Therapeutic and economic value of medicines
Fimea produces and compiles assessments of the therapeutic and economic value of medicines, and coordinates the related collaboration in Finland. The purpose of these assessments is to compare the various pharmacotherapies available for specific diseases. Assessments are performed to support decision-making related to e.g. the adoption of medicines and reimbursement.
A medicine sold in Finland must have a marketing authorization granted by Fimea or the European Commission. In order to obtain a marketing authorisation, the efficacy, safety and adequate quality of the medicine must have been demonstrated. Assessments of the therapeutic and economic value focus on relative effectiveness, safety and economic aspects of the pharmacotherapies under evaluation. Social and ethical aspects are also accounted for in the assessment when applicable. Proving the therapeutic and economic value of a medicine is not a prerequisite for a marketing authorisation.
Fimea produces assessments that vary in terms of scope and content, depending on the topic and purpose of the assessment. Topics for the assessment of therapeutic and economic value can be suggested and submitted by email to email@example.com. Fimea processes the suggested topics and makes decisions on starting an assessment internally.
The processes followed in the assessment of pharmacotherapies are described in Fimea's recommendation for the assessment of the therapeutic and economic value of medicines and in the rapid assessment protocol for new hospital-only medicines. The latter is still in a pilot stage.
Depending on the purpose, Fimea produces the following assessments of pharmacotherapies:
- A rapid assessment of hospital-only medicines is carried out in order to provide information on the therapeutic and economic value of a new medicine in a situation where a hospital is considering the adoption of the medicine.
- Rapid reviews are based on existing international assessments or literature. A rapid review provides a summary of the effects and costs of pharmacotherapies. It may also provide a description of the current management of the disease or health condition in Finland, or the applicability of the research evidence in Finland.
- A single technology assessment involves the comparison of a pharmacotherapy against the most appropriate treatment or a few selected treatments for a specific therapeutic indication.
- A multiple technology assessment involves the comparison of several alternative pharmacotherapies for a specific therapeutic indication, or of one pharmacotherapy for several therapeutic indications against one or a few treatment options considered to be the most appropriate.
Assessment recommendations and terminology
Fimea has published two recommendations for the assessment of therapeutic and economic value of medicines. Furthermore, terminology used in assessments has been published.
The recommendations describe the processes, methods and reporting practices used in the assessment of therapeutic and economic value of pharmacotherapies.The objective of the terminology is to improve the consistency of the terminology and concepts used, and to help establish a set terminology in Finnish.