A look into the future by Jürgen Windeler, IQWiG’s Director
IQWiG has not only survived the first 10 years, it has in fact become an important and widely recognized organization – both in the German health care system and in the European HTA community. The next 10 years will be about holding and expanding this position and using it to implement necessary improvements. The dynamics of the last years have been remarkable. Could one have imagined 10 years ago that
- newly approved drugs would be subject to systematic assessment?
- in this assessment, not “just any” advantage is enough, but the current healthcare standard is the benchmark, i.e. the added benefit is decisive?
- pharmaceutical companies must disclose all documents on the methods and results of their studies?
- prices are set on the basis of a therapeutic added value?
- studies are being initiated and conducted of which individual experts claimed beforehand that they were not feasible or were superfluous?
- studies can in future be co-funded by statutory health insurance?
- evidence-based information is regarded to be indispensable, even for cancer Screening?
This represents progress that IQWiG substantially contributed to by its work and by the way it positioned itself.
The next 10 years
In view of what has been achieved so far, it does not seem fully utopian to describe the situation in 10 years (at the latest) as follows:
Benefit assessments also for older drugs
Drugs already being used in health care will be systematically evaluated. We have too many drugs that have not been sufficiently evaluated with regard to their benefit or are superfluous. The assessment of the established drug market was stopped for formally comprehensible reasons. However, price discounts alone will not solve the problems in health care. We thus need regulations for older drugs such as those already successfully implemented for new drugs.
Medical devices are subject to (early) benefit assessment
The investigation of inpatient examination and treatment procedures (§ 137c Social Code Book V) originally aimed to enable research. However, it actually promotes the largely uncontrolled flow of so-called innovations into the system. But, as AMNOG fell from the tree as an overripe apple, in 10 years there will also be a systematic assessment of medical devices. First signals in this regard are already recognizable today.
All relevant documents from regulation procedures are public
Since its establishment, transparency has been a key objective at IQWiG. However, the Institute has not only made transparency the basis of its own work and practically implemented this; it also requests transparency from others – from industry as well as the scientific community.
As early as 2005 the Institute reached a pioneering agreement with pharmaceutical companies, which has proved to be successful in practice and is now also being used with manufacturers of medical devices. AMNOG has emphasized the Institute’s efforts to achieve transparency. The next steps will be to make data from studies of drugs already approved publicly available, as well as relevant information from CE certification procedures. New requirements will also be specified with regard to the publication of non-industry sponsored studies.
HTA processes are agreed upon at a European Level
The healthcare systems in Europe differ considerably and HTA must support decisions on a national level. In this respect, the European HTA institutions need to achieve a certain level of standardization. The current EU-wide projects will result in a set of rules in terms of guidelines that could form the basis for assessments conducted by national agencies.
A platform following the model of the British website “NHS choices” is available
Informedhealth.org is an offer for all consumers and patients to obtain comprehensive, evidence-based and independent information on questions concerning health issues such as prevention as well as diagnosis and treatment of diseases. However, it is impossible for IQWiG alone to cover the whole need for information. The effort required would be too great, especially if information on the healthcare system itself is also to be provided. We aim to establish collaborations with other institutions here, where we all agree to adhere to standards and share the work, so that we can provide the high-quality information needed by consumers and patients.
Exposing gaps in knowledge results in the development of concepts for studies
IQWiG has always regarded it to be its responsibility to raise awareness of the gaps in knowledge identified through its work. Fortunately, this has often been taken up and implemented in concepts for studies. One of the prominent results is the internationally unique study on the treatment of early stage prostate cancer (PREFERE).
It would be most desirable if the necessity of such activities found even greater acceptance in Germany.
Prognoses about the future are difficult, so surprises are fairly certain. We will work on being able to report (partly surprising) progress when we look back on the next decade. In short: we are really looking forward to the tasks facing us over the next 10 years.