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Do they have a potential benefit? Assessing medical devices

If the benefit of a new examination or treatment method had not yet been sufficiently investigated, IQWiG and the G-BA could so far only wait and hope for better studies. However, now the assessment of the potential of medical devices has been introduced, which could help fill some of the gaps in evidence.

Make or break

Up to 2013 there were two possibilities for a new examination or treatment procedure as soon as the G-BA had decided on its reimbursability. Either the evidence of its benefit, often assessed with the support of IQWiG, was so good that it was reimbursed. Or the evidence available was insufficient to grant reimbursement, and that was it. Sometimes the G-BA discontinued consultations in order to wait for better evidence, often in vain. Many stakeholders therefore requested a third option by which missing studies could be initiated. In the past, high-quality studies were only initiated this way in exceptional cases.

Third way

With the Structure of Health Care Act of the Statutory Health Insurance (GKV-VStG ), in 2012 the so-called testing regulation for examination and treatment procedures was introduced. Now the G-BA is able not only to assess the evidence, but also improve it by initiating high-quality clinical studies if the “potential of a necessary treatment alternative” of a procedure is recognized. Under certain conditions the G-BA may also be involved in funding. But this regulation does not only apply to procedures selected by the G-BA. The manufacturers of medical devices, as well as other service providers, can also suggest the testing of procedures. In this way industry can invest in studies with a design regarded by the G-BA to be appropriate. The aim of the new regulation is to initiate without delay the conduct of high-quality studies for promising new procedures; the results of such studies would then enable a reliable decision by the G-BA.

Double potential

In May 2013 the G-BA awarded a regular commission to IQWiG for the assessment of the potential of medical devices, which precedes each decision on testing according to §137e Social Code Book V.

IQWiG first had to develop a methodological concept. The basis for the assessment of potential is the application submitted by the manufacturer or provider. The application contains, among other things, information on the medical device, i.e. the new examination or treatment procedure, and on the current state of knowledge on benefits and risks. It may already contain key points for a study on the testing of the device. On the basis of the documents submitted, IQWiG first evaluates whether the new procedure possesses the “potential for a necessary treatment alternative”, for example, due to its mode of action. Secondly, a potential for clinical testing must also be recognizable. The documents must be sufficiently informative that a study of high enough quality can be planned to assess the procedure. 

Reduced requirements

In comparison with the benefit assessments otherwise conducted by IQWiG, the requirements for the evidence are clearly lower here. But mere claims or hopes are insufficient: A “justified expectation” has at least to exist that the new innovation is more effective than established procedures with regard to patient-relevant outcomes (morbidity, mortality, and quality of life).

6-week processing period

As soon as IQWiG receives a specific commission for assessment from the G-BA, the clock starts ticking. Six weeks after submission of the application for testing, the Institute presents its results report. In the report IQWiG states whether the procedure shows sufficient potential as a treatment alternative and whether the documents are sufficiently informative that a study to assess benefit can be planned. If this is the case, the Institute outlines a possible study on testing. If the application already contains key points for such a study, IQWiG assesses whether they are suitable. The Institute also roughly estimates the costs for scientific support and analysis.

Six assessment steps

An application runs through 6 individual steps at the Institute.

IQWiG first assesses the research question: For example, is the choice of comparator intervention appropriate? It then assesses whether the literature search strategy of the applicant reveals major flaws. However, it is not the Institute’s responsibility to supplement the information in the application, for example, by searching for additional studies.

In a third step IQWiG reviews the evidence: Are the classification of study type and the evaluation of the certainty of results comprehensible? For example, comparative cohort studies provide more reliable results than mere case series.

In a fourth step the results reported in the application are evaluated. How plausible are they, and were the main patient-relevant outcomes considered?

On this basis, in a fifth step the Institute assesses the potential of the procedure as a treatment alternative. Do the submitted data suggest that the new procedure could offer patient-relevant advantages compared with established procedures? Or must one conversely assume that the new procedure has no benefit and may even be harmful?

In a last step IQWiG outlines a study through which this potential can be evaluated. This is usually a randomized controlled trial (RCT). For example, IQWiG specifies which patient-relevant outcomes on benefits or harms should be recorded over which period of time, as well as which sample size will roughly be required.

Specific protection

The highly confidential documents submitted by manufacturers or providers in the assessment procedure are subject to specific protection. Unauthorized third parties within or outside IQWiG are therefore unable to ascertain how many commissions were awarded to IQWiG or which topics are being assessed. What is to be tested is decided annually by the G-BA at the time of budget preparation; this was decided for the first time in spring 2014. Only when the G-BA passes a testing directive are the corresponding application and the report on the assessment of potential published.


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