Analysis of indirect treatment comparisons in national health technology assessments and requirements for industry submissions.

Abstract

Aim: To determine the preferred methodologies of health technology assessment (HTA) agencies across Europe, Canada and Australia to ascertain acceptance of indirect treatment comparisons (ITC) as a source of comparative evidence. Method: A review of official submission guidelines and analysis of comments in HTA submissions that have used different ITC methodologies. Conclusion: ITC is generally accepted as a technique that allows demonstration of noninferiority to a comparator provided the chosen methodology and underlying assumptions are clear and justified. However, HTA agencies are more likely to closely scrutinize submitted data and evaluate statistical significance of results when superiority is claimed. In addition, the HTA agencies in scope tended to be cautious and only accept ITC data as support for similarity of treatments.