Oxlumo (lumasiran) — Medical Mutual

Primary Hyperoxaluria Type 1 (PH1)

Initial criteria

Patient has not had a liver transplant; AND
Must be prescribed by, or in consultation with, a specialist in genetics, nephrology or urology; AND
Will not be used in combination with other urinary oxalate reducing agents (i.e., nedosiran, etc.); AND
Patient has a definitive diagnosis of primary hyperoxaluria type 1 as evidenced by one of the following: o Patient has a biallelic pathogenic mutation in the alanine: glyoxylate aminotransferase (AGXT) gene as identified on molecular genetic testing; OR o Identification of alanine: glyoxylate aminotransferase (AGT) enzyme deficiency on liver biopsy; AND
Patient has a baseline for one or more of the following: o Urinary oxalate excretion level (corrected for BSA) o Spot urinary oxalate: creatinine ratio o Estimated glomerular filtration rate (eGFR) o 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: o Decrease in urinary oxalate excretion level (corrected for BSA) from baseline o Reduction in spot urinary oxalate: creatinine ratio from baseline o Stabilization of estimated glomerular filtration rate (eGFR) o Decrease in plasma oxalate level from baseline

initial 6 months, renewal 12 months