Working With Epistemic Uncertainties: Emerging Entanglements Within Conditional Reimbursement Practices

Objectives: HTA agencies are experimenting with conditional reimbursement approaches allowing greater flexibility to cope with epistemic uncertainties generated by new health technologies and pharmaceuticals lacking evidence. While some research into promises and effects of conditional reimbursement is conducted, little empirical research investigates how such policies play out in practice. In this paper, we analyze two cases of conditional reimbursement in the Netherlands. Methods: Case studies were purposively selected. We conducted document analysis combined with semi-structured in-depth interviews (n = 28). We analyzed both case studies together through initial thematic analysis and additional abductive analysis. Results were verified through data triangulation. We performed a member check in which we presented our preliminary analysis during a reflection meeting with key stakeholders. Results: We identified three tensions in the practices of CED-schemes: proceduralism versus improvisation, steering professionals versus providing leeway, involving patients as data subjects versus legitimate stakeholders. These tensions explicate several sources of epistemic uncertainties that extend beyond methodological and more well-known socio-political pressures such as from industry on regular reimbursement decision-making process. We note the importance of improvisation work, of normative considerations, and of epistemic hierarchies. Conclusions: We postulate that the emerging uncertainties within the practice of CED-schemes are to an extent unavoidable as they emerge from the necessarily interactive and normative nature of human relations. We conceptualize this with the notion of ‘epistemic entanglements’, which highlights how normative and scientific dimensions are interwoven in reimbursement decisions. As epistemic uncertainties are difficult to reduce and tame in practice the need for a more reflexive and inclusive approach to conditional reimbursement decision-making becomes apparent. Public interest abstract: New technologies and personalized medicines can have great health benefits for patients, but often not enough knowledge is available to assess whether these innovations live up to their expectations. At the same time, despite this uncertainty, governments need to make a decision about whether or not to reimburse these innovations. Many countries are experimenting with forms of conditional reimbursement: temporarily reimbursement of technologies until more evidence is collected regarding (cost-)effectiveness in practice. Although much literature addresses potential benefits and drawbacks of conditional reimbursement policies, few studies look into how such policies play out in practice. In our research we study two examples of conditional reimbursement practices. We show conditional reimbursement practices lead to three new tensions. We conclude that HTA agencies would benefit from approaches that recognize that evidence-development and normative considerations are intertwined.