RIVFLOZA (nedosiran)

Self-Administration – Subcutaneous injection

Diagnosis considered for coverage:
  • Primary Hyperoxaluria Type 1 (PH1): Indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR ≥ 30 mL/min/1.73 m2. 
     
Coverage Criteria:

For diagnosis of PH1:

  • Diagnosis of primary hyperoxaluria type1 (PH1), AND
  • Patient is 9 years of age or older AND
  • Patient has preserved kidney function (e.g., eGFR greater than or equal to 30mL/min/1.73m^2)
  • Patient has not received a liver transplant AND
  • Prescribed by or in consultation with one of the following:
    • Hepatologist
    • Nephrologist
    • Urologist
    • Geneticist
    • Specialists with expertise in the treatment of PH1 AND
  • Disease has been confirmed by BOTH of the following:
    • One of the following:
      • Elevated urinary oxalate excretion OR
      • Elevated plasma oxalate concentration OR 
      • Spot urinary oxalate to creatinine molar ratio greater than normal for age, AND
    • One of the following: 
      • Genetic testing demonstrating a mutation in the alanine: glyoxylate aminotransferase (AGXT) gene OR
      • Liver biopsy demonstrating absence or reduced alanine: glyoxylate aminotransferase (AGT) activity 
Reauthorization Criteria:

For diagnosis of PH1:

  • Patient demonstrates positive clinical response to therapy (e.g., decreased urinary oxalate excretion, decreased plasma oxalate concentration) AND
  • Patient has not received a liver transplant AND
  • Prescribed in consultation with one of the following: 
    • Hepatologist
    • Nephrologist
    • Urologist
    • Geneticist
    • Specialists with expertise in treatment of PH1
Coverage Duration: 
  • Initial: 12 months
  • Reauthorization: 12 months
Dosing: 

For diagnosis of PH1:

  

Age Body Weight Dosing Regimen                                        
Adults and adolescents 12 years and older Greater than or equal to 50 kg 160 mg once monthly (pre-filled syringe, 1 mL)                                        
  Less than 50 kg 128 mg once monthly (pre-filled syringe, 0.8 mL)                                        
Children 9 to 11 years Greater than or equal to 50 kg 160 mg once monthly (pre-filled syringe, 1 mL)                                        
  Less than 50 kg 3.3 mg/kg once monthly, not to exceed 128 mg (vial, dose volume rounded to nearest 0.1 mL)                                        

 

  • Missed dosed: If a planned dose is missed, administer dose as soon as possible. If the planned dose is missed by more than 7 days, administer as soon as possible and resume monthly dosing from the most recent administered dose
Authorization is not covered for the following:


The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Additional Information: 

 

  • The safety and effectiveness of RIVFLOZA in patients younger than 9 years of age have not been established.
  • Liver transplantation provides the definitive cure for PH type 1 by restoring the missing enzyme, which lowers oxalate production to the normal range.
  • A healthcare professional, caregiver, or patient 12 years of age and older may inject RIVFLOZA using the pre-filled syringe. In pediatric patients 9 to 11 years of age who weigh ≥50 kg, a healthcare professional or caregiver may inject RIVFLOZA using the pre-filled syringe.
  • For people 12 years and older, RIVFLOZA may be self-administered.
  • For children 9 to 11 years of age, RIVFLOZA may be administered by a caregiver (after training and guidance from a healthcare provider for the single-dose vial).
     
Policy Updates:
  • 9/1/2024 - New Policy for Rivfloza approved by WHA P&T Committee. (P&T, 8/20/2024) 
References:

 

  1. Rivfloza prescribing information. Pyramid Laboratories. Costa Mesa, CA. September 2023. 
  2. UptoDate: Primary hyperoxaluria. Available at https://www.uptodate.com/contents/primary-hyperoxaluria?search=primary%20hyperoxaluria&source=search_result&selectedTitle=1~26&usage_type=default&display_rank=1. Accessed February 12, 2024. 
  3. Rivfloza. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed May 29, 2024. http://www.micromedexsolutions.com.

 

Last review date: September 1, 2024

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