Evinacumab (Evkeeza) for Homozygous Familial Hypercholesterolemia — Coverage Criteria
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Covers prior authorization, clinical criteria, and continuation requirements for evinacumab (Evkeeza) as adjunct therapy to lower LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) for Blue Cross Blue Shield of Tennessee members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial therapy for HoFH (authorization up to 6 months)
Covered when ALL of the following are met:
Diagnosis confirmation may include genetic variants (biallelic LDLR, APOB, PCSK9, LDLRAP1) or clinical criteria such as untreated LDL-C > 400 mg/dL with parental LDL-C ≥190 mg/dL or childhood xanthomas.
Major ASCVD risk factors and clinical ASCVD definitions referenced in Appendix.
Concomitant therapies may include statins, ezetimibe, PCSK9-directed therapy, or LDL apheresis as applicable.
Continuation of therapy (authorization up to 12 months)
Covered when ALL of the following are met:
Applies to continued treatment, including new members transferring care.
Required for continuation approval (authorization up to 12 months).
Any indication other than the FDA‑approved indication for evinacumab (Evkeeza) in homozygous familial hypercholesterolemia (HoFH) is considered experimental/investigational and is not covered.
Use of evinacumab (Evkeeza) for indications other than HoFH is not medically necessary and will be denied as experimental/investigational.
Coding and Diagnostic Thresholds
Provider Actions and Prior Authorization
Prior Authorization Required
Prior authorization is required. Initial approvals may be granted for up to 6 months; continuation approvals may be granted for up to 12 months when continuation criteria are met.
- Initial authorization duration: up to 6 months
- Continuation authorization duration: up to 12 months when continuation criteria are met
Concomitant / Previous Therapy Requirements
For members 10 years of age and older, the member must be on maximally tolerated lipid‑lowering therapy and receiving stable treatment with at least three lipid‑lowering therapies (e.g., statins, ezetimibe, PCSK9‑directed therapy) at the maximally tolerated dose prior to initiation. For members 7 to less than 10 years of age, the member must have an intolerance or contraindication to other lipid‑lowering therapies or be receiving stable treatment with at least one lipid‑lowering therapy (e.g., statins, LDL apheresis) at the maximally tolerated dose and will continue concomitant lipid‑lowering therapy. Members 1 year to less than 7 years of age are eligible under age criteria.
- Members ≥10 years: must be on maximally tolerated lipid‑lowering therapy and receiving stable treatment with ≥3 lipid‑lowering therapies prior to initiation
- Members 7 to <10 years: intolerance/contraindication to other therapies OR stable treatment with ≥1 lipid‑lowering therapy at maximally tolerated dose
- Members 1 to <7 years: eligible per age criteria (no concomitant therapy requirement)
Background
Evinacumab (Evkeeza) is indicated as an adjunct to diet, exercise, and other LDL‑C lowering therapies to reduce LDL‑C in adult and pediatric patients aged 1 year and older with homozygous familial hypercholesterolemia (HoFH). Requests for treatment outside this FDA‑approved indication are considered experimental/investigational and not medically necessary.
Definitions
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