Belgium has approved its first medicine through a new fast track procedure designed to give patients quicker access to promising treatments before they receive full European authorization. The drug, Atrasentan from Novartis Pharma, targets a rare autoimmune kidney disease called IgA nephropathy.
The Early and Equitable Fast Access procedure, in place since January 1, allows the government to reimburse certain medicines based on strong clinical trial results, even before the European Medicines Agency gives final approval. Health minister Frank Vandenbroucke said the process cuts months of waiting time for patients. “Patients no longer have to wait through months of procedures to gain access to a newly developed medicine,” he said in response to a parliamentary question.
Under the plan, the treating nephrologist submits an application on the patient’s behalf. The health insurance scheme covers the full cost of the drug at 700 euros per month per patient, with no out of pocket expense. It also pays a one time fee of 25,000 euros to cover the cost of setting up the case file. Approximately 22.5 new cases per million inhabitants are diagnosed each year in Belgium.
The minister noted that the temporary reimbursement also makes Belgium a more attractive market for pharmaceutical companies. “This makes our market more attractive to pharmaceutical companies and increases patients’ chances of gaining rapid access to new treatments here,” Vandenbroucke said.
Looking ahead, the fast access procedure is expected to speed the arrival of other innovative drugs to Belgian patients. The approval of Atrasentan marks a first step in what officials hope will become a routine pathway for life changing therapies, offering a model for other countries seeking to balance early access with cost control.