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The Nordic countries join forces in HTA medicine assessments
The Nordic HTA authorities are now working more closely together in the assessment of medicines and healthcare technologies. The aim of the cooperation is to harmonize processes and produce joint assessments that each country can use in its own decision-making.
A Fimea exchange program played a key role in enabling the closer cooperation seen today. In 2015, Tuomas Oravilahti, Chief Specialist at Fimea, took part in a public administration exchange program in Norway, where he worked with local HTA experts.
“We discussed the kinds of issues we work with and how we deal with them,” Oravilahti recalled at Medaffcon’s EMMA event on 10 September.
Soon Finland and Norway brought Sweden into the discussions. Official cooperation under the name FINOSE began in 2018. The collaboration began in a very practical way.
“We realized that we were all doing the same assessments and similar reports. It was only natural to look at how we could join forces.”
Nordic HTA cooperation began not with a political decision, but as a bottom-up initiative from the experts themselves. Since 2024, all Nordic countries have been involved, and the cooperation is now called Joint Nordic HTA Bodies (JNHB).
In the first years, the focus was on refining processes and guidelines. Now there are, for example, the JNHB Process Guideline and the JNHB Submission Dossier Template for companies. Collaboration with NED (New Expensive Drugs) has also been developed.
National decision-making remains
The JNHB assessment process progresses step by step. First comes horizon scanning, where new products entering the market are screened. If a product seems suitable for a joint assessment, the authorities contact the company. Next comes a discussion and a possible meeting. If the company considers the process useful, the assessment begins. The goal is to complete the assessment in 90 days.
Each assessment results in a joint English-language report, which the countries then use in their national decision-making.
“It is important to remember that national decision-making remains with each country. Reimbursement negotiations are conducted nationally, but the joint report can support them,” Oravilahti explains.
What is the benefit for companies of participating in a Nordic assessment? According to Oravilahti, experiences vary.
“The process usually requires more work than a national assessment, but significantly less than five separate national assessments. Smaller companies without local resources can benefit from this cooperation.”
Cooperation also with the NED network
Companies should contact JNHB well in advance, preferably once the PICO, the key questions of the assessment, has been defined for the Joint Clinical Assessment (JCA). Typically, around day 120 of the marketing authorization process. Contact is made by email, and the earlier the discussion starts, the more smoothly the process goes.
JNHB has carried out nine assessments since its establishment in 2018. According to Oravilahti, the network also cooperates with NED (New Expensive Drugs). JNHB informs NED about assessments, and NED in turn communicates if the negotiations lead to an agreement.
“None of the members of JNHB are part of NED, because we are not decision-makers,” Oravilahti says.
More information
Medaffcon’s annual EMMA event was held on September 10th at the Espoo Museum of Modern Art – and for the first time also in Stockholm. Since 2016, EMMA has brought together experts and decision-makers to explore timely themes in healthcare, market access, data-driven decision-making and more.
