Unlike so-called comfort drugs, the pharmaceutical company must therefore receive marketing authorisation from the EMA for treatments for diseases such as cancer, rare diseases, and in this case vitiligo. While this applies to each Member State, it is possible that one country will make a treatment available on its territory earlier than another.
It is the firm that decides whether or not, and when, it submits the file for reimbursement.
Anne Heyndrickx, a drug expert at the Solidaris research and health division, tells us that it is the firm that has the upper hand in introducing Opzelura or other new molecules into Belgium: “It is the firm that decides whether or not, and when, it submits the file for reimbursement. The important element is that firms try to maximize the price they will obtain for these reimbursed drugs. So, firms will go first to the countries where the prices are the highest.“
Anne Heindrickx adds that it is in these negotiations that the national strategy can have an impact on access to the product: “A country that tries to control these prices may have drugs that will arrive a little later than another country. Because in the drug reimbursement system, the competent authorities look at the prices that are practiced elsewhere, and try not to pay more. But the firms will be careful not to lower their prices too early, because they will first try to set the highest price.“
In Belgium, it is the National Institute for Health and Disability Insurance (INAMI) that assesses whether or not a medication should be reimbursed based on the benefit/risk balance and the reimbursement terms. As for the price, it is the FPS Economy that is competent in this matter. The Solidaris medication expert emphasizes that it is the Minister of Social Affairs who will make the final decision. The company that produces Opzelura did indeed submit the reimbursement application in Belgium later than in other countries. It is at the end of the procedure that we will know whether this cream will be reimbursed or not.
