OBJECTIVES: To assess the different requirements and processes in Nordic countries that may affect strategic decisions for pharmaceutical companies, such as whether or when to submit an HTA dossier in this region.
METHODS: Guidelines and process documents in the four countries were reviewed up to June 2019, including websites of the dental and pharmaceutical benefits agency (TLV) and the new therapies council (Sweden), the pharmaceuticals pricing board (Hila; Finland), Amgros I/S and the Danish medicine council (Denmark), and the Norwegian medicines agency (NoMA; Norway).
RESULTS: The review identified several areas with implications for market access strategy. Sweden allows for HTA submissions up to 90 days before European marketing authorisation, while, for other countries, submission is at the time of approval. The published process takes 12 weeks in Denmark (the actual time including clock-stops is normally longer), with a maximum of 180 days in the other countries. Cost-effectiveness or cost-minimisation analyses are required in Finland, Norway, and Sweden, while Denmark requires a cost-analysis that does not include clinical benefits. All countries require comparative clinical evidence within the indication, either using head-to-head data or network meta-analyses. Denmark requires the publication of all data used in the submission, while the other countries allow confidential information to be submitted.
CONCLUSIONS:The different processes and requirements among Nordic countries likely affect strategic decision-making by pharmaceutical companies regarding submissions for hospital drugs. The similar requirements of Finland, Norway, and Sweden allow efficiencies in submission planning. Not allowing confidential information in Denmark means that early submission, without the inclusion of confidential data, may lead to negative reimbursement decisions, with implications for market access strategy.
