No abstract

The German submission requires a comparison of the drug to be assessed with the appropriate comparative therapy (ACT). In contrast, for the NICE submission an economic evaluation is required beside the clinical evidence of all the drugs in the specific disease area. The assessment of vedolizumab was performed by the IQWiG for both indications simultaneously whereas NICE did the assessment for the two indications separately. The G-BA defined either adalimumab (ADA) or infliximab (INF) as ACT. As a direct comparison was not possible an indirect comparison was performed but the results were not considered by IQWiG due to different study design. No additional benefit was determined in both indications. By contrast network meta-analyses (NMA) were performed for the NICE submissions. Although NICE noticed that the NMA results are afflicted with uncertainties, vedolizumab was classified as cost-effective in both indications. ConClusions: The G-BA defined an ACT whereas the data of all drugs approved in disease areas are considered in the NICE submission. Indirect comparisons were not considered by IQWiG. In contrast, the results of the NMAs performed for the NICE submissions were discussed. The focus of the G-BA is on the assessment of the additional benefit against the ACT. That result is the basis for the price negotiation. By contrast, NICE is primarily interested in the cost-effectiveness of a drug.