For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.
The IQWiG and the Federal Joint Committee (G-BA) evaluated the clinical data for each of these methods, which had in each case been compiled by the hospital and the medical device manufacturer. In some cases, the manufacturer had already started its own study, so that the main decision to be made was whether an additional study in Germany was reasonable.
For six of the seven invasive procedures, due to a lack of meaningful data, no robust conclusions can be drawn on the benefit, harm, or ineffectiveness for patients. IQWiG developed key points for co-funded studies in each case unless promising studies are already being conducted. However, the data indicate a benefit for transcranial magnetic resonance-guided focused ultrasound (TK-MRgFUS) in patients with essential tremor who are ineligible for deep brain stimulation (DBS).
An overview of the early benefit assessment results for the considered procedures is provided below:
- Transcranial magnetic resonance-guided focused ultrasound for essential tremor: In patients ineligible for DBS, a randomized controlled trial (RCT) showed advantages of TK-MRgFUS versus placebo or no treatment for some outcomes: tremor, activities of daily living, and health-related quality of life. Therefore, based on the documents available, a benefit of TK-MRgFUS versus conservative treatment alone can be identified. To a limited extent, these results can also be applied to patients who are eligible for DBS. Ultimately, however, it is questionable whether someone with severe tremor benefits at least from the targeted destruction of brain tissue using TK-MRgFUS as from the implantation of a DBS probe. To be able to answer this question, a comparative testing study would be helpful – possibly supplemented by data from a disease registry
- A drug-coated balloon catheter (DBC) for urethral strictures: Overall, the evidence on this method versus the evidence on already existing treatment options is too sparse to be able to make an assessment. A testing study could provide the necessary findings for the benefit assessment of the method. As it is still unclear whether a study already underway abroad (ROBUST-III) is suitable for a benefit assessment, the IQWiG has designed key points for a testing study in Germany to examine the benefit of urethral DCB versus urethrotomia interna in men with short strictures in the anterior urethra. Since a urethral DCB is less invasive than urethroplasty, when comparing these two procedures, it is sufficient to demonstrate that urethral DCB is non-inferior to urethroplasty in men with symptomatic short and radiogenically induced urethral stenosis. RCTs with 100 to 500 patients are needed for both populations
- Irreversible electroporation (IRE) for chronic bronchitis: Due to insufficient evidence, no conclusions can be inferred as to the advantages and disadvantages of IRE. Before starting a testing study in Germany, the IQWiG recommends awaiting the results of a promising study that has just begun abroad (RheSolve in Europe, the USA, and Canada)
- Endoscopic duodenal mucosal resurfacing (DMR) for type 2 diabetes: The four studies available only provide data on the frequency of (severe) side effects. However, a testing study could provide the findings needed for a benefit assessment: To be able to prove a difference in the diabetes remission rate, a medium-sized RCT comparing DMR and conservative treatment would be required
- Percutaneous implantation of an interatrial shunt for the treatment of heart failure: Of the three ongoing RCTs, the RELIEVE-HF study (with several German study centers) seems particularly suitable: If the study is conducted and completed as planned and provides usable analyses, the findings needed for the benefit assessment of percutaneous implantation of an interatrial shunt in patients with heart failure and limited pump function could be available in the foreseeable future. A separate testing study would then not be required
- Coronary lithoplasty for coronary heart disease: Due to a lack of comparative data, no sound findings on the effect of coronary intravascular lithoplasty can be derived from the study results. Currently, severely calcified constrictions in coronary vessels are pre-treated using other procedures such as reaming (rotablation). A testing study in the form of an RCT with patients with calcified, non-pretreated coronary stenoses and a medical indication for percutaneous coronary intervention could provide the scientific basis for a benefit assessment. The study objective would be to compare coronary intravascular lithoplasty with alternative pre-treatment procedures to prevent serious cardiovascular events
- Endovascular stent-graft for tricuspid regurgitation: Due to a lack of comparative data, the advantages and disadvantages of the method remain unclear. To demonstrate a difference in health-related quality of life, a medium-sized RCT comparing endovascular implantation of the stent-graft with sham treatment would be required as a testing study
The full details in German can be found here.
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