The risk-sharing agreement introduces a new option for managing the uncertainty related to the reimbursability of novel medicinal products. This uncertainty may be related to incomplete evidence, for example, on the effectiveness in a patient sub-category, the correct dosage etc. Currently, such uncertainty can be managed by limiting the reimbursability of the medicinal product from the indication in the marketing authorisation. In the future, the agreement can be made either separately or at the same time as the restricted reimbursement limitations are imposed.
An element of the overall savings package, the procedure will also speed up the reimbursability and new indication extension decisions regarding novel medicines. The possibility awarded to the pharmaceutical companies to negotiate, as necessary, on the risk-sharing agreement supports the Finnish innovation policy and the objectives of the Health Sector Growth Strategy outlined in 2014.
The agreement procedure will always be a part of the price and reimbursability application process. The adoption of any internationally known agreement models is possible but at the beginning, the focus is on models that are as simple as possible.
Having an agreement is a possibility from the company’s point of view. It is neither an obligation nor a right of the company. Although the information on the agreement is in the public domain, all business secrets of the company will remain confidential. The maximum duration of the agreement is five years.
The agreement procedure will first be experimented with on the basis of a temporary three-year act. Access to the system will be very limited due to scarce resources. During the experiment, the functioning of the reform is followed, also looking at eventual needs of amendment and resourcing.