Announcements

Artificial intelligence (AI) is increasingly used in diagnostic imaging to support image interpretation, prioritise examinations, and improve clinical workflows. In the context of rising imaging volumes and limited human resources, AI-supported digital health technologies (DHTs) are discussed as potential tools to alleviate pressures on radiology services; however, their benefit for healthcare delivery has not yet been systematically assessed.

The aim of this work was to identify and prioritise AI-supported DHTs relevant for Austrian hospitals and to systematically evaluate the prioritised application with regard to clinical effectiveness, organisational implications, and resource requirements. Following a stakeholder-based prioritisation process, an AI-supported application for analysing chest X-ray images in patients with suspected lung cancer was selected. The evidence base comprised three health technology assessments and two additional primary studies. No patient-relevant clinical outcomes were reported, and evidence on diagnostic performance, organisational effects, and costs was limited.

Clinical documentation is a major driver of administrative burden and workload in hospitals. AI-enabled digital health technologies (DHTs) are increasingly promoted as tools to support or partially automate documentation tasks, with the potential to reduce clinician burden. This review provides a systematic overview of current AI applications for clinical documentation, including AI scribes, text structuring, AI-generated documentation, patient-friendly summaries, error detection, and automated billing code assignment. Based on a systematic literature search including seven reviews and 200 primary studies, the evidence shows heterogeneous and context-dependent performance. While clinicians often report high satisfaction; accuracy, completeness, and productivity gains vary across use cases, and human oversight remains essential. Evidence on organisational impacts, implementation requirements, and long-term performance is limited. A structured, risk-based approach with appropriate governance is required before routine implementation in hospital settings.

Zemcelpro^® is a cryopreserved stem cell therapy consisting of two different cell components derived from the same unit of cord blood: (1) expanded CD34+ cells (dorocubicel), which are expanded ex vivo using the small molecule UM171, and (2) unexpanded CD34– cells, which include CD3+ T-cells. The aim of this single intravenous infusion is to get an anti-tumour response and to enable immune reconstitution in adult patients with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation (allo-HSCT) after myeloablative conditioning who lack other suitable donor cells. In the pooled analysis of two single-arm phase 1/2 and 2 studies (n=25, median follow-up: 13.27 months), the overall survival rate was 66.0% at 12 months and 51.4% at 24 months. Progression-free survival was 52.8% (12 months) and 45.3% (24 months). Median time to neutrophil engraftment was 20 days. Regarding safety (n=116, median follow-up: 22.49 months), the most common severe adverse events (grade >=3) were lymphopenia (46.6%), anaemia (44.0%), neutropenia (35.3%), thrombocytopenia (31.9%), and acute graft-versus-host disease (22.4%). Overall, there were 42 deaths (36.2%), 26 due to disease progression or relapse (22.4%), 15 due to treatment-related mortality (12.9%). The available evidence is limited by small sample sizes, short follow-up periods, and a lack of quality-of-life data.

Article 57 of the new Medicines Directive stipulates a reporting obligation for public contributions to the R&D of medicinal products. This handbook presents the HI-PRIX framework for systematically identifying and documenting public contributions to pharmaceutical R&D across eight categories spanning basic research through post-market evidence generation. Our analysis reveals that the public is not a part of the innovation ecosystem but the main driver of it.

Telemonitoring for heart failure (HF) captures patient data such as body weight, blood pressure, and heart rate via mobile applications to complement nurse-led disease management programmes (DMPs). In Austria, DMPs for HF patients are already in use, with telemonitoring implemented differently across regions. The aim was to systematically assess the efficacy and safety of non-invasive telemonitoring in addition to DMPs compared to DMPs without telemonitoring in HF patients post-hospital discharge, and to develop an evaluation concept for digital health technologies (DHTs) in Austrian DMPs. A systematic literature search in four databases (1,351 hits) identified three randomised controlled trials (2007–2015) with a total of 527 patients (approximately 189 HF patients in telemonitoring + DMP groups, certainty of evidence: predominantly moderate). Regarding efficacy, one study reported a statistically significant reduction in HF-related rehospitalisation, and another study reported a statistically significant improvement in quality of life (MLWHFQ). All three studies found no significant differences for all-cause mortality and all-cause rehospitalisation. No safety data were reported. For Austrian DHTs in DMPs, an evaluation concept was developed based on the ASSESS-DHT Manual, amongst others, recommending controlled trials (e.g., cluster RCT) with primary endpoints of HF mortality and quality of life. The available evidence has limitations: lack of statistical precision, lack of cost-effectiveness data, and small sample sizes.

Obecabtagene autoleucel (obe-cel, AUCATZYL^®) is an autologous CAR T cell therapy in which the patient's own T-cells are genetically modified with an anti-CD19 CAR to specifically recognise and attack CD19-positive leukaemia cells. The goal of this treatment is to achieve remission in adult patients aged 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia. In the multicentre, single-arm, open-label Phase 1b/2 FELIX trial, the efficacy analysis of cohort 2A (n=94, median follow-up: 20.3 months) showed an overall response rate of 77%, including 55% complete remission, a median duration of response of 14.1 months, and an event-free survival of 9.0 months. For all infused patients (n=127, median follow-up: 21.5 months), the median overall survival was 15.6 months. Regarding safety, the most frequent severe adverse events (grade ?3) were febrile neutropenia (12.6%), immune effector cell-associated neurotoxicity syndrome (6.3%), and sepsis (5.5%). Cytokine release syndrome occurred in 68.5% of patients, with grade ?3 in 2.4%. After obe-cel infusion, 35% of patients died, with two deaths (1.6%) being treatment-related. The available evidence is limited, as there was no direct comparison with other therapies and quality-of-life data were lacking.

Inappropriate prescriptions, particularly for antibiotics and opioids, contribute significantly to antibiotic resistance, opioid dependence and rising healthcare costs. Despite available guidelines, a discrepancy often exists between evidence-based recommendation and actual prescribing practices. Nudging interventions promise to optimise prescribing decisions without prohibitions or financial incentives. This research project uses a systematic review to investigate which behavioural nudging interventions can optimise doctors' prescribing practices in an evidence-based manner. For this purpose, randomised controlled trials were analysed, and experts were consulted on the feasibility of implementation in the Austrian healthcare sector.

Fact Sheet No. 198 (November 2025) 
Tislelizumab (Tevimbra®) with platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma

Fact Sheet No. 199 (November 2025)
Tislelizumab (Tevimbra®) with chemotherapy for the first-line treatment of HER-2-negative locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

Fact Sheet No. 202 (November 2025)
Pembrolizumab (Keytruda®) for the treatment of malignant pleural mesothelioma

Fact Sheet No. 208 (November 2025)
Blinatumomab (Blincyto®) monotherapy as part of consolidation therapy for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL)

Fact Sheet No. 225 (November 2025)
Tislelizumab (Tevimbra®) with etoposide and platinum chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer

Fact Sheet No. 233 (November 2025)
Tislelizumab (Tevimbra®) in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma

Fact Sheet No. 241 (November 2025)
Tislelizumab (Tevimbra®) with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer