Repatha — Medica
Heterozygous Familial Hypercholesterolemia (HeFH)
Initial criteria
- age ≥ 10 years
- ONE of the following: untreated LDL-C ≥ 190 mg/dL prior to treatment OR diagnosis confirmed by genetic testing (LDLR, APOB, PCSK9, or LDLRAP1 gene) OR diagnosis by meeting Dutch Lipid Network score > 5 OR Simon Broome criteria for definite or possible/probable familial hypercholesterolemia
- AND ONE of the following: (a) tried one high-intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as single-entity or combination) for ≥ 8 continuous weeks AND LDL-C after treatment remains ≥ 70 mg/dL OR (b) statin intolerant by either (1) rhabdomyolysis or (2) skeletal-related muscle symptoms occurring with both atorvastatin and rosuvastatin that resolved upon discontinuation
Reauthorization criteria
- Patient currently receiving Repatha and prescriber confirms response to therapy, such as decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels
Approval duration
1 year