Coverage is subject to the specific terms of the member’s benefit plan.
The use of evinacumab-dgnb (Evkeeza) may be considered medically necessary when ALL of the following criteria are met:
- The member meets age and dosing requirements per prescribing information; and
- The prescriber is, or is in consult with a cardiologist, endocrinologist, or lipid specialist; and
- The member has homozygous familial hypercholesterolemia confirmed by documentation of one of the following:
- Genetic testing confirming two mutant alleles at the low-density lipoprotein receptor (LDLR), apolipoprotein B (apo B), proprotein convertase subtilisin kexin type 9 (PCSK9) or low-density lipoprotein receptor adaptor protein 1 (LDLRAP1 gene locus; or
- Untreated total cholesterol of > 500mg/dL with one of the following:
- Cutaneous or tendon xanthoma before age 10 years; or
- Evidence of heterozygous familial hypercholesterolemia in both parents; or
- Low-density lipoprotein cholesterol (LDL-C) level greater than 100 mg/dL after a 90-day trial of each of the following, as evidenced by paid claims or pharmacy printouts or clinical justification as to why a treatment is unable to be used (subject to clinical review):
- PCSK9 inhibitor and ezetimibe combined with rosuvastatin ≥20 mg or atorvastatin ≥ 40 mg; and
- Nexlizet and ezetimibe combined with rosuvastatin ≥20 mg or atorvastatin ≥ 40 mg.
Initial Authorization: 6 months
Continuation of therapy with evinacumab-dgnb (Evkeeza) may be considered medically necessary when the following is met:
- The member has an LDL-C level less than 100 mg/dL or has achieved a 40% reduction
Continuation Authorization: 12 months
Evinacumab-dgnb (Evkeeza) for any other indication is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.