LOMITAPIDE CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Pregnancy
- Lactating
- Concomitant use of moderate or strong inhibitors of CYP 3A4
- Moderate or severe liver disease (e.g., Child-Pugh Category B or C) or active liver disease, including unexplained persistent elevation of serum transaminases
Inclusion Criteria
- Provider certification for prescribing due to increased risk of hepatotoxicity
- Diagnosis of homozygous familial hypercholesterolemia (HoFH)
- Patient education on and willingness/ability to follow a low-fat diet (<20% daily calories from fat)
- Insufficient reduction in LDL-C with PCSK9 inhibitor (e.g., alirocumab)
- Receipt of LDL-C apheresis, if patient is a candidate and therapy is accessible
- Confirmed negative pregnancy test, if applicable
Additional Inclusion Criteria
- Pregnancy exclusion required prior to therapy for females who can become pregnant
- Counseling on treatment risks vs benefits and requirement for effective contraception during therapy for females who can become pregnant
Diagnostic & Safety Requirements
- HoFH diagnosis must be confirmed via: 1) genetic testing (LDL receptor mutation: true homozygote or double heterozygote), OR 2) untreated LDL >500 mg/dL, OR 3) receiving maximal lipid-lowering therapy with confirmed adherence and LDL >300 mg/dL
- Diagnosis must include physical findings: tendon xanthomas at any age, arcus corneae in patients <45 years, or tuberous xanthomas/xanthelasma in patients <20 years
- Safety and efficacy not established for patients without HoFH; restricted to confirmed HoFH cases only