The Minister of Health, Welfare and Sport (WVS) asked Zorginstituut Nederland (National Health Care Institute) to carry out an assessment of whether dimethyl fumarate (Skilarence®) is interchangeable with a medicinal product that is already included in the Medicine Reimbursement System (GVS). The Zorginstituut has completed its assessment.
Advice
Based on the current criteria for interchangeability, dimethyl fumarate (Skilarence®) is interchangeable with another medicinal product in the GVS that has the same active substance, namely Tecfidera®.
Thus, in principle, Skilarence® is eligible for inclusion on List 1A in a new cluster with Tecfidera®. This is in keeping with the Ministry's policy to minimise off-label use and to give preference to registered products. However, its inclusion in the GVS will be accompanied by additional costs amounting to approximately €7 million in comparison with the existing pharmacy preparations.
This report is a summary of recommendations by Zorginstituut Nederland. The original text of this excerpt is in Dutch.