September 17, 2024
We've all heard the expression ‘Resources are scarce for unlimited needs’. This scenario applies to many sectors, but it is particularly relevant when we talk about the health sector, namely when making decisions about what to fund, which, ultimately, have repercussions on the health of citizens. Health technologies are part of health expenses in a global market that represents 10% of the European Union's (EU) gross domestic product.1
The EUnetHTA* Joint Actions on Heath Technology Assessment (HTA) have identified 9 areas in which HTA should be carried out (4 clinical areas and 5 non-clinical areas).1 Regulation (EU) 2021/2282 of the European Parliament and of the Council, which entered in force on 12 January 2022, will apply from 12 January 2025 onwards. This regulation seems to have arisen from the need to harmonise the HTA process between the various Member States, seeking to reduce the divergence between assessments, the number of different data requests for Health Technology Developers and the duplication of assessments by the various Member States, since the experience with EUnetHTA was not sufficient to respond to the aforementioned problem.1
One of the objectives requested to the EC was the development of legislation that would make it possible to assess the added therapeutic value and relative effectiveness of health technologies compared to the best available alternative and that would take into account not only the degree of innovation but also the benefits for patients. The interest extends to a concern about the administrative burden that Health Technology Developers face in regard to requirements and deadlines in each Member State. This regulation defines the submission of only one application to the EU, which includes all the relevant clinical evidence for decision-making. It should be emphasised that the outcome of the joint clinical assessments should not affect the discretion of Member States to carry out assessments on the clinical added value of the health technologies concerned or predetermine subsequent decisions on pricing and reimbursement of health technologies.1
It is, therefore, a multi-stage process, with the initial submission of a single HTA application to the EU. This request results in the preparation of a joint clinical assessment report**. The national phase continues with the fulfilment of the requirements of each Member State, which remain responsible for the process at local level. It is important to note that even though a national assessment may take place (for example, analysing evidence data that was not considered in the joint clinical assessment), the joint clinical assessment reports should be part of the documentation whenever they are available. These may be non-binding documents and considered of scientific nature only. The HTA carried out at local level should be shared with the Member States Coordination Group on HTA, responsible for joint clinical assessments.1
In which situations will the Regulation apply in a first phase?
In the first phase, the application of the Regulation will start with a small number of medicines to be evaluated together, namely, advanced therapy medicinal products (ATMPs) and medicines with new active substances indicated for the treatment of cancer whose Marketing Authorisation application by centralised procedure is submitted as from 12 January 2025. After three years from the implementation date, from 13 January 2028 onwards, orphan medicinal products will also be included; it is expected a progressive increase in the number of joint clinical assessments, which should be carried out for other medicinal products submitted by centralised procedure and whenever a new therapeutic indication is approved. In the case of medical devices, those classified as higher risk classes (IIb or III) and medical devices for in vitro diagnostic classified as class D will also be subject to joint clinical assessments. All new medicines will be covered from 13 January 2030 onwards.1
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*The activities of EUnetHTA 21 (European network for Health Technology Assessment), created as a joint consortium of national HTA agencies from 12 EU countries, including Portugal, through INFARMED, with funding from the EC, focused on supporting a future EU HTA system under the HTA Regulation. Joint work was carried out, which contributed to obtain reliable and transferable information. Several documents were produced, such as results of the joint assessments of medicinal products and medical devices and methodological guidelines for carrying out joint evaluations.2,3
**Joint ClinicalAssessment Report1
It should be factualand limited to a description of the scientific analysis, including relativeeffects of the health technology on health outcomes, the degree of certainty ofthe relative effects taking into account the strengths and limitations of theavailable evidence.
It should not contain anyvalue judgement, any ranking of health outcomes, any conclusions on the overallbenefit or added clinical value of the health technology assessed, any positionon the target population in which the health technology should be used, nor anyposition on the place the health technology should have in the therapeutic,diagnostic or prophylactic strategy.
