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FINOSE, a Nordic cooperation

A Memorandum of Understanding (MoU) to start a co-operation has been signed by the Director Generals of Fimea, NoMA and TLV.

The co-operation means that the three agencies will write joint assessment reports for pharmaceutical products that contain both relative clinical and health economic assessments.

Pharmaceutical companies who have a new, but not yet authorized, medical product are welcome to contact one of the three agencies to start the discussion about a possible joint FINOSE assessment. Companies that chose to participate send in their submission file or equivalent health economic documentation to all three agencies. The company shall also sign the wavier of confidentiality to make it possible for the agencies to share information between them. In lack of defined joint processes, relevant national ones will be followed. After the joint assessment, national decisions or recommendations will be made, following national regulations.

If there is an available joint relative effectiveness assessment report from EUnetHTA, that can be used as ground for a joint health economic analysis between Fimea, NoMA and TLV.

To launch this cooperation, they gathered three Nordic HTA agencies – Sweden’s Dental and Pharmaceutical Benefits Agency, the Norwegian Medicines Agency and the Finnish Medicines Agency gathered representatives from the European HTA community – from European Commission level to individual agencies country by country – and the global pharmaceutical industry to discuss two current topics:

  • The move towards cross-country collaboration by European HTA agencies
  • How Real-World Evidence can make a difference in HTA decision making

The group gathered at Stallmästaregården in Stockholm for a day of networking and discussion. This note is a summary of the discussions that were held among this group.

Senast uppdaterad 26 juni 2019