W-29: Quality of Decision-making Process in the Development, Review and Reimbursement of Medicines; Its Importance and Implication
Centre For Innovation In Regulatory Science (CIRS) United Kingdom
To evaluate the quality of the decision making processes by companies for evidence generation to support reimbursement and HTA agencies appraisal process to recommend reimbursement, in comparison with results from a regulatory perspective on company decision to submit and agency review decision.
Questionnaires on reimbursement decision making were sent to 16 HTA agencies (Australia, Europe, Canada, Latin America) and 24 multinational companies and compared with published results of questionnaires sent to 14 regulatory agencies (Australia, Asia, Europe, North America) and 25 companies.
All the companies and HTA agencies indicated that they have a committee that is involved in the reimbursement decision-making process. This was in line with the results from the regulatory respondents. There was divergence regarding the type of system that was used: all HTA agencies and 75% of companies indicated that their organization’s decision-making process was mixed (takes into account quantitative and qualitative elements), as opposed to regulatory agencies and companies where it was either qualitative or quantitative. Similarities were seen amongst companies for both the reimbursement and regulatory internal decision making: decisions were made either through consensus (66% and 41% respectively) or by one individual (34% and 35%). On the other hand, HTA agencies used a majority vote (63%) or consensus (37%) and for regulatory agencies the decision was made by 1 individual (67%), followed by majority (22%) and consensus (11%). Formal decision-making frameworks were used by 75% of HTA agencies and 50% of companies for reimbursement decision making, which is comparable to the regulatory findings. All the respondents recognized that biases occur during their organisation’s decision making, resulting in actions being taken less thoughtfully; appearing in the presence of conflicting/emotional incentives or leading to patterns being recognized even where there are none. Although only 25% companies and 25% HTA agencies undertook formal assessments of decision-making quality regarding reimbursement, which is similar to 41% companies and 11% agencies regarding regulatory decision making, the majority of participants agreed that the quality of decision making can be measured, both regarding reimbursement (75% company, 63% HTA agency) and regulatory submission and approval (100% company, 90% agency). Moreover, all the reimbursement and the majority of regulatory participants felt that there was room for improvement for their organisation’s decision-making processes.
The science of decision making is well established. However, research on decision making to enable a quality process during medicines’ development, regulatory review, and HTA is less well articulated and it is not certain how it is being applied by companies and agencies.
The results demonstrate some similarities between the decision-making processes of companies and agencies during reimbursement and regulatory approval, such as the use of committees for those processes, the relatively infrequent use of formal frameworks, particularly for companies, as well as the occurrence of biases. Nevertheless, HTA and regulatory agencies use different processes to arrive at the final decision either through consensus, majority or one individual making the decision; as well as different systems, with mixed systems being used primarily by HTA agencies and companies during evidence generation to support reimbursement.
It has been recognized that if a group wants to improve their decision-making process, it needs to measure itself internally. Despite the fact that most participants recognize the need to improve the quality of their decision-making process, the majority of the companies, regulatory and HTA agencies do not currently perform any formal assessments.
These findings support the need to further characterize and improve the quality of the decision-making processes of companies and agencies. Further research into agency and company committees could uncover additional insights into the factors that influence decision making, identify ways for structuring the process and ultimately enable quality, trust and predictability to be built into the critical decisions during medicines’ development, regulatory review and reimbursement of medicines.
Bujar M, McAuslane N, Salek S, Walker S. Quality of regulatory decision-making practices: issues facing companies and agencies. Therapeutic Innovation & Regulatory Science. 2016. doi:10.1177/2168479016628573.