New Med Tech-related HTAs to support reimbursement decision-making in Austria

The Austrian Federal Ministry of Health receives proposals for the inclusion of new medical interventions in the catalog of individual medical services (MEL) for reimbursement. The Ministry of Health prioritizes the topics (interventions) for the Austrian Institute for HTA (AIHTA) assessment. AIHTA evaluates the effectiveness and safety of these new interventions based on systematic reviews for each intervention, provides a summary of the scientific evidence according to the GRADE scheme, and publishes results in so-called decision support documents.

On July 15, 2024, AIHTA published four decision support documents for newly assessed procedures. Some examples are provided below:

• Thermal ablation for early-stage breast cancer: cryoablation, microwaves, radiofrequency, high-intensity focused ultrasound, and laser ablation. Evidence comparing thermal ablation with standard surgery was only available for cryoablation, radiofrequency, and microwave ablation (none was identified for high-intensity focused ultrasound and laser ablation). Results with low to very low certainty of evidence suggest that these treatments have comparable overall survival rates, disease-free survival times, and tumor recurrence rates, and are generally safe, with only mild to moderate adverse events. However, there is a risk that these results were influenced by tumor resection and adjuvant therapies. The overall evidence-based conclusion is "No evidence or inconclusive evidence available to demonstrate an additional benefit of the intervention of interest". High-quality, long-term RCTs with standardized methods and non-inferiority designs are required to establish thermal ablation as a viable alternative to surgery. A re-evaluation is not recommended before 2034, as currently only one study on cryoablation has been identified, and there are no ongoing clinical comparative studies on other ablation techniques.
• Drug-coated balloon catheter for the treatment of urethral strictures. The report assessed the clinical effectiveness and safety of the Optilume urethral drug-coated balloon (DCB) for treating urethral strictures. It was concluded that the DCB has short-term benefits compared to a mixed comparator group of urethrotomy (DVIU) and dilation, but long-term efficacy is uncertain. The DCB's safety profile is favorable. The overall evidence-based conclusion is "No evidence or inconclusive evidence available to demonstrate an additional benefit of the intervention of interest". Further comparative studies are needed to strengthen the evidence. It was recommended that a re-evaluation be conducted after the results of the BALDIKA study are available. 

The other two new assessments concerned the gastrointestinal and orthopedic fields.

Furthermore, two previous decision support documents related to cardiovascular (Leadless Pacemakers) and men's health (Temporary Nitinol Implantation, TIND) areas were updated.

See the details in German and English here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.