The Federal Joint Committee (G-BA) has signed a contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery. This new procedure is being tested in comparison to the usual, non-invasive monitoring. After the national rules-based Europe-wide tendering process, the G-BA now commissioned the Institute of Myocardial Infarction Research (IHF) in Ludwigshafen to accompany and evaluate the trial study scientifically. The G-BA assumes that the first patients will be engaged in the study at the beginning of 2020.
The telemedical monitoring of the blood pressure in the pulmonary artery is performed by means of a sensor, permanently inserted into this blood vessel, and associated hardware and software for signal processing and the measurement results displaying. The aim is to detect changes in the blood flow at an early stage, in order to be able to optimally adjust the patient's medication therapy and thus to avoid heart failure decompensation, usually accompanied by edema (abnormal accumulation of fluid in the interstitium, located beneath the skin and in the cavities of the body) and shortness of breath.
The instrument for testing of new promising research and treatment methods, the benefits of which have not yet been proven, was introduced in Germany by legislators in 2012. If scientific evidence indicates that the method has the potential to provide a treatment alternative, the G-BA may initiate a trial study and provide financial support. The legal basis for this is § 137e SGB V.
The trial study has been requested by a medical device manufacturer. They have been able to show that the measurement and monitoring of pulmonary artery pressure using implanted NYHA III cardiac failure therapy optimization sensor has the potential to provide a treatment alternative to non-invasive monitoring. At the same time, the G-BA, based on the documents submitted with the application, has determined that a trial study can be designed, providing an assessment of the benefits of this method at a sufficiently secure level of knowledge for future policy decisions.
Therefore, the IHF, in a first step, will prepare the study protocol and obtain the regulatory approvals required for the study start, as well as for a positive opinion from the ethics committee(s). In addition, the IHF is mandated to designate the study centers, which will then include the appropriate patients in the study and perform the treatment and follow-up.
The services provided and prescribed in the course of the study trial will be directly reimbursed by the health insurance funds. For benefits not yet covered by the benefits catalog of the statutory health insurance, the reimbursement must be agreed within three months at the state level.
After completion of the study, the IHF will evaluate the data collected and submit a final report on the study results to the G-BA. In the subsequent assessment process, the G-BA will examine whether the new study results sufficiently substantiate the benefit of the treatment method.
The full details in German can be found here