The scheme to obtain quick access to reimbursement for innovative drugs in Belgium is called "Unmet Medical Need." It is active since 2016, but the list of indications for drugs eligible for this reimbursement is annually updated. In November 2020, the list of indications (unmet needs) for 2021 was established.
Some innovative drugs can be the subject of intervention even before their registration when they treat a serious or fatal disease, and there is no therapeutic alternative. This procedure is called "Unmet Medical Need" and allows faster access to innovative drugs.
In order to be reimbursed, the innovative drugs have to meet the following criteria:
- The indication for this drug must be included in the list of unmet medical needs established by the General Council of the National Sickness and Invalidity Insurance Institution (INAMI/RIZIV);
- The drug must not have a therapeutic alternative;
- An emergency medical program must be set up for this drug by the Federal Agency for Medicines and Health Products;
- A positive cohort decision for this drug in the indication concerned by the College of Medical Directors.
The list of unmet medical needs for 2021 with priority indicators is already available.
The full details in French or Dutch can be found here