Regulatory uncertainty in "home-brew" lab testing

Laboratory-Developed Tests: A Legislative and Regulatory Review

In vitro diagnostics regulation requires continuous adaptation to technologic innovation. Unfortunately, there is a lack of understanding that such a crucial task should be performed efficiently. Europe has waited 23 years for a new regulation!. Anyway, US is under the same trend. Laboratory developed tests were initially regulated 25 years ago and there are still pending issues in the new draft legislation. If you want to know the details, an article in Clinical Chemistry explains the whole issue.

A quarter of a century after the FDA first asserted regulatory authority over LDTs in a draft guidance document, rules and/or guidance regarding LDT oversight have not been implemented. As such, legal questions regarding MDA authority over LDTs and the FDA draft guidance approach have neither been escalated to nor resolved by the judiciary. In addition, many questions central to this debate have not been answered. Are clinical laboratories manufacturers? Should laboratory devices and procedures be regulated similarly? Are there always clear limits between laboratory operations and the practice of laboratory medicine? Any future LDTregulatory or legislative efforts will need to balance and address these concerns if they are to be successful. It is unlikely that interpretation of current statutes and regulations can fully resolve these issues.

 Josep Moscardó, Barcelona landscape

The cost of a year of life gained

Four years ago in my post: How much does healthcare cost during your life? I said  that it was 111.936 € for women and 81.566 € for men (on average and without any additional assumption about changes in unit costs or quality of life). Now you can find in Health Economics, an estimation of the cost of one additional year of life adjusted by quality.

 The mean cost of an additional Quality-Adjusted Life Year (QALY) within a National Health Service (NHS) reveals how much health is lost, on average, when services currently provided by the NHS are displaced. This value has been suggested as a proxy of the average opportunity cost required to set a cost-effectiveness threshold when facing fixed budget constraints. The aim of this paper is to generate information on the marginal cost per QALY in the Spanish NHS that can be used to inform a cost-effectiveness threshold

And the answer is:

A cost per QALY of between 21,000€ and 24,000€ in Spain, depending on whether we take an average across different age groups or the value derived from the whole population model, respectively.

Conclusion: A cost-effectiveness threshold based on the estimated opportunity cost derived from this study is below the figure of 30,000€ commonly cited in Spain. Further work on societal values of health gains is needed to provide decision makers with the relevant information required in different decision-making contexts.

Interesting result, though expenditures are not necessary "social preferences". Cost-effectiveness threshold literature sometimes try to focus on a normative decision for the society society from a technical point of view. I'm interested in the political one.

Au Grand Palais, maintenant

Evidence of what

Evidence-Based Health Policy

Evidence as a topic suggests a common shared framework of values. We all know that this is far from current health policy across countries and within countries. Evidence is difficult to assess without taking into account the underlying values of a community. However, health economists and epidemiologists insist on it. In my opinion we have to know better what works according to social expectations. However we have to avoid the confusion between any descriptive and normative framework. Evidence sounds that any desparture from it may sound unacceptable.
Anyway, NEJM provides a perspective on the issue, and these are key statements in a figure: