Announcements
Current & archive
Genetic Testing in the Context of Familial Hypercholesterolaemia Management
Molecular genetic diagnostics (GDx) is an increasingly important tool in the so-called "precision medicine" and personalised health care, including organised screening programs. For a structured and controlled implementation of GDx, organisational-regulatory and ethical aspects, as well as far-reaching economic effects have to be considered in addition to efficacy and safety concerns.
The aim of the present report was to illustrate the general complexity of such (predictive) diagnostic tests and systematic test strategies using the example of familial hypercholesterolemia (FH).
Publication: HTA Project report No. 130: http://eprints.aihta.at/1281/
Contact: Melanie Walter, Christoph Strohmaier
Effectiveness of Music Therapy for Autism Spectrum Disorder, Dementia, Depression, Insomnia and Schizophrenia
In Vienna, in 1958, for the very first time in Europe, the institutionalisation process started with founding the Austrian Society for the Promotion of Music Medical Science. One year later, the first training course in Europe was established. Today, music therapy is understood as an expression promoting, scientific-artistic-creative and independent form of treatment using active and receptive music therapeutic methods. In an update of Cochrane Reviews, the effectiveness and applied methods of music therapy in autism, dementia, depression, sleep disorder and schizophrenia were examined. The results suggest that music therapy can help patients in terms of physical and psychosocial aspects.
Publication: HTA Projektbericht No. 133: http://eprints.aihta.at/1280/
Contact: Lucia Gassner
Framework for reimbursement decisions of digital health technologies (mHealth) and its (retrospective) application on selected examples
Digital health applications have the potential to improve disease monitoring and management. For the majority of available digital health applications, however, there is little evidence of (medical, organizational or economic) benefit. The thorough evaluation of a digital health application requires additional technology-specific domains. Decision-makers are thus faced with new challenges in the evaluation of these applications.
The aim of this report was to provide guidance to funding institutions and manufacturers as to what evidence is expected for which type of digital health application. For this purpose, the applicability of currently available assessment frameworks for digital health applications was examined.
Publication: HTA Projektbericht No. 134: https://eprints.aihta.at/1279
Contact: Reinhard Jeindl, Claudia Wild
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our three new HSO Fact Sheets.
Fact Sheet No. 25 (October 2020)
Blinatumomab (Blincyto®) for the treatment of patients with Philadelphia chromosome positive B-precursor acute lymphoblastic leukaemia (ALL)
Fact Sheet No. 26 (October 2020)
Nivolumab (Opdivo®) as monotherapy for the treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OESCC)
Fact Sheet No. 27 (October 2020)
Autologous anti-CD19-transduced CD3+ cells (Tecartus®) for the treatment of relapsed or refractory mantle cell lymphoma (MCL)
Covid-19: HSS/ Horizon Scanning Living Document (v08 November 2020)
The establishment of a HSS/ Horizon Scanning System for Covid19 interventions has the intentions of informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and to monitor them over the next few months in order to support evidence-based purchasing if necessary. The products are monitored with regard to the status of the clinical studies up to approval and finally evaluated for their benefit and harm.
All work steps are conducted in close international (European) cooperation.
Publications:
- Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Home-Treatment in Child and Adolescent Psychiatry: An Analysis of the Effectiveness and Possible Implementation in Austria
The Austrian child and adolescent psychiatric care landscape is characterised by substantial deficits on the intramural, as well as, on the extramural level. To overcome these supply shortfalls alternative outreach approaches, such as home-treatment, can be introduced to facilitate the reduction of hospitalisations. In this context, the present report aimed to systematically characterise international home-treatment-models considering their effectiveness and safety in the area of child and adolescent psychiatry. In addition, the fundamental challenges of implementing such treatment approaches were examined, taking into account the current Austrian care situation.
Publication: AIHTA Project report No. 129: http://eprints.aihta.at/1275/
Contact: Sarah Wolf, Nicole Grössmann
Horizon Scanning in Oncology - Fact Sheets
We are pleased to introduce our five new HSO Fact Sheets.
Fact Sheet No. 20 (September 2020)
Atezolizumab (Tecentriq®) plus bevacizumab for the treatment of advanced or unresectable hepatocellular carcinoma (HCC)
Fact Sheet No. 21 (September 2020)
Nivolumab (Opdivo®) plus ipilimumab (Yervoy®) and chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC)
Fact Sheet No. 22 (September 2020)
Niraparib (Zejula®) in patients with newly diagnosed advanced ovarian cancer
Fact Sheet No. 23 (September 2020)
Olaparib (Lynparza®) for metastatic castration-resistant prostate cancer (mCRPC)
Fact Sheet No. 24 (September 2020)
Olaparib (Lynparza®) plus bevacizumab as first-line maintenance treatment in patients with ovarian cancer
Covid-19: HSS/ Horizon Scanning Living Document (v07 October 2020)
The establishment of a HSS/ Horizon Scanning System for Covid19 interventions has the intentions of informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and to monitor them over the next few months in order to support evidence-based purchasing if necessary. The products are monitored with regard to the status of the clinical studies up to approval and finally evaluated for their benefit and harm.
All work steps are conducted in close international (European) cooperation.
Publications:
- Policy Brief No. 002: http://eprints.aihta.at/1234/
Contact: Claudia Wild
Covid-19: HSS/ Horizon Scanning Living Document (v06 September 2020)
he establishment of a HSS/ Horizon Scanning System for Covid19 interventions has the intentions of informing health policy makers at an early stage which interventions (vaccinations and drugs) are currently undergoing clinical trials and to monitor them over the next few months in order to support evidence-based purchasing if necessary. The products are monitored with regard to the status of the clinical studies up to approval and finally evaluated for their benefit and harm.
All work steps are conducted in close international (European) cooperation.
Publications:
- Policy Brief No. 002: http://eprints.aihta.at/1234/
- EUnetHTA Remdesivir Report
Contact: Claudia Wild
CAR-T Celltherapies, ATMPs and Gene Therapies in Development, Horizon Scanning
It is predicted that by 2022 there will be about 16 "Advanced Therapies Medicinal Products" (ATMPs) on the market, about 2-4 new therapies per year. There are currently 11 ATMPs approved. According to the annual report of the "Alliance of Regenerative Medicine (ARM)", by the end of 2019 more than 1,000 clinical trials worldwide are investigating regenerative/ advanced therapies for various diseases, 94 of which are in phase 3, 591 in phase 2, 60% in oncological indications alone. Among the best known already approved are the CAR-T cell therapies (2 approved in Europe, 1 in the approval process) and gene therapies for spinal muscular atrophy (also 2 approved in Europe, 1 in the approval process). Two Horizon Scanning reports – a cooperation project of AIHTA and Tirol Kliniken - dealt with a look into the near future of further gene therapies.
The European Medicines Agency (EMA) classifies ATMPs into three main types: Gene therapeutics and somatic cell therapeutic drugs and tissue engineering products. The two reports should address the questions for which indications CAR-T cell therapies and other ATMPs/gene therapies are in development and by when a marketing authorization is expected. To answer the questions, a systematic search of study registries was performed to identify gene therapies in development and ATMPs, followed by the extraction of data on the identified ongoing clinical trials, complemented by a search of the EMA database of drugs under evaluation to identify those therapies that are expected to be approved soon. Finally, published information on the products, their indication and patient population was collected. The search identified 32 ATMPs in 8 broad indication areas and 13 CAR-T cell therapies in haematological malignancies at an advanced stage of development.
Publications:
- Car-T Cell Therapies, Policy Brief No. 6a: http://eprints.aihta.at/1268/
- ATMPs and Gene Therapies, Policy Brief No. 6b: http://eprints.aihta.at/1269/
Contact: Claudia Wild