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Inclisiran creates unique opportunities and challenges for patient access to therapy: early experience in a United States Lipid Clinic

Published:October 31, 2022DOI:https://doi.org/10.1016/j.jacl.2022.10.009

      Highlights

      • Early US clinical experience with inclisiran since FDA approval in 2021 is unknown.
      • Use of alternate injection centers expedites access to inclisiran.
      • 100% of patients with Medicare were able to access inclisiran.
      • Only 3 of 12 (25%) patients with non-Medicare insurance had inclisiran approved.
      • These findings have important implications for future access to inclisiran in the US.
      We report an early experience with inclisiran, an siRNA targeting PCSK9 administered by a healthcare professional, in an academic lipid clinic. 37 patients were prescribed inclisiran, age (mean±SD) 66±13 years, 26 (70%) women, 32 (87%) White, LDL-C 113±62 mg/dL, 18 (49%) with ASCVD and 19 (51%) with HeFH. Most patients were referred to alternate injection centers. Inclisiran was approved by insurance for 25 (68%), denied for 9 (24%), with 3 under review. While 100% of patients with Medicare obtained access to inclisiran, only 3 of 12 (25%) patients with non-Medicare insurance received approval. Approved patients were older (72±8 vs 52±13 years, p<0.001), disproportionately Medicare enrollees (88%, p<0.001), less had HeFH (40% vs 89%, p=0.019), more had ASCVD (60% vs 11%, p=0.019), less were on a statin (28% vs 78%, p=0.017), and pre-treatment LDL-C was higher (121±65 vs 77±40 mg/dL, p=0.039). These findings have implications for the future of inclisiran in the U.S. and whether inclisiran can be made more accessible, including to younger patients with non-Medicare insurance.

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