Coverage is subject to the specific terms of the member’s benefit plan.
The use of lumasiran (Oxlumo) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is, or in consult with, a nephrologist, urologist, geneticist or other healthcare provider experience in treating primary hyperoxaluria type 1 (PH1); and
- The individual must have a diagnosis of polyneuropathy of primary hyperoxaluria type 1 (PH1) confirmed by one of the following (as evidenced with submitted documentation):
- Mutation in the alanine:glyoxylate aminotransferase (AGXT) gene confirmed by genetic testing; or
- Liver enzyme analysis confirming absent or significant deficiency in alanine:glyoxylate aminotransferase (AGT) activity; and
- Individual does not have secondary causes of hyperoxaluria (e.g., diet with excessive intake of oxalate, gastric bypass surgery, IBD, other intestinal disorders, etc.); and
- The individual has had at least a 90-day trial of pyridoxine (vitamin B6) of maximally tolerated doses (maximum dose, 20 mg/kg per day) that failed to achieve at least a 30% reduction in urinary oxalate excretion; and
- Patient has not received a liver transplant; and
- The provider must submit documentation of one of the following:
- Elevated urinary oxalate excretion (i.e., > 1 mmol/1.73 m2 per day [90 mg/1.73 m2 per day]); or
- Elevated urinary oxalate:creatinine ratio as defined by age defined laboratory reference range; or
- Elevated urinary excretion of glycolate (i.e., > 0.5 mmol/1.73 m2 per day [45 mg/1.73 m2 per day]).
Initial Authorization: 6 months
Continuation of therapy with lumasiran (Oxlumo) may be considered medically necessary when ALL of the following are met:
- The individual must have experienced meaningful clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g. chart notes) attached to the request (subject to clinical review) including one of the following scores and symptoms:
- Reduced signs and symptoms of PH1 (e.g., nephrocalcinosis, formation of renal stones, renal impairment); or
- Decreased or normalized urinary oxalate excretion; or
- Decreased or normalized urinary oxalate:creatinine ratio relative to normative values for age; or
- Decreased or normalized plasma oxalate and glyoxylate concentrations.
Continuation Authorization: 12 months
Lumasiran (Oxlumo) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indication.