Mapping Access Pathways for New Medicines in Finland: A Real-World Review of HTA and Reimbursement Decisions
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 analyze the evaluation and access outcomes of new medicinal products in Finland across outpatient (retail pharmacy) and hospital pathways, and to quantify the role of national health technology assessment (HTA) bodies and reimbursement agencies in determining availability.
METHODS: This retrospective mapping study included 183 new medicines authorized in Finland between 2020 and 2022. Vaccines and Covid-19 medicines (n=23) were excluded from the dataset. Products were categorized into outpatient (n=94) and hospital (n=66) groups based on the route of administration and the assessing authority. Data were extracted on evaluation activity across key institutions (e.g., Finnish Medicines Agency (Fimea), Council for Choices in Health Care in Finland (COHERE), the Pharmaceuticals Pricing Board (PPB)), reimbursement outcomes, and final access or procurement decisions.
RESULTS: Of outpatient products (n=94), 51 (54%) were submitted for reimbursement evaluation to the PPB. Of these, 41 (80%) were approved, with 21 receiving reimbursement and 20 conditional reimbursement. Nine applications were rejected, and one was still under review. Notably, reimbursement applications had not been submitted to the PPB for 43 outpatient products (46%). Among hospital products (n=66), 24 were assessed by Fimea HTA, and 23 of these underwent COHERE assessment. COHERE issued 11 conditional and 10 negative recommendations. Downstream access varied: 13 received national procurement decisions, 6 were evaluated at the hospital level (mini-HTA), and 29 had no publicly available assessment data. Unfortunately, 36 hospital products (55%) were not assessed by Fimea HTA, thus blocking access completely or making it very challenging.
CONCLUSIONS: The Finnish access system demonstrates fragmentation and variability across retail and hospital pathways. A large proportion of new products remain unevaluated or outside formal reimbursement channels. Improved coordination and transparency in HTA and procurement processes may enhance equitable and timely access.
METHODS: This retrospective mapping study included 183 new medicines authorized in Finland between 2020 and 2022. Vaccines and Covid-19 medicines (n=23) were excluded from the dataset. Products were categorized into outpatient (n=94) and hospital (n=66) groups based on the route of administration and the assessing authority. Data were extracted on evaluation activity across key institutions (e.g., Finnish Medicines Agency (Fimea), Council for Choices in Health Care in Finland (COHERE), the Pharmaceuticals Pricing Board (PPB)), reimbursement outcomes, and final access or procurement decisions.
RESULTS: Of outpatient products (n=94), 51 (54%) were submitted for reimbursement evaluation to the PPB. Of these, 41 (80%) were approved, with 21 receiving reimbursement and 20 conditional reimbursement. Nine applications were rejected, and one was still under review. Notably, reimbursement applications had not been submitted to the PPB for 43 outpatient products (46%). Among hospital products (n=66), 24 were assessed by Fimea HTA, and 23 of these underwent COHERE assessment. COHERE issued 11 conditional and 10 negative recommendations. Downstream access varied: 13 received national procurement decisions, 6 were evaluated at the hospital level (mini-HTA), and 29 had no publicly available assessment data. Unfortunately, 36 hospital products (55%) were not assessed by Fimea HTA, thus blocking access completely or making it very challenging.
CONCLUSIONS: The Finnish access system demonstrates fragmentation and variability across retail and hospital pathways. A large proportion of new products remain unevaluated or outside formal reimbursement channels. Improved coordination and transparency in HTA and procurement processes may enhance equitable and timely access.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR136
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas