Added benefit of vedolizumab is not proven

PUBLIC RELEASE DATE:

23-Oct-2014

Contact: Dr. Anna-Sabine Ernst presse@iqwig.de 49-022-135-6850 Institute for Quality and Efficiency in Health Care

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.

G-BA specified adalimumab or infliximab as comparator therapy

Crohn disease and ulcerative colitis are chronic inflammatory bowel diseases. Vedolizumab is an option when conventional therapy is not tolerated or does not provide sufficient release of symptoms. This conventional treatment can also be a tumour necrosis factor alpha (TNF) antagonist.

The Federal Joint Committee (G-BA) specified a TNF antagonist (adalimumab or infliximab) as appropriate comparator therapy for both therapeutic indications. It is to be noted that it is possible to switch to a different TNF antagonist or to adjust the dose in case of treatment failure with a TNF Antagonist.

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.

Ulcerative colitis: indirect comparison with placebo as common comparator

Read this article:
Added benefit of vedolizumab is not proven