OBJECTIVES: This study discusses tangible ways to improve synergies among regulatory, HTA and clinical guideline development processes. The aim was to discover how convergence of evidentiary needs among stakeholders may be achieved, and to identify to which extent converge can be achieved.

METHODS: Eight online dual moderator (mini) focus groups were organized in April/May 2021, contextualized within the case studies diabetes mellitus (DM), head and neck cancer (HN), multiple sclerosis (MS) and myelodysplastic syndromes (MDS). Forty-two experienced (over 10 years) regulators, HTA representatives and clinical guideline developers participated.

RESULTS: Convergence among healthcare decision-makers may be achieved through improved communication, e.g. through shared definitions and methods. Institutionalization of multi-stakeholder early dialogues could enhance mutual understanding, manage expectations and build trust. A culture that is receptive to change, governance based on motivated individual leadership, as well as the right incentives and legislation may facilitate these changes.

Limits to convergence exist as collaborative core data sets should be inclusive rather than aligned. Deliberation and decision-making is preferably independent, though an exception may exist for regional efforts with shared interests. Alignment could be sought in pragmatic clinical trial design, patient registries, assessment methods, policies and timelines. There was a call for a life-cycle approach, although this must first prove beneficial to motivate stakeholders for additional data generation and reassessments. Alignment efforts should aim to simplify or centralize the European market access system, in order to scrutinize the use of resources. The required prioritization may be achieved through horizon scanning or based on unmet medical need. Smaller and lower income countries should be included in alignment efforts.

CONCLUSIONS: Actors in the field believe that improved communication may increase mutual awareness among stakeholders and thus improve alignment. Alignment should respect the individual stakeholder’s remits and geographical independency. Despite, alignment may enhance patient access and reduce duplication of efforts.