Proof of medical benefit - the major hurdle

Proof of medical benefit is often the biggest hurdle in the context of a HiMi application for therapeutically effective products.
The requirements catalogue of the GKV-Spitzenverband states:

(...) Proof must be provided:
The medical benefit of the registered medical device for the claimed product type/indication(s) by:
- Qualitatively appropriate medical evaluations

The assessments must also substantiate the following parameters:

Now, depending on the respective product type, various questions follow that must be answered in the "appropriate medical evaluation". .
Regulatory affairs managers then reflexively turn first to the clinical evaluation report. In diesem Bericht sollten die medizinischen Aspekte erschöpfend diskutiert worden sein und auch für die Hilfsmittelnummer verwendbar sein. Der Gedanke ist auch gar nicht abwegig. Tatsächlich zielen die meisten Fragen des GKV Spitzenverbands auf die erfolgreiche Behandlung und deren Randbedingungen ab. Ergänzend kommen usability-Aspekte (Gebrauchstauglichkeit) hinzu.
In other words, questions relating to handling by patients. These points could also have played a role in one or other discussion during the clinical evaluation if the clinical data situation allowed it. And this is where we come very close to the stumbling block.

It all depends on the context: clinical evaluation vs. medical evaluation

Clinical evaluation rarely uses "own" clinical data. Instead, data is used that was collected with a similar, equivalent product. The latter, i.e. the comparability, must also be documented very precisely by the team of authors of a clinical evaluation. The effort involved in the comparative discussion is often no less than the search for suitable literature. The limits of comparability are reached at the latest when material data, processing data etc. of the competitor products cannot be accessed. These so-called information gaps are then filled, for example, by own material tests. This procedure is completely normal for clinical evaluations.
However, this does not fulfil the requirements of a HiMi application. It is quite unlikely that clinical data collected with a comparator product can be successfully transferred to a company's own product without restriction in such a way that the medical benefit for the HiMi number application can be demonstrated. This means that manufacturers must obtain their own clinical data with their own product(s).

Hersteller*innen, die im Rahmen des Konformitätsbewertungsverfahrens eine klinische Studie mit ihrem Produkt planen, könnten ja die HiMi-Anforderungen/Fragestellungen am besten gleich mit einbauen in den Plan für die klinischen Prüfer*innen. Aber auch hier kann es Probleme geben. Die klinischen Studie laufen meist in klinischen Zentren und nicht in einer home-care environment. Here, too, transfer is only possible to a limited extent. The products on the list of medical aids (Hilfsmittelverzeichnis, HMV) are intended to work at home, wherever patients are. The transfer from the clinical environment to the home environment does not work. In the clinic, you have medical staff around you. This is not usually the case at home, to mention just one point of criticism. It is not without reason that a not insignificant aspect of the expert opinion on medical benefits is the question of error-free use by patients in the home environment.

Can the supporting documents be brought together?

n our day-to-day work, we also regularly try to bring together the two seemingly closely related verification documents for the technical documentation / CE file and for the HiMi application to the GKV umbrella organisation.
However, we have to realise that the path from clinical evaluation to an appropriate assessment of the medical benefit is a difficult one, which in the end is often not economically justifiable. The reverse is not the case, however. The expert opinion on the medical benefit of a company's own product may be able to fill a gap in the clinical evaluation, despite the lack of evidence. In this case, the company's own clinical data is available, which often strengthens comparability with other products and can also convince notified bodies or state authorities. The topic of "medical benefit" and "clinical evaluation" is an extensive one.

Is this also an issue for you? Then get in touch with us. We will be happy to help you find an efficient way.

(1 Rating(s), average: 5.00 out of 5)

Loading...