The Ludwig Boltzmann Institute– Health Technology Assessment (LBI-HTA) is the main health technology appraisal body in Austria. It is an independent organization that on request provides scientific support for decision-making regarding the inclusion of health technologies (medical devices and in-vitro diagnostics) into the national benefit catalogue by the Ministry of Health. LBI-HTA produces different types of reports. The most relevant reports regarding market access of medical devices are so-called decision support documents (DSD) which are systematic, scientific review papers with a focus on efficacy and safety of technology (HTA reports).
In decision support documents, the LBI-HTA gives its evidence-based recommendation in the form of four categories:
- Recommendation for inclusion
- Limmited recommendation for inclusion
- Preliminary no recommendation for inclusion
- No recommendation for inclusion
Recommendations by the LBI-HTA are not binding, yet, they are in 90 % of cases followed by the decision maker, the Federal Health Commission (BGK).
During the year 2017, the LBI-HTA produced seven decision support documents with relevance for medical devices of which 2 were updates of previous reports. Following were the report titles and LBI-HTA’s recommendation expressed in category numbers described above:
- Extracorporeal cytokine haemadsorption therapy in patients with sepsis or SIRS; 3
- Prostate artery embolisation for benign prostatic hyperplasia; 3
- Radiofrequency ablation for metastatic spinal lesions; 2
- Electric stimulation therapy (EST) in patients with gastroesophageal reflux disease (GERD); 3
- Leadless pacemakers for right ventricle pacing, update; 3
- Repetitive transcranial magnetic stimulation for treatment-resistant major depression; 2
- Percutaneous volume reduction of the disc with focus on chemonucleolysis, update
- Recommendation for chemonucleolysis: 2
- Recommendation for further percutaneous intervertebral disk volume reduction (percutaneous nucleotomy, percutaneous laser disc decompression or IDET): 3
All reports published in 2017 are available in the LBI-HTA repository.
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