The application of the EU HTA Regulation began in January 2025. Initially, the regulation applies to new cancer medicines and advanced therapy medicinal products (ATMPs) for which marketing authorization has been sought through the European Medicines Agency (EMA) centralized procedure after 12 January 2025. Necessary amendments have been made to Chapter 6 of the Health Insurance Act (932/2024) due to the regulation.
This bulletin explains how the Pharmaceuticals Pricing Board (PPB) responds to the so-called PICO inquiry, which is the first phase of the joint clinical assessment (JCA). PICO defines the subject of the assessment, comparator treatments, and outcomes to be reported. The inquiry is necessary due to varying information needs among member states, for example, due to differences in treatment practices. The inquiry is conducted shortly after the marketing authorization process begins at EMA.
To respond to the PICO inquiry, member states receive a PICO proposal prepared by designated assessors based on, among other things, European treatment guidelines. In Finland, PPB (for outpatient medicines) or Fimea (for hospital medicines) responds to PICO inquiries, depending on which authority is likely to assess the medicine. PPB and Fimea consult each other on the division of responsibilities when necessary.
The PICO inquiry begins on day 22 after the submission of marketing authorization and HTA assessment documents in the standard procedure, and on day 8 in the accelerated procedure. The response deadlines are short: 21 days for the standard procedure and 14 days for the accelerated one.
PPB responds using treatment guidelines, reimbursement and consumption statistics, and insights from its clinical experts. The marketing authorization holder may also voluntarily submit their view on how PICO should be defined in Finland for the specific medicine.
Due to the tight schedule, the company must submit its view to PPB as soon as possible and no later than two weeks after submitting the marketing authorization application (one week in the accelerated procedure). Advance notice of the comment is recommended. To ensure quick usability, the comment should include source references and supporting material, such as expert statements.
Comments and advance notices should be sent to PPB via email at hila.stm@gov.fi or, if the message contains confidential information, via turvaviesti.gov.fi
Based on member state responses, the designated assessor and co-assessor compile the final PICO framework, which guides the assessment. Clinical experts and patient representatives are also consulted. The final PICO is shared with the marketing authorization holder.
The European Commission announces the start of each assessment. Information about the medicine is mostly considered trade secrets and is therefore only partially public before marketing authorization. The marketing authorization holder has the right to access PPB’s PICO response. The response reflects the view based on available information at the time and does not bind PPB in reimbursement decisions. It does not affect the obligation to submit a detailed reimbursement application. The holder decides the scope of the reimbursement application regardless of PPB’s response.
PPB will later publish more guidance on reimbursement applications for medicines under joint European assessment.
For general inquiries, contact Director Reima Palonen at +358 2951 63090 or reima.palonen@gov.fi .