Our solution
The solution was to perform a detailed and clear analysis that outlined why an ITC could not be performed in this indication and that the only relevant comparative information could be retrieved from the clinical trial. The analysis focused on the inherent assumptions of NMAs and MAICs and assessing to which extent these assumptions were violated. NMAs are the preferred methodology; however, they require a network of treatments that are connected by common comparators in respective RCTs and similar patient populations with regard to treatment effect modifiers (TEM). A review of published ITCs and HTA submissions was performed to determine which parameters would need to be similar between populations. Due to differences in indication and recruitment procedures, an NMA could not be performed. Therefore, the potential for performing both anchored and unanchored MAICs was assessed for treatments that could be seen as relevant comparators based on an investigation of the treatment landscape. Several TEMs were not reported in the comparator studies, and the difference in indication could not be adjusted to match the populations. The only MAIC possible would be severely biased and, due to the inherent reduction in precision arising from the matching process, i.e., a large reduction in effective sample size, would not be able to provide useful information on the relative effectiveness between the treatments. These limitations of the data and the available evidence were outlined in a detailed manner and concluded that no ITC would be possible.
Our impact
Our conclusions and evidence were accepted and supported by HTA agencies globally, providing our clients with an improved needed substantiation of the comparative landscape and eventually providing a large group of patients with much-needed access to improved therapeutic options for treating their cancer. The client’s satisfaction and continued collaboration proved the project's success.