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Wednesday, September 10, 2014 1:02:42 PM
I found this page of interest, even though it appears to mainly apply to medical devices in Germany:
http://www.ispor.org/htaroadmaps/germanymd.asp
It shows a nice Background. It shows many of the institutions involved. Describes the lengthy process of obtaining "codes" (G-DRG ... Diagnosis Related Group).
The G-DRG system is maintained by the “Institute for the Hospital Remuneration System” (Institut für das Entgeltsystem im Krankenhaus, Siegburg) also known as InEK. InEK is responsible for the collection and processing of hospital costing data, the updating of the funding units associated with each funding code and the updating of the funding codes themselves. The institute is also responsible for certifying the logic system of various grouper software available to German hospitals. However, InEK does maintain neither the diagnostic, nor the procedural codes employed by G-DRG, which are responsibilities of the “German Institute of Medical Documentation and Information” (Deutsche Institut für Medizinische Dokumentation und Information) or DIMDI.
I also found this of interest ... and wonder whether the process might be similar for DCVax-L reimbursement ...
Quick Pathway to Access for Innovative Products – The NUB Application
Recognising the need for a mechanism allowing innovation within the G-DRG system, the InEK has created an “on-top” funding process for innovative products. This process, known as NUB (Neue Untersuchungs- und Behandlungsmethoden) Application can be filed by hospitals only for technologies that have just been introduced in Germany. Every hospital will need to apply separately (electronic application at InEK) and the “on-top” payment (if the application is approved) will be available only to the hospitals that applied for it and not to every hospital in Germany. Approved applications are subsequently monitored by InEK and should the new technology be adequately used; correctly coded; and, exhibit a cost profile of sufficient difference, the InEK may integrate it permanently to the G-DRG. It should be noted that InEK makes no decision on the actual amount of the “on-top” payment. That will need to be directly negotiated between the successful hospital applicants and the SHIs. The NUB pathway has the potential to accelerate market access for new technologies but requires significant effort from its users.
Also see;
http://www.ispor.org/HTARoadMaps/Germany.asp
includes:
Cost-Benefit-Assessment
In January 2008 (updated to version 2.0 in March 2009), the IQWiG published their first draft of the ‘Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System’. In contrast to other HTA agencies like NICE (England & Wales), SMC (Scotland) or TLV (Sweden), the German IQWiG did not use the incremental-cost-effectiveness-ratio (ICER) approach, but they introduce a different methodological instrument, the efficiency frontier. Within the efficiency frontier, all available compounds / agents have to be compared using their total benefit in relation to their total costs. This results in an efficiency frontier. New agents have to show comparable efficiency, compared to (a) the cost-benefit ratio of the alternative with the best available maximum benefit, or (b) compared to the mean cost-benefit-ratio within the specific indication.
Since the new methods have been published, there is an ongoing crucial discussion in Germany whether the new methods are consistent with federal social law (§§ 31, (2a); 35b; 139a social code book) and whether the efficiency frontline approach is appropriate to use.
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