Table 1.

Identified key domains to address the challenge of processes

Process Challenges
Key Domains	Address challenge of multiple PICOs	Time and capacity challenges	Integrating all involved stakeholders	Conflicts and aligning	Interaction with health technology developer
Description	PICO is the basis for both the advice as well as the assessment. Early discussion of PICO and agreement across regulatory and HTA stakeholders is critical to design a clinical development program	Ensure sufficient capacities to allow for early and inclusive collaboration e.g., sufficient joint early advice opportunities and to allow sufficient time for submission, generation and publication of the assessment report so national processes are not impacted	EU HTA will shape future oncology care across Europe. Early and inclusive involvement of all stakeholders (patients, HTA bodies, regulators, clinicians, industry) is key to ensure success of the regulation	Overcoming current multiplicity and/or duplication of national HTA procedures is at the heart of the EU HTA regulation. Resolution of divergences between national and EU HTA bodies and between the various other stakeholders is key	Early and inclusive collaboration between clinicians, patients, regulators, HTA bodies and the industry to ensure that the developed medicines are addressing an unmet medical need
Guiding Questions	What is the rationale for different PICOs? Are there options to decrease fragmentation of PICOs? How can the challenge of a PICO changing from advice to assessment be addressed?	What is the expected number of new oncology drug applications / year and the related joint scientific advice capabilities of EMA/ EU HTA? What can be done to increase the number of available joint scientific advice slots?	How are the various stakeholders involved throughout a medicine’s HTA process? How will their input be used and where can it help improve the quality and usability of the assessment? How to ensure a strong clinical input?	How to ensure national HTA bodies incorporate the JCA into their process, improving the quality of decision-making and enabling timely patient access? How to resolve or contextualise different recommendations of regulators vs HTA bodies?	What are benefits of early and inclusive collaboration with the HTD in delivering the objectives of the Regulation? At what stages and frequency should this engagement occur?