In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published five decision support documents. The assessed technologies included implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure, intrauterine ultrasound-guided transcervical radiofrequency ablation, percutaneous transvascular implantation of a coronary sinus reducing stent, radiofrequency-induced intravesical chemohyperthermia for non-muscle invasive bladder cancer, and Vascular photodynamic therapy with Padeliporfin (Tookad® solution).
The Austrian Ministry of Health receives proposals for reimbursement of new medical interventions every year. The research is conducted with the aim to evaluate the efficacy and safety of interventions suggested being included in the MEL (individual medical services) catalog. Themes (interventions) were prioritized by the Ministry of Health and contracted to the AIHTA. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme.
The first evaluation report is implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure. A systematic literature review was conducted to compare the effectiveness and safety of the CardioMEMS™ HF system for the remote monitoring of patients with advanced heart failure (NYHA III) compared to patients in standard monitoring programs. One randomized controlled trial (RCT) and two observational studies were included for the assessment of the technology. The evidence showed a clinical benefit of the CardioMEMS™ HF system in terms of hospitalization rates and quality of life. Only a small number of serious adverse events were observed. The intervention was recommended for inclusion in the catalog of services with restrictions. Re-evaluation of the CardioMEMS™ HF system after completion of the current studies was recommended.
The second report is intrauterine ultrasound-guided transcervical radiofrequency ablation. A systematic literature review was conducted to establish if the transcervical fibroid ablation (TFA) is more effective and safer or just as effective but safer regarding patient-relevant endpoints. Three prospective single-arm studies were included. The quality of the evidence with regard to effectiveness and safety was rated as low or very low for all relevant outcomes. The inclusion of the technology in the service catalog was not recommended.
The third report is percutaneous transvascular implantation of a coronary sinus reducing stent. A systematic literature review was conducted to compare the efficacy and safety of percutaneous transvascular implantation of a coronary sinus reducing stent (CSRS) to the sham procedure in patients with refractory angina pectoris. A randomized, controlled trial was included to analyze clinical efficacy, and seven studies were included to analyze the safety of the CSRS. The overall strength of the evidence for effectiveness and safety was rated as moderate. An inclusion in the service catalog is currently not recommended. A re-evaluation is recommended to be done in 2022.
The other report is radiofrequency-induced intravesical chemohyperthermia for non-muscle invasive bladder cancer. A systematic literature review was conducted to examine whether the radiofrequency-induced intravesical chemohyperthermia (RF-CHT) is safer and more effective than other interventions in non-muscle-invasive bladder cancer. Four RCTs and one non-RCT were included in the analysis. As a result, the technology was classified as experimental and should only be used in clinical studies.
The last report is vascular photodynamic therapy with Padeliporfin (Tookad® solution). A systematic literature review was conducted to investigate the use of vascular-targeted photodynamic (VTP) therapy with Tookad® Soluble in patients with localized low-risk prostate cancer compared to standard therapies (active surveillance or radical therapies). No study was available for VTP therapy vs. radical therapies. Only one RCT and its four-year follow-up study were included for the evaluation of clinical effectiveness outcomes VTP therapy vs. active surveillance. One RCT and one prospective single-arm study were included for the evaluation of safety-related outcomes. The inclusion of VTP therapy with Tookad® Soluble in the Austrian hospital benefit catalog is currently not recommended. A re-evaluation is recommended for intermediate-risk prostate cancer patients in 2030 after the completion of an ongoing RCT.
See all decision support documents in German and/or English here.
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