Presentation (CTI)

OBJECTIVES: The Nordic countries (Denmark, Finland, Norway, and Sweden) are recognized for high-quality healthcare systems. However, their market access pathways for introducing medical devices differ significantly in governance, health technology assessment (HTA) requirements, transparency, and funding mechanisms. These differences present challenges for manufacturers and influence patient access to innovative medical technologies. This study aims to compare the market access availability processes for medical devices across Denmark, Finland, Norway, and Sweden, focusing on governance structures, HTA frameworks, transparency, and funding models.
METHODS: A desk-based research approach was employed to analyze publicly available information from government websites, HTA agency reports, and industry publications. The analysis examined governance frameworks, approval processes, transparency in decision-making, funding mechanisms, and case studies of HTA-evaluated products.
RESULTS: Key identified country findings: Sweden: The Medical Technology Product Council Council (MTP-rådet) and the Dental and Pharmaceutical Benefits Agency (TLV) conduct HTAs, which are advisory and includes a national recommendation. HTA conclusions are publicly available, though public participation is absent. Nationally introduced consumable devices may qualify for high-cost protection (Högkostnadsskydd), while others face regional reimbursement variability. Norway: "Nye Metoder" oversee national HTAs, while regional health authorities conduct “mini-HTAs”. HTA requests and decisions are published, but few devices have been assessed. Funding is regionally allocated. Denmark: HTA assessments are no longer required. Funding sources include public healthcare budgets or patient co-payments potentially supported by private insurance (Sygesikring Danmark). • Finland: HTA assessments are not required. The Finnish medicine agency (Fimea) manages device registration in the Central Equipment Register (CERE), mandatory for market entry. Funding is regionally budgeted.
CONCLUSIONS: The Nordic countries exhibit diverse governance structures and market access processes for medical devices. While Sweden and Norway maintain structured HTA frameworks, Denmark and Finland do not require HTA assessments. The assessment of HTA-approved products highlights the impact of these processes on market entry and patient access.