Purpose:In this workshop, the speakers propose to confront different perspectives: an academic professor, a national payer from the G-BA, Germany, and a regional payer from Spain (Catalonia) in order to share what the actual evidence requirements to minimize uncertainty are. But also to answer the following questions: How should evidence be presented? How could commitments such as Coverage Evidence Development (CED), Payment for Performance (P4P), time-limited requirements reassure payers? How to address the difficulty for payers to reverse an initial decision? How to avoid that uncertainty is managed implicitly or sometimes irrationally by payers?
Description:With ever rising prices of new breakthrough drugs, it has become critical for payers to manage uncertainty around the benefits delivered by those drugs. In order to assess the uncertainty associated with new interventions there are several technical tools such as modelling, including probabilistic and deterministic sensitivity analysis. Payers have established new practices that limit the potential opportunity cost associated with uncertainty at the time of launch, including measures targeting individuals (P4P) or populations (CED), time-limited requirements for additional evidence, restricted and controlled coverage in limited populations, but also flexible payment etc. Although all these measures have been implemented differently in several countries they do not seem to be sufficient to reassure payers, and the difficulty to reverse an initial favourable decision by accepting low evidence levels appears to be an important component of payers’ decision making. Based on their long experience, the contributors will explain how uncertainty has become a critical issue for payers and why, and how they have changed the level of evidence required to minimize uncertainty. Contributors will involve the audience by encouraging them to provide input and real life experience to enlarge the contribution to this debate.