Early Assessment of Medical Technologies to Inform Product Development and Market Access: A Review of Methods and Applications

Article excerpt

1. Introduction

Worldwide, billions of dollars are invested in medical product development and there is increasing pressure to maximize the revenues of these investments.[1] That is, governments need to be informed about the benefits of spending public resources, companies need more information to manage their product development portfolios and even universities may need to direct their research programmes in order to maximize societal benefits. Therefore, many people have urged for more interaction and an open innovation vision.[2-6] Most of the deliberation takes place around the need to balance the expected economic growth from investing in new medical technology against the control of the ever-increasing healthcare spending due to medical technology. For the latter purpose, several people have worked on tools to inform policy makers about adopting new medical technologies.[7-9] However, notwithstanding the importance of the timely informing of decision agencies for regulating market access, many decisions regarding, for instance, target population and setting, and technology design features such as connectivity with existing data infrastructure and other technologies, are already taken in earlier stages of development and might be difficult (i.e. expensive) to change at this point.[10] Hence, it seems appropriate to ask, 'are these investments justified by the public benefits and what can be done to identify successful products and to increase the efficiency of product development and use of public resources?'[11]

1.1 Justifying Public Spending: Economic Development vs Cost Control in Healthcare

Compared with many other markets, public investments in healthcare research are less likely to lead to economic growth because of the strict regulation of market access. Here, innovators and policy makers are clearly faced with market constraints as they apply in healthcare. Although several countries do not have a strict regime of utilitarian reasoning, most do adopt some form of health technology assessment (HTA) to inform decision makers. HTA mainly supports decisions on coverage and adoption of new medical products from a variety of perspectives, including economic, ethical and regulatory. Increasingly, the patients' perspective forms a part of the HTA deliberative process. In contrast with many other markets, adoption in healthcare is directly related to the ability to produce cost-effective solutions. Despite criticism against resource allocation decisions using cost-effectiveness analysis, it seems that most people and even industry have adopted this way of reasoning. Cookson et al.[12] concluded that the UK National Institute for Health and Clinical Excellence (NICE) does not challenge industry to produce value for money but has become their 'golden goose'.

It may also explain industry's reluctance for innovation in market access regulation and pricing as, for example, developed by the German Institute for Quality and Efficiency in Health Care (IQWiG).[13] It is assumed that changes in access regulation and reimbursement introduce uncertainty and do interfere with a company's product development strategy. For instance, value-based pricing as a principle of cost regulation may disincentivize investment in new product development.[14] Therefore, industry may prefer strict regulations such as cost per QALY thresholds as implemented by NICE. As many investments in medical product development simply do not lead to useful or cost-effective products, the market access regulation in healthcare can therefore only serve as a starting point in analyses that support early-stage decision making.

1.2 Early Health Technology Assessment (HTA): Concepts and Applications to Inform Health Policy

Several attempts have been made to inform health policy about new and emerging technologies.[7-9,15-17] Often this is called horizon scanning systems (HSS), but some have introduced it as 'early warning systems'. …