New med tech-related decision support documents published in Austria

18

Aug 2022

On July 15, 2022, the Austrian Institute for HTA (AIHTA) published five decision support documents, which provide recommendations regarding the inclusion of new medical interventions in the catalog of individual medical services of the performance-oriented hospital financing (Leistungsorientierten Krankenanstaltenfinanzierung, LKF) model, as well as four updates to previous decision support documents. The decisions relate mainly to cardiovascular and gastrointestinal technology groups.

The Austrian Ministry of Health annually proposes numerous new medical interventions for inclusion in the service catalog (so-called individual medical services, MEL) for reimbursement. The AIHTA provides a 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.

The newly published decision support documents include:

  • "Chemosaturation with percutaneous liver perfusion for patients with liver cancer” assessed whether percutaneous liver perfusion (PHP) is more effective and safer than the best available treatment for patients with liver cancer. No studies regarding primary liver cancer were identified. The existing evidence indicated that the inclusion of PHP for secondary liver cancer in the benefits catalog could not be supported at the review time. New study results (ongoing NCT03086993) would potentially influence the effect estimate considerably. Therefore, a re-evaluation was recommended in 2024;
  • “Hepatic and portal vein embolization before major hepatectomy” assessed whether hepatic and portal vein embolization (HPVE) in comparison to portal vein embolization (PVE) or other techniques intended to induce the future liver remnant hypertrophy before major hepatectomy is a more effective and safe procedure. High-quality evidence on the safety and effectiveness of HPVE in comparison to PVE was lacking. Re-evaluation was recommended in 2023 when evidence from the ongoing randomized controlled trials becomes available;
  • The decision support document, “His bundle pacing for patients requiring a permanent pacemaker or cardiac resynchronization”, assessed whether His bundle pacing in patients with heart failure, cardiac conduction system disease, or atrial fibrillation is more effective and safer regarding patient-relevant outcomes and adverse events in comparison with standard care (e.g., right ventricular pacing or biventricular pacing). Based on the available evidence, the inclusion of the technology in the hospital benefit catalog was not recommended at the time of the review. Re-evaluation is recommended in 2026 if the larger ongoing randomized controlled trials are published by then;
  • “Lower esophageal sphincter devices for laparoscopic surgery in patients with gastroesophageal reflux disease (GERD)” assessed whether minimally invasive laparoscopic approaches in the treatment of GERD are more effective and equally safe than currently used standard treatments (proton pump inhibitor (PPI) medication and laparoscopic fundoplication). The focus was on the following three medical devices: Magnetic sphincter augmentation (MSA) with a magnetic ring implant (LINX® reflux management system from Ethicon, Johnson & Johnson/Torax Medical), a non-active implant made of medical silicone (RefluxStopTM [RS] from Implantica Trading AG) and electrostimulation therapy (EST) (EndoStim® from EndoStim® Inc.). Due to the very low quality of the currently available evidence and the lack of studies with relevant comparators, the inclusion of the three laparoscopic approaches in the Austrian hospital benefit catalog was not recommended at the time of the review.
  • “Microwave ablation for liver tumors” evaluated the effectiveness and safety of microwave ablation (MWA) compared with resection, transcatheter arterial chemoembolization (TACE), or other ablation techniques in patients with primary or secondary liver tumors. Based on the evidence, MWA was comparable to radiofrequency ablation for treating early-stage hepatocellular carcinoma (HCC). The inclusion in the benefits catalog was only recommended for treating this specific population group. MWA was not recommended for treating other stages of HCC, other types of primary liver tumors, or treatment of secondary liver tumors due to a lack of evidence. A re-evaluation of MWA for secondary liver cancer treatment was recommended in 2025.

The updated decision support documents concern the following technologies:

  • “Percutaneous coronary interventions (PCI) for chronic total occlusion (CTO)” (the initial report was published in 2013). The evaluation was aimed to compare the efficacy and safety of PCI with medical therapy or coronary artery bypass graft (CABG) in patients with CTO. Available evidence suggested that PCI in CTO was more effective and as safe as drug therapy alone in relieving angina symptoms and improving quality of life. The technology should be restricted to selected patients and limited to specialized clinical settings. Compared to CABG, however, the evidence was insufficient to conclude comparative efficacy and safety;
  • “Percutaneous transvascular implantation of a coronary sinus reducing stent” (the initial report was published in 2020) aimed to re-evaluate the evidence on the efficacy and safety of the coronary sinus reducing stent (CSRS) in patients with refractory angina pectoris (AP). In the absence of new comparative evidence, the conclusion about the effectiveness and safety of CSRS in the 2020 assessment report remains unchanged. Results from well-designed, sufficiently large randomized controlled trials are lacking to clarify the role of CSRS in clinical practice. The inclusion of the technology in the catalog of benefits was not recommended. The re-evaluation was recommended in 2025 when the COSIRA-II study results were published;
  • “Subcutaneous implantable cardioverter-defibrillator (S-ICD)” (the initial report was published in 2018) aimed to re-evaluate the evidence on the efficacy and safety of S-ICDs compared to transvenous implantable cardioverter defibrillators in patients at an increased risk of sudden cardiac death and an ICD indication for primary or secondary prevention. As a result, the recommendation of the previous systematic review from 2018 to reimburse S-ICDs with the restrictions should be upheld: the existing code (DE112) should be maintained, including reimbursement after approval by the state healthcare fund. In addition, close monitoring of the use of S-ICDs was recommended. A re-evaluation was recommended from 2024 at the earliest after an ongoing randomized control study has been completed;
  • “Upper airway stimulation in moderate-to-severe sleep apnea” (second update of the decision support document) assessed the efficacy and safety of hypoglossal nerve stimulation (HGNS) based on the 2020 EUnetHTA report and performed an update search. The available evidence did not allow any valid conclusions about the effectiveness of HGNS compared to no therapy and whether HGNS is safe in the target population. The re-evaluation was recommended in 2024.

The full details list of decision support documents in German and/or English can be found here.

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