Logo_AIHTA
  • English
            Menu_button
                          • Announcements
                                  Video
                                  Video: What is HTA?    
                                  • Home
                                  • News
                                  • Announcements

                                  Announcements

                                  Fotoleiste-1b

                                   

                                  Current & archive

                                  Sh-masterthesis-neu-aihta-format-20250822-korr-sh-20250908-sb-003
                                  @ stock.adobe.com

                                  Digital health technologies for self-identification of the risk of perinatal mental illness

                                  The aim of this systematic review was to assess the effectiveness and safety as primary outcomes and implementation considerations of digital health technologies for self-identification of the risk of perinatal mental ill-ness, with a focus on social, organizational, and legal aspects as secondary outcomes. Six studies and one review were included, covering mobile applications, web platforms, and text-based interventions.

                                  Publication: HTA Project Report No. 167: https://eprints.aihta.at/1571
                                  Contact: Yui Hidaka

                                   

                                  More...

                                  Adobestock-123504209-von-africa-studio4
                                  ©stock.adobe.com

                                  Lifileucel (AMTAGVI®) for previously treated unresectable or metastatic melanoma

                                  Lifileucel (AMTAGVI®) is an autologous tumour-infiltrating lymphocyte therapy in which T-cells are isolated from the patient’s tissue, expanded ex vivo, and reinfused. The goal of this treatment is to trigger an antitumor response in patients with previously treated, unresectable or metastatic melanoma. In a single-arm Phase 2 multi-cohort study, the pooled analysis of two cohorts showed a complete response rate of 5%, a partial response rate of 26%, and a stable disease rate of 46%. Additional results include an objective response rate of 31.4%, a median overall survival of 13.9 months, and a progression-free survival of 4.1 months. Regarding safety, all patients experienced at least one treatment-emergent adverse event, with thrombocytopenia (76.9%), anaemia (50.0%), and febrile neutropenia (41.7%) being the most frequently observed. Six patients died within 30 days after lifileucel infusion. However, the available evidence is limited as the efficacy of lifileucel was not directly compared with other therapies.

                                  Publication: Decision Support Document for the Austrian Appraisal Board No. 004: https://eprints.aihta.at/1570
                                  Contact: Sarah Wolf

                                   

                                  More...

                                  2431
                                  ©stock.adobe.com

                                  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...

                                  Adobestock-759106717-von-mark-sutton
                                  ©stock.adobe.com

                                  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

                                  More...

                                  Cart-cell
                                  AI generated

                                  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

                                  More...

                                  Adobestock-123504209-von-africa-studio1
                                  ©stock.adobe.com

                                  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

                                  More...

                                  Adobestock-123504209-von-africa-studio2
                                  ©stock.adobe.com

                                  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

                                  More...

                                  Adobestock-123504209-von-africa-studio3
                                  ©stock.adobe.com

                                  Exagamglogene autotemcel (Exa-cel, Casgevy®) for the treatment of beta-thalassemia and severe sickle cell disease

                                  Exagamglogene autotemcel (exa-cel, Casgevy®) received conditional marketing authorization from the European Medicines Agency (EMA) on February 9, 2024, as the first CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-based gene therapy. It is classified as an Advanced Therapy Medicinal Product (ATMP) and has orphan drug status for two indications. Exa-cel is approved for treating transfusion-dependent ß-thalassemia (TDT) and severe sickle cell disease (SCD) in patients aged twelve years or older who are eligible for hematopoietic stem cell transplantation but lack a human leukocyte antigen (HLA)-matched related donor.

                                  The studies to date (two single-arm studies) show a significant improvement in symptoms in the majority of patients treated. In beta-thalassemia, 32 out of 35 people no longer needed blood transfusions after the therapy. In sickle cell disease, 29 out of 30 patients no longer had severe pain crises. These improvements lasted for at least one to two years in both diseases. The patients' quality of life was noticeably improved as a result. Long-term experience is not yet available.

                                  Publication: Decision Support Document for the Austrian Appraisal Board No. 001:
                                  https://eprints.aihta.at/1548/
                                  Contact: Nicole Grössmann-Waniek

                                  More...

                                  Assess-dht-website-launch-visual-23
                                  ©stock.adobe.com

                                  ASSESS-DHT: Telehealth in Diabetes: EU mapping and systematic evaluation of organizational aspects

                                  The number of people living with diabetes is increasing globally, with approximately 90% having Type 2 Diabetes Mellitus (T2DM). The fundamental management of T2DM relies on maintaining a healthy lifestyle. This includes regular medical visits for monitoring, balanced diet management, regular exercise, and maintaining a healthy body weight. Telehealth has gained attention as a means of supporting the continuous self-management and treatment of people living with diabetes.

                                  This report focuses on diabetes telehealth programs currently available or being piloted in European countries. It examines their organizational aspects based on findings from a scoping review and a questionnaire survey.

                                  Publication: HTA Project Report No. 161: https://eprints.aihta.at/1555/
                                  Contact: Yui Hidaka

                                  More...

                                  2195
                                  ©stock.adobe.com

                                  Horizon Scanning in Oncology - Fact Sheets

                                  We are pleased to introduce you five new Fact Sheets.

                                  Fact Sheet No. 191 (September 2024)
                                  Daratumumab (Darzalex®) with bortezomib, lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma (MM)

                                  Fact Sheet No. 192 (September 2024)
                                  Serplulimab (Hetronifly®) with carboplatin and etoposide for the first?line treatment of extensive?stage small cell lung cancer (ES-SCLC)

                                  Fact Sheet No. 193 (September 2024)
                                  Mirvetuximab soravtansine (Elahere®) for the treatment of adults with folate receptor-alpha (FR?) positive epithelial ovarian, fallopian tube and primary peritoneal cancer

                                  Fact Sheet No. 194 (September 2024)
                                  Pembrolizumab (Keytruda®) with chemoradiotherapy (CRT) for the treatment of FIGO 2014 Stage III - IVA locally advanced cervical cancer

                                  Fact Sheet No. 195 (September 2024)
                                  Pembrolizumab (Keytruda®) for the treatment of adults with endometrial carcinoma

                                  More...

                                  « < 1 2 3 4 5 ... > »
                                  Displaying results 1 to 10.
                                                                                                      Netzwerk
                                                                                                      • Ebm
                                                                                                      • Inahta
                                                                                                      Shareholder
                                                                                                      • Bmfg
                                                                                                      • Sv
                                                                                                      • Wgfond
                                                                                                      • Noe
                                                                                                      • Ooghfond
                                                                                                      • Ghls
                                                                                                      • Tirol
                                                                                                      • Vorarlberg
                                                                                                      • Kghfond
                                                                                                      • Ghpf
                                                                                                      • Burgef
                                                                                                                © 2025 HTA Austria - Austrian Institute for Health Technology Assessment GmbH. Alle Rechte vorbehalten.
                                                                                                                • Log in