Nedosiran (Rivfloza™)

Restricted Product(s):

• nedosiran (Rivfloza™) subcutaneous 80mg single-dose vial for administration by a healthcare professional

FDA Approved Use:

For treatment of children 9 to 11 years of age weighing less than 50kg with primary hyperoxaluria type 1 (PH1)and relatively preserved kidney function (e.g., eGFR ≥ 30 mL/min/1.73 m2 ) to lower urinary oxalate levels

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is 9 to 11 years of age and weighs less than 50kg [medical record documentation required]; AND 
2. The patient has a diagnosis of primary hyperoxaluria type 1 (PH1) [medical record documentation required]; AND 
3. The diagnosis has been confirmed by at least one of the following [medical record documentation required]: a. Molecular genetic testing demonstrating AGXT gene mutation; OR b. Liver biopsy demonstrating alanine-glyoxylate aminotransferase (AGT) deficiency; AND 
4. The requested agent will be used to lower urinary oxalate levels [medical record documentation required]; AND 
5. The patient has an eGFR greater than or equal to 30 mL/minute/1.73 m2 [medical record documentation required]; AND 
6. The patient will NOT be using the requested agent in combination with Oxlumo; AND 
7. The patient has NOT had a previous kidney or liver transplant [medical record documentation required]; AND 
8. 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 
9. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
10. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below) *

Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval; OR 
2. The patient would have met initial criteria for approval at the time they started therapy; AND 
3. The patient is 9 to 11 years of age and weighs less than 50kg [medical record documentation required]; AND 
4. 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 
5. The patient has an eGFR greater than or equal to 30 mL/minute/1.73 m2 ; [medical record documentation required];AND 
6. The patient has NOT had a previous kidney or liver transplant [medical record documentation required]; AND 
7. The patient will NOT be using the requested agent in combination with Oxlumo; AND 
8. 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 
9. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND 
10. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below) *

Duration of Approval: 365 days (1 year)

*Site of Care Medical Necessity Criteria

1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR 
2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met: 
   1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR 
   2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR 
   3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR 
   4. Re-initiation of therapy, defined as ONE of the following: 
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR 
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR 
   5. Requirement of a change in the requested restricted product formulation; AND 
3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional. 

References:

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

Policy Implementation/Update Information

February 2024: Original medical policy criteria issued.