Praluent — Cigna
Heterozygous Familial Hypercholesterolemia (HeFH)
Initial criteria
- Patient age ≥ 8 years; AND
- Patient meets ONE of the following (a–c): a) untreated LDL-C ≥ 190 mg/dL; OR b) diagnosis confirmed by genetic testing (LDLR, APOB, PCSK9, or LDLRAP1 variants); OR c) diagnostic criteria met: Dutch Lipid Network score > 5 OR Simon Broome criteria 'definite' or 'possible/probable'; AND
- Patient meets ONE of the following (a or b): a) BOTH of the following [(1) and (2)]: (1) tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily) for ≥ 8 continuous weeks; AND (2) LDL-C after treatment remains ≥ 70 mg/dL; OR b) patient determined statin intolerant by having statin-related rhabdomyolysis OR skeletal muscle symptoms with both atorvastatin and rosuvastatin trials resolving upon discontinuation.
Reauthorization criteria
- Patient currently receiving Praluent and, according to the prescriber, has experienced a response to therapy (e.g., decrease in LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels).
Approval duration
1 year