Are you ready for the Danish Medicines Council version 2.0?

From 2021 the Danish Medicines Council will change their assessment framework and include QALYs in their decision analytic framework. This will inherently mean a greater focus on cost-effectiveness than in the current process. In addition, the structural setup and requirements will undoubtedly change.

Over the coming weeks, we will focus on each of the essential elements of the new process, include key learnings from the current process, and provide our assessment of the importance of each individual element. We will review the following elements:

  • The QALY – what is it, and how will it impact the process?
  • The clinical application
  • The health economic application
  • The negotiation process

Each element is essential to address optimally. Consequently, it is imperative to be prepared for the new process to increase the chances of a process without delays and a successful outcome – i.e. a win-win for all stakeholders.