With the possibility to analyze gene expression a plethora of new genomic tests are surging into the medical market. The assessment of these new technologies in Health Technology Assessment (HTA) reports is challenging and we need international consensus on uniform criteria to support HTA, but also to establish clear and standardized requirements for clinical studies.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has been commissioned to assess the benefits and harms of biomarkers to predict which women would benefit from chemotherapy treatment after surgery of primary breast cancer. The final report was published in October, 2016 (1).

Only eight studies complied with the inclusion criteria of the systematic review. No prognostic study fulfilled the inclusion criteria. Only two randomized controlled trials (RCTs) delivered information utilizable for benefit assessment. Based mainly on 5-year results from the MINDACT trial, the report concluded that there currently is not enough information to support a positive decision on biomarkers in this specific indication. Ongoing randomized controlled trials like TailorX, PlanB, RxPONDER, ADAPT or OPTIMA are expected to provide some additional evidence in the near future. After publication of the IQWiG report an extensive debate on several methodological characteristics of this report was fuelled. In addition, some other HTA agencies, such as the National Institute for Health and Care Excellence (NICE) made slightly different conclusions.

The presentation will give a résumé of the main arguments and focus on differences between the IQWiG report and other HTA reports. Questions, like the required study type, study characteristics (for example, attrition rate, follow up, outcomes), data quality, cut-offs or patient preferences in diagnostic information will be provided. The aim of the presentation and discussion is to get a step forward in defining key characteristics and elements of benefit assessment and primary studies for these new technologies. A consensus among HTA reviewers in these approaches seems to be essential in the near future.