BEMPEDOIC ACID TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- End stage renal disease on dialysis
- Advanced heart failure with limited prognosis
- Severe comorbid non-cardiovascular condition expected to limit life expectancy
- Pregnant or lactating status
Primary Inclusion Criteria (Patient must meet at least one)
- History of ASCVD (Atherosclerotic cardiovascular disease)
- Severe primary hypercholesterolemia (e.g., HeFH, LDL-C > 190 mg/dL) without ASCVD
Additional Required 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 per established guidelines
- Contraindication, intolerance to, or insufficient LDL-C reduction with ezetimibe, requiring further LDL-C lowering per established guidelines
- Contraindication, intolerance to, or insufficient LDL-C reduction with a monoclonal antibody inhibitor of PCSK9, requiring further LDL-C lowering per established guidelines
- Provider acknowledges potential for adverse events with bempedoic acid and will monitor as clinically appropriate
Pregnancy & Reproductive Considerations
- Evaluate pregnancy status prior to initiating treatment due to potential fetal harm
- Provide contraceptive counseling on risks vs. benefits if pregnancy occurs during treatment
- Discontinue therapy if pregnancy occurs unless benefits outweigh potential risk to the fetus
Statin Intolerance Definition & Clinical Context
- Documented intolerance requires a trial of at least 2 statins causing intolerable unexplained skeletal muscle-related complaints (pain/ache, weakness/cramping) that start or worsen during treatment and resolve upon cessation
- One statin trial must be at the lowest approved dose with alternate day dosing attempted
- 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)
Stepwise Therapy & PCSK9 Preference Guidance
- Patients on lower than optimal statin doses should receive ezetimibe as second-line treatment
- For patients on suboptimal statin dosing + ezetimibe with insufficient LDL reduction or unmet goals despite confirmed adherence, consider monoclonal antibody inhibitors of PCSK9
- For completely statin-intolerant patients where ezetimibe is insufficient or not expected to provide desired LDL-C reduction, a monoclonal antibody inhibitor of PCSK9 is preferred over bempedoic acid due to greater expected LDL-C reduction magnitude (50-60% vs 16-36%) and adverse event potential
- For patients with statin intolerance without established ASCVD and LDL-C <190 mg/dL, utilize ezetimibe, bile acid sequestrant (BAS), or combination in appropriate candidates
- For high-risk patients (e.g., diabetes mellitus, 10-year risk score >20%, subclinical atherosclerosis by imaging) without established ASCVD and LDL-C <190 mg/dL: If ezetimibe/BAS/combination fails to achieve clinically meaningful LDL-C reduction (>30% or >50%) or meet goals despite adherence, consider monoclonal antibody inhibitors of PCSK9 or bempedoic acid; PCSK9 inhibitors are preferred due to greater expected reduction and adverse event profile