EARLY NICE DECISION PROBLEM MEETINGS- IMPLICATIONS FOR CROSS-FUNCTIONAL INDUSTRY TEAMS

The National Institute for Health and Care Excellence (NICE) in England and Wales is currently piloting a process whereby decision problem meetings are held several months before starting a technology appraisal, rather than approximately 10 weeks after formal invitation for the manufacturer to submit evidence, per current protocol. In general, the purpose and outcomes of the meeting, involving the NICE team and representatives from the evidence research group (ERG), do not change other than happening earlier. However, the meeting does allow manufacturers and sponsors to signal potential regulatory developments during the appraisal, ahead of the submission, to indicate potential inclusion and handling of patient access scheme proposals. For the meeting, an outline is required to demonstrate how the manufacturer/sponsor intends to approach the decision problem. This outline is to include, but is not limited to: evidence sources to be used; evidence likely to become available during the appraisal and how this might be managed; the planned approach to disease and economic modelling; potential challenges in interpreting the evidence; proposed approach to handling of uncertainty. If adopted, there are several implications of this new process for manufacturers/sponsors: market access strategy will need to be considered earlier than currently, with implications for data availability and analyses, value story development, positioning and indications, etc; cost-effectiveness models and their base cases will need earlier definition and completion; intentions regarding patient access schemes must be made before submission; ERGs may be reviewing limited published evidence in fast-moving therapy areas; ,manufacturer market access groups will require more information from clinical, regulatory, medical affairs, modellers, epidemiologists much sooner that they currently do. Therefore, this seemingly simple change of meeting date relative to time of submission has important implications for manufacturers beyond their market access teams that require careful consideration in terms of planning and communication.