GVS advice roxadustat (Evrenzo®) for the treatment of symptomatic anaemia in chronic kidney damage
The National Health Care Institute has completed its assessment (using the CBG-ZIN parallel procedure) whether roxadustat (Evrenzo®) can be included in the Medication Reimbursement System (GVS). Roxadustat is registered for the treatment of symptomatic anaemia in chronic kidney damage (CNS) in adult patients. Roxadustat (Evrenzo®) is not interchangeable with any product in the GVS. The National Health Care Institute advice is to include roxadustat in List 1B of the GVS.
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Evrenzo® is available as tablets with 20, 50, 70, 100 or 150 mg roxadustat and is registered for the treatment of symptomatic anaemia in chronic kidney damage (CNS) in adult patients.
The National Health Care Institute has concluded that, in the treatment of adult patients with symptomatic anaemia in case of chronic kidney damage, roxadustat complies with the established medical science and medical practice.
In the GVS, the classification of medicinal products into groups of interchangeability distinguishes between, among other things, medicinal products administered through injection and non-injection medicinal products. For this reason, roxadustat, which is administered orally, is not interchangeable with darbepoetin alfa, methoxy polyethylene glycol-epoetin beta and epoetin, which are administered by injection (subcutaneous or intravenous).
Based on the considerations mentioned in the report, the Zorginstituut reccomends the Minister to include roxadustat (Evrenzo®) on List 1B of the GVS.
Parallel Procedure CBG-ZIN pilot
In the Parallel Procedure CBG-ZIN pilot, the reimbursement process starts while the registration process has not yet been completed. Medicinal products that go through this parallel procedure, rather than the current sequential procedures, will become available to patients more quickly. Due to the parallel procedure, the National Health Care Institute can rule on the reimbursement immediately after registration.
This report is a summary of recommendations by the National Health Care Institute The original text is in Dutch.