Brussels (Brussels Morning) The Covid-19 pandemic has shaken up the world. More importantly, it has shown us how important it is to share our expertise and resources, and that includes the need for a strong and inclusive European Health Union. One important area where cooperation has to be strengthened within the EU is in the field of Health Technology Assessment (HTA).
Assessments on new emerging health technologies carried out jointly by experts from member states could have benefited the Union in the course of the current pandemic by facilitating a much quicker and more efficient exchange of information between HTA bodies as to what works and what does not work in terms of treatment options, diagnostic kits and protective equipment, according to the available evidences. Simultaneous structured cooperation would have made work much more efficient, valuable, and viable for all member states. Moreover, an existing HTA coordination group comprising national HTA agencies would have been able to provide an analysis of available evidence to all member states in a relatively short time, thereby helping them determine and shape key national decisions. Had the Union had the help of the coordination group, we could have avoided the widespread diversity of approaches that occurred within the EU, which surely failed to help deliver a rapidly coordinated response to the common challenge faced by all.
What is HTA?
HTA is a research-based tool to support decision-making in the healthcare sector. It assesses the added value of new or existing health technologies such as medicines, medical devices and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis or treatment, when compared with other health technologies. HTA is defined as a multidisciplinary process that summarises information in a systematic, unbiased and robust manner concerning the medical, economic, organisational, social and ethical issues related to the use of a health technology. HTA, therefore, makes it clear as to whether a new health technology should be reimbursed by health insurers or national health systems. Although regulation of pharmaceuticals and medical devices is largely done at European level, HTAs are still carried out at national level.
Currently, the HTA process is performed by about 50 different HTA bodies established in 26 member states and in Norway. Some use the same methods to assess medicine and medical devices while others take a different approach. This means that the level and speed of patient access to new medicines and medical devices across the EU can vary significantly.
Although cross-border European cooperation such as the HTA Network and EUnetHTA has existed at a technical level for years, it has become clear that cooperation on a voluntary basis is not optimal and that the results are seldom adopted.
The HTA regulation addresses the shortcomings of the current model of EU cooperation on HTA, which in its current form, as noted, remains purely voluntary. This leads to delayed and distorted market access for health technologies because the various HTA processes and methodologies that do exist across the EU contribute to duplication of work for national HTA bodies and the industry in general, and therefore compound the unsustainability of current cooperation.
With this regulation, we make the first step of the HTA — that is the clinical assessment — a joint one with all member states. At the same time, the HTA regulation marks a first step towards a stronger European Health Union and delivers a first output of the Pharmaceutical Strategy for Europe.
What is certain in respect of the HTA debate is that EU cooperation is needed to ensure a constant exchange of information and knowledge between the Union’s HTA institutions in order to increase synergies between member states, to streamline HTA methodologies, to increase transparency and evidence-based decision making, as well as to enhance predictability for the industry as a whole. Also, it means that the industry can devote the freed up time and resources to medical research instead of remaining preoccupied with the demands of the multiple bureaucratic submission systems across the Union.
Cooperation at EU level will lead to significantly greater efficiency. Nowadays, the development of new drugs and new medical technologies is moving faster than ever. The joint approach has the advantage that we can draw on the expertise of all member states. This is particularly helpful when needing specialists for assessments in the field of niche products. Individual countries will be able to make better use of scarce resources and focus on issues of specific importance to their respective countries, while at the same time taking advantage of the comprehensive data collected at the EU level. Accordingly, such cooperation will provide timely results and a high quality consistency.
Parliament’s mark on the HTA-Regulation
After almost four years in the making, the European Parliament gave the final green light during its last December plenary session and the HTA regulation is now ready to come into force. When the Commission initially put the HTA regulation forward in January 2018 it required improving. Among other issues, Parliament focused on the need for stronger stakeholder involvement, an ambitious timeline and increased transparency and implemented appropriate measures accordingly
With regard to the timeline, the first step will be to assess all new cancer drugs, as well as all so-called advanced therapy medicinal products (ATMPs), medicines for human use that are based on genes, tissues or cells. Three years hence, a second step will require that all drugs against rare diseases are added and then, after two more years, it will apply to all other drugs and medical products. The pooling of resources, especially those for scientifically complex drugs such as cancer drugs or ATMPs, will help ensure that there is easier access to these across the Union. The outcome of the joint assessment will be key to support all member states in their national decisions and negotiations.
This regulation will not only benefit member states by providing better data for national decision-making and enhancing their healthcare systems to become more sustainable by selecting the technologies for which HTA has shown an added value, but it will also be of major value to patients, insofar as innovative technologies become available faster. Moreover, the EP has ensured that the involvement of all stakeholders, patients and healthcare professionals especially, is secured throughout the process. By making the publication of reports mandatory, the joint process will not only be shared but will also be more transparent and more comprehensible.
Finally, in strengthening cooperation at EU level, the competent authorities will be supported more effectively when it comes to assessing the real added value for patients of new therapeutic options. More and more pharmaceutical products do not reach the patients where needed. This is due to a number of reasons, including market failure, lack of competition and individual company marketing strategies. Markets can be flooded with products with extremely high prices, yet not have any actual added value. We owe it to all European citizens, who need to be confident that the newly launched medicines will meet the highest standards and be equally accessible – wherever they may be in the EU.
The first health technologies are expected to be assessed as of 2025 following the transitional period of three years. It will be worth the wait. Not only will the new regulation benefit member states, HTA bodies and HTA developers amongst others, but by making sure that the most valuable advances in health technology are available across the Union it will benefit citizens as whole.