The application instructions for preparing a health economic evaluation to be attached to the application for reimbursement status and wholesale price for a medicinal product have been updated. The update was prepared in a working committee with participants from the Pharmaceuticals Pricing Board, the Social Insurance Institution of Finland, Finnish Medicines Agency and Pharma Industry Finland.
The revised instructions were published on 1 December 2023 in Finnish, Swedish and English on the website of the Pharmaceuticals Pricing Board and will be applied for applications received in the Pharmaceuticals Pricing Board from 1 January 2024 onwards.
The updates concern among other matters the following:
- The comparator product should, as a rule, have an approved indication and be approved for reimbursement for the use concerned.
- Considering the reliability of a study setting it is justified to include the comparative treatment or treatments from the randomized, controlled trials in the evaluation. In situations where the choice of comparative treatment is not unanimous it is particularly justified to compare the application preparation to more than one comparative treatment options.
- Probabilities of meeting the endpoint and hazards over time must be presented as diagrams.
- The cost effectiveness model needs to facilitate the addition of new scenarios and it must be made known in the report where in the model used information can be found. Description must be provided on how the sensitivity analyses are repeatable in the electronic model.
- In base case, the prices of medicinal products must remain the same throughout the time horizon of the model.
- The uncertainty related to actual costs of hospital products should be evaluated with sensitivity analysis.
- If information on health-related quality of life of comparative treatments is collected in the clinical trials, the information must be presented.
Inquiries
Kalle Aaltonen, Senior Specialist, tel. +358 295 163 439
Kaisa Vaarala, Senior Specialist, tel +358 295 163 559
Senni Kaunisto, Chief Pharmaceutical Officer, tel +358 295 163 458
Jaana Viikinkoski, Chief Pharmaceutical Officer, tel +358 295 163 532
Maija Hakuri, Chief Pharmaceutical Officer, tel +358 295 163 774
E-mail firstname.lastname@gov.fi