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                                      Welcome to the homepage of AIHTA!

                                      AIHTA is an academic non-profit institute. At our website we wish to present our research and give support for health care decision-making. Here all of our reports are available for free. For further information please contact the AIHTA team.

                                      In the News section you will find our most recent publications: newsletter, project-reports etc. Previous reports you might find via Research areas, Research projects and Repository.

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                                      Newsletter

                                      Inhalt

                                      • Editorial: Priorisierung von Impfprogrammen auf Basis von Simulationen
                                      • Traumatherapie für geflüchtete Kinder und Jugendliche
                                      • Sondenlose Herzschrittmacher
                                      • Temporäre Nitinol-Implantation (TIND) bei gutartiger Prostatavergrößerung
                                      • Inselzelltransplantation bei chronischer Pankreatitis und Typ-1-Diabetes
                                      • Medikamentenbeschichteter Ballonkatheter zur Behandlung von Harnröhrenverengungen
                                      • Thermoablationsverfahren zur Behandlung von Brustkrebs im Frühstadium
                                      • Einzeitiger matrix-assistierter Knorpelersatz mit und ohne Knochenmarkaspirat im Knie
                                      • Termine
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                                      Announcement

                                      Evaluation of individual medical procedures - Reports 2025

                                      We are pleased to introduce our new reports.

                                      Decision Support Documents 2025:

                                      • DSD 143: Islet cell transplantation for chronic pancreatitis, type 1 diabetes, with and without kidney transplantation https://eprints.aihta.at/1564
                                      • DSD 144: Drug-coated balloon catheter for the treatment of urethral strictures https://eprints.aihta.at/1565
                                      • DSD 145: Thermal ablation for early-stage breast cancer: cryoablation, microwave, radiofrequency, high-intensity focused ultrasound, and laser ablation https://eprints.aihta.at/1566
                                      • DSD 146: One-stage matrix-assisted cartilage repair with and without bone marrow aspirate concentrate in the knee https://eprints.aihta.at/1567

                                      + 2 Updates

                                      • DSD 97:  Leadless cardiac pacemakers. 3rd Update 2025 https://eprints.aihta.at/1568
                                      • DSD 129: Temporary nitinol implantation for the treatment of benign prostatic hyperplasia https://eprints.aihta.at/1569

                                      More...

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                                      Announcement

                                      Trauma Care: Teaching Recovery Technique (TRT) to children and adolescent refugees. Systematic Review and Evaluation of Austrian TRT-Programme at AFYA

                                      Traumatic experiences are a predictor of ill mental health, primarily posttraumatic stress disorder (PTSD), depression and anxiety.  The Children and War Foundation has developed a group-based trauma-focused cognitive behavioural therapy (TF-CBT) – the Teaching Recovery Techniques (TRT) - for children and adolescents exposed to war, violence, and displacement. TRT is a programme designed for health promotion and prevention in low-resource settings and is facilitated by trained laypersons, often from the same cultural background as the participants. This report aims to synthesise the empirical evidence on the effectiveness of TRT programmes in other countries and to put the results of the Austrian TRT programme at AFYA in context.

                                      Publication: HTA Project Report No. 165: https://eprints.aihta.at/1563/
                                      Contact: Claudia Wild

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                                      Announcement

                                      CAR-T cell therapy: Updated effectiveness and safety results from real-world evidence: A systematic review

                                      CAR-T cell therapy, a personalized form of immunotherapy for certain blood cancers, is gaining global relevance. This review analyzed real-world data from 26 studies (2,716 patients) on six EMA-approved CAR-T products. Results show that real-world outcomes are generally comparable to clinical trials, with better results than non-CAR-T treatments. However, due to study limitations and risk of bias, the effectiveness and safety of CAR-T therapy remain uncertain. Longer follow-ups and broader indications offer new insights but highlight the need for more robust evidence.

                                      Publication: HTA Project Report No. 166: https://eprints.aihta.at/1562/
                                      Contact: Ingrid Zechmeister-Koss

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                                      Announcement

                                      Teprotumumab (TEPEZZA®) for moderate-to-severe thyroid eye disease

                                      Teprotumumab (TEPEZZA®) is a human monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), blocking its activation and signalling. Thereby, it prevents symptoms of moderate-to-severe thyroid eye disease (TED, Graves´ orbitopathy), including lid retraction, soft tissue involvement, proptosis and diplopia. Currently, teprotumumab is under evaluation by the European Medicines Agency (EMA) for market authorisation and is expected to be approved by the European Commission (EC) in July 2025. Compared to placebo, teprotumumab significantly improved proptosis response, clinical activity score (CAS), and Graves’ ophthalmopathy-specific quality-of-life scores in three clinical studies and one observational study. The most frequent adverse events included muscle spasms, alopecia, nausea and fatigue. Additionally, 12-15% of teprotumumab patients reported (partially irreparable) hearing damage. TED reactivation rates varied from 26% to 29%, and 65.4% of patients experienced a regression. Notably, 33% of patients maintained a sustained response through the 24-month follow-up. The available evidence is limited, as efficacy has only been tested against a placebo, not the standard of care.

                                      Publication: Decision Support Document for the Austrian Appraisal Board No. 003: https://eprints.aihta.at/1560/
                                      Contact: AIHTA Bewertungsboard Team: bewertungsboard@aihta.at

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                                      Announcement

                                      Fidanacogene elaparvovec (BEQVEZ®) for the treatment of moderate and severe haemophilia B

                                      Fidanacogene elaparvovec (BEQVEZ®) received conditional marketing authorisation from the European Commission on 24th July 2024 for treating severe and moderate haemophilia B. It is the second gene therapy approved in Europe for this condition and is classified as an Advanced Therapy Medicinal Product (ATMP). This gene therapy is approved for adults with no history of factor IX inhibitors and no detectable antibodies against AAVRh74var. It is administered as a one-time intravenous infusion and uses a viral vector to introduce the functioning coagulation factor IX gene into liver cells, where it continuously produces the missing factor.

                                      Fidanacogene elaparvovec demonstrated a 71% reduction in annual bleeding rate compared to previous FIX prophylaxis in a single-arm Phase 3 study (BENEGENE-2, n=45). The effect was maintained for up to 48 months. Adverse effects occurred in 84% of patients treated, with 16% experiencing serious reactions. The most common side effect was elevated aminotransferase levels (53%). The study's methodological limitations include a short follow-up period, a lack of a control group, and changes to the primary endpoint. As the therapy is administered only once intravenously, interviewed patients express optimism about the reduced treatment burden and improved quality of life that may result from a simplified form of therapy and freedom from treatment. At the same time, patients are concerned about the uncertainty regarding long-term efficacy and potential side effects. Therefore, it is recommended that patients receive an infusion in specialised centres with subsequent monitoring in local facilities. Additionally, mandatory follow-up of all treated patients is deemed necessary.

                                      In Austria, 130 patients were reported by the Austrian Haemophilia Society (ÖHR) in 2024. Of these, 22.3% were affected by moderate haemophilia and 24.6% by severe haemophilia. Currently, no price for fidanacogene elaparvovec is available in Europe, so the budget impact analysis (BIA) was based on a preliminary price of 3.4 million euros per administration. Assuming nine patients receive the therapy with an increasing uptake over three years (year 1: 20%, year 2: 30%, year 3: 50%), the total three-year budget impact would amount to approximately 41 million euros. This represents a 3-fold increase compared to the current treatment. In the long term (after about 12 years), costs could be offset by the elimination of prophylaxis.

                                      Publication: Decision Support Document for the Austrian Appraisal Board No. 002: 
                                      https://eprints.aihta.at/1558/
                                      Contact: Sarah Wolf

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                                      Newsletter

                                      Inhalt

                                      • Editorial: Im Spannungsfeld zwischen Machbarkeit und Menschlichkeit
                                      • BE: Identifikation und Priorisierung von Gesundheitsbedarfen
                                      • D: Sachverständigenrat Gesundheit und Pflege veröffentlicht Gutachten zu Arzneimittelpreisen
                                      • D: Mindestmengen bei seltenen Erkrankungen
                                      • CAN: Effektive Gruppeninterventionen für Personen, die häusliche Gewalt ausüben
                                      • Termine
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                                      Newsletter

                                      Inhalt

                                      • Editorial: Bewertungsboard: AIHTA zieht positive Bilanz
                                      • HTA zu Fidanacogene elaparvovec (BEQVEZ®)
                                      • Neuerscheinung: INAHTA Weißbuch zur Förderung der ökologischen Nachhaltigkeit
                                      • EU-HTA Verfahren: Erste klinische Bewertungen gestartet
                                      • Studie: Kann KI bei der Erstellung systematischer Übersichtsarbeiten helfen?
                                      • D: Aktualisierung DMP koronare Herzkrankheit
                                      • Termine
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                                      Newsletter

                                      Inhalt

                                      • Editorial: EU-HTA-Verordnung: Erste Verfahren gestartet – ein weiterer Meilenstein für HTA in Österreich
                                      • Framework für Managed Entry Agreements bei kostenintensiven, einmaligen Therapien mit kurativem Potenzial
                                      • Bevölkerungsgesundheitseffekte von NICE empfohlener Arzneimittel in England
                                      • Quantifizierung von Low-Value Care in Deutschland
                                      • Framework für die Anwendung von Kosteneffektivitätsanalysen zur Unterstützung von Preis- und Erstattungsentscheidungen für neue Arzneimittel in dynamischen Gesundheitsmärkten
                                      • Termine (+Umfrage)
                                      • Themen-Vorschau
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                                      Newsletter

                                      Inhalt

                                      • Editorial: Bewährtes bewahren, Neues gestalten: Ein Institut in Bewegung
                                      • Qualitätsindikatoren zur Überwachung der Qualität von multidisziplinären pädiatrischen Adipositaszentren
                                      • Gen-Panels zur Identifizierung angeborener Immundefekte
                                      • Methoden zur Vorausschätzung der Arzneimittelausgaben in Belgien
                                      • Implementierung eines durch künstliche Intelligenz gestützten Krankenhaus-Koordinationszentrum im National Health Service
                                      • Termine
                                      • Themen-Vorschau
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