The conditional reimbursement status was written into the Finnish Health Insurance Act and was taken into use at the beginning of 2017. The temporary Act will remain in force until the end of this year. Tiia Tammi works in Oriola's Market Access team, with pricing and reimbursement applications for medicines as her main area of responsibility.
Tiia, what does conditional reimbursability mean?
- For a specific reason, the Pharmaceuticals Pricing Board, PPB, can grant the reimbursement status and wholesale price of a medicinal product with a marketing authorisation on a conditional basis. This means that a confidential agreement between the Pharmaceuticals Pricing Board and the marketing authorisation holder is included in the price and reimbursement decision. The agreement can be financial or outcome-based, and its purpose is to share the uncertainty related to the adoption of the medicine between the pharmaceutical company and society.
Why was conditional reimbursability introduced in Finland?
- Conditional reimbursability was introduced because new, increasingly expensive products with limited study evidence and user experience are entering the market. This can be the case with, for example, orphan diseases. In these cases, there is uncertainty associated with the introduction of the medicine, and this uncertainty can be managed through an agreement on the sharing of responsibilities. Conditional reimbursability makes it possible to make new medicines available to patients more quickly while keeping the costs to society reasonable.
When and in what situation is conditional reimbursement granted?
- According to the Health Insurance Act, the Pharmaceuticals Pricing Board can grant the reimbursement status and wholesale price of a medicine on a conditional basis if a special therapeutic need for the new medicinal treatment has been demonstrated. Additionally, there must be significant uncertainty concerning the treatment costs, the therapeutic value of the medicinal product, cost-effectiveness or other similar factors affecting the reimbursement status or the evaluation of the reasonability of the wholesale price.
How many conditional reimbursement agreements have been made?
- By 1st June 2019, 29 conditional reimbursement agreements have been made, 24 of which are in force. All the conditional reimbursement agreements made so far have been financial agreements in which cost-related uncertainty has been shared between a pharmaceutical company and society.
Why are all the conditional reimbursement agreements that have been made so far financial agreements?
- Based on public discussion, financial agreements have been found easier to implement than outcome-based agreements. An outcome-based agreement requires proof of factors relating, for example, to the treatment effect of the medicine or to improvements in the quality of life. Collecting this kind of data is often seen as challenging. However, our Real World Evidence services make it possible to collect information directly from patients.
What will happen to conditional reimbursability at the beginning of 2020?
- The temporary Act will remain in force until 31st December 2019. However, agreements that are in force will continue until the end of the agreement period. Both the Pharmaceuticals Pricing Board and pharmaceutical companies have taken a favourable view of conditional reimbursability. It appears that all parties would be willing to continue using the conditional reimbursement procedure in the future, but its continuation still requires a legislative change.