Reimbursement for innovative medical technology is an essential part in the process of developing and launching new medical technologies. We would recommend not only to focus on the regulatory pathways. The way to approval is mostly very clearly defined and achievable. However the issue how a potential customer will earn money with the emerging medical technology is a major threshold in the market launch. In sananet’s experience not the regulatory approval but the lack of reimbursement and/or alternative ways for the user to get payment out of the use of your diagnostic / therapy product caused the failure of innovative products.
To apply for reimbursement for an innovative medical technology, be it diagnostics or therapy is difficult. The health care system is expensive and health insurance companies are understandably reluctant to reimburse new medical technologies. sananet can guide or personally take the responsibility for the application process of your reimbursement process in Germany.
In Germany, for novel innovative health care methods, there is a way to apply for a subsidized study (Erprobungsregelung nach § 137e SGB V). These studies are in principal organized by the same organization who handles the application for reimbursement.
Successful fulfilment of such a study could make the application for reimbursement of your innovative medical equipment much easier.
sananet can help you in the process (not the study itself) in Germany.
There is a new chance for innovative products Since 2011 : Modellvorhaben according to §§ 63 – 65 SGB V. These pilot projects (Modellvorhaben) are intended to experiment with inter-disciplinary and cross-sectoral deliveries of care. These pilot projects are limited to 8 years. Contracting partners are Physicians’ associations, associations of pharmacists and sickness funds. While on the first glance this seems to be a great chance for innovative medical devices and new pharmaceuticals, it is not totally without risk to apply for. The final result might be negative and in this case would greatly diminish chances for regular reimbursement. If you decide to go down the way of a pilot project, you better make it right.
If reimbursement for your medical device or biotechnology product is not given in the near future, to sell in-between, there might be ways around.
One potential work around would be a patient individual case by case application (individual case request with approval). Potential niche are patients who cannot tolerate todays standard method.
sananet would help creating the paperwork for the application, finding a reference site (doctor) and set a precedent.
Another option, especially in the in hospital setting with DRG-reimbursement is, to have a business case. sananet can create a set of information for the end customer (e.g. hospital administration) with which it is possible to calculate the economic advantage of your innovative medical technology over the current standard procedure. Generally the business case will consist of a calculation (e.g. Excel spreadsheet) and additional material (studies) which supports the assumptions of the calculation.
sananet consults to achieve reimbursement for medical technology. Reimbursement application process for the reimbursement of diagnostic and innovative therapies.