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.
Keywords
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Article info
Publication history
Published online: October 31, 2022
Accepted:
October 21,
2022
Received:
July 25,
2022
Identification
Copyright
© 2022 National Lipid Association. Published by Elsevier Inc. All rights reserved.
