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Research from the Karolinska Institute indicates ESC/EAS 2019 dyslipidemia guidelines could create an unforeseen financial burden due to new eligibility for PSCK9 class.
While the onus behind the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) dyslipidemia guidelines may have been to further reduce the burden of cardiovascular disease, a recent study from Swedish investigators suggests the new guidelines may come with a serious financial impact for some patients.
Analysis of the SWEDEHEART registry found that—because of changes from previous guidelines—an increase in the number of patients eligible for PCSK9 inhibitors could result in more than 50% of patients with a recent myocardial infarction (MI) being labeled as eligible for use, which investigators suggest could become a major issue due to their increased cost.
"Our analyses highlight yet another situation for which we need to consider what we deem reasonable in terms of the number of patients being treated, the expected health gains and cost,” said lead investigator Peter Ueda, intern physician and postdoctoral researcher at the Department of Medicine in Solna, in a statement.
With the issuance of the ESC/EAS 2019 dyslipidemia guidelines, Ueda and colleagues from Karolinska Institutet sought to determine how the new guidelines might impact eligibility for patients with a recent MI to receive additional lipid-lowering therapy. Briefly, the new guidelines, which recommended an LDL-C level of less than 1.4 mmol and a 50% or greater reduction in LDL-C level, had a lower LDL-C target goal and recommended more aggressive lowering therapy compared to the 2016 dyslipidemia guidelines.
SWEDEHEART contained 44,890 individuals and survived until discharge, but 19,424 of these individuals were excluded based on the investigators' inclusion criteria. The most common reasons for exclusion included missing LDL-C at index MI, no registered follow-up visit, and missing LDL-C at the follow-up visit.
Ultimately a cohort of 25,466 patients who had suffered an MI event from 2013-2017 and had attended a follow-up visit within 6-10 weeks were identified for inclusion. Most patients included in the analysis were receiving high-intensity statins and, according to 2019, 82.9% of the patients would be eligible for additional lipid-lowering therapy.
To evaluate treatment intensification scenarios needed to achieve the new LDL-C target, investigators conducted 2 Monte Carlo simulations. The first simulation examined a maximized uptake of high-intensity statin therapy followed by maximized use of ezetimibe and then add-on therapy with a PCSK9 inhibitor. In the second simulation, investigators assumed patients were already receiving maximally tolerated statin therapy at the follow-up visit and patients eligible for additional therapy first received ezetimibe followed by a PCSK9 inhibitor.
The first simulation revealed the LDL-C target was reached in 19.9% of patients using high-intensity statin monotherapy and in 29.5% with high-intensity statins and ezetimibe—leaving 50.7% of patients still eligible for PCSK9 inhibitors. Results of the second simulation indicated use of alirocumab or evolocumab led to achieving the LDL-C target in 86.7% and 90.7% of patients, respectively.
In their discussion of results, Ueda and colleagues noted the increased annual cost of achieving the new LDL-C target set forth in 2019 guidelines the financial burden on Europe and other countries using the guidelines could be substantial. Investigators noted data indicates the annual cost of PCSK9 inhibitor use per patient was more than $4,800 (€4555), which is significantly greater than the $36 (€34).
"If half of the patients with heart attacks would be eligible for this drug, the financial burden on health systems throughout Europe and other countries using the ESC/EAS guidelines may be substantial unless the cost of treatment is reduced,” said Ali Allahyari, resident physician in cardiology and doctoral student at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, in the aforementioned statement.
This study, “Application of the 2019 ESC/EAS dyslipidaemia guidelines to nationwide data of patients with a recent myocardial infarction: a simulation study,” was published in the European Heart Journal