Improving patient access to novel medical technologies in Europe

Abstract

The European Society of Cardiology (ESC) organized a one-day workshop with clinicians, health economic experts, and health technology appraisal experts to discuss the equity of patient access to novel medical technologies in Europe. Two index technologies were considered: implantable cardioverter defibrillators (ICDs) and drug-eluting stents (DES). The use of ICDs range from 35 implants/million population in Portugal to 166 implants/million population in Germany, whereas for implants of DES (as percentage of total stents) it is lowest in Germany at 14% and high in Portugal at 65%. These differences can in part be explained by a lack of structured implementation of guidelines, the direct cost in relation to the overall healthcare budget, and to differences in procedures and models applied by Health Technology Assessment (HTA) agencies in Europe. The workshop participants concluded that physicians need to be involved in a more structured way in HTA and need to become better acquainted with its methods and terminology. Clinical guidelines should be systematically translated, explained, disseminated, updated, and adopted by cardiologists in Europe. Clinically appropriate, consistent and transparent health economic models need to be developed and high-quality international outcome and cost data should be used. A process for funding of a technology should be developed after a positive recommendation from HTA agencies. Both the ESC and the national cardiac societies should build-up health economic expertise and engage more actively in discussions with stakeholders involved in the provision of healthcare.

The Impact of Medical Technology on Health: A Longitudinal Analysis of Ischemic Heart Disease

“…In the treatment of IHD one may expect in Spain yet more improvements in health (gains in years of life) as a result of medical technology, because the rates of use of these techniques are still rather reduced compared with other countries, adjusting for “need” (mortality). There are important geographic differences as to the application of these techniques [34]. The number of diagnostic cardiological studies, in particular of coronary angiography diagnoses, doubled in 10 years.…”

A strategy to offset the extra cost of sirolimus-eluting stent in patients undergoing intervention for acute myocardial infarction

“…By abolishing or greatly reducing intimal hyperplasia, these new coronary devices are currently regarded as a major breakthrough [20][21][22]. However, their uptake remains highly restricted in several countries due to the absence of specific reimbursement [6]. Based on initial randomized studies in selected patients or lesions subsets, SES were proposed to be reasonably costeffective [8,9].…”

“…The routine use of SES, however, would result in higher up front procedural costs due to an almost three times greater price than BMS [5]. At present, cost constraints and lack of incremental reimbursement have limited their utilization in daily practice in many European countries [6] and whether the subsequent reduction in the need for target vessel revascularization (TVR) will reasonably offset the extra costs of SES at baseline remains largely debated [7].…”

Analysing uncertainty around costs of innovative medical technologies: The case of fibrin sealant (QUIXIL®) for total knee replacement

“…Whilst the safety and performance of medical technologies in Europe is assured through mandatory CE-Marking and approval processes of the European Medical Agency (EMEA), economic evaluation is increasingly required, particularly when manufacturers claim to provide additional clinical or cost benefits compared to existing technologies [1][2][3]. The level of evidence available on a technology at the time of launch, however, is inevitably limited and to a large extent determined by the regulatory requirements in place [4].…”