Belgium introduces “linked” reimbursement procedure for personalised medicines and companion diagnostics

From 1 July 2019, laboratory tests that predict whether a patient could therapeutically benefit from "personalised" medical treatment will be reimbursed quickly via a new procedure.

In the context of personalised medicine, patients are tested before the start of a treatment and are only given a particular medicine when it has been demonstrated that they are most likely to respond well to that therapy. These tests, called "companion diagnostics" or "predictive biomarkers", are laboratory tests that predict whether a patient will benefit therapeutically from treatment with a "personalised" medicine, and/or will experience fewer side effects. Treatments and laboratory tests follow two different routes with different reimbursement procedures at the level of the National Institute for Health and Invalidity Insurance (NIHDI). Previously, the reimbursement of a test was sometimes delayed in comparison with the reimbursement of the medicine.

To resolve this problem, a reimbursement procedure has been developed that links both the treatments and the laboratory tests. In this linked procedure, the medicine and the predictive biomarker are evaluated together as a package. At the end of the procedure, the Belgian Minister of Social Affairs takes a decision on the reimbursement of both the medicine and the biomarker. This procedure is sufficiently flexible to adjust to the rapid developments in this field on a monthly basis. A new Article 33ter has been added to the existing nomenclature of medical benefits (as incorporated in the Royal Decree of 14 September 1984 establishing the nomenclature of medical provisions for compulsory insurance for medical care and benefits).

An application of the newly developed reimbursement procedure was recently announced by the Belgian Minister of Health. Breast cancer patients may use the "MammaPrint" genetic test to find out whether chemo treatment is necessary. The pilot project was launched by the Minister of Health and will run for three years. A budget of EUR 2 million has been set aside for the project. The accredited breast cancer clinics decide for themselves who qualifies for the free tests. The test will be reimbursed in full, if taken in approved centres, as from 1 June 2019.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2019 Issue (Thomson Reuters).