Feb 17, 2019
Personalized medicine and companion diagnostics in Belgium
An update on the current requests to the Drug Reimbursement Commission concerning drugs related to a molecular biology test. In 2019, the reimbursement requests for lorlatinib, gilteritinib, larotrectinib, dasatinib, and their linked molecular biology markers were submitted.

Personalized medicines and molecular companion diagnostics for which a reimbursement request has been submitted (2019, therapeutic area - Hematology-Oncology):
  • Lorlatinib – ALK (linked marker)
  • Gilteritinib - FLT3-TKD and FLT3-ITD (linked marker)
  • Larotrectinib – NTRK (linked marker)
  • Dasatinib – BCR / ABL1 (linked marker)

It can not be predicted whether these products (and tests) will be reimbursed or not. This decision is to be taken by the Minister of Social Affairs on the advice of the Drug Reimbursement Commission (DRC). As additional expertise, the DRC receives, for these files, a notice from the Companion Diagnostics platform (CDx). The DRC procedure takes 180 calendar days. The procedure can be suspended when the firms request it (for example, to answer questions from the DRC or to react to the evaluation report or the proposal of the DRC) or when negotiations with a view to the conclusion of an agreement are started.

It is also possible to find information on products that may soon arrive on the market before a reimbursement request is submitted to the Drug Reimbursement Commission. These include, in particular:
With the specific reimbursement procedure, personalized medicines and associated molecular companion diagnostics tests can be reimbursed quickly and flexibly. For the introduction of these new products into the health system to be successful, it is therefore particularly important that the laboratories and doctors in the field are informed of what is happening so that they can prepare as much as possible and react quickly.

See full details in French and Dutch here.

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