ISSUE: Comparator choice is highly influential on the value assessment of health technologies. Different HTA systems across Europe have different reference cases with respect to defining comparators. A notable point of difference relates to the extent to which treatments that do not represent "established clinical management” should be included, and how this term is defined. For example, treatments that made available only via a temporary/conditional managed access agreement (MAA), and are therefore used in clinical practice but might not be considered as “established” given the uncertainty surrounding their long-term reimbursement.

MAAs are being increasingly used as a route to market access, meaning that in some disease areas standard clinical practice is increasingly dominated by treatments made available through such arrangements. This context is expected to only become more prevalent as treatments become more expensive or associated with more uncertainty and MAAs see more usage. This raises the importance of the question of appropriately and consistently defining comparators.

OVERVIEW: Naomi van Hest will set the scene of how HTA reference cases for comparators differ across Europe and how these differences can impact decision-making (10 minutes), and will moderate the subsequent discussion. Jacoline Bouvy will present the argument for excluding treatments that are not formally part of established clinical management, due to conditional reimbursement through managed access agreements (10 minutes). Gérard De Pouvourville will present the counter argument to this, highlighting the reasons for including these treatments (10 minutes). Finally, Mark Sculpher will provide his thoughts on the strengths and limitations of the different approaches, and on considerations for HTA systems going forwards into an era of increasing managed access agreements (15 minutes). Audience participation will be encouraged via interactive polling and a Q&A discussion (10 minutes). It is expected that pharmaceutical companies, HTA bodies and consultancies will benefit from attending.