Proving the Medical Benefit is a Common Hurdle
The proof of medical benefit is often the biggest hurdle in the context of an HMV application for therapeutically effective products. The catalogue of requirements of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) then states:
(…) Evidence must be provided:
The medical benefit of the registered medical technical aid for the claimed product type/indications by:
– Qualitatively appropriate medical evaluations.
The evaluations must also substantiate the following parameters:
Now, depending on the respective product type, various questions follow which have to be answered in the “adequate medical evaluation”.
As a reflex, regulatory affairs managers then first reach for the clinical evaluation report. In this report, the medical aspects should have been discussed exhaustively and should also be usable for the HMV code (HMV = Hilfsmittelverzeichnis). The idea is not far-fetched at all. In fact, most of the HMV-questions are aimed at successful treatment and its marginal conditions. In addition, there are usability aspects.
In other words, questions that concern the handling by patients. These points could also have played a role in one or the other discussion during the clinical evaluation, if the clinical data situation allowed it. And here we are closing in on the issue.
Context is Key: Clinical Evaluation vs Evaluation of Medical Benefit
In clinical evaluation, “own” clinical data are rarely used. Rather, data are used that were collected with a similar, an equivalent product. The comparability must also be proven very precisely by the team of authors of a clinical evaluation. The effort of the comparative discussion is often no less than the search for suitable literature. The limits of comparability are reached at the latest where 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 meet the requirements of an HMV application. It is quite unlikely that clinical data collected with a comparative product can be transferred without restriction and with success to one’s own product in such a way that the medical benefit for the HiMi number (Hilfsmittelnummer = HMV code) application can be proven. Therefore, own clinical data must be obtained with the own product(s).
Manufacturers who plan a clinical study with their product as part of the conformity assessment procedure could ideally include the HiMi requirements/questions in the plan for the clinical investigators. Be aware, also here, too, there can be problems. Clinical trials are usually conducted in clinical centres and not in a home-care environment. Here, too, transfer is only possible to a limited extent. The products listed in the medical technial aids register (HMV, Hilfsmittelverzeichnis) are supposed to work at home, where patients are. The transfer from the clinical environment to the home environment does not work. In the clinic I have medical staff around me. I don’t have that 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 benefit is the question of error-free application by patients in the home environment.
Applying One to the Other
In our daily work, we also regularly try to bring together the two seemingly close documents for the CE file and for the HiMi application. However, we have to realise that the path from the clinical evaluation to the appropriate medical evaluation is a difficult one, which in the end is often not economically justifiable. The reverse is true, however. The case report (expert opinion) on the medical benefit with one’s own product can possibly fill a gap in the clinical evaluation despite not having too much evidence. Here I have my own clinical data, which often strengthen the comparability with other products to an unexpected degree and can also convince the notified body or the competent authority. The topic of “medical benefit” and “clinical evaluation” is an extensive one.
If you, too, are struggling with this topic, please contact us. We’d be happy to help you find an efficient way.