Response to IQWiG assessment: Agendia’s Chief Clinical Officer affirms clinical utility of MammaPrint® in identifying breast cancer patients who can safely forego chemotherapy, following MINDACT trial

  • Gene expression-based tests are an integral part of modern oncology treatment strategies
  • The MammaPrint® test, supported by the MINDACT study, reflects the leading edge technology and evidence for patients and physicians in need of clinically relevant information on which to base treatment decisions
  • Access to clinically proven tests like MammaPrint should be available to all qualifying patients in Germany

We were concerned by the outcome of Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) assessment of reimbursement for the use of gene expression-based tests for determining risk of recurrence of breast cancer. We disagree with its rationale for stating that there is not a clear patient benefit for the use of such tests, and for questioning the approach taken by the clinicians who designed the supporting trials. Based on more than 12 years of clinical trials, supporting thousands of patients, we are convinced that gene expression-based tests like MammaPrint provide substantial benefit to patients and physicians in need of definitive answers to inform their treatment decisions.

However, we are proud that MammaPrint was the only test fully assessed by IQWiG due to the evidence provided by the MINDACT trial, the only study to fully publish its results, and of IQWIG’s acknowledgement of the highest level of evidence for the clinical utility of MammaPrint.

The MINDACT trial was designed by leading European clinicians and conducted by 112 institutions, to answer the question: can genomic profiling of breast cancers with high-risk clinical and pathological features identify women who can safely avoid adjuvant chemotherapy? MINDACT was coordinated and sponsored by the European Organisation of Research and Treatment of Cancer (EORTC) as part of an extensive partnership with the BIG (Breast International Group) and other partners including patient advocate groups. The trial endpoint, as agreed by key opinion leaders involved in the trial’s design, was Distant Metastasis Free Survival (DMFS) at five years. In the clinical community the general consensus is that chemotherapy benefit is mainly seen within the first five years (as observed in the Oxford Overview Analysis, Lancet, 2012) Moreover, five-year metastatis free survival data is commonly accepted by regulators as the basis for approval and implementation of novel therapies.

An additional five-year follow-up will be performed but the investigators of the trial concluded the data mature for the chemotherapy primary end point. Postponing the use of gene expression-based tests for another five years will lead to thousands of patients in Germany potentially receiving unnecessary chemotherapy.

The patient impact of the side effects of chemotherapy are widely documented[i] and the MINDACT study results show that, by using the MammaPrint test, a 46% reduction in use of chemotherapy can be achieved in this patient population. As a result, the number of women having to endure needless chemotherapy with accompanied adverse events and toxicity, but without beneficial effect, will be substantially reduced.

Agendia hopes that the Federal Joint Committee (G-BA) will take a patient-oriented approach to their forthcoming reimbursement decision-making process which considers both the proven clinical benefit of MammaPrint to patients in Germany and highest level of evidence of the test’s performance, provided by the landmark MINDACT trial.

At Agendia we are committed to provide access for all patients to MammaPrint via our BRIDGE initiative, and are working with payers and health insurers in Germany to ensure that breast cancer patients can make an informed decision regarding their optimal treatment plan.  Until formal decisions have been made we are doing our utmost to deliver the benefits of MammaPrint to those who are candidates for the test.

Chemotherapy plays a central role in the fight against breast cancer, but modern cancer therapy means that this highly stressful therapy must be used very consciously and purposefully, and only when there is a proven advantage. Gene expression-based tests like MammaPrint are the key to enabling more precise, individualised treatment.

 
Bastiaan van der Baan
Chief Clinical and Business Development Officer
Agendia

 

The IQWiG announcement can be found here (in German): https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/biomarker-tests-bei-brustkrebs-entscheidung-uber-chemotherapie-bleibt-schwierig.7700.html

 

For more information about the MINDACT trial, visit: http://www.agendia.com/healthcare-professionals/the-mindact-trial/

 

[i] H. A. Azim Jr, E. de Azambuja, M. Colozza, J. Bines & M. J. Piccart. Long-term toxic effects of adjuvant chemotherapy in breast cancer. Annals of Oncology 2011, 22: 1939–1947 http://annonc.oxfordjournals.org/content/early/2011/02/02/annonc.mdq683.full