New med tech-related decision support documents published in Austria

The Austrian Ministry of Health proposes every year numerous new medical interventions for inclusion in the service catalog (so-called individual medical services, MEL) for reimbursement. The Austrian Institute for Health Technology Assessment (AIHTA) provides the systematic assessment of the effectiveness and safety of these new interventions. The topics (interventions) are prioritized by the Ministry of Health. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme.

In July 2021, the Austrian Institute for Health Technology Assessment (AIHTA) published six new decision support documents and one update to a previous decision support document. The new decision support documents are:

• Percutaneous left ventricular assist devices: micro-axial flow pumps. A systematic literature review was conducted to evaluate the efficacy and safety of micro-axial percutaneous left ventricular assist devices (pLVAD) in patients with a diagnosis of cardiogenic shock or patients undergoing percutaneous coronary intervention (PCI) in comparison to standard care alone, updating the evidence synthesis published by Health Quality Ontario in 2017. The Impella® device was the only micro-axial pLVAD available on the market. The existing evidence was not sufficient to prove that the assessed technology micro-axial percutaneous left ventricular assist devices are more effective and equally safe than the comparator standard care in patients with cardiogenic shock or patients undergoing high-risk percutaneous coronary interventions. Therefore, the inclusion of the technology in the hospital benefit catalog was not recommended for both indications at the time of the review. Re-evaluation was recommended in 2024 if the larger ongoing randomized trials are published by then;
• Liposuction for surgical therapy of lipoedema. A systematic literature review was conducted to assess the clinical effectiveness and safety of liposuction in patients with lipoedema (stage I-III) in comparison to any conservative treatment, concerning patient-relevant outcomes, as reduction of pain, reduction in the size of extremities, improvement of QoL, and procedure-related adverse events. The available evidence was not sufficient to prove that liposuction was more effective and equally safe or equally effective but safer than conservative therapy for lipoedema. Inclusion of the technology in the hospital benefit catalog was not recommended at the time of conducting the review. A re-evaluation was recommended after the completion of ongoing RCT, expected in 2025;
• Triphasic biomaterial for augmentation of the osteoporotic femoral neck. A systematic literature review was conducted to evaluate the effectiveness and safety of OSSURE® local osteo-enhancement procedure (LOEP) - injection of a calcium-based biomaterial (AGN1) to prevent and treat osteoporotic hip fractures compared with standard osteoporotic management. The available evidence was not sufficient to determine whether AGN1 LOEP is as safe or more effective than conservative treatments in preventing fractures. The inclusion of AGN1 LOEP in the Austrian hospital benefit catalog was not recommended at the time of conducting the review. A re-evaluation was recommended only after robust data from RCTs are available;
• Endoscopic plication therapy in patients with gastroesophageal reflux disease (GERD). A systematic literature review was conducted to analyze whether endoscopic plication systems are more effective and equally safe than currently used standard treatments (proton pump inhibitors (PPI) and laparoscopic surgery) for the treatment of GERD. The focus was on three endoscopic devices available on the market: ultrasound endoscopic endostapler (MUSETM), transoral incisionless fundoplication (EsophyXZ®), and endoscopic full-thickness plication (GERDxTM). The available evidence was not sufficient to prove that endoscopic plication is more effective and equally safe or equally effective and safer than laparoscopic surgery, PPI therapy and/or sham treatment in chronic GERD patients. Therefore, the inclusion of endoscopic plication systems in the Austrian hospital benefit catalog was not recommended at the time of the review. A re-evaluation was recommended in 2023 at the earliest after the results of the ongoing RCT are published and adequate additional trials have potentially become accessible;
• Allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures / pseudarthroses. A systematic literature review was conducted to analyze whether the allogeneic bone screw Shark Screw® is more effective and equally safe compared to metallic or bioabsorbable bone screws concerning economically relevant endpoints from a health care system perspective. At the time of conducting the review, there was no published evidence to prove that the allogeneic Shark Screw® transplant was more effective than or as safe as metal or biodegradable bone screws in patients with hallux valgus or fractures/pseudarthroses of the scaphoid bone concerning the number and duration of hospitalizations, the duration of the surgical procedure, the revision rates, the period of convalescence, implant breakage during surgery, as well as major postoperative complications; thus, the inclusion of the technology in the Austrian hospital benefit catalog was not recommended at that moment. A re-evaluation was recommended in 2025 at the earliest, as the clinical trials search did not identify any ongoing controlled studies;
• Surgical interventions for the treatment of benign prostatic hyperplasia - German summary of the EUnetHTA assessment. This summary is based on the EUnetHTA assessment, which evaluates clinical effectiveness and safety of a total of 21 surgical technologies in comparison to transurethral resection of the prostate (TURP), open prostatectomy, or between each other. The functional endpoints of clinical efficacy showed statistically significant differences in only a few interventional comparisons. Only a few procedures could offer a certain advantage over TURP in regard to the effects on sexual activity. Some newer technologies may offer some advantage over TURP in relation to safety and side effects. A few technologies showed evidence of a positive or negative effect on urinary tract infection and incontinence. Overall, small sample sizes, biases in study design, heterogeneous populations, and undefined primary hypothesis indicated the need for more and better research so that the advantages and disadvantages of all these technologies could be more clearly defined.

The updated decision support document concerns implantation of bulking agents for faecal incontinence. An update of a systematic literature review was conducted to evaluate whether implantable bulking agents are superior or inferior to injectable bulking agents as second-line therapy in terms of clinical effectiveness and safety for faecal incontinence (FI). It was recommended that implantable bulking agents might be a minimally invasive approach in FI treatment if conservative therapies fail.

See the full list of decision support documents in German and/or English here.

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