Medical Necessity Determination for Inclisiran (Leqvio)

Primary Recommendation

• The American College of Cardiology recommends that inclisiran is not medically necessary for patients without current LDL-C levels and inadequate documentation of ASCVD 1, 2

Critical Documentation Deficiencies

• The American College of Cardiology guidelines require current LDL-C ≥70 mg/dL for patients with ASCVD to justify inclisiran therapy, with a strength of evidence based on clinical trials 1, 3
• Clinical ASCVD requires documented history of myocardial infarction, acute coronary syndrome, coronary revascularization, stroke, TIA, or peripheral arterial disease, as defined by the American College of Cardiology 1, 2

Statin Intolerance Documentation

• The American College of Cardiology guidelines consider statin intolerance as a criterion for inclisiran therapy, with documentation of elevated liver enzymes or other adverse effects 1, 3

Guideline-Based Treatment Algorithm

• The American College of Cardiology recommends PCSK9 monoclonal antibodies (evolocumab or alirocumab) as preferred over inclisiran due to proven cardiovascular outcomes benefits in clinical trials 1, 3
• Inclisiran should be considered primarily in patients with demonstrated poor adherence to PCSK9 mAbs, adverse effects from both PCSK9 mAbs, or inability to self-inject, according to the American College of Cardiology guidelines 1, 3

Required Actions for Reconsideration

• The American College of Cardiology recommends obtaining current LDL-C level, ideally within 4 weeks of the appeal, to assess medical necessity for inclisiran therapy 1, 5
• Clear documentation of clinical ASCVD with specific events and dates is required, or confirmation of baseline untreated LDL-C ≥190 mg/dL, as defined by the American College of Cardiology 1, 2