{ "title": "First medicine approved under \u2018fast access\u2019 procedure", "modified_at": "2026-06-30 13:54:54", "published_at": "2026-06-30 13:54:00", "url": "https://belganewsagency-eu.prezly.com/first-medicine-approved-under-fast-access-procedure", "short_url": "http://prez.ly/WYJd", "culture": "en_BE", "language": "EN", "slug": "first-medicine-approved-under-fast-access-procedure", "body": "

Belgium has given the green light to a new medicine via the Early and Equitable Fast Access procedure for the first time. The process means the cost of promising medicines can be reimbursed before they have been authorised by the European authorities. The first medicine to benefit was a treatment for kidney disease.

The procedure has been in place since 1 January and ensures that patients receive faster access to new treatments. For certain medicines, promising results are already evident in clinical trials, even before approval by the European Medicines Agency. The new process ensures these treatments reach patients sooner by reimbursing them at an early stage.

“Patients no longer have to wait through months of procedures to gain access to a newly developed medicine,” said Health minister Frank Vandenbroucke, of Vooruit, in response to a parliamentary question on Tuesday.

"This makes our market more attractive to pharmaceutical companies and increases patients’ chances of gaining rapid access to new treatments"

“The new treatment is reimbursed on a temporary basis. This makes our market more attractive to pharmaceutical companies and increases patients’ chances of gaining rapid access to new treatments here.”

A medicine was approved via this procedure for the first time last week: Atrasentan from Novartis Pharma, which is intended for certain patients with IgA nephropathy, an autoimmune kidney disease. Approximately 22.5 new cases per million inhabitants are diagnosed each year in Belgium.

The treating nephrologist submits the application on behalf of the patient. The health insurance scheme pays 700 euros per month per patient, at no cost to the individual. Insurance also covers the costs of setting up the case file, a one-off payment of 25,000 euros.

The scheme will run for two years.

 

An employee in a Febelco warehouse for medicines and pharmaceutical products in Frameries, October 2025 © PHOTO NICOLAS TUCAT / AFP

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