Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Lumasiran (Oxlumo) is considered medically necessary for the treatment of primary hyperoxaluria type 1 (PH1) when the following criteria are met:
- Individual meets at least ONE of the following:
- Individual has signs and symptoms of PH1 (e.g., recurrent kidney stones, urolithiasis, infantile oxalosis, failure to thrive and renal failure, nephrocalcinosis associated with decreased GFR, oxalate crystals in any biological fluid or tissue, increased serum creatinine with calcium oxylate (CaOx) stones, CaOx tissue deposits, renal failure of unknown causes, etc.); or
- Individual does not have signs or symptoms but does have a family history of genetically confirmed PH1; and
- Individual has genetic testing indicating homozygosity or compound heterozygosity for known mutations of AGXT; and
- Individual has ONE of the following:
- Plasma oxalate (POx) greater than the upper limit of normal; or
- Urine oxalate (UOx) greater than the upper limit of normal; or
- UOx/creatinine (Cr) greater than the normal for age; 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
- Individual has not had or is not scheduled for a liver and/or kidney transplant; and
- Lumasiran (Oxlumo) is prescribed by or in consultation with a nephrologist or other healthcare provider experience in treating PH1.
Reauthorization of lumasiran (Oxlumo) is considered medically necessary when the following criteria are met:
- Individual diagnosed with PH1; and
- Individual has reduced signs and symptoms of PH1 with lumasiran (Oxlumo) treatment; and
- Individual's laboratory values have improved or normalized; and
- Lumasiran (Oxlumo) is prescribed by or in consultation with a nephrologist or other healthcare provider experience in treating PH1.
The use of 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
