Criteria
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 individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational);
and
-
Evinacumab-dgnb (Evkeeza) must be prescribed by, or in consult with, a cardiologist, endocrinologist, or lipid specialist;
and
-
Documentation of one of the following must be provided:
-
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 greater than 500mg/dL with one of the following:
-
Cutaneous or tendon xanthoma before age 10 years;
or
-
Evidence of total cholesterol greater than 250 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 greater than or equal to 20 mg or atorvastatin greater than or equal to 40 mg;
and
- Nexlizet and ezetimibe combined with rosuvastatin greater than or equal to 20 mg or atorvastatin greater than or equal to 40 mg.
Initial Authorization: Six (6) months
Reauthorization Criteria
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.
The use of evinacumab-dgnb (Evkeeza) 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 Code
