The hospital—Laura Sampietro-Colom

Hospitals are one of the main entry doors of health technologies, but they are also the place where innovation usually flourishes in pursuit of solutions to health and healthcare needs not solved in every-day clinical practice. While sometimes the ideas brought by healthcare professionals seem at first very interesting; only very few of them reach the market. This is due to several reasons, but one of the most important is the lack of a systematic analysis about the potential value of the technology in the early stages of development. Clinicians are usually not familiar with the type of information that is required for making adoption decisions, neither do they know how to analyze whether the product has a chance of properly solving the identified problem (considering all stakeholder perspectives). HTA brings the scientific knowledge and the accumulated life experience on how technologies should be valued, and how they actually are valued by those who will decide on their incorporation and coverage in health systems. By applying early HTA in hospitals, developers can demonstrate the value of their prototypes. Moreover, hospitals can become a perfect lab for start-ups/spin-offs to co-develop technologies and to test their value. An example of this is the evaluation of software (integrated in magnetic resonance technology) developed within a hospital to visualize existing conductivity channels in the heart tissue after a massive myocardial infarction (Reference Crespo, Linhart, Acosta, Soto-Iglesias, Martinez and Jauregui14).

Nevertheless, there are challenges to carry out early HTA that need to be overcome at the hospital level. Still many healthcare professionals are not aware of what HTA is, and those who know it see HTA far from their clinical practice, like something that happens on a macro level and cannot help them in advancing the development of their technologies. One solution is to apply existing expertise on hospital-based HTA in hospitals. Unfortunately, although there is an increasing interest to adopt hospital-based HTA (Reference Sampietro-Colom and Martin15), as exemplified by countries like China and Poland and some European countries, still most university hospitals lack this expertise.

The patient—Dominique Hamerlijnck

Involving patient experts and patient organizations early in the development process of new innovations increases the possibility that innovations will capture the values that are important to patients. To achieve this, technology developers and researchers need to work closely together with patient experts and patient organizations, co-creating from the very beginning. This is also emphasized by Patients Active in Research and Dialogues for and Improved Generation of Medicines (PARADIGM), a European initiative and public-private partnership co-led by the European Patients' Forum (EPF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). PARADIGM develops tools to achieve the co-creation process, especially with patients. All stakeholders, including patients, should be invited to join in an early dialogue. Based on the good evidence input from all stakeholders, joint inquiry can help formulate the right questions and perspective. Where do the needs and requirements of all participants (e.g., patients, scientists, companies, physicians, researchers) meet and which new technologies will benefit all? What are viable options for improvement? How can the technologies, whether medicines or devices, create a positive result for all? What are the relevant questions to ask? And, most importantly from the patient perspective: What outcomes merit improvement? How can these be measured in a fit-for-purpose way? How can we attain content and construct validity and reliability, and measures sufficiently sensitive to detect meaningful within-group and within-patient change (16)? By listening to patients and translating their views, wishes, and needs into questions that are germane for all stakeholders, we can ensure that the health outcomes will be relevant for the patients targeted.

Early HTA can be useful to monitor whether stakeholders agree on the chosen approach, whether advice and scientific evidence is obtained from all, to record progress, and verify whether each step reflects the various ideas and desired outcomes and how this can be improved if needed. Finally, it is recommended to obtain the regulator's perspective on the plans and next steps. This will help save money and effort in both the research and health budgets.

The assessor—Øyvind Melien

While in the inception of health technologies there is a tendency to focus on the launch phase, it is crucial to extend the scope to the innovation's life cycle for the benefit of the patients. Research and development, introduction, follow-up, improvement, or disinvestment of health technologies all rely on continuous information and evaluation with reference to relevance, needs, efficiency, safety, and economic viability. In this chain of events, early HTA may fill a gap by facilitating the interaction among and information dissemination to relevant stakeholders such as patient representatives, health professionals, research and development, industry, authorities, and procurement organizations. A major driving force and consideration in modern medicine is to promote targeted interventions in accordance with the concepts of personalized medicine to address the needs of both the individual patient and the healthcare system in general. Early HTA may then support the development of such targeted health interventions by capturing, evaluating, and sharing valuable data at an early stage to steer the research and development processes into the desired direction. That way it may help improve the life-cycle perspective of novel health technologies from their inception and inform stakeholder dialogues early in the process.

The medical device industry—Markus Siebert

In medical device industry, early HTA is first and foremost an internal process that needs to be established within the company. Because it is so different from traditional HTA, we would prefer to call the approach an “early value assessment.” It involves a multi-disciplinary venture initiated at the inception phase of a technology or during the due diligence process of a potential acquisition. Input from Pricing Health Economics & Reimbursement, Sales & Marketing, Regulatory Affairs, and Clinical Affairs is gathered, incorporating the voices of the relevant geographies. By factoring in its values for payers and/or society early on, the value proposition and price of a technology can be determined in such a way as to improve its acceptability and adoption rate. If this approach is not followed, this may result in an innovation that is not needed or brought to market at costs (and hence prices) that are unrealistic in the eyes of both payers and customers—ultimately impeding market access.

Accordingly, an early value assessment should be a standard component of any pre-market strategy for medical device innovations that are “disruptive” from a technological or financial perspective, at the stage of technology scanning and product conception. For this approach to be successful, robust internal processes need to be established, starting with a decision-making tool that helps determine when an early HTA is needed. Outreach initiatives, comprising early dialogues, need to be launched targeting the most important external stakeholders—payers, hospitals, and where appropriate, patients—to assess their needs and willingness and ability to pay. The technology in question needs to be positioned against the current and possible future realities of coverage, reimbursement, and cost-effectiveness in major geographies of the world.

The results from the early HTA need to inform product design, clinical and economic evidence strategies, and price setting. Although we can draw from existing academic expertise in HTA and hospital-based HTA, it is fair to say that early value assessment also requires new tools and skills. It needs to move much faster than traditional HTA, simulate scenarios, elicit multi-stakeholder input through early dialogues, and ultimately combine the rigor of science with pragmatic advice to industry.

The policy maker—Payam Abrishami

New medical and data-driven technologies are often developed and introduced in the healthcare system in a highly dynamic process. From the policy maker perspective, two characteristics of this process signify the importance of early HTA: the diversity of stakeholders involved and a traditional separation of development and evaluation in the innovation process.

Decisions on the development and introduction of novel technologies are typically made by diverse stakeholders in decentralized arrangements (i.e., at the discretion of local stakeholders in advance or absence of explicit national assessments). Second, new technology is often introduced in a sequential fashion: from ideation to prototype design, to proof of principle, market entry, financing, acquisition, spread, and implementation. Since these tasks are distinctive in terms of execution and immediate information needs, a division of labor in the introduction of innovations seems inevitable. While the responsibilities are dispersed, the purpose is fairly shared: providing value for the patient and value for society (16). Early HTA can be seen as an (as yet missing) “link” between the different loci and foci of technological innovations and the desirable value for patient and society. Early HTA is also congruent with the current policies of regulatory agencies and health authorities to favor promising innovations without imposing strict actuarial controls or top-down restrictions, and is well-attuned to the decentralized, market-oriented processes in introducing medical innovations.

Accordingly, early HTA should have an iterative nature, particularly for expensive technologies or innovations with a broad application field and a potential for large-scale, drastic changes such as telecare, artificial intelligence, gene editing. It helps stakeholders to:

• • clarify the innovation's value proposition, with stakeholders collaboratively identifying claims of benefit of a new medical technology and clarifying its place in the entire care pathway, and

• • establish and sustain “innovating-in-research”/managed entry schemes, where early HTA enhances mutual understanding and alignment between regulatory and HTA agencies, and among innovators, medical professionals, and health insurers/payers on what kind of evidence is relevant to demonstrate the claimed (added) benefits. This involves agreeing on the design of clinical and cost-effectiveness studies early on, including the target population, comparator, relevant outcome measure(s), follow-up period, and, notably, consideration of all relevant patient perspectives. In so doing, early HTA can promote a shift from a first-innovate-then-evaluate approach toward an iterative innovate-and-evaluate approach.