September 28, 2016

Who sets the cut-off?

The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics

All what you need to know about the implications of stratified medicine, you can get it in one article. That's great. And at the same time worrying or amazing for somebody. You'll see that stratified medicine reduces the size of the market with the use of biomarkers. Than, more accuracy is more costly. However, who sets the cut-off? This is the question. Trusheim and Berndt shed light on the issue:
Setting the cut-off value for the imperfectly performing companion diagnostic presents multiple challenges to the scientist, regulator, ethicist, marketer, clinician, and payer. Scientists might seek natural break points connected to a biological mechanistic rationale, or struggle to define the proper balance between diagnostic sensitivity and specificity. Regulators might seek a division that maximizes the benefit:risk ratio with the greatest certainty. Ethicists might be concerned with issues of denying care to some or knowingly causing harm to some (statistically) to benefit others. Marketers might seek to optimize revenues by balancing efficacy improvements, and the correlated pricing and market share, with the number of eligible patients in the market. Clinicians might seek to know the likelihood that their individual patient will respond to treatment or will incur an adverse event. Payers might focus on the net clinical benefit to their specifically covered population and the overall affordability of the resulting net total outlays for the actually treated population. Although clearly having overlapping perspectives, when selecting the CDx cut-off each stakeholder brings its own unique view of the issues to emphasize and the proper metrics to optimize.
Meanwhile, you'll not be able to find any implication of the regulator on selecting the right cut-off in the new european draft rules for in vitro diagnostic tests. This is a new missed chance.

Man Ray, Hands, 1966, screenprint