As Germany goes to the polls, the VDGH, which represents in vitro diagnostics companies in Germany, has published a new policy paper on the future of healthcare. VDGH Managing Director Martin Walger tells Gary Finnegan why this is a crucial moment for health policy
The paper was released just ahead of federal elections in Germany and seeks to highlight the value of laboratory diagnostics. Tackling major challenges such as access to laboratory innovations, pricing challenges and personalised medicines, the report also applies to other European markets.
What practical steps can be taken to accelerate access to laboratory innovations?
This is one of the most difficult tasks we have to tackle and there are no simple solutions. If assessment procedures take significantly longer than the IVD product lifecycle, industry will suffer. But do we persuade politicians and decision makers with that argument? We are asking for appropriate methods and decision procedures which are transparent.
Are you concerned that prices do not match the quality/value of diagnostic products? Is the situation any worse for diagnostics than it is for devices, IT or medicines?
The German market is faced with very low prices for most diagnostics services, and this is especially pronounced in clinical chemistry. A high market concentration among the medical laboratories makes this problem worse. In the long run, the innovation capabilities of our industry also depend on the level of remuneration.
Can you give an example of how early diagnosis can improve outcomes for patients and deliver long-term value for the economy and society?
As far as I can see, the benefits of early diagnosis to prevent colon cancer are the best documented. Germany will rearrange its early detection programme this year, introducing specific cancer screening tests called “iFOB-Tests” and regular invitations for statutory health insurance patients to participate. The same applies to cervical cancer screening.
What role can diagnostics play in overcoming the challenge of antibiotic resistance?
Experts say that around half of the medical prescriptions for antibiotics are not appropriate. The tag line is: “Big drugs for bad bugs”. Let us add: Smart tests. Lab diagnostics are a key component of antibiotic stewardship beginning with a precise distinction between viral and bacterial infections (starting at the primary physician’s office) and following with resistance tests and therapeutic drug monitoring in the hospital.
Diabetes is one of the biggest challenges in modern healthcare: how has the role of diagnostics evolved in recent years and has the reimbursement system kept pace with these advances?
Some 415 million people worldwide suffer from diabetes. We are facing a diabetes tsunami. The IVD industry evolved new technologies such as Continuous Glucose Monitoring (CGM) and Flash Glucose Monitoring (FGM) which – together with conventional technologies – contribute to an effective therapy and enable people with diabetes to live a good life. We are in the lucky situation to have reimbursement for these new technologies in Germany. More problematic are price pressure and rationing for blood glucose measurement, because the quality of patient treatment can suffer.
What is the role of diagnostic information in personalised medicine? How can the full potential of this technology be unlocked to improve patient outcomes?
Diagnostic information will predict the therapeutic response – this is the great promise. From a technical point of view the digitalization of our health care systems will be a driver of future developments. A corresponding medical competence in personalised medicine is the second important point. And finally, the reimbursement of companion diagnostics must keep pace with medical advancements. This means: If the drug information requires testing, the reimbursement of the diagnostic service must be guaranteed.
What impact will new EU IVD regulations have on the industry?
On the one hand, manufactures have to spend more money and put in more work to bring new products to market – or to keeping older ones on the market. On the other hand, as more than 85% of the product will fall under the assessment of a notified body, manufactures might struggle to find a notified body. VDGH looks forward to the results of the impact assessment driven by MedTech Europe to give a better overview of the manufactures needs and problems regarding the implementation of the regulation.
You can find the policy paper in English here.