Repatha (evolocumab) — Medica

Initial criteria

• age ≥ 18 years
• Patient has had ONE of the following: a previous myocardial infarction or a history of an acute coronary syndrome OR angina (stable or unstable) OR a past history of stroke or transient ischemic attack OR coronary artery disease OR peripheral arterial disease OR has undergone a coronary or other arterial revascularization procedure (e.g., coronary artery bypass graft surgery, percutaneous coronary intervention, angioplasty, or coronary stent placement)
• Patient meets ONE of the following: (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 ≥ 55 mg/dL; OR (b) Statin intolerant as shown by ONE of the following: (1) Experienced statin-related rhabdomyolysis (CK ≥ 10× ULN with evidence of acute renal injury or myoglobinuria) OR (2) ALL of the following: (a) Experienced skeletal-related muscle symptoms AND (b) Symptoms resolved after discontinuation of statin AND (c) Symptoms recurred after re-challenge with at least one high-intensity statin)

Approval duration

1 year