DIA EUROPE 2018

Unmet need is an important criterion for medicines to qualify for facilitated and accelerated regulatory review and approval processes. Yet slightly different definitions of the term are used by the EMA. Some payers have special considerations for medicines of high unmet need, like the End of Life criteria in the UK. More often, however, when it comes to health technology assessment (HTA) and price negotiations, payers argue that unmet need is not well defined or not clearly demonstrated. Patients have another personal perspective. The lack of common interpretation leads to inconsistent signals for companies when looking at their R&D prioritisation models and the actual patient access. As a result, medicines that have achieved fast regulatory approval on grounds like unmet need may lose that advantage during the subsequent market access processes. In this dialogue session, we will explore two areas in detail: Can stakeholders align on a common definition of unmet need that would provide more predictability for all? Should there be a different assessment of price relative to value in drugs that address areas of unmet need?