RIVFLOZA (nedosiran)

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:

• 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.