The hole for genetic testing market entry

Technology Assessment on Genetic Testing or Molecular Pathology Testing of Cancers with Unknown Primary Site to Determine Origin
Update on Emerging Genetic Tests Currently Available for Clinical Use in Common Cancers

AHRQ has just published two reports of interest. The first is devoted  to assess the evidence on the analytical validity, clinical validity, and clinical utility of commercially available genetic tests for identifying the tissue of origin (TOO) of the cancer in patients with cancer of unknown primary (CUP) site. The second describes genetic tests that have applications in the common solid tumors (breast, lung, colorectal, pancreas, etc.) as well as tests that are used in hematologic cancers (leukemia, lymphoma) and are already available in clinical practice.While the first is an assessment, the second is informative.
There is still a third report to be released and meanwhile NRD explains its conclusions. Having selected 11 prognostic tests, only around half had evidence supporting their prognostic accuracy or clinical validity. Therefore the question is always the same: why these tests without evidence are on the market? Why have they been approved by the FDA?. There is a big regulatory hole to fill in.

Conflicts of interest (in medicine)

I would like to attend this seminar:

Professor George Lowenstein
Behavioural Economics and Conflicts of Interest

“A conflict of interest is a clash between an individual’s professional responsibilities and their personal, typically financial, interests. Traditional economics has not shed much light on conflicts of interest, perhaps in part because it has not recognized the importance of professionalism as a motive in human behaviour. In this talk I will present results from a variety of studies that examine the behavioural economics of conflict of interest. Focusing mainly on conflicts of interest in medicine, some of the research shows how people who care deeply about behaving in a professional fashion can be corrupted by economic incentives. Other research shows how disclosing conflicts of interest, far from helping the recipient of information, can backfire, helping the advice-giver and hurting the advice recipient.”

Lecture Theatre 3, Cambridge Judge Business School. Tuesday 25th February 5-6.30pm. No need to register but arrive early in order to get a seat.

Unfortunately, I can't attend. Any info will be appreciated.
You may follow events on Behavioral Economics, here.

PS. Our public expenditure on health on 2012 gave ground, and was close to 5 years before: 2007. Such expenditure over GDP is still at 2008 position: 5,3% , while our GDP per capita (27.442€) is  at levels before 2006 (!). Therefore we are spending on health (more than) proportionally to our GDP historical trend, however our GDP has shrinked a lot. And we maintain distance to OECD average health expenditure (6,69%) although our per capita GDP is 2,7% larger. That's all right now, it's an issue of months.

PS. Interesting post by Josep Maria Via.

The market size of stratified medicine

Defining and quantifying the use of personalized medicines

There is a lot of noise around the message that the personalised-stratified medicine era has arrived. If you split the clamour from the message, the result is close to 34 medicines at the end of 2012, and in market volume accounted for 3% of the global market by the end of 2009. You'll find this details at NRD and this is the key comment:

First, in terms of characteristics, oncology agents dominate personalized medicine utilization, and disproportionately address unmet medical needs as revealed by priority, accelerated, and orphan disease FDA designations. Second, older drugs that have become personalized medicines post-launch have had a significant impact on the growth of small-molecule personalized medicines; however, the translation from label to clinical practice remains uncertain. Third, per capita usage of personalized medicines in the EU5 markets is greater than in the United States, with usage rates in Japan and the rest of the world growing rapidly

 Affair in Cascais

Club des Belugas- the Chin Chin Sessions

Everything is connected

Pla Interdepartamental de Salut Pública

We all know that improving population health is a task that exceeds the healthcare system. The political debate is too focused on healthcare rather than other determinants to improve health. However, today is a different day. A new plan to introduce health in all policies has been approved and this means a change in the agenda. We'll see how this will be managed, since it is a new approach.
Have a look at the document. The authors have been working hard for months on it. Such policy follows EU criteria and represents an innovation in the current health policy landscape. Let's see how effective it is.

Capitalism and morality

Market Reasoning as Moral Reasoning: Why Economists Should Re-engage with Political Philosophy

I found this article. Have a look at the abstract:

In my book What Money Can't Buy: The Moral Limits of Markets (2012), I try to show that market values and market reasoning increasingly reach into spheres of life previously governed by nonmarket norms. I argue that this tendency is troubling; putting a price on every human activity erodes certain moral and civic goods worth caring about. We therefore need a public debate about where markets serve the public good and where they don't belong. In this article, I would like to develop a related theme: When it comes to deciding whether these or those goods should be allocated by the market or by nonmarket principles, economics is a poor guide. Deciding which social practices should be governed by market mechanisms requires a form of economic reasoning that is bound up with moral reasoning. But mainstream economic thinking currently asserts its independence from the contested terrain of moral and political philosophy. If economics is to help us decide where markets serve the public good and where they don't belong, it should relinquish the claim to be a value-neutral science and reconnect with its origins in moral and political philosophy.

There are health economics implications, with a little effort you can find them.

Effectiveness, first things first

Homeopathy in Healthcare – Effectiveness, Appropriateness,Safety, CostsAn HTA report on homeopathy as part of the Swiss Complementary Medicine Evaluation Programme

Swiss government requested a report on homeopathy through the Complementary Medicine Evaluation Program, just to understand its cost-effectiveness. You'll find the complete story in this blog.
The key table is here.Such report and this table created controversy due to conflicts of interest of their authors.
Finally the government decided not to include homeopathy in the reimbursed benefit basket.
Is there any reason to regulate when the effectiveness has not been demonstrated?. This is my question today to a regulator that it seems busy on this issue. My answer is clear, it is unnecessary. He has to inform the citizens and incriminate providers in case of false advertising.

PS. I already said this before, here and here .

Competing on biosimilars

One year ago McKinsey released a report on biosimilars. They explained what happened in Europe after 2005 regulation. Now NRD has published an interesting article by Henry Grabowsky et al. that shows wide differences within Europe. In Germany, 42% of the market of Epoetin is biosimilar, while UK remains at 7,9% (!). The article explains the reasons behind such variation. If we have to summarise in one cause, this would be: incentive regulation. And since prices are 25% less than original products, such difference has high opportunity costs for UK citizens (however the price levels in Germany is higher than the UK).
In their words:

One major finding is that the competitive performance of the biosimilars we analysed in Europe is mixed both across countries and products. Although the European Union has a common regulatory system for approving biosimilars, differences in reimbursement practices and incentives as well as variations in medical practices have resulted in  different outcomes across countries.

Does anybody know what's happening here?

PS. IMS presentation.