Researchers assessed the added benefit of fingolimod in comparison with the appropriate comparator therapy for the expansion of the therapeutic indication of fingolimod approved in May 2014.
Multiple sclerosis (MS) patients may not find added benefits while using fingolimod (brand name Gilenya) for its new therapeutic indication, according to findings published by the German Institute for Quality and Efficiency in Health Care (IQWiG).
The research, published in four dossier assessments, aimed to assess the added benefit of fingolimod in comparison with the appropriate comparator therapy (ACT) for the expansion of the therapeutic indication of fingolimod approved in May 2014. The study authors noted that this expansion was for adult MS patients who have previously been treated with disease modifying therapy other than interferon beta.
The new assessment was necessary because in October 2015, the therapeutic uses for fingolimod were modified again for MS patients. Previous therapies no longer needed to last at least one year and diagnostic criteria such as “highly active” were removed. For patients with rapidly evolving sever MS and those who had not yet received their full interferon beta treatments, fingolimod was found to be effective in the old reports. But the current assessment did not review these patient groups because the new guidelines indicate fingolimod is no longer approved for patients without the full year of interferon beta treatment.
The researchers found, in alignment with the new guidelines, that there appeared to be no measured benefit or harm from use of fingolimod than compared to the use of ACT for any of the patient outcomes examined.
“The result remains the same: An added benefit of fingolimod in comparison with the appropriate comparator therapies is not proven for patients with highly active RRMS despite full previous treatment with at least one disease modifying therapy,” stated an IQWiG press release.
The study authors added that the Federal Joint Committee (G BA) supervised part of the research and will produce a commentary before making a decision on the extent of the potential added benefit of fingolimod.