The "secret update"?

The changes in the new deliverable include a glossary and a detailed description of the start of the PICO scoping in the individual member states by a basic PICO scheme, which will be developed by the responsible assessors. According to the update, the assessors shall work out a consolidated PICO proposal once they have received relevant information on the therapeutic indication from the following sources:

• European guidelines for the disease area to obtain information on the natural history of the disease, available therapy alternatives, and relevant endpoints,
• Alternative guideline documents (if no European guidelines have been identified for the disease area of the claimed therapeutic indication),
• Clinical opinions from relevant experts in the field of application.

Furthermore, Member States should provide additional PICO(s) and subpopulations when responding to the PICO scoping if the assessors' proposal does not fully cover their national requirements. The guidance further states that in cases where there is no suitable comparator for all patients in a given population (in heterogeneous subpopulations and in the absence of a clearly defined evidence-based standard of care), the different treatment options and comparators should be regrouped as so-called "individualized treatment", similar to the "patient-individualized therapy" known in Germany, and a PICO should also be distinctly defined for "individualized treatment". The document further includes new details about the process of reducing the total number of PICO schemes during the PICO consolidation.

With the probable postponement of the publication of the first Implementing Act on JCA to Q1 2024, the new guidance document brings new insights into the implementation of the PICO scoping process, which will be of high strategic importance for the market access process of future drugs. Which of the proposed amendments will ultimately be adopted in the legally binding Implementing Act will, however, only become clear after its publication.

If you are looking for a strategic partner to achieve the greatest possible planning certainty for your product's EU HTA process in view of the current situation or need further insights into the current changes to the scoping process, please do not hesitate to contact us. We are the market access special forces.

Sources:

• EUnetHTA 21 Deliverable 4.2, Version 1.0 (currently not available)
• EunetHTA 21 Deliverable D4.2, Version 1.1 (currently not available)
• We will be happy to provide you with the sources on request.