Gesetzliche Krankenversicherung
BVMed Conference With G-BA and IQWiG: Medtech Trial Regulation Also Has Advantages
30.10.2013|Berlin/Germany|
The trial regulation for new examination and treatment methods of medical technologies can help accelerating the pace at which medtech innovations are accepted into comprehensive coverage. The trial regulation offers a simplified and quicker access to the outpatient sector, claimed Olaf Winkler of BVMed on the intention of German legislation at the conference ”The Trial Regulation for Medical Devices in Practice”. Dr. Fülöp Scheibler from the Institute for Quality and Economic Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) is optimistic about the trial regulation: ”It is an additional option. It does not eliminate any of the other procedures. It provides a path to get innovations on the market more rapidly.” The consultant Dr. Hubertus Rosery considers it positive that manufacturers have a right to apply themselves, thereby shortening the usual benefit analysis of the Joint Federal Committee (JFC) for the outpatient sector. Rosery recommends medtech companies to take advantage of a consultation with the JFC on this issue. New instrument for the JFC
The Law on the Stabilization and Structural Reform of the Statutory Health Insurance from 2011 stipulates that innovative medical technologies may be used on patients within the scope of a ”trial regulation” as long as the treatment method offers the ”potential of a required alternative form of therapy”. The study is to be conducted by institutions commissioned by the JFC.
JFC deadlines and criteria
JFC member Brigitte Maier explained that JFC‘s ”Trial Sub-group” now meets twice a month. The sub-group is planning the consultations that must be conducted within 8 weeks after the application. The JFC‘s Method Assessment Subcommittee is preparing the decision-making documents for the JFC plenum. The time specification stipulates that a decision must be issued latest 3 months after an application. It is important to comply with the assessment criteria of a health technology assessment. Many companies were not aware of these criteria, said Maier.
The assessment criteria set forth in the Social Security Code Book V comprise ”benefit”, ”medical necessity” and ”cost effectiveness”:
> The assessment of benefit includes patient-relevant endpoints such as morbidity, mortality and health-related quality of life. The benefit is evaluated compared to other methods with the same objective. It is also considered with regard to risks and adverse side effects.
> The assessment of medical necessity takes into consideration the relevance of the medical problem definition, the natural course of the disease, and the diagnostic or therapeutic alternatives.
> The assessment of cost effectiveness comprises the cost-benefit consideration, both with respect to individual patients and the entirety of insurants (along with an estimation of subsequent costs) as well as the cost-benefit estimation compared to other methods.