Recently the United Kingdom's (UK) National Institute for Health and Clinical Excellence (NICE) announced their refusal to recommend the use of three genomics diagnostic tests for breast cancer therapeutic decision-making (Oncotype DX, MammaPrint, Mammostrat) and to recommend a forth one, the Immuno Histo Chemistry-4 test, IHC4, for research of analytical validity in local laboratories only. This decision was based on the opinion of a panel of experts regarding the tests’ lack of sufficient evidence about clinical and economic effectiveness.
The 43-page report, available at NICE’s website: http://www.nice.org.uk/, was released in January 2012 on a preliminary basis pending comments of interested stakeholders after a consultation period ending on February 24th. Agents of manufacturing companies expressed their disagreement with NICE’s decision and expect to submit new clinical trials and cost-effectiveness data with the hope of overturning the initial decision.
According to members of the panel, clinical evidence presented by manufacturers was supported by studies at a high risk for errors, the brief follow-up periods, not developed with UK populations or with insufficient indication of good economic performance when analyzed in light of current clinical practices with or without concurrent use of the Nottingham Prognostic Index (NPI). Currently, UK physicians estimate prognosis of breast cancer recurrence using tools such as the NPI, established in 1982, or the “Adjuvant!” online software for supporting their decisions whether to provide or not adjuvant chemotherapy to breast cancer patients. However, these tools may provide inaccurate orientation to treating doctors regarding provision of chemotherapy because they base their estimations on tumor characteristics not associated with advances in oncological genomics.
The panel found that the tests’ proposed advantages varied and that none of them were good enough to make a statement of inclusion in the guidelines. NICE set an expected standard incremental cost-effectiveness ratio (ICER) of £20,000 ($31,778) per QALY (quality-adjusted life year) gained for any of these tests to be considered cost-effective when compared to current clinical practice alone or with NPI. None of the results for the economic analyses of genomics diagnostics achieved this threshold.
Breast cancer is a relevant health issue since it is the most commonly diagnosed malignancy among women in the UK and is the second largest cause of cancer death in women with more than ten thousand deaths yearly. UK population’s composition by ethnic background has shown that people of Asian, Chinese, African, and mixed backgrounds have lower incidence rates of breast cancer than Britons of white race.
Stay tuned for more news in this continuing saga and the world of personalized medicine.