Finland has updated the health-economic evaluation requirements used in applications for medicine reimbursement and reasonable wholesale prices. The revised guidance from the Pharmaceuticals Pricing Board (Lääkkeiden hintalautakunta, Hila) applies to applications received from 1 August 2026.
The changes strengthen how clinical evidence feeds into economic modelling. Where a medicine has undergone EU Joint Clinical Assessment (JCA), applicants must consider whether the JCA populations and comparators are appropriate for the Finnish reimbursement application. JCA information should be used where applicable to estimate relative effectiveness, with justification where available JCA evidence is not used.
Hila has also tightened evidence traceability. Applicants should generally base health effects on outcomes observed in the population covered by the evaluation and must report the data cut-off date for the underlying analyses. Unpublished indirect comparisons require justification and detailed methodological reporting.
Model transparency receives greater attention. Markov and partitioned-survival models must graph the proportion of patients occupying each health state over time. Applicants using R must provide clearly structured and commented code, relevant input files, information on packages and self-written functions, and the R version used. Essential VBA macros in Excel models must also be described. Applicants must disclose any use of artificial intelligence and explain how it was applied.
Cost inputs have also been standardised further. Historical unit costs are now brought to current values using the consumer price index, and the date of medicine-price data used in models must be specified.
The underlying framework retains Finland’s preference for cost-utility analysis, a 3% discount rate and broad inclusion of direct healthcare and comparable social-care costs. The revision instead raises expectations for reproducibility and evidence provenance, particularly as EU clinical assessment becomes part of national reimbursement submissions.
Source: Pharmaceuticals Pricing Board
Link: Hakemusohje terveystaloudellisesta selvityksestä on päivitetty (Updated application instructions for health economic evaluation) Source link
Date: 1 July 2026
Source: Pharmaceuticals Pricing Board
Link: Application instructions – health economic evaluation Updated instructions
Date: 1 July 2026
Source: Pharmaceuticals Pricing Board
Link: Application instructions – health economic evaluation Previous instructions
Date: 28 March 2025
