Improving patient access to novel medical technologies in Europe.

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.

Patient access to medical technology across Europe.

Access to medical technology differs across Europe. Differences in funding and reimbursement systems create barriers for the adoption of new and innovative medical technology. It is obvious that a joint effort between representatives from the industry and the profession has great potential to emphasise inequitable discrepancies and thereby improve the availability of accepted innovations in cardiovascular medicine. It is equally obvious that future efforts to overcome such restrictions to availability must be directed at the individual country level. The involvement of the profession, perhaps best accomplished by activation of National Cardiac Societies, will be mandatory for success. Collaboration with the industry is then a likely key factor for success. Presently there seems to be a great lack of knowledge and interest for this important aspect of a well functioning health care system and the responsibility to improve it remains with the professional societies. They need to allocate time and resources for this purpose, educate their members and lobby within their countries with the ambition to create better, more uniform and transparent procedures, and to become natural partners in the funding and reimbursement processes.

Health technology assessment for medical devices in Europe. What must be considered.

OBJECTIVE: To inform about the specifics of medical devices and the resulting consequences for health technology assessment (HTA) and to present the European industry position on this topic. METHODS: The paper is based on an intensive debate within Eucomed, the European trade association in the field of medical devices, informed by an HTA Experts Group, comprising experts from within and outside the medical device industry. RESULTS: Based on the specifics of medical devices, there are a number of methodologic considerations that require a tailored HTA, differing from the approach taken for, for example, pharmaceutical products. These differences have an impact on the selection of the technology, the timing of the assessment, the study design, and the patient population. CONCLUSION: The European medical device industry can commit to an HTA that takes into consideration the specifics of medical technologies, which is appropriate and fair, and which is done under full participation of industry. Under these circumstances HTA can be a useful tool to support rational decision making in health care.