PREFER patient input to decision making under evaluation
PREFER has developed a framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making. We have asked the European Medicines Agency and EUnetHTA to assess our framework and issue a public opinion on how useful our approach is from the regulatory and health technology assessment perspective. EMA has now published the draft opinion for public consultation! We now invite you and other stakeholders to give your input by 25 November 2021!
Including patient preferences in decision-making is an important part of patient-focused drug development. Stakeholders' concerns about the lack of a clear, practical framework for measuring patient preferences became visible in our initial research and more recently at the DIA-PREFER workshop on patient preferences.
We have developed a framework for patient preferences, and Points to Consider for Methods Selection, which is currently under evaluation by the European Medicines Agency (EMA) and HTA bodies (EUnetHTA) in what is called a methods qualification procedure. To explain what is in the documents for those who are not familiar with patient preferences, we also organsed a webinar 31 August to introduce the PREFER framework for patient preferences and PREFER’s Points to Consider for Method Selection and how patient preference study results can be applied to regulatory and HTA decision-making.
Want to give input?
The draft opinion from EMA is now available. If you want to give input, you need to use the template provided by EMA. The template is linked in the draft opinion document.
The public consultation is open until 25 November. After the close of the consultation, comments will be compiled by EMA and reviewed by SAWP and potentially, the draft Qualification Opnion will amended according to the comments recieved. The more comments, the longer this process will take. Once the SAWP is satisfied with the final version of the opinion, it will go to the CHMP for final endorsement. We expect to to have a final version by end of March 2022.