Rapid HTA of MammaPrint® test in Belgium

Gene expression profiling (GEP) tests aim to improve decision-making related to adjuvant chemotherapy treatment for women with early breast cancer. After the publication of the results from the MINDACT randomized control trial on MammaPrint® in August 2016, RIZIV/INAMI requested from KCE to update their HTA report. An assessment of the clinical utility of MammaPrint® has recently been finalized by the Dutch National Healthcare Institute (Zorginstituut Nederland (ZiN)), as part of an EUnetHTA joint production, which KCE reviewed. The objective of this report is to complete the clinical assessment, with an evaluation of the cost-effectiveness of MammaPrint® in the Belgian settings.

In this publication, the KCE has performed a systematic literature review of economic studies in order to evaluate the cost-effectiveness of the method.

Key conclusions from the systematic literature review are the following:

• All economic models published up to date presented a crucial limitation: no economic evaluation was yet based on the MINDACT RCT data, and thus, all studies relied on inputs from different sources, mostly retrospective analyses, modelled together resulting in significant uncertainties
• No economic evaluations up to date used the relevant comparison: MammaPrint® in addition to Adjuvant! Online versus Adjuvant! Online alone
• The increments seen in Life-Years-Gained when using MammaPrint® in these studies do not reflect the small (non-significant) decreases in the DMFS point estimates found in the MINDACT trial. Nevertheless, some gains in QALYs by avoiding chemotherapy, especially in the short term, are possible
• Sources for one of the essential factors in the evaluations (QoL) were relatively out-dated and were derived in all cases from studies with small sample sizes
• Although the awaited 10-year results from the MINDACT trial should provide more robust data on overall survival and AEs, they will not fill in the current evidence gaps regarding QoL

When identified economic data were applied to the Belgian context, the following conclusions were made:

• The overall ER+ HER2- early breast cancer population in Belgium in 2014 was approximately 6367 patients, 3069 of which are classified as high clinical risk patients (≈48%)
• From the potential target population of MammaPrint®, (i.e. high clinical risk patients according to the modified A!O), 35% received chemotherapy treatment in Belgium in 2014 overall (or 47% excluding patients aged 71+ as per the MINDACT trial)
• Estimates show approximate mean chemotherapy-related costs in Belgium of €11 411 without considering sick leave costs and of €15 044 when the latter are included
• Given the uncertainties surrounding the limited data on the clinical utility of MammaPrint®, no reliable incremental cost-effectiveness ratio could be calculated

See the full report English here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.