What patients are eligible for Repatha (evolocumab)?

Eligibility Criteria for Repatha (Evolocumab)

Repatha (evolocumab) is indicated for patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia who require additional LDL-C lowering despite maximally tolerated statin therapy plus ezetimibe. 1

Patients with Clinical ASCVD

Very High-Risk ASCVD Patients

• Patients with a history of multiple major ASCVD events (recent acute coronary syndrome, history of myocardial infarction, history of ischemic stroke, symptomatic peripheral arterial disease) 1
• Patients with one major ASCVD event plus multiple high-risk conditions (age ≥65 years, heterozygous familial hypercholesterolemia, history of coronary revascularization, diabetes, hypertension, CKD, current smoking, persistently elevated LDL-C ≥100 mg/dL despite maximally tolerated statin plus ezetimibe, history of heart failure) 1
• LDL-C ≥70 mg/dL (≥1.8 mmol/L) despite maximally tolerated statin therapy plus ezetimibe 1

Algorithm for ASCVD Patients

1. Start with maximally tolerated high-intensity statin therapy 1
2. If LDL-C remains ≥70 mg/dL, add ezetimibe 1
3. If LDL-C still remains ≥70 mg/dL after adding ezetimibe, consider adding Repatha 1

Patients with Familial Hypercholesterolemia

Heterozygous Familial Hypercholesterolemia (HeFH)

• Age 30-75 years with LDL-C ≥100 mg/dL despite maximally tolerated statin plus ezetimibe 1
• Patients with additional risk factors may be eligible with LDL-C ≥140 mg/dL (≥3.6 mmol/L) 1
• Additional risk factors include: diabetes with target organ damage, lipoprotein(a) >50 mg/dL, major risk factors (smoking, marked hypertension), untreated patients >40 years of age, or premature ASCVD in first-degree relatives 1

Homozygous Familial Hypercholesterolemia (HoFH)

• Patients with HoFH who have some residual LDL receptor activity (>2%) 1
• Not recommended for patients with negative/negative LDLR mutations with LDL receptor activity below 2% 1
• Can be used with or without lipoprotein apheresis 2

Severe Primary Hypercholesterolemia

• Baseline LDL-C ≥220 mg/dL with LDL-C remaining ≥130 mg/dL despite maximally tolerated statin plus ezetimibe 1

Special Considerations

Statin Intolerance

• Patients who cannot tolerate adequate statin doses due to adverse effects 3, 4
• Documented history of statin intolerance with inadequate LDL-C reduction on non-statin therapies 5

Diabetes Patients

• Patients with diabetes and ASCVD show greater absolute risk reduction with PCSK9 inhibitor therapy compared to those without diabetes 1
• Particularly beneficial for diabetes patients with target organ damage or additional major risk factors 1

Monitoring and Response Assessment

• LDL-C levels should be assessed 4 weeks after initiating therapy 1
• Expected LDL-C reduction: 50-60% from baseline when added to statin therapy 3, 4
• For HoFH patients, expected LDL-C reduction is approximately 30% 3, 2

Important Caveats

• Before considering Repatha, ensure patient adherence to statin and ezetimibe therapy 1
• Cost-effectiveness should be considered in the decision-making process 1
• Ezetimibe should be tried before Repatha due to its lower cost and established safety profile 1
• Patients with HoFH may require more frequent dosing (420 mg every 2 weeks rather than monthly) for optimal effect 2