INCLISIRAN 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
- Pregnancy or lactating
Inclusion Criteria
- History of atherosclerotic cardiovascular disease (ASCVD)
- Severe hypercholesterolemia (e.g., heterozygous familial hypercholesterolemia [HeFH], LDL-C > 190 mg/dL) without ASCVD
Additional Inclusion Criteria
- Contraindication, intolerance to, or insufficient LDL-C reduction requiring further LDL-C lowering to reduce ASCVD risk consistent with established guidelines after a trial of:
- Maximally tolerated dose of statin (may be none; confirmed statin intolerance is intolerance to at least 2 statins, one at the lowest approved daily dose and trial of alternate day dosing)
- Ezetimibe
- Monoclonal antibody inhibitor of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor)
- Patient is willing to return for subcutaneous administration of inclisiran by a healthcare provider at the initial visit, at 3 months and every 6 months thereafter
Pregnancy Considerations
- Evaluate pregnancy status prior to initiating treatment since inclisiran may cause fetal harm
- Counseling provided on potential risks vs benefits of treatment is recommended
- Use of effective contraception during therapy is recommended for patients who can become pregnant