Uncertainty tolerance among experts involved in drug reimbursement recommendations: Qualitative evidence from HTA committees in Canada and Poland.

Abstract Objectives Drug reimbursement decisions often rely on health technology assessment (HTA). Increasingly, new drugs have limited clinical evidence and uncertain clinical benefit. Our goal was to describe how members of drug advisory committees and other stakeholders conceptualize and tolerate uncertainty and how they rationalize uncertainty tolerance. Methods Our triangulated parallel design applied two qualitative methods. We interviewed 31 members of drug advisory committees in Canada and Poland about their information needs and included hypothetical scenarios with uncertain clinical benefits. Respondents speculated about their likely reimbursement recommendation. We analyzed written recommendations of the pan Canadian Oncology Drug Review for drugs with uncertain benefit and compared initial recommendations to the responses from patient and clinician groups. Results Uncertainty tolerance varied among committee members and across jurisdictions. In the scenario analysis, 7 Canadian and 11 Polish respondents leaned against recommending a hypothetical drug with uncertain clinical benefit, whereas 5 Canadian and 5 Polish respondents leaned in favour. Those against rationalized that uncertainty increases potential harm; those in favour rationalized that patients often have no alternatives. The document analysis revealed that patients had higher uncertainty tolerance in general. Conclusions Uncertainty tolerance varies among committee members and other stakeholders depending on their backgrounds and on the decision contexts. We argue that policy guidance around uncertainty management could improve the transparency and consistency of recommendations.