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Lumasiran for Primary Hyperoxaluria Type 1

Initial Treatment
Lumasiran may be considered medically necessary when ALL of the following are met:

Diagnosis of primary hyperoxaluria type 1 confirmed by identification of biallelic pathogenic variants in alanine:glyoxylate aminotransferase (AGT or AGXT) gene OR liver biopsy demonstrating AGT deficiency

Presence of 1 of the following clinical signs or symptom of primary hyperoxaluria type 1:

Elevated urine oxalate excretion (body surface area-normalized daily urine oxalate excretion output ≥ 0.7 mmol/1.73 m2 )

Elevated plasma oxalate concentration > 20 μmol/L or > 1.76 mg/L

Urine oxalate excretion:creatinine ratio above age-specific upper limit of normal

Individual has not received a liver or kidney transplant

The estimated glomerular filtration rate is > 30 mL/min/1.73m2

Prescribed by or in consultation with a nephrologist, urologist, geneticist, or any healthcare provider with expertise in treating primary hyperoxaluria type 1

Initial approval is for 6 months, limited to the United States Food and Drug Administration approved dosing.

Continuation of Treatment

Incremental reauthorization for lumasiran for 1 year may be considered medically necessary when ALL of the following are met:

Individual was previously approved for lumasiran based on criteria cited above

Documented evidence to support clinically meaningful response to therapy from pre-treatment baseline (e.g., decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, decreased plasma oxalate concentrations, improvement, stabilization or slowed worsening of nephrocalcinosis, renal stone events, renal impairment or systemic calcinosis)

Individual has not received a liver or kidney transplant

Prescribed by or in consultation with a nephrologist, urologist, geneticist, or any healthcare provider with expertise in treating primary hyperoxaluria type 1

Does not exceed United States Food and Drug Administration approved maintenance dose.

Lumasiran is considered investigational when the above criteria are not met.

Lumasiran is considered investigational for all other indications.

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