Utilization of innovative medical technologies in German inpatient care: does evidence matter?

Background The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care. Methods This study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment—databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis. Results The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies. Conclusions This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development. Supplementary Information The online version contains supplementary material available at 10.1186/s12961-023-01047-w.


Appendix 1: Description of included technologies
From the total sample of 27 technologies [1] 25 were included into the analysis.Of these, 19 are used for diseases of the circulatory system, four for diseases of the urogenital system, and two for respiratory conditions.[3]; # The "#" symbol replaces the 5th or 6th digit in the procedure code, indicating that the codes with these positions have been included in the calculation of procedure numbers.The "#" represents any number or letter within the specified root, as defined in the procedure catalogue.Across the 25 included technologies, the number of identified products available in Europe and Germany between 2005 and 2017 ranges from one (e.g., MVAC) to 16 (MT) (Table 1.2).Most products were CE-certified for the first time after 2000.For some technologies, it was not possible to determine a product intended specifically for the indication (i.e., DCB-AV, DCB-IV, and DES-LLV), and for some products the year of approval was unavailable.

Figure 11. 3 (
Figure 11.3 (A-C) Results in publications presented by LoE, year of publication and technology (by availability of negative results)

Table 1 .
1 Description of technologies and respective procedure codes (alphabetically sorted) The fully implantable fluid-filled silicone balloons are placed on both sides of the urethra at the bladder outlet for the treatment of urinary incontinence in men and women.Implant is inserted endovascularly into the coronary vessel and keeps the stenosed lesion mechanically open for a period of several years, during which time it is completely reabsorbed by the body.

Abbreviation of NUB (N=25) Area of application Description Hospital procedures: Min (year)/ Max (year) 1 Procedure codes 2
All procedure codes from the OPS version 2005 to the OPS version 2017 can be accessed on the pages of the Federal Institute for Drugs and Medical Devices (BfArM), formerly the German Institute of Medical Documentation and Information (DIMDI) lead to the electrode tip located in the heart, the excimer laser emits short, high energy, low temperature pulses that ablate small amounts of tissue (photoablation) and expose the electrode.Device for continuous monitoring of ECG information over a long period of time, which is implanted subcutaneously on an outpatient basis under local anaesthesia.A single-channel ECG is continuously recorded in an endless loop ("loop recorder") via surface electrodes on the housing.Pathological sequences can be automatically detected and stored.5 (2005) / 956 (2017) 5-377.8 in connection to 8-835.##FD-ULVTreatment of aneurysm of upper leg vesselsSelf-expanding blood flow modulators (grid/stent structures) which are placed endovascularly directly into the aneurysm outpouching so that a functional separation between the outflow vessel and the aneurysm outpouching is created at the aneurysm base.Minimally invasive heart support system (left ventricle) that can be introduced into the heart via a percutaneous access in the groin via the femoral artery without opening the chest and can also be removed in the same way.Notes:1Data was provided by the funder, available at[2]; 2

Table 1 .
2 Technologies, products and year of CE marking sorted by anatomical region

Table 1 .2 Technologies in sample by anatomical region Anatomical regions of procedures
Notes: * approval year of the first product variation; ** exact year of approval not available; Abbreviations: Abd -abdominal; DCB -drig coated baloons; DES -drug eluting stents; PDD -photodynamic diagnostics; UK -United Kingdom Source: Compiled by the authors based on different sources

Table 3 .
1 General inclusion and exclusion criteria1The main aim of the publication is to evaluate effects of the technology captured by the OPS (the intervention within the PICO of the publication is the technology of interest, in some cases the technology of interest can be a comparator) a) There should be at least one arm in the evaluation which include only the technology of interest with similar functionality and purpose AND the results are published (at least in forms of tables) i.When there is a small percentage (≤ 10%) of other products in the same arm, then include ii.When there is a percentage > 10% of other products in the same arm AND the results are differentiated by included products, then include iii.When there are different technologies with different functionality and purpose, but which are parts of the same procedure, then include b) Include if the study compares two variants of the same product of the same manufacturer and change

Table 5 .
3 Extracted information per guideline

Table 9 .
1 Number of included publications with systematic reviews and randomized controlled trials