Rivfloza (nedosiran subcutaneous) — Medical Mutual

Primary Hyperoxaluria Type 1 (PH1)

Initial criteria

Patient is at least 2 years of age; AND
Patient has not had a liver transplant; AND
Must be prescribed by, or in consultation with, a specialist in genetics, nephrology or urology; AND
Patient does not have severe renal impairment defined as an eGFR <30 mL/min/1.73 m2; AND
Will not be used in combination with other urinary oxalate reducing agents (i.e., lumasiran, etc.); AND
Patient has a definitive diagnosis of primary hyperoxaluria type 1 as evidenced by one of the following: Patient has a biallelic pathogenic mutation in the AGXT gene as identified on molecular genetic testing OR Identification of AGT enzyme deficiency on liver biopsy; AND
Patient has a baseline for one or more of the following: Urinary oxalate excretion level (corrected for BSA) OR Spot urinary oxalate: creatinine ratio OR Estimated glomerular filtration rate (eGFR) OR Plasma oxalate level

Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe injection site reactions, etc.; AND
Disease response as evidenced by at least one of the following: Decrease in urinary oxalate excretion level (corrected for BSA) from baseline OR Reduction in spot urinary oxalate: creatinine ratio from baseline OR Stabilization of eGFR OR Decrease in plasma oxalate level from baseline

initial 6 months, renewal 12 months