Nexlizet — Medica

Heterozygous Familial Hypercholesterolemia (HeFH)

Initial criteria

Patient meets ALL of the following:
i. age ≥ 18 years; AND
ii. ONE of the following:
a) Untreated LDL-C level ≥ 190 mg/dL (prior to antihyperlipidemic treatment); OR
b) Diagnosis confirmed by genetic testing (e.g., pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1 gene); OR
c) Diagnosed with heterozygous familial hypercholesterolemia by meeting ONE of the following diagnostic criteria:
(1) Dutch Lipid Network criteria score > 5; OR
(2) Simon Broome criteria met threshold for definite or possible/probable familial hypercholesterolemia; AND
iii. ONE of the following:
a) BOTH of the following:
(1) Tried one high-intensity statin therapy (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily as single-entity or combination) for ≥ 8 continuous weeks; AND
(2) LDL-C level after this regimen remains ≥ 70 mg/dL; OR
b) Determined to be statin intolerant by meeting ONE of the following:
(1) Experienced statin-related rhabdomyolysis (CK ≥ 10× ULN with end organ damage or myoglobinuria); OR
(2) ALL of the following:
(a) Experienced skeletal-related muscle symptoms (e.g., myopathy, myalgia); AND
(b) Symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin; AND
(c) Symptoms resolved upon discontinuation of each statin.

Patient currently receiving Nexlizet. Approve if according to the prescriber the patient has experienced a response to therapy (e.g., decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels).
If the patient is restarting therapy or has not previously received approval, Initial Therapy criteria must be met.

1 year