Fragmentation in Access Pathways: A Review of HTA and Decision-Making Processes for Medicines in Finland
Author(s)
Saku Torvinen, MSc, PhD1, Riikka Viitanen, PhD2, Mirka Mähönen, MSc2, Tero Ylisaukko-oja, PhD2.
1Director Market Access, MedEngine, Helsinki, Finland, 2MedEngine, Helsinki, Finland.
1Director Market Access, MedEngine, Helsinki, Finland, 2MedEngine, Helsinki, Finland.
OBJECTIVES: To evaluate the structure and functioning of Finland’s multi-channel health technology assessment (HTA) and decision-making system for outpatient and hospital medicines, and to identify differences in evaluation criteria, timelines, and implementation outcomes.
METHODS: This analysis included medicinal products that were granted marketing authorization between 2020 and 2022. Data were obtained from the Finnish Medicines Agency (Fimea) website, listing products granted a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP). National HTA decisions regarding approval or rejection, access recommendations, and the eventual adoption of products into use were systematically reviewed. Vaccines and Covid-19 medicines were excluded from the analysis. The study also compared the criteria and processing times used by different HTA authorities and assessed systemic challenges and areas for improvement.
RESULTS: Only a portion of newly authorized medicinal products were evaluated or progressed through the HTA process. The evaluation and adoption timelines for hospital medicines were notably longer than those for outpatient products (range: 10.5-26.6 months vs. 3.9-6.0 months). Criteria for assessment varied significantly: outpatient medicine evaluations are governed by strictly defined provisions under the Health Insurance Act, while the less specific Health Care Act guides hospital medicine assessments. Furthermore, hospital medicine adoption decisions are more fragmented, as recommendations from the national coordination body (COHERE) are non-binding and hospitals may independently decide on the product adoption.
CONCLUSIONS: These findings highlight significant disparities in HTA processes between outpatient and hospital medicines in Finland. The fragmented framework contributes to variation in access timelines and implementation. Greater alignment, transparency, and binding guidance could improve consistency and equity in patient access to new, effective treatments.
METHODS: This analysis included medicinal products that were granted marketing authorization between 2020 and 2022. Data were obtained from the Finnish Medicines Agency (Fimea) website, listing products granted a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP). National HTA decisions regarding approval or rejection, access recommendations, and the eventual adoption of products into use were systematically reviewed. Vaccines and Covid-19 medicines were excluded from the analysis. The study also compared the criteria and processing times used by different HTA authorities and assessed systemic challenges and areas for improvement.
RESULTS: Only a portion of newly authorized medicinal products were evaluated or progressed through the HTA process. The evaluation and adoption timelines for hospital medicines were notably longer than those for outpatient products (range: 10.5-26.6 months vs. 3.9-6.0 months). Criteria for assessment varied significantly: outpatient medicine evaluations are governed by strictly defined provisions under the Health Insurance Act, while the less specific Health Care Act guides hospital medicine assessments. Furthermore, hospital medicine adoption decisions are more fragmented, as recommendations from the national coordination body (COHERE) are non-binding and hospitals may independently decide on the product adoption.
CONCLUSIONS: These findings highlight significant disparities in HTA processes between outpatient and hospital medicines in Finland. The fragmented framework contributes to variation in access timelines and implementation. Greater alignment, transparency, and binding guidance could improve consistency and equity in patient access to new, effective treatments.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR98
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas