Reimbursement of personalized medicine and companion diagnostics in Belgium

Laboratory examinations that can predict whether a patient will receive therapeutic benefits from “personalized” drug treatment or from so-called "molecular companions diagnostics" can be promptly and flexibly reimbursed using the new specific procedure from July 1, 2019.

In personalized medicine, patients are tested before starting treatment. A medicine is given only when it was previously shown that patients are likely to respond well to therapy. These tests, called “companion diagnostics” or “predictive biomarkers,” are laboratory tests that predict whether a patient will be therapeutically treated with a “personalized” drug, and/or will experience fewer side effects.

Drugs and laboratory tests are two distinct technologies that require different expertise and reimbursement by the INAMI is also obtained through other procedures. As a result, it was previously possible for the test to be reimbursed later than the drug. In this procedure, the drug and the predictive biomarker are evaluated together as a whole.

To enable the use of the coupled procedure, "personalized" medicines are brought together in a new chapter on drugs: Chapter VIII. At the same time, a new Article 33ter has been created in the current INAMI/RIZIV Nomenclature, which only includes benefits related to the reimbursement of "personalized" medicine.

The following new codes have been introduced:

• Detection of an acquired molecular anomaly with a predictive value of therapeutic response to a pharmaceutical specialty listed in Chapter VIII of the Royal Decree of 1 February 2018 using a molecular biological method in the diagnostic investigation phase, LEVEL 1 (594016-594020)
• Screening for an acquired molecular abnormality, by monitoring the therapeutic response to a pharmaceutical specialty listed in Chapter VIII of the Royal Decree of 1 February 2018 using a molecular biological method, LEVEL 1 (594031-594042)
• Detection of an acquired molecular anomaly with a predictive value of therapeutic response to a pharmaceutical specialty listed in Chapter VIII of the Royal Decree of 1 February 2018 using a molecular biological method in the diagnostic investigation phase, LEVEL 2 (594053-594064)
• Detection of an acquired molecular abnormality, by monitoring the therapeutic response to a pharmaceutical specialty listed in Chapter VIII of the Royal Decree of 1 February 2018 using a molecular biological method, LEVEL 2 (594075-594086)
• Screening for an acquired molecular anomaly with a predictive value of therapeutic response to a pharmaceutical specialty listed in Chapter VIII of the Royal Decree of 1 February 2018 using a molecular biological method in the diagnostic investigation phase, LEVEL 3 (594090-594101)
• Detection of an acquired molecular abnormality, by monitoring the therapeutic response to a pharmaceutical specialty listed in Chapter VIII of the Royal Decree of 1 February 2018 using a molecular biological method, LEVEL 3 (594112-594123)

See the details in French here.

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