Result card

  • ETH11: What are the consequences of implementing / not implementing uPA/PAI-1, Oncotype or Mammaprint on justice in the health care system? Are principles of fairness, justness and solidarity respected?
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What are the consequences of implementing / not implementing uPA/PAI-1, Oncotype or Mammaprint on justice in the health care system? Are principles of fairness, justness and solidarity respected?

Authors: Dario Sacchini, Roberta Minacori, Pietro Refolo

Internal reviewers: Petra Schnell-Inderst, Mirella Marlow, Narine Sahakyan

Up to now, through the available studies, it is not possible to evaluate the consequences of using these tests on a large scale, within a healthcare system, because the clinical efficacy data are still insufficient and still heterogeneous for these three tests. In addition, the three tests so far have probably had different frequencies of use in the USA and Europe. Moreover, among the economic analyses that have been conducted on these assays, almost all of them involve the Oncotype DX test; only one study examined MammaPrint, and one study compared directly the cost-effectiveness of Oncotype DX and MammaPrint {40, 41, 42, 43, 44, 45, 46, 47, 48}. The use of these gene expression profiling tests for early-stage breast cancer may have significant effects on patient outcomes, medical services use, and costs. These tests may potentially contribute to higher quality, more efficient care and reduce rising healthcare expenditures. A key challenge for patients with breast cancer and their healthcare providers, while making treatment decisions, relates to the decision to use or forego adjuvant chemotherapy. Chemotherapy is expensive for payers and healthcare systems and it can produce significant side-effects (e.g., myelosuppression and permanent ovarian failure), which may have a substantial impact on quality of life. Thus, assessing the outcomes, use, and costs associated with these genomic diagnostic tests is critical for future clinical and health policy decision making as well as for future applications in healthcare systems.

The few available studies suggest that, although both Oncotype DX and MammaPrint are costly and have high incremental cost-effectiveness ratio (ICERs), it is reasonable to presume a willingness to pay for testing strategies that are likely to yield reduced expenditures for payers, health systems, patients, and society in the long term.

Unfortunately, however, these studies are at an early stage, so inconclusive.

From the point of view of justice within the healthcare system, it is not reasonable to deny resources to populations on the basis of unproven new treatments. In particular the uncertain correlation between these tests and both distant recurrence and overall survival, plus their relatively high ICER mean that other more effective treatments may need to be foregone in order for patients to access these tests.

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Completely
Sacchini D et al. Result Card ETH11 In: Sacchini D et al. Ethical analysis In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=113

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