New health technology assessment (HTA) statistics produced by Denmark’s Medicine Council (Medicinrådet) for 2024 have prompted GlobalData to take the opportunity to assess evolving HTA trends in the Nordic market.
In recent years, Demark switched to a quality-adjusted life year (QALY) approach to new medicine evaluations. The new processes were intended to improve the transparency and consistency of HTA evaluations, as well as to facilitate faster patient access and reduce evaluators’ workload. The incorporation of QALYs into a health economic analysis was also accompanied by the launch of a conditional reimbursement approval pathway in Denmark for medicines that are likely to be cost-effective but where there is uncertainty regarding efficacy, safety, or treatment costs. While the new decision-making processes had a slow start when launched in 2021, the latest decision data appears to finally show that a link is emerging between QALY HTA outputs and an increase in positive outcomes.
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The Medicine Council reports producing a record number of positive HTA outcomes in 2024. The fundamentally improved predictability of the HTA landscape was evident from a 64% rate of assessed medicines receiving a positive evaluation. For anti-cancer medicines, this percentage reached 69%. An unknown percentage of the evaluation decisions involve re-assessments of previous recommendations.
Within the Nordic region, Norway had the largest volume of HTA decisions, followed by Denmark and Sweden. GlobalData assesses that the number of positive and neutral decisions (positive, with restrictions), including indication expansions, amounted to 81 in Denmark, resulting in a 69% positive ratio versus a 71% and 72% share in Norway and Sweden, respectively.
In Denmark, the number of total HTA decisions between 2020 and 2024 is noticeably volatile but is assessed to be increasing at an average annual growth rate (AAGR) of 43%. This is comparable to Sweden which had an AAGR of 32%, whereas the overall volume of decisions made in Norway in each of these years was relatively stable or even saw a slight fall in the AAGR of -1.7%.
There is a latent risk that the favourable reimbursement trends seen in Denmark in 2024 could be reversed next year due to the system being overloaded by a rising tide of HTA applications. In Q4 2024, the Medicine Council predicted that higher assessment workloads in H1 2025 may translate into 40% longer case processing times for HTA reviews in early 2025, with the average case duration potentially reaching 27 weeks compared to 19 weeks in 2024. Indeed, the severity of the HTA backlog is such that the processing of some applications was briefly paused in November and December 2024, while the Medicine Council attempts to get a better grip on the situation. Furthermore, the implementation of the EU’s new Health Technology Assessment Regulation (HTAR) will add to the resource pressures that the Medicine Council is operating under in 2025. From 2025, the Medicines Council will be responsible for substantial new tasks connected with HTAR, including performing and utilising joint clinical assessments (JCAs) of advanced therapy medicinal products and oncology medicines from January 2025. EU-wide joint HTAs will be used as a key input within health economic analyses.
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By GlobalDataThe full impact of the regulation on case processing is not expected to materialise until the second half of 2025 when the first JCA reviews are completed. However, while JCAs may potentially reduce evaluators’ workload in the longer term, there are shorter-term concerns over the capacity of the Danish HTA body to manage the workload associated with JCAs’ uniform approach to handling clinical-level data, especially as the Medicine Council’s funding allocation is set to be constrained by 2025 regional budgets.
This article is produced as part of GlobalData’s Price Intelligence (POLI) service, the world’s leading resource for global pharmaceutical pricing, HTA and market access intelligence integrated with the broader epidemiology, disease, clinical trials and manufacturing expertise of GlobalData’s Pharmaceutical Intelligence Center. Our unparalleled team of in-house experts monitor P&R policy developments, outcomes and data analytics around the world every day to give our clients the edge by providing critical early warning signals and insights. For a demo or further information, please contact us here.
