OBJECTIVES:

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) entered into force in January 2022 and will apply from January 2025. The aim of the HTAR is to improve the availability of innovative technologies for EU patients and to increase efficiency through joint clinical assessment (JCA).

The process foresees that, according to principals of evidence-based medicine, the PICO criteria (Patient Population, Intervention, Comparator, Outcome) are used and defined at national level. All PICO criteria are then to be addressed in the JCA.

The objective of this analysis was to evaluate the overlaps and differences in the PICO criteria between different EU countries.

METHODS:

We compared the PICO criteria of individual EU countries, explicitly France, Germany, Spain, Italy, Belgium and Netherlands. First, we compared the current methods of HTA of the EU countries according to the applicable regulations. In addition, we surveyed local HTA experts using a standardized questionnaire.

RESULTS:

We identified both overlaps as well as differences between the EU countries regarding the PICO criteria. For example, the relevant patient population can either be the population according to EMA approved indication, the study population, or the population to be reimbursed depending on the country. Equally, country differences are shown in the relevant comparator because the standard of care depends on country specific guidelines and reimbursed drugs. Concerning the outcome, the currently accepted endpoints differ between the countries.

CONCLUSIONS:

Per current EUnetHTA scoping process there will not be an aligned PICO grid. This leads to several challenges such as the generation of an extensive amount of data that was not planned a priori within a short time frame. Further, it is not possible to provide direct comparisons for all comparators based on the clinical development program. An alignment of PICO criteria requirements should therefore be considered.