Full data results of the PLATO health economics substudy demonstrate that even at a higher drug cost and incremental cost per acute coronary syndromes (ACS) patient, ticagrelor (Brilique, AstraZeneca) numerically lowered non-drug healthcare costs versus generic clopidogrel and is cost-effective. The results have been published online in the European Heart Journal.
The cost-effectiveness of ticagrelor was driven by the mortality benefit seen in the pivotal PLATO trial, which showed ticagrelor was cost-effective across all major patient subgroups.
The analysis used in the health economics substudy included the Swedish costs for both ticagrelor and generic clopidogrel and found that though treating acute coronary syndrome (ACS) patients with ticagrelor costs an additional average of €96 per patient/year, treatment with ticagrelor resulted in a 21% mortality benefit and lower healthcare costs at 12 months as compared to generic clopidogrel.
“What is striking about these data is that they showed treatment with ticagrelor was cost- effective for ACS patients, compared to the lower-priced generic option, because the medicine improved survival, reduced recurrent events and reduced other healthcare costs,” said Lars Wallentin, Uppsala Clinical Research Centre, Sweden.
An initial analysis from the PLATO HECON substudy on resource utilisation and cost was first presented in November 2010 at the American Heart Association annual meeting in an abstract presentation titled: “Health Economics in the Platelet inhibition and patient outcomes (PLATO) randomised trial: Report on within trial resource use patterns”. This analysis excluded drug costs and concomitant drugs and did not account for the mortality data.
Following was a presentation at the 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting that showed the overall cost impact of using ticagrelor instead of generic clopidogrel was cost-effective. The newly published data set included cardiovascular events, costs and quality-of-life data, drug costs and long-term data in the analyses and assessed the long-term cost-effectiveness of treating ACS patients for 12 months with ticagrelor and aspirin according to the EU label. In the analysis, ticagrelor was associated with a quality-adjusted life year (QALY) gain of 0.1316 at a lifetime incremental cost of €362, yielding a cost per QALY gained as compared to clopidogrel of €2,372.
Cost per QALY is an important measure used by national governments and their reimbursement agencies to assess cost-effectiveness of medical treatments. In order to prioritise treatments, the long-term costs and health outcomes of different treatment strategies are assessed and compared. While no universal threshold for cost-effectiveness exists, generally, a cost per QALY in the range of €25,000 ($33,000) to €38,000 ($50,000) is considered cost-effective.
The PLATO health economics data is part of a prospectively designed substudy of PLATO designed to help address important questions related to the access and affordability of ticagrelor around the world. To date, ticagrelor has received positive reimbursement recommendations in 25 countries, including European markets such as the UK, Germany and Italy.
PLATO (Platelet inhibition and patient outcomes) was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of ticagrelor versus clopidogrel, both given in combination with aspirin. The study was designed to establish whether ticagrelor could achieve a clinically meaningful reduction in cardiovascular events in acute coronary syndrome patients, above and beyond that afforded by clopidogrel.
PLATO demonstrated that treatment with ticagrelor led to a greater reduction in the primary end point – a composite of cardiovascular death, myocardial infarction, or stroke – compared to patients who received clopidogrel [9.8% vs. 11.7% at 12 months; 16% relative risk reduction (RRR); 95% CI, 0.77 to 0.92; p<0.001]. The difference in treatments was driven by cardiovascular death and myocardial infarction with no difference in stroke. The absolute difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continued to diverge throughout the 12-month treatment period [1.9% absolute risk reduction (ARR)].
The PLATO study also demonstrated that treatment with ticagrelor for 12 months was associated with a 21% RRR in cardiovascular death (4% vs. 5.1%; 1.1% ARR; p=0.001) and a 16% RRR in myocardial infarction compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% ARR; p<0.005).