kiny
Well-known member
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- Apr 28, 2011
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IQWiG. Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, is an independent organisation employed by the German government to test and assess the benefits and safety of medication.
https://www.iqwig.de/download/A14-23_Vedolizumab_Kurzfassung_Nutzenbewertung-35a-SGB-V.pdf
https://www.iqwig.de/en/press/press-releases/press-releases/added-benefit-of-vedolizumab-is-not-proven.6354.html
2014-10-15
Added benefit of vedolizumab is not proven
Dossier contained no suitable data for Crohn disease or ulcerative colitis
Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the drug offers an added benefit over the appropriate comparator therapy in these patient groups. According to the findings, such an added benefit is not proven because the dossier contained no suitable data for any of the two therapeutic indications.
Drug manufacturer presented no studies for Crohn disease
In its dossier, the manufacturer identified no randomized controlled trial (RCT) that directly compared vedolizumab with adalimumab for patients with moderately to severely active Crohn disease. Since it also conducted no indirect comparisons on the basis of RCTs, an added benefit of vedolizumab for the therapeutic indication Crohn disease is not proven.
Side effects were not analysed adequately
The indirect comparison was also unsuitable for a second reason: The adverse events in the vedolizumab study were not analysed adequately.
https://www.iqwig.de/download/A14-23_Vedolizumab_Kurzfassung_Nutzenbewertung-35a-SGB-V.pdf
https://www.iqwig.de/en/press/press-releases/press-releases/added-benefit-of-vedolizumab-is-not-proven.6354.html
2014-10-15
Added benefit of vedolizumab is not proven
Dossier contained no suitable data for Crohn disease or ulcerative colitis
Vedolizumab (trade name Entyvio) has been approved since May 2014 for patients with moderately to severely active Crohn disease or ulcerative colitis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the drug offers an added benefit over the appropriate comparator therapy in these patient groups. According to the findings, such an added benefit is not proven because the dossier contained no suitable data for any of the two therapeutic indications.
Drug manufacturer presented no studies for Crohn disease
In its dossier, the manufacturer identified no randomized controlled trial (RCT) that directly compared vedolizumab with adalimumab for patients with moderately to severely active Crohn disease. Since it also conducted no indirect comparisons on the basis of RCTs, an added benefit of vedolizumab for the therapeutic indication Crohn disease is not proven.
Side effects were not analysed adequately
The indirect comparison was also unsuitable for a second reason: The adverse events in the vedolizumab study were not analysed adequately.
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