Advertisement
Brief Communication| Volume 17, ISSUE 1, P73-77, January 2023

Download started.

Ok

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.

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Clinical Lipidology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

      1. Leqvio Prescribing Information (Food and Drug Administration) (2021).

        • Parham JS
        • Goldberg AC.
        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
        • Ray KK
        • Wright RS
        • Kallend D
        • et al.
        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
        • Wright RS
        • Ray KK
        • Raal FJ
        • et al.
        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
        • Mach F
        • Baigent C
        • Catapano AL
        • et al.
        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
        • Gidding SS
        • Champagne MA
        • de Ferranti SD
        • et al.
        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
        • Goldberg AC
        • Hopkins PN
        • Toth PP
        • et al.
        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
        • Navar AM
        • Taylor B
        • Mulder H
        • et al.
        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
        • Doshi JA
        • Puckett JT
        • Parmacek MS
        • Rader DJ.
        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
        • Cannon CP
        • de Lemos JA
        • Rosenson RS
        • et al.
        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
        • Virani SS
        • Kennedy KF
        • Akeroyd JM
        • et al.
        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
        • Desai NR
        • Campbell C
        • Electricwala B
        • et al.
        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