Application of PCSK9 Inhibitors in Practice

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

PCSK9i (protein convertase subtilisin/kexin type 9 inhibitors) are set to revolutionize the treatment of hypercholesterolemia in the management of atherosclerotic risk, but numerous reports have detailed unprecedented barriers to access for these drugs. To overcome these challenges, our group created a model to facilitate provision of this new therapy for patients who qualify according to Food and Drug Administration criteria. This report details the real-world follow-up experience of PCSK9i use in a large patient cohort structured to ensure rigor in data collection, analysis, and interpretation. The 271 patients approved and actively followed in our PCSK9i clinic between July 2015 and August 2018 represent a 97% approval rate from insurance, with 28% of prescriptions requiring at least one appeal. Over 50% of patients were statin intolerant. On average, there was a median lapse of 15 days between initial visit and insurance approval. PCSK9i therapy was affordable for most patients, with an average monthly out-of-pocket expense of $58.05 (median $0). Only 2.3% of patients were unable to initiate or continue therapy because of cost. Reductions from baseline in LDL (low-density lipoprotein) cholesterol and Lp(a) (lipoprotein [a])were comparable to published reports with median reductions of 60% and 23% at 1 year, respectively. PCSK9i therapy was well-tolerated overall, though 9% of patients reported adverse events, and 5% of patients discontinued due mostly to musculoskeletal and flu-like symptoms. Our practice model demonstrates that PCSK9i therapy can be accessed easily and affordably for the majority of eligible patients, resulting in dramatic improvement in lipid profile results. Moreover, our registry data suggest that results from the prospective clinical trials of PCSK9i on LDL and Lp(a) reduction and on tolerability are applicable to a real-world cohort.

Original languageEnglish (US)
Pages (from-to)32-37
Number of pages6
JournalCirculation Research
Volume124
Issue number1
DOIs
StatePublished - Jan 4 2019

Fingerprint

Subtilisin
Proteins
Insurance
Therapeutics
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Risk Management
United States Food and Drug Administration
Health Expenditures
Hypercholesterolemia
LDL Cholesterol
Lipoproteins
Prescriptions
Registries
Clinical Trials
Lipids
Costs and Cost Analysis
Pharmaceutical Preparations

Keywords

  • drug adherence
  • LDL-cholesterol
  • lipoprotein(a)
  • PCSK9
  • PCSK9 inhibitors

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

Cite this

Application of PCSK9 Inhibitors in Practice. / Kaufman, Tina; Warden, Bruce A.; Minnier, Jessica; Miles, Joshua R.; Duell, Paul; Purnell, Jonathan; Wojcik, Cezary; Fazio, Sergio; Shapiro, Michael.

In: Circulation Research, Vol. 124, No. 1, 04.01.2019, p. 32-37.

Research output: Contribution to journalArticle

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