In the early benefit assessments for new drugs the use of indirect comparisons can be necessary. For the assessment of results presented from indirect comparisons and network meta-analyses, transparent and detailed documentation is required.
We wanted to answer three questions: How often do pharmaceutical companies use indirect comparisons in their early benefit assessment reports (dossiers)? How often does the Institute for Quality and Efficiency in Health Care (IQWiG) accept these indirect comparisons and their results in the dossier assessment? Finally, what are the reasons for non-acceptance?
We evaluated all dossier assessments that were commissioned and published on the website www.iqwig.de between 1 January 2011 and 31 December 2016 with respect to the three questions above.
Seventy-one of 183 early benefit assessments (39%) included indirect comparisons and we therefore evaluated them. Only 11 of 71 indirect comparisons (15%) could be used for a benefit assessment and only three resulted in a hint of added benefit, which is a proportion of 4% of the 71 assessments with indirect comparisons. The reasons for non-acceptance of the indirect comparisons were inadequate study populations or therapies, inadequate literature searches and the use of unadjusted indirect comparison methods.
Indirect comparisons are frequently used in the dossiers of pharmaceutical companies. However, in most cases the indirect comparisons presented cannot be used for assessment of benefit. Pharmaceutical companies should submit evidence from indirect comparisons only if the study population and therapy address the question of the benefit assessment. Finally, adequate methods for indirect comparisons must be used to obtain interpretable results.
Patient or healthcare consumer involvement: