The conditional reimbursement status was written into the Finnish Health Insurance Act and came into use at the beginning of 2017, and was originally intended to remain in force until the end of the current year. On 26 November 2019, the Parliament of Finland approved a bill extending the Temporary Act until 2025. The new Temporary Act still needs to be confirmed by the Finnish President, and it will come into effect as planned on 1 January 2020.
There are some changes included in the new Temporary Act. For example, from now on, the reasonableness of the wholesale price of a conditionally reimbursable product does not need to be evaluated as strictly as in the normal price confirmation procedure. The use of a conditionally reimbursed product as a comparator product has been clarified: the confirmed wholesale price of a conditionally reimbursable product cannot be used to justify the reasonableness of the wholesale price of a product subject to application, but a conditionally reimbursable product can be used as a comparator in other respects. Additionally, the five-year maximum duration of conditional reimbursability will no longer apply.
Q&A about conditional reimbursement in Finland
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.
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.
Raisa Viljakainen, Head of Market and Hospital Access, will be happy to tell you how our experts can support you in all aspect related to pricing and reimbursement. Read more about our services here.