Belgium Fast Access Medicines Revolutionize Treatment for IgA Nephropathy

Belgium Fast Access Medicines has moved from policy to practice. Authorities have granted temporary reimbursement to Atrasentan, the first therapy approved under the new Early and Equitable Fast Access procedure, offering quicker hope to patients with IgA nephropathy while anchoring the country’s Rare Diseases Plan 2026–2030.

Kidney Patients Gain Earliest Access

This pioneering decision targets adults with IgA nephropathy, an autoimmune kidney disease that affects roughly 22.5 new patients per million inhabitants annually in Belgium. By activating the procedure before European Medicines Agency approval, clinicians can now prescribe Atrasentan immediately, with the health system covering €700 per patient per month plus a €25,000 one-off case-file fee for up to two years.

Inside the Fast Access Mechanism

Under the Belgium Fast Access Medicines pathway, treating nephrologists submit applications on behalf of individual patients based on compelling clinical trial data. The temporary reimbursement window gives developers and health economists a structured period to generate real-world evidence while patients receive innovative therapy without delay.

€25 Million Dedicated to Speed

The Rare Diseases Plan backs this initiative with a dedicated €25 million envelope specifically for orphan medicines under the fast-access route, complemented by €4 million in annual structural funding split between care coordination and expertise mapping across eight reference centres. These investments form part of six reform axes that include faster diagnosis, clearer referral pathways, better data infrastructure, and stronger patient information.

Belgium Fast Access Medicines sends a clear message to pharmaceutical companies: rapid, predictable reimbursement is possible when unmet need is high. The two-year evidence window also gives HEOR teams a defined timeframe to demonstrate value, potentially smoothing the transition from temporary to permanent reimbursement while keeping budgetary controls intact.