Nexletol — Medica

heterozygous familial hypercholesterolemia (HeFH)

Initial criteria

Patient is ≥ 18 years of age
Patient meets ONE of the following (a, b, or c):
a) Untreated LDL-C level ≥ 190 mg/dL (prior to treatment with antihyperlipidemic agents); OR
b) Diagnosis confirmed by genetic testing for pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 gene; OR
c) Diagnosis of HeFH confirmed by Dutch Lipid Network criteria score > 5 OR Simon Broome criteria meeting 'definite' or 'possible/probable' threshold
AND
Patient meets ONE of the following (a or b):
a) Patient meets ALL of the following [(1), (2), and (3)]:
(1) Patient has tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily; rosuvastatin ≥ 20 mg daily [single-entity or combination])
(2) Patient has tried one high-intensity statin above along with ezetimibe (as single-entity or combination product) for ≥ 8 continuous weeks
(3) LDL-C level after this treatment regimen remains ≥ 70 mg/dL
OR
b) Patient has been determined to be statin intolerant by meeting ONE of the following [(1) or (2)]:
(1) Patient experienced statin-related rhabdomyolysis; OR
(2) Patient meets ALL of the following [(a), (b), and (c)]:
(a) Patient experienced skeletal-related muscle symptoms (e.g., myopathy or myalgia)
(b) The skeletal-related muscle symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin (as single-entity or combination products)
(c) The skeletal-related muscle symptoms resolved upon discontinuation of each respective statin therapy (atorvastatin and rosuvastatin)

According to the prescriber, the patient has experienced a response to therapy (e.g., decrease in LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels)

1 year