EVINACUMAB-DGNB INJ,SOLN

Clinical Criteria Summary

History of serious hypersensitivity reactions to evinacumab-dgnb or any of its excipients
Does not have a confirmed diagnosis of Homozygous Familial Hypercholesterolemia (HoFH)
Patient is receiving lomitapide
Patient is pregnant

Care provided by VA/VA Community Care provider specializing in Cardiology, Endocrinology or locally designed specialty provider with expertise in lipid management
Genetic or clinical confirmation of HoFH diagnosis
Receiving maximally tolerated low-density lipoprotein cholesterol (LDL-C) lowering therapies including statins, ezetimibe and PCSK9 inhibitors and need for further LDL-C lowering to reduce cardiovascular disease (CVD) risk (e.g., LDL-C remains > 70 mg/dL in patients with CVD, > 100 mg/dL without CVD, LDL-C reduction <50% from baseline and/or patient having recurrent CVD events)
Receiving LDL-C apheresis if patient is a candidate for therapy and if therapy is accessible
Patient is willing and able to travel to receive evinacumab-dgnb infusions every 4 weeks

Evaluate pregnancy status prior to initiating treatment since evinacumab-dgnb may cause fetal harm
Contraceptive counseling on the potential risks vs. benefits of taking evinacumab-dgnb if a patient were to become pregnant is recommended
Use of effective contraception is advised during treatment and for at least 5 months after the last dose
Supplemental Diagnostic Criteria for HoFH (Patient must meet one or more)
Confirmation with genetic testing (mutation in LDL receptor: true homozygote or compound heterozygote)
Untreated LDL-C of >500 mg/dL
LDL-C remains >300 mg/dL despite maximally tolerated, clinically indicated lipid-lowering therapy (e.g., statins, ezetimibe, PCSK9 inhibitors) and adherence is confirmed, AND presence of any of the following physical findings including tendon xanthomas at any age, arcus corneae in patients <45 years or tuberous xanthomas or xanthelasma in patients <20 years

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