Announcements

Tisotumab vedotin is an antibody-drug conjugate consisting of a monoclonal antibody linked to a microtubule inhibitor. The antibody specifically binds to tissue factor on the cell surface; the complex is internalised, and the cytotoxic agent is released, leading to the death of cancer cells. Tisotumab vedotin is administered as monotherapy for the treatment of adult patients with cervical cancer whose disease has progressed during or after systemic therapy. It is given as an intravenous infusion every three weeks until disease progression or unacceptable toxicity occurs. The innovaTV 301 study demonstrated an overall survival (OS) benefit for tisotumab vedotin (n=253) compared with chemotherapy (n=249; HR 0.70, 95% CI 0.54-0.89), with a median OS increase of approximately 2 months. Progression-free survival was also improved by about 1.3 months. However, no clear improvement in quality of life was demonstrated. Treatment-emergent adverse events (TEAEs) were common in both treatment arms, but grade ?3 TEAEs and serious adverse events occurred less frequently with tisotumab vedotin. Ocular events occurred significantly more frequently. Regarding the quality of evidence, there are concerns about the risk of bias, particularly with respect to missing data and the reporting of outcomes. Tisotumab vedotin received approval from the European Commission in March 2025.

Teplizumab (TEIZEILD®) is a monoclonal anti-CD3 antibody that modulates the autoimmune response in stage 2 type 1 diabetes by inhibiting autoreactive T cells and preserving endogenous insulin secretion. This single intravenous 14-day infusion course is indicated for adults and children aged 8 years and older with stage 2 T1D to delay progression to stage 3. In the randomised, placebo-controlled phase 2 TN-10 trial (n=76, median follow-up: 24.5 months), the median time to T1D diagnosis was 48.4 months with teplizumab versus 24.4 months with placebo (p<0.01). C-peptide levels were significantly higher in the teplizumab group (1.94 vs 1.72 pmol/ml; p<0.01). Regarding safety, adverse events occurred in nearly all patients; the most common were haematological disorders (75%, predominantly lymphopenia) and skin reactions (36%). Severe adverse events (grade ?3) occurred mainly within the first 30 days and were largely reversible. The available evidence is limited by a small sample size, absence of quality-of-life data, and limited long-term follow-up. Teplizumab received marketing authorisation from the European Commission in early January 2026.

Substance use disorders are among the world's greatest public health challenges. The EU project FALCO examined which outcome instruments are suitable for the long-term evaluation of music therapy in the treatment of substance use disorders. Instruments measuring stable constructs – such as depression, problem severity, and self-efficacy – were identified as most appropriate. Service user interviews revealed social parameters as the most frequently mentioned aspect of recovery, with children, pets, and employment as key facilitators. Validated instruments exist, but gaps remain. Future research should prioritise long-term studies, core outcome sets, and culturally adapted instruments incorporating social and socioeconomic dimensions.

Austria currently lacks a formally endorsed national health economic evaluation guideline (HEEG) with detailed methodological specifications, which hinders the broader application of health economic evidence in reimbursement decisions. This review systematically examined mandatory HEEGs from high-income countries to identify common standards for conducting health economic evaluations, synthesising findings into a structured overview of methodological convergence and divergence at the international level. The results are intended to support Austrian policymakersand HTA stakeholders in developing a nationally tailored, methodologically robust guideline applicable across a wide range of healthcare decision-making contexts.

Anxiety and depressive disorders account for a significant proportion of the global mental health burden. Treatment challenges in antidepressant therapy have stimulated interest in adjunctive nutritional interventions, such as B vitamins, due to their role in neurobiological processes relevant to mood regulation. However, existing systematic reviews have not focused specifically on adjunctive regimens combining multiple B vitamins with antidepressants. Consequently, this systematic review aimed to evaluate the efficacy and safety of combining a vitamin B complex (?2 B vitamins) with antidepressant medication to improve symptom severity in depression and anxiety.

High-throughput sequencing technologies enable the simultaneous analysis of multiple genes or the entire genome in a single run and are increasingly used for the detection of clinically relevant genetic alterations. This assessment evaluated the clinical effectiveness, safety, and economic, organisational, and ethical aspects of high-throughput sequencing for the detection of PIK3CA, AKT1, PTEN, and ESR1 genetic alterations in breast cancer diagnostics. The target population comprises adults diagnosed with HR+/HER2–, locally advanced or metastatic breast cancer.

Carrier screening is a screening strategy designed to identify asymptomatic individuals who carry pathogenic variants for autosomal recessive and X-linked hereditary conditions. This assessment evaluated the clinical effectiveness, safety, economic, organisational, and ethical aspects of different carrier screening strategies: universal versus risk-based approaches and single-disease panels versus expanded carrier screening (ECS). The target population comprised reproductive-age individuals and pregnant women.

Technological advances in genetic testing expand clinical care, yet necessitate evidence-based decision-making. This scoping review establishes the methodological basis for topic prioritisation in Austria by mapping application fields and analysing international evidence-based reimbursement processes. This report is the first part within the project Genetic Testing in Austria and informs topic prioritisation for two assessments in the field.

Reliable cost data is the cornerstone of informed healthcare decision-making. This project analyses international guidelines to map best practices in costing processes. On this basis, well-founded recommendations for the evaluation of health care services can be derived, promoting comparability and transparency.

Polypharmacy poses major challenges to medication safety, particularly for older people with multimorbidity. This report summarises the current evidence on the effectiveness, safety, organisational aspects and costs of structured medication reviews (SMRs). It also compares implementation models across selected European countries.