Criteria
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 FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- Lumasiran (Oxlumo) must be prescribed by, or in consult with, a nephrologist, urologist, geneticist or other provider experience in treating primary hyperoxaluria type 1 (PH1); and
- Documentation of the member’s diagnosis must be submitted, as evidenced by the following:
- 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
- The individual has not received a liver transplant; and
- Documentation of the one (1) of the following must be submitted:
- Elevated urinary oxalate excretion (i.e., greater than 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., greater than 0.5 mmol/1.73 m2 per day [45 mg/1.73 m2 per day]).
Initial Authorization: Six (6) months
Reauthorization Criteria
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 lumasiran (Oxlumo), 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.
Lumasiran (Oxlumo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
