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Evidence requirements for the authorization and reimbursement of high-risk medical devices in the USA, Europe, Australia and Canada: An analysis of seven high-risk medical devices
This research first explored the authorization systems for high-risk medical devices in four selected regions (USA, Canada, Australia and Europe) of the western world. Secondly, it analyzed the clinical evidence accessible at time of market approval and decision support (HTA) for reimbursement for seven selected high-risk medical devices. The results support a change in the European authorization system towards a transparent and evidence-based regulation process: All seven medical devices have been approved in the European Union through an appointed Notified Body, only four by the Australian TGA, one each by the US-American FDA and by the Canadian TPD. In comparison to the other three regulatory systems, the number of approved devices in Europe is high, esp. if additionally taken into consideration that four further devices were also assessed by the FDA, but either rejected or not approved for general use.
Publication: LBI-HTA Project report No. 73: https://eprints.aihta.at/1017
Contact: Claudia Wild
Occupational therapy in children and adolescents. Literature review on indications, utilisation and recommendations
The frequency of prescriptions and underlying indications of occupational therapy (OT) in children and adolescents in Austria are unclear. The aim of the project was to identify fields of application and recommendations for OT as well as information on the frequency of prescriptions from (German) health insurance reports. We included 24 review articles, 20 guidelines and 4 health reports.
The results show that among many other indication areas CNS-disorders, developmental delays and ADHD were mentioned most often. Detailed, indication-specific information concerning prescription of OT for children and young people cannot be found.
Publication: LBI-HTA Project report No. 70: https://eprints.aihta.at/1016
Contact: Johanna Breuer
Horizon Scanning in Onkology - Reports
We are pleased to introduce our new HSO report.
Identification of ineffective interventions and technologies Existing models and their implementation
This systematic analysis of 8 already implemented models for the identification of ineffective interventions and technologies highlights existing commonalities between these models as well as general challenges that arise from the development and implementation of such models.
Publication: LBI-HTA Projektbericht Nr. 68: https://eprints.aihta.at/1014
Contakt: Julia Mayer
Mental Health Rehabilitation for Children and Adolescents – Systematic overview of evaluation outcomes and instruments
Zostavax® for the prevention of herpes zoster and postherpetic neuralagia. Pilot assessment using the draft HTA Core Model for Rapid Relative Effectiveness Assessment. Pilot-ID: WP-SA-1
Herpes Zoster (Shingles) primarily occurs in people over 50 years old. The disease is hardly lethal, however, it is often associated with long-term pain (postherpetic neuralgia) and decreased quality of life. Since 2006, a vaccine against Herpes Zoster (Zostavax®) has been licensed for persons aged 50+. Completed studies so far have shown that vaccination decreases Herpes Zoster incidence, however, the benefit for patients in terms of quality of life or long-term pain is unclear. Moreover, the vaccine’s efficacy in terms of Herpes Zoster incidence decreases substantially with age. Overall mortality and hospital admissions on a population level won’t be reduced with vaccination. Because safety data have indicated an increased risk for severe adverse events in people over 80 years of age after vaccination, members of this age group should rigorously weigh benefit against risks.
Publication: Decision Support Document Nr. 73: https://eprints.aihta.at/1013/
Contact: Ingrid Zechmeister-Koss
Horizon Scanning in Onkology - Reports
We are pleased to introduce two new HSO reports.
DSD HSO No. 39
Pomalidomide (Pomalyst®) for the ? 3rd-line therapy of patients with relapsed and refractory multiple myeloma
DSD HSO No. 40
Regorafenib (Stivarga®) for heavily pretreated patients with metastatic colorectal cancer (mCRC)
Horizon Scanning in Onkology - Reports
We are pleased to introduce our new HSO report.
DSD HSO No. 38
Aflibercept (Zaltrap®) in addition to FOLFIRI for the 2nd line therapy of metastatic colorectal cancer
Cervical cancer screening: p16/KI-67 Dual Stain test (CINtec® PLUS) in the triage of equivocal results or mild to moderate dysplasia in pap cytology
Each year around 30 000 women in Austria receive a PAPIII or PAPIIID cytology result during routine cervical cancer screening. Roughly equivalent to ASC-US or LSIL cytology, the risk of progression to cancer for these patients is unclear and requires further diagnostic investigation: for many of the women the ensuing procedures and potential adverse effects turn out to be unnecessary. The p16/Ki-67 Dual Stain test (CINtec® PLUS) claims to improve the triage of these women. In a systematic review though we could not identify sufficient evidence to support the utility of the p16/Ki-67 Dual Stain test in the triage of equivocal or mild to moderate dysplasia results in Austria.
Publication: LBI-HTA Project report No. 72: https://eprints.aihta.at/1009/
Contact: Agnes Kisser
