- •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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Leqvio Prescribing Information (Food and Drug Administration) (2021).
- Major concepts in treatment with bempedoic acid and inclisiran that clinicians need to know.Curr Atheroscler Rep. Jun 06 2022; https://doi.org/10.1007/s11883-022-01036-4
- Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol.N Engl J Med. 04 16 2020; 382: 1507-1519https://doi.org/10.1056/NEJMoa1912387
- Pooled patient-level analysis of inclisiran trials in patients with familial hypercholesterolemia or atherosclerosis.J Am Coll Cardiol. 03 09 2021; 77: 1182-1193https://doi.org/10.1016/j.jacc.2020.12.058
- 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk.Eur Heart J. 01 01 2020; 41: 111-188https://doi.org/10.1093/eurheartj/ehz455
- The agenda for familial hypercholesterolemia: a scientific statement from the American Heart Association.Circulation. Dec 01 2015; 132: 2167-2192https://doi.org/10.1161/CIR.0000000000000297
- Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia.J Clin Lipidol. Jun 2011; 5 (Suppl): S1-S8https://doi.org/10.1016/j.jacl.2011.04.003
- Association of prior authorization and out-of-pocket costs with patient access to PCSK9 inhibitor therapy.JAMA Cardiol. 11 01 2017; 2: 1217-1225https://doi.org/10.1001/jamacardio.2017.3451
- Prior authorization requirements for proprotein convertase subtilisin/kexin type 9 inhibitors across US private and public payers.Circ Cardiovasc Qual Outcomes. 01 2018; 11e003939https://doi.org/10.1161/CIRCOUTCOMES.117.003939
- Use of lipid-lowering therapies over 2 years in GOULD, a registry of patients with atherosclerotic cardiovascular disease in the US.JAMA Cardiol. Jun 16 2021; https://doi.org/10.1001/jamacardio.2021.1810
- Variation in lipid-lowering therapy use in patients with low-density lipoprotein cholesterol ≥190 mg/dL: insights from the National Cardiovascular Data Registry-Practice Innovation and Clinical Excellence Registry.Circ Cardiovasc Qual Outcomes. 05 2018; 11e004652https://doi.org/10.1161/CIRCOUTCOMES.118.004652
- Cost effectiveness of inclisiran in atherosclerotic cardiovascular patients with elevated low-density lipoprotein cholesterol despite statin use: a threshold analysis.Am J Cardiovasc Drugs. 2022 Sep; 22: 545-556https://doi.org/10.1007/s40256-022-00534-9
Published online: October 31, 2022
Accepted: October 21, 2022
Received: July 25, 2022
© 2022 National Lipid Association. Published by Elsevier Inc. All rights reserved.