ALIROCUMAB INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- End-stage renal disease on dialysis
- Advanced heart failure with limited prognosis
- Severe comorbid non-cardiovascular condition that is expected to limit life expectancy
- Pregnant or lactating status
- Primary Inclusion Criteria (One must be met)
- History of atherosclerotic cardiovascular disease (ASCVD)
- Severe primary hypercholesterolemia (e.g., heterozygous familial hypercholesterolemia [HeFH], LDL-C > 190 mg/dL) without ASCVD
- Additional Inclusion Criteria (All must be met)
- Contraindication, intolerance to, or insufficient LDL-C reduction with maximally tolerated dose of statin, requiring further LDL-C lowering to reduce ASCVD risk consistent with established guidelines
- Contraindication, intolerance to, or insufficient LDL-C reduction with ezetimibe, requiring further LDL-C lowering to reduce ASCVD risk consistent with established guidelines
Additional Inclusion Criteria (Select if Applicable)
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
Statin Intolerance & Management Guidelines
- Statins remain the treatment of choice; PCSK9 inhibitors augment LDL-C lowering when used with statins
- Documented statin intolerance requires a trial of at least 2 statins resulting in intolerable unexplained skeletal muscle-related complaints (pain/ache, weakness, or cramping) that resolve upon discontinuation
- One statin causing symptoms must be trialed at the lowest approved dose; alternate day dosing should be attempted
- Evaluate and address factors increasing risk for statin intolerance or non-statin causes of muscle symptoms (e.g., hypothyroidism, vitamin D deficiency, drug-drug interactions, excessive alcohol use)
- Patients on lower than optimal statin doses should receive ezetimibe as second-line therapy
- For patients on suboptimal statin doses plus ezetimibe: Consider PCSK9 inhibitor if LDL reduction from untreated baseline is less than clinically desired and/or LDL-C goal is not achieved despite confirmed adherence
- For completely statin-intolerant patients: Consider PCSK9 inhibitor if ezetimibe has not/is not expected to provide clinically desired LDL-C reduction or achieve LDL-C goal despite confirmed adherence
High-Risk Patients Without Established ASCVD
- Utilize ezetimibe, bile acid sequestrant (BAS), or combination in appropriate candidates
- For high-risk patients (e.g., diabetes mellitus, 10-year risk score > 20%, presence of subclinical atherosclerosis by imaging including coronary artery calcium assessment and coronary CT): Consider PCSK9 inhibitor if LDL-C is not reduced by a clinically meaningful percentage from baseline (>30% or >50% based on risk/need) and/or goals are not reached despite confirmed adherence