7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist, gastroenterologist, urologist, geneticist) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND 
8. If request is for Rivfloza single dose vial, patient must meet the following [medical record documentation required]:
   1. The patient must be between 9 to 11 years of age; AND 
   2. The patient’s body weight must be less than 50 kg; AND 
   3. Medication will be given by a caregiver who has received administration education from the healthcare provider; AND 
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 180 days (6 months)

Continuation Criteria

1. The patient has been previously approved for Rivfloza with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy [medical record documentation required]; AND 
2. The patient has demonstrated a positive clinical response while using the medication, as demonstrated by improvement, stabilization, or slowed worsening of disease [e.g., reduction from baseline in laboratory parameters (e.g., 24-hour urinary oxalate excretion, spot urinary oxalate: creatinine ratio, plasma oxalate concentration), improvement/stabilization/slowed worsening of clinical manifestations (e.g., eGFR, nephrocalcinosis, renal stone events, systemic oxalosis, renal impairment)] [medical record documentation required]; AND
3. The patient has an eGFR greater than or equal to 30 mL/minute/1.73 m2 [medical record documentation required]; AND 
4. The patient will NOT be using the requested agent in combination with Oxlumo; AND 
5. The patient has NOT had a previous liver transplant [medical record documentation required]; AND 
6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist, gastroenterologist, urologist, geneticist) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND 
7. If request is for Rivfloza single dose vial, patient must meet the following [medical record documentation required]:
   1. The patient must be between 9 to 11 years of age; AND 
   2. The patient’s body weight must be less than 50 kg; AND 
   3. Medication will be given by a caregiver who has received administration education from the healthcare provider.

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 Q2 annually.

May 2024: Criteria update: Removed requirement that patient has NOT had kidney transplant.
February 2024: Original utilization management policy issued.