Health technology assessment in interventional electrophysiology and device therapy: a position paper of the European Heart Rhythm Association

Abstract

Healthcare systems face an increasing demand for costly medical interventions. The primary concern of a physician is centred around the best possible treatment for his or her patients, according to patients' requests and expectations. The healthcare system, in contrast, is ideally concerned with the assignment of resources in the best interest of society.1 Clinicians, public health physicians, economists, commissioners, managers, and politicians need to find ways to balance between what is best for the individual patient and what society can realistically afford.1–3 Appraisals of the clinical effectiveness, cost-effectiveness, cost-impact, and commissioning of emerging therapies can inform such judgements and decisions. Health technology assessments (HTAs) provide a means for assessing the clinical and cost-effectiveness of healthcare interventions.4 The aim of HTAs is to provide unbiased, rigorous, and transparent guidance in the application of emerging therapies, in the background of available resources.5,6 They are, in effect, a link between clinical evidence and policy-making, informing government agencies, healthcare professionals and administrators, private sector organizations, the healthcare industry, as well as patients, carers, and the general public. The past decade has witnessed relentless advances in interventional electrophysiology and device therapy. This has mainly been attributable to the development of cardiac resynchronization therapy (CRT),7 the widening indications for implantable cardioverter defibrillator therapy,8,9 and the emergence of ablation for atrial fibrillation (AF).10–12 Characteristically, these therapies involve initial costly equipment and procedures, delivered in a specific infrastructure, while their benefits are generally accrued over the long term. Not surprisingly, such therapies attract scrutiny from commissioners and policy-makers. In this position paper, we review a series of issues that are related to HTAs for catheter ablation and device therapy and that in our view deserve attention. The mission of a HTA is to offer guidance to decision-making at the level of the individual clinician, hospital, health economy, and a healthcare system as a whole. The inputs to a HTA come from clinicians, clinical guideline groups, epidemiologists, biostatisticians, economists, commissioners, and health policy-makers (Figure 1). To maintain transparency, HTAs count on the participation of other stakeholders, such as paramedical professional groups, technologies' producers, and patient groups. It is this multidisciplinary approach that has popularized HTAs in the implementation of clinical interventions.2 Regional policy decision-making as well as regional economics are pivotal in the delivery of healthcare and therefore, regional input is required in the development of HTAs. This is particularly important in communities such as Europe, where wealth, healthcare provision, and costs of medical interventions vary widely. While harmonization of healthcare provision remains an unlikely option in today's Europe,13 aspirations towards a common ground should not be dismissed. The recommendations from bodies such as the EuNetHTA network14 (Supplementary material online, Table S1) strive to establish such common ground. The process of health technology assessment. The HTA process consists of three phases: scoping, assessment, and appraisal15 (Supplementary material online, Table S2). The benefits of a given therapy may be measured in terms of efficacy or effectiveness. While both of these are measures of how well a technology improves patients' health, efficacy refers to the benefit of using a technology under ideal conditions, e.g. within a managed randomized controlled trial, whereas effectiveness refers to the benefit of using a technology in the ‘real world’. Both measures have their advantages, but reflect different aspects of the therapy and/or the specific population in question. Systematic reviews have become the most widely accepted means of appraising evidence of clinical efficacy and clinical effectiveness. In recent years, many recommendations on how best to conduct systematic reviews have been developed.6 The Cochrane Collaboration, the Scottish Intercollegiate Guideline Network Review Group, and the German Institute for Quality and Efficiency in Health Care are among the most prominent organizations that provide guidance on systematic reviews. Tools, such as PRISMA and MOOSE, should also be used in reporting the findings of systematic reviews.16 The outcomes of medical interventions or programmes may be measured in terms of physiological outcomes, clinician-reported outcomes, caregiver-reported outcomes, or patient-reported outcomes.17,18 It is accepted, however, that patients are the most legitimate source of information about their own health18 and therefore patient-related outcomes have been adopted as the most important reference. In the specific field of electrophysiolog