Unfortunately the US government has discontinued the Healthcare Horizon Scanning System. It was a framework to detect innovations before entering into the market. One of the last reports was on cost impact of these technologies:
We completed 53 rapid cost analyses on 55 topics over a period of 4 months from July through November 2014. The topics consisted of selected Potential High Impact ntervention reports published in 2013 and 2014. These 55 topics had a designation of oderate or high potential for high impact in those reports. To estimate potential costs of these new and emerging interventions, we sought to identify data on the following: revalence of the disease or condition targeted by each intervention; actual or projected doption of the new intervention; costs of the intervention; costs of a similar intervention; and costs of an alternative intervention used for the disease or condition
It seems that something similar is being proposed in Europe. Let's wait and see. Meanwhile check the canadians.
The topic sould be at the top of health policy agenda (at least as it is in this blog). New evidence confirms the additional safety risks of european bad regulation.
In the European Union, medical devices are approved by private notified bodies if they meet performance criteria and are likely to be safe, but notified bodies generally do not require evidence of effectiveness for most devices. Many high risk devices are approved faster in the EU than in the United States, where the Food and Drug Administration usually requires prospective clinical trials of such devices.
The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU.
This means exactly 2.9-fold greater rate of safety alerts and recalls and a 4.6-fold greater rate of recalls than devices approved first in the US (and if you look at the confidence intervals you'll get more worried). How can we trust the european regulator?. For decades, European Union has leaved its citizens with less safety protection than is required for medical devices. A perfectly designed absurdity to disseminate risk for european citizens that the new proposed regulation is unable to correct.
PS. If you wnat to understand the differences between EU and US regulation, read this NEJM article or Milbank one..
If you want to know if some device is effective, there is a standard way to demonstrate it: a clinical trial. This is precisely what has been done on the impact of wearables on weight loss. And the result is:
Among young adults with a BMI between 25 and less than 40, the
addition of a wearable technology device to a standard behavioral
intervention resulted in less weight loss over 24 months. Devices that
monitor and provide feedback on physical activity may not offer an
advantage over standard behavioral weight loss approaches.
That's amazing! Why is there so many articles pushing wearables for weigth loss when there are very few clinical trials, and their results are clearly against their use?. This is a marketing bubble and somebody should tell clearly that they could use wearables but for other reasons.
PS. Let's imagine that somebody wants to relate wearables for weight loss reduction with insurance premiums! Nothing to add.
If there is an example of how one part of an organization can't speak with the other is the European Union and Health Policy. If we are talking about medical devices, health issues are at the back, industry is writing the regulations. If we are talking about options for improvement, economics unit explains what health unit has to do. A perfectly designed mess.
Take the example of this week. A Joint report, that is an economics report with elementary mistakes for any health economist. Take this statement:
"Competition between hospital providers can lead to higher quality under strict price regulation." (p.70)
Does anybody know what does really mean strict regulation? Who is writing such things and being paid with our taxes?.
If you check another report on the topic by experts of the European Union you'll find an opposite recomendation.
"The conditions for competition to be a useful instrument vary across countries, health care subsectors and time. There is no golden rule or unique set of conditions that can be met to ensure that competition will always improve the attainment of health system goals." (p.4)
Definitely, the EU is in the middle of no judicious health policy.
In summary, an avoidable report that you can skip reading and devote your time to hearing Bob Dylan music for example, the new Nobel Prize.
Come gather 'round people where ever you roam
And admit that the waters around you have grown
And accept it that soon you'll be drenched to the bone
If your time to you is worth savin'
Then you better start swimmin' or you'll sink like a stone,
For the times they are a' changin'!
Come writers and critics who prophesy with your pen
And keep your eyes wide the chance won't come again
And don't speak too soon for the wheel's still in spin
And there's no tellin' who that it's namin'
For the loser now will be later to win
For the times they are a' changin'!
Come senators, congressmen please heed the call
Don't stand in the doorway don't block up the hall
For he that gets hurt will be he who has stalled
There's a battle outside and it's ragin'
It'll soon shake your windows and rattle your walls
For the times they are a' changin'!
Come mothers and fathers throughout the land
And don't criticize what you can't understand
Your sons and your daughters are beyond your command
Your old road is rapidly agin'
Please get out of the new one if you can't lend your hand
For the times they are a' changin'!
The line it is drawn the curse it is cast
The slow one now will later be fast
As the present now will later be past
The order is rapidly fadin'
And the first one now will later be last
For the times they are a' changin'!
After all these years, a new proposal for regulating in vitro diagnostics and medical devices in EU is available. Current regulation was enacted in 1998, and this one could be applicable in 2022, 24 years after, pas mal for the busy politicians!.
And this is a proposal, there were previous unapproved proposals, and this one has to pass the Council and the Parliament. I will not enter into the details.
It was supposed to increase safety and efficacy, but the main problem remains with who has to enforce them. Notified bodies, a subcontracting regulatory firms network, with vested interests with industry can't claim independence. And specifically, the methods for evaluate the analytical validity, clinical validity and utility is uncertain. No regulator will confirm us that the cut-off values of diagnostic tests are set according to the best evidence and greatest benefit. In US, FDA is the responsible.
In summary, a new missed opportunity for european citizens. A greater risk and uncertain effectiveness in diagnostic tests and medical devices.
PS. The latest known example of the impact of wrong regulation is this one. Those affected can't read this blog, they are blind.
Cost-effectiveness may be considered a focal point for health economists. However the trip from theory to implementation raises many doubts. The reductionist perspectives of some health economists consider that politicians are rational in decision making. And this is not the case. I suggest you a look at this article:
The cost-effectiveness model generally used for the evaluation of health technologies—and health care and public health interventions more widely—has become a central tool for public-sector policy makers in many health care systems. It was developed to help decision makers with fixed public resources to compare (1) different interventions for the same health problem and (2) programs in different disease areas. For a particular level of health care resources, the goal is to
choose from among all possible combination of programs the set that maximizes total health benefits produced. The traditional CEA methods presume the existence of only one salient constraint— the public finance budget constraint. Yet all of the evidence suggests that many other constraints impinge on decision makers, at least in the short run.
A fundamental reason for the failure to implement is that CEA assumes a single constraint, in the form of the budget constraint, whereas in reality decision makers may be faced with numerous other constraints. The objective of this article is to develop a typology of constraints that may act as barriers to implementation of cost-effectiveness recommendations. Six categories of constraints are considered: the design of the health system; costs of implementing change; system interactions between interventions; uncertainty in estimates of costs and benefits; weak governance; and political constraints.
There is intelligent life beyond cost-effectiveness...
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.
