EUnetHTA aimed to build a strong network of HTA institutions and develop a range of practical tools that would increase the impact of HTA at all levels of healthcare. It also sought to reduce duplication of effort and to increase HTA input to decision making in European countries and the EU.

1. To increase the impact of HTA at all levels of healthcare

The EUnetHTA network is a structure for HTA collaboration in Europe, allowing national and regional HTA agencies, research institutions and health ministries to exchange information. This is important for facilitating harmonisation of policy and enhancing the impact of HTA on patient outcomes.

The network’s objectives are to increase the use, quality and efficiency of European HTA. The aim is to establish an effective and sustainable HTA collaboration that brings added value at the regional, national and European level.

It also aims to address methodological challenges in the implementation of Joint Action 3 (JA3), which requires rapid relative efficacy assessments (REAs). A pilot on REAs is being run jointly with the EMA in 2021.

REAs are comprehensive assessments of the evidence that support the clinical efficacy, safety and cost effectiveness of a new medical product or intervention. They consist of nine domains, including health problem and current use; description and technical characteristics; safety; effectiveness; costs and economic evaluation; ethical, organisational, patient/social and legal aspects.

2. To reduce duplication of effort

EUnetHTA aims to reduce duplication of effort by connecting public national/regional HTA agencies, research institutions and health ministries, to enable effective exchange of information and support to policy decisions in Europe. In addition, EUnetHTA aims to increase the impact of HTA at all levels and strengthen the link between HTA and healthcare policy making in European countries and the EU.

To support the strategic objectives of the project, EUnetHTA aims to make use of contemporary technical opportunities, including Web-based tools developed by other HTA organizations and modern information and communication technology. These innovations have the potential to change the way HTA is carried out.

The production process of EUnetHTA REAs was changed following JA2 experiences and a survey conducted in JA3 (see Table 1). These changes focused on procedural aspects such as transparency, usability, and inclusiveness.

In order to reduce duplication of effort, the POP database was used as a tool to inform HTA agencies when other Partners had started working on the same topic. This information allowed partners to defer their own assessment until the other Partner has finished its project and to save on resources.

3. To increase HTA input to decision making

Health technology assessment (HTA) is defined as a multidisciplinary process that summarizes information about medical, social, economic and ethical issues related to the use of a health technology in a systematic and transparent manner.

The practice of HTA varies considerably across national settings and is highly context-dependent. It informs policy and decision making in a range of political, economic and institutional contexts.

EUnetHTA aims to increase HTA input to decision making in European countries and the EU. This involves supporting countries with limited experience in HTA; strengthening the link between HTA and healthcare policy making at all levels of healthcare; and ensuring that national health systems are well-equipped to implement the findings of HTA reports, both through direct policy impact and by facilitating knowledge translation and quality improvement.

In addition to this, EUnetHTA aims to improve the usability of REAs through procedural changes. These changes are based on qualitative and quantitative feedback from JA2 experiences and recommendations, JA3 feedback workshops and evaluation and implementation surveys.

4. To support countries with limited experience in HTA

Healthcare decision-makers throughout Europe rely on HTA to ensure they are making evidence-based decisions. This involves a range of analyses including relative efficacy and relative effectiveness assessment, which assess the medical or therapeutic added value of medicines compared with alternatives in a controlled environment (relative efficacy) or in real-life settings (relative effectiveness).

A common challenge in CEE countries is that there are limited resources for HTA. In addition, there is a lack of top-level policymakers who have experience in HTA.

Therefore, HTA doers have to be creative and specialized in order to produce effective assessments. This means that training of HTA professionals and staff is vital.

EUnetHTA aims to support countries with limited experience in HTA by developing tools and information resources for HTA implementation. It also aims to create social coherence and establish a communication platform for HTA in Europe. To achieve these objectives, EUnetHTA will focus on the following areas:

HTA is one of the final steps that pharmaceutical companies must undergo before their medicines can be marketed in Europe. It is a vital step for market access and can be costly and time-consuming.

The European Commission recently rolled out a new regulation to harmonise HTA cooperation across Europe. This will benefit patients and providers by reducing duplication of work and accelerating medicines access.

What is an HTA?

An HTA is a structured process used to assess the clinical and economic evidence surrounding the use of new health technologies. This process ensures that new technologies are added only after proven effectiveness and cost-effectiveness have been shown. This is important for reducing the risk of adding or removing unproven technologies that may increase health costs.

The European HTA process consists of two main components – assessment and appraisal (see Figure 2 for a description of these processes). In an assessment, evidence is assembled to evaluate the clinical and economic impact of a technology. The appraisal phase uses the evidence gathered during the assessment to make recommendations about how a new technology should be covered by a health system or payer.

As the global pharmaceutical industry continues to develop new products, there is a need for increased understanding of how these products can benefit patients and what the appropriate pricing should be for these products. This is an area that is rapidly evolving and has spawned many new approaches to health technology assessment.

Depending on the goals and preferences of a health system or payer, an HTA may be carried out as a stand-alone process or part of a larger price determination process. The latter usually entails negotiations between the manufacturer and health system or payer about prices for the technology. The negotiation process is usually based on an assessment of the price-effectiveness of the drug or technology and is often not completely transparent, as it requires that each party be willing to share relevant information about costs and savings.

Another approach to HTA is a “managed access” program. This is a recent development that allows manufacturers to obtain approval of a new technology based on less developed clinical trial results/data provided they collect more robust clinical data that will support its use in the real world. This is often called conditional approval and has the potential to accelerate the pace of a new technology’s access into a healthcare setting, while also potentially improving patient outcomes and decreasing treatment cost.

This type of process could be incorporated into the U.S. drug pricing landscape in the future, although it is likely that implementation will be complex. It will need to be adapted to the political environment and public distrust of government interference in healthcare. It will also need to incorporate a range of factors such as transparency, stakeholder engagement and the impact on access to the technology.

How is an HTA carried out?

Health technology assessment (HTA) is a process by which the properties of a health technology, including the medical, economic and social effects, are evaluated and compared to those of alternative alternatives. It is a systematic method that summarises the available information to help inform decision-making about new technologies in healthcare.

HTA is grounded in a variety of methods, ranging from policy analysis, evidence-based medicine and health economic evaluation to social science. It gives context-specific input to healthcare policies and decisions, which is important in ensuring that the right interventions are used at the right time.

In most cases, HTA is a two-part process. The first part, called assessment, involves systematic review and evaluation of scientific evidence about clinical outcomes and/or economic costs associated with a particular health intervention. This information is then used by the second part, called appraisal, to develop coverage recommendations.

Depending on the goals and preferences of the health system or payer, the HTA process can be implemented in different ways. For example, some countries choose to negotiate prices with drug companies. Others prefer to use risk-sharing schemes that allow companies to discount the list price of a drug in return for providing patients with better access to the medication.

The basic criteria that HTA bodies apply in their decision-making are the comparative clinical and cost-effectiveness of a new drug or technology to its existing standard of care. In addition to this, HTA bodies take into account the benefits that a technology or drug would bring to a health system and whether those benefits are worth the additional cost to the health system.

However, the complexities of implementing an HTA in the U.S., particularly when incorporating economic evidence, may make it difficult for HTA bodies to be influential in the coverage decisions of public and private payers. This is also true in Europe.

Hence, there is an urgent need to identify best practice for conducting HTAs across the European Union and its Member States. This will help to ensure that HTA is an effective and efficient tool for evaluating and informing the use of health technology and to contribute to a more sustainable and competitive healthcare system. The objective is to create a framework that is easy to apply and which allows HTA to become more transparent, consistent and effective.

What are the basic criteria that HTA bodies apply in their decision-making?

Health technology assessment (HTA) is a systematic process that helps governments and other decision-makers in health systems to assess the value of new medicines and technologies. This is a key part of policy-making in many countries. It is used to determine whether a medicine or technology should be made available and to generate guidance on how the new medicine or technology should be prescribed safely and effectively.

In HTA, the benefits of a drug or technology are compared with other treatments that have already been approved and are being used in the same patient populations in the health system under consideration. This comparative clinical and cost-effectiveness analysis is important because it helps the health system decide whether a new treatment offers genuine value to their health system at a price that they are willing to pay.

This is often done through a combination of different methods and approaches, depending on the type of HTA body that is carrying out the appraisal. Some are reliant on high-quality, rigorous studies while others rely more on qualitative research and a variety of other methods such as economic modelling and risk-sharing schemes.

One of the key criteria that are used by HTA bodies in their decision-making is to understand the impact that a new drug or technology will have on patients and their families. This can include what it means to their quality of life, their ability to function, and how their time spent with their family and carers is affected.

The patient and carer voice is often captured during the appraisal process through written requests for information or through participation in a face-to-face committee meeting. Some HTA bodies proactively contact patient and carer organisations to involve them in the appraisal process, and this can help shape the decision-making of the appraisal committees.

The HTA process is often very complex and a significant amount of work is required before any new medicine or technology can be made available. Therefore, it is important that patient and carer organisations have a strong understanding of the different steps of the process. This includes the development of submissions, the assessment process and the deliberations of the appraisal committees.

What is the impact of an HTA?

HTAs have become increasingly central to pricing and reimbursement decisions around the world, and there is growing interest in measuring the impact of these processes. However, there is limited evidence about the link between HTA and outcomes in terms of health improvements.

It is important that an HTA process produces results that are useful for policy makers and the public. These can include a better understanding of the costs and benefits of health technologies. They can also include evidence on how to best use these technologies for improving health.

There are several factors that influence the impact of an HTA, such as the nature of the decision made and the methods used to conduct it. It is also important to consider how the findings of an HTA are disseminated and what happens with them once they have been reported.

Ideally, a well-developed HTA process will have a positive impact on a range of stakeholders, such as the medical community, patients and industry. This is particularly true for medicines, where the process can help ensure that new medicines and technology are available in the health system at an early stage of their development.

In some countries, HTA bodies may also be involved in the development of regulatory pathways or other guidances for medicines and technologies. This can have a positive impact on the ability of health systems to make effective decisions about which technologies are likely to be of use.

Some countries are also working to promote “managed access” programmes for new drugs and technologies. These involve allowing a medicine to be approved on less robust clinical trial data, but with the condition that further research is conducted in order to demonstrate the effectiveness of the treatment. This is a valuable development for the future of the field of HTA, and can offer an earlier route to market.

A more recent development in the field of HTA has been to support the introduction of accelerated approval processes for new health technologies. These have been especially relevant during the pandemic, where regulators had to approve treatments for the flu in a much shorter time period than usual.

Health technology assessment (HTA) is the systematic analysis of the medical, social, economic, and ethical issues of a new health technology. Its aim is to provide evidence-based conclusions that support the decision-making process of health policymakers.

Over the past 15 years, HTA has developed on the European level. From EUR-ASSESS in 1994 through to the development of EUnetHTA and its accompanying network up to the recent elaboration of the EU HTA Regulation, this article shows milestones and developments.

The Network

Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of a health care technology. It covers medical, social, ethical, and economic dimensions and informs decision-making in health policy. HTA aims to identify the best medical practice and help decision makers invest in safe, effective technologies that are not harmful to patients or society at large.

Until recently, there were no structures in place that could provide a common framework for HTA across the EU. This resulted in a number of issues, including duplicative and repetitive work at the Member State level, delayed patient access to novel therapies, and increased costs for both companies and societies.

Therefore, the European Commission was determined to change this situation. It aimed to reinvent EU-wide HTA cooperation, with a particular focus on mandatory joint clinical assessments.

The aim was to streamline the process and share resources, while arriving at a single consensus view on assessments that would be binding across the entire EU. It hoped that this would help to avoid duplicative work by ensuring predictability in the processes.

In its earliest years, EUnetHTA gathered input from different stakeholder institutions, such as trade associations and research organisations. The results of this work were compiled in a set of reports, called the JA1 to JA3 series.

These reports, along with the corresponding methodology and web-based tools, formed the basis for EUnetHTA’s activities. These reports also contributed to the development of a legal and regulatory framework for HTA in the EU.

The resulting EU-HTA Regulation is now in force, and has the potential to secure timely patient access to new medicines by eliminating duplicative work at the national level. However, the regulation has been revised and rewritten several times over the past three years.

Purpose

Health Technology Assessment (HTA) aims to inform policy-making in the health area by providing evidence on benefits and efficacy, clinical and technical safety, and cost effectiveness of new technologies. It is a multidisciplinary, comprehensive and systematic process that involves a wide range of stakeholders, including regulatory authorities, medical experts, patients and patient organisations, and other health care professionals.

In Europe, there are a number of government-appointed bodies responsible for HTA. They vary in their structure, function, remit, and approach. Some are dedicated to synthesising and critically reviewing evidence submissions while others are responsible for the appraisal function, which may include a more thorough review of the overall health impact of a new technology.

The European network for Health Technology Assessment was established in 2006 to link public national and regional HTA agencies, research institutions and ministries of health, enabling an effective exchange of information and support to policy decisions by the Member States. EUnetHTA consists of sixty-four partner organisations from 27 European Union and EEA countries plus Norway.

Since the launch of EUnetHTA JA1, which ran from October 2012 to September 2015, the network has developed a set of methods, tools, and proposals for integrating HTA into policy-making processes within the Union. In addition, the network has produced twenty-seven assessments which are being used in national processes across Europe.

In 2018 the Commission presented a proposal for a Regulation on Health Technology Assessment and amending Directive 2011/24/EU, which was quickly adopted by the European Parliament in 2018. It includes four key elements: 1) mandatory joint clinical assessments; 2) a new coordination group to coordinate these assessments; 3) continuing voluntary cooperation in areas not covered by the mandatory assessments in which individual EU countries will continue to be responsible (non-clinical aspects of health technologies, decisions on pricing and reimbursement); and 4) the establishment of a European Network of Health Technology Assessments (EUnetHTA) to ensure a constant exchange of information and knowledge between HTA institutions in Europe, to increase synergies between Member States, to streamline HTA methodologies, to increase transparency and evidence-based decision-making, and to ensure business predictability.

Structure

The European network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organizations from thirty European countries. EUnetHTA’s main goals are to promote more effective use of resources, increase HTA input to decision making, strengthen the link between HTA and policy making, and support countries with limited experience in HTA.

The network has developed various tools for capacity building, such as a handbook on HTA capacity building and a toolkit for adapting existing HTA reports to other settings. Moreover, it has promoted a network-wide information service on new and emerging technologies.

In the fifth project phase, EUnetHTA aimed to improve the efficiency and standardization of joint work by setting up a quality management system (QMS). A dedicated work package was established to coordinate all QMS-related activities.

Several working groups defined processes and methods to support the assessment teams in producing high-quality assessment reports. The resulting concepts were integrated into a new web platform and made available to the members through a Companion Guide.

However, a number of needs expressed by the assessment teams could not be addressed and required further development and implementation in the future. Consequently, the project’s final evaluation report suggests that the development of a solid permanent QMS with structures and mechanisms for quality improvement and evaluation is essential to support future European HTA collaboration.

In addition to providing a framework for a sustainable and enduring EU network for HTA, the JA3 project also contributed to the capacity building of assessment teams in various European countries. In particular, a series of Standard Operating Procedures (SOPs) were developed in order to define the structure of assessment teams and their tasks. The SOPs include guidelines for the identification of assessors, internal and external review processes, and the collaboration with patients/patient representatives, healthcare professionals, and manufacturers/marketing authorization holders. The SOPs also provide a checklist for quality control, email templates, and links to relevant methodological guidelines and tools.

Activities

Health technology assessment (HTA) is a process that involves an analysis of the medical, social and economic issues related to a new health technology. It seeks to provide health policy makers with the best available information on a new drug or technology. It aims to avoid duplication of work between Member States and to ensure that new technologies are only added to the health package once they have been proven to be effective and cost-effective.

The HTA process begins with a submission by industry for a new drug or technology, and is followed by a clinical assessment of the evidence. This is carried out by a multi-disciplinary committee, which can include representatives from doctors and other healthcare professionals. It also takes into account wider input from stakeholders such as patients and payers in the context of the healthcare system.

Ultimately, this assessment results in a recommendation or conclusion on whether the new drug or technology should be included in the healthcare package for use in the country. This decision is then adapted to the national reimbursement system, and the technology may be used or removed depending on how it fits into the health package.

This process is often accompanied by a European Public Assessment Report (EPAR). It provides health technology assessment bodies (HTABs) with the best available scientific evidence on the medical, social and economic aspects of a new drug or technology.

The EPAR is designed to meet the requirements of both HTABs and regulators, and should therefore be optimised for both. This study aimed to identify opportunities for this by examining the requirements of both HTABs and EMA in the area of clinical evidence, through a literature review and expert interviews with regulators and HTABs.

Conclusions

High quality standards in HTA play an important role in ensuring that health technologies, such as medicines, are developed and used for their full potential benefit. This is essential for patients, the European healthcare system and the wider public. Poor evaluation standards, in contrast, can result in the uptake of technologies that offer little or no added value.

The European network for Health Technology Assessment (EUnetHTA) is a group of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or contribute to HTA in Europe. It is designed to facilitate the exchange of information and knowledge between the different HTA bodies in the EU and to enhance the production of reliable, transferable and useful information on the short- and long-term effectiveness of health technologies.

Currently, there are three Joint Actions aiming at increasing synergies between HTA bodies in the EU and to develop common assessment methodologies and produce joint clinical assessments and full HTA reports. Several other projects are also underway to address specific issues such as the integration of real world data in HTA, joint scientific consultations and cost-effectiveness analysis.

However, the scope of HTA in Europe remains vast and it is not possible to solve all the underlying challenges by voluntary cooperation within a single project. Therefore, we conducted a semiquantitative survey with representatives of HTA bodies to identify the main issues and challenges that need to be addressed in order to successfully implement the European regulation on HTA.

We identified 19 domains related to four key areas processes, uncertainty, comparator choice and endpoint selection that urgently need to be addressed in order to ensure the success of the HTA regulation. These domains included: integrating evidence from clinical as well as real world data sources; generation of comparative evidence in small patient numbers; and including specificities of new health technologies for which some data may not be readily available.