European Union: The New EU Regulation On Health Technology Assessment

In the context of a global pandemic caused by the Covid-19 virus, the emergence of new health technologies, such as new vaccines created from mRNA, is a structural component, and as such, indispensable to health systems. In fact, the connection between technology and health has never been so close. This connection is enabling new technologies to treat new and old diseases, improving the quality of life of patients, and increasingly focusing the treatment on their individual needs and the outcome of such treatments

The technological bases of care have increased dramatically in the last century, particularly in terms of equipment, medical devices, and medicines. While generating unequivocal health gains, health technologies also raised questions regarding financial sustainability of

health systems with consequences for patient effectiveness as well as resource allocation.

The concept of health technology assessment

The expression health technology is used to cover any aspect of healthcare, including prevention programs (example: vaccination programs), diagnostic tests, a device or piece of equipment, a drug or a procedure, being that health technology assessment (HTA) is a form of a policy that examinates short and long-term consequences of using a healthcare technology. It is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. This procedure aims to contribute to the formulation of safe and effective patientcentred health policies in order to deliver the best treatment that brings most value to the patient.

The goal of HTA is to inform the development of safe and effective, health policies that are patient focused and seek to achieve best value as defined by decision makers. HTA supports decisions such as:

• Should treatment A be reimbursed in a national healthcare system?
• For which patients should it be provided?
• What are the characteristics of the patient and the disease which best suit the treatment?
• What is its cost and effectiveness of such treatment?

HTA may look at the impact of a technology on an individual patient, on a group of similar patients, on the healthcare system as a whole, or on all of these. HTA may also use modelling, where specific assumptions are used to make an estimate or 'best guess' to predict, for example, the cost of using a technology in a certain setting or in a certain patient.

Correlation between health technology assessment and Value-Based HealthcareValue-Based Healthcare (VBH) is accompanied by considerable ambiguity concerning the very meaning of the concept. Despite this ambiguity, it is safe to say that this new way of looking at health management argues that the value in health care consists of what matters most to patients, meaning, the health status they achieve (outcomes) and the price they must pay for it (costs). According to this new method of health care delivery, providers should focus on generating maximum value for their patients by helping them achieve the best possible outcomes and by doing so in a cost-efficient way. The use of this approach can include a reduction of costs to achieve better health and the increase of treatment efficiencies and patient satisfaction.

Value-Based Healthcare (VBH) is accompanied by considerable ambiguity concerning the very meaning of the concept. Despite this ambiguity, it is safe to say that this new way of looking at health management argues that the value in health care consists of what matters most to patients, meaning, the health status they achieve (outcomes) and the price they must pay for it (costs). According to this new method of health care delivery, providers should focus on generating maximum value for their patients by helping them achieve the best possible outcomes and by doing so in a cost-efficient way. The use of this approach can include a reduction of costs to achieve better health and the increase of treatment efficiencies and patient satisfaction.

Given the fact that VBH focuses on health status (outcomes) achieved by a certain treatment and the price the patient must pay for it (costs), in a cost-efficient way, new technologies and the information available regarding the use of said new technologies plays a decisive role in implementing a VBH system. To that end, the process regarding health technology assessment can provide a precious help in assessing the added value of new or existing health technologies – medicines, medical devices and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis, or treatment – compared with other health technologies. HTA can be used not only to guide different authorities about whether a new treatment or other technologies should be available on the national health service, but also to assess if a certain treatment for a certain disease or a specific condition provides value in terms of health status for that particular patient in a cost-efficient way. HTA can therefore provide information to support decisions about priorities in healthcare or specific decisions about whether new treatments should be introduced, what is the cost-effectiveness of its use in certain patients and its positive or negative effects. By using this detailed information patients and health care providers can decide which of the available treatment options best meets their needs

HTA can also be used as a tool to implement a VBH system through a health economics assessment. In this regard, the assessment of a new treatment can be made through principles of economics that are applied to health and

healthcare. In this perspective health economics can be used to provide evidence to support value for money considerations. Health economics data may cover both direct costs (such as the number of drugs used by a patient or the number of hospital visits in a given period) and indirect costs (such as the cost of time lost from work). The economic data combined with clinical effectiveness data leads to cost-effectiveness estimates.

HTA process and its considerations about health economics, cost, effectiveness, application to certain patients and comparison with procedures, drugs or medical devices is shaping the way health care providers look at the needs of their patients. In doing so, HTA can serve as a precious tool of data that allows health stakeholders, including government decisions and hospital management, to implement a real VBH system, focusing on creating value treatments with good outcomes for the patients in a costefficient way, using new technologies or assessing from all the medical options that can be applied to a certain patient the ones who suits them better

HTA Regulation in the EU

The HTA process is currently performed by 50 HTA agencies across Europe. Nevertheless, approaches vary from country to country which means a fragmentation of HTA criteria with serious negative impacts on the European health market and patients in its Member States.

To support cooperation between HTA bodies, the European Union has made substantial investments. Two Joint Actions have been carried out together with a number of projects. A third Joint Action was launched in June 2016 and run until 2020. This third Joint Action focused on developing common assessment methodologies, piloting, and producing joint clinical assessments and full HTA reports, and on developing and maintaining common criteria. In addition, following the adoption of the CrossBorder Healthcare Directive (Directive 2011/24/ EU), the HTA Network was established in 2013 to provide strategic and political guidance to the scientific and technical cooperation at Unionlevel

Following the negotiations set on June 22, 2021, the Council of the European Union and the

European Parliament reached a provisional agreement on the European Commission's proposal for a European health technology assessment regulation (HTA Regulation), which aims to harmonize the clinical benefit assessment of health technologies across the EU.

This provisional agreement which now establishes the new Regulation (EU) 2021/2282 of the European Parliament and of the Council Of 15 December 2021 aims to achieve the following specific objectives:

• Improve the availability of innovative health technologies for EU patients;
• Ensure efficient use of resources and strengthen the quality of HTA across the EU;
• Improve business predictability

This new Regulation establishes a support framework and procedures for cooperation on health technology assessment at an EU level and common rules for the clinical assessment of health technologies (article 1 of the regulation proposal). The Member State Coordination Group on Health Technology Assessment (the Coordination Group) is formally established in Article 3 along with its composition, roles, and responsibilities to oversee the joint work referred to in Chapter II. This joint work is based on the annual work program of the Coordination Group which is outlined in Article 4 of the Regulation. The annual work program provides clarity on the planned work of the Group and allows health technology developers to foresee any expected involvement they may have in the joint work for the year ahead.

The joint clinical assessments will be one of the main proponents of the future joint work, being those assessments limited to: (i) medicinal products undergoing the central marketing authorization procedure, new active substances and existing products for which the marketing authorization is extended to a new therapeutic indication, medicinal products undergoing the central marketing authorization procedure, new active substances and existing products for which the marketing authorization is extended to a new therapeutic indication (ii) certain classes of medical devices and in vitro diagnostic medical devices (iii) potential impact on patients, public health, or healthcare systems (e.g., burden of disease, budget impact, transformative technology) (iv) significant cross-border dimension, and (v) Union-wide added value.

Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 provides for progressive implementation of the amount of joint clinical assessments during the transitional period. This means that the number of joint clinical assessments will increase gradually during the first three years after the date of application, considering specific selection criteria.

Chapter III of the Regulation lays down common rules for carrying out clinical assessments at Member State-level which will then be developed in detail in tertiary legislation. These rules will ensure a harmonized approach to clinical assessment across EU Member States.

Closing notes

Common rules in all EU Member States about HTA can serve as grounds for establishing a deeper VBH system. The correlation between, HTA criteria, mainly the criteria that sets rules to assess the health status (outcomes) achieved by a certain treatment and the price the patient must pay for it (costs), in a cost-efficient way, can be a precious help to implement a real VBH system in the European Union. With this regulation patients will be empowered, and medical personal better informed by having access to a Joint Clinical Assessment report that is of high scientific quality, transparent and accessible to the public.

To establish a VBH system it is necessary to provide the right tools that enable medical personnel as well as health care providers to compare various health care options, choosing among them the ones that offer a better treatment to the patient, with better results and at an efficient cost. The new EU Regulation

could set equal criteria for different Member States, serving as a driver for the implementation of a European-wide VBH system.

Although we do not yet know the full extent of what the Joint Clinical Assessment report will present, this Regulation can establish a true cooperation in HTA, giving a real opportunity to relate the cost-benefit of each treatment to individual patient considerations, implementing what may be the beginning of a real VBH system.

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