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                                2121

                                Horizon Scanning in Onkology - Reports

                                We are pleased to introduce our new HSO report.

                                DSD HSO No. 60
                                Obinutuzumab (Gazyvaro®) in combination with bendamustine for the treatment of relapsed/refractory follicular lymphoma (FL)

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                                Update Re-orientation of the Austrian parent-child preventive care programme Part IX: Recommendations from evidence-based guidelines for screening measures covering early childhood (0-6 yrs.)

                                We are pleased to present an update report covering evidence-based, international screening recommendations for children (0-6 years). Based on the extensive, original report part IX from 2013 an update was performed in terms of new or updated screening recommendations for children.

                                Publication: LBI-HTA Project report No. 62 - Update 2016: https://eprints.aihta.at/996/

                                Contact: Brigitte Piso

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                                249

                                Evaluation of individual medical procedures 2016 - Reports

                                We are pleased to introduce our new reports.

                                Decision Support Documents 2016:

                                • DSD 97: Leadless pacemakers for right ventricle pacin
                                  https://eprints.aihta.at/1094/
                                • DSD 98: Single-step scaffold-based cartilage repair in the knee
                                  https://eprints.aihta.at/1095/
                                • DSD 99: Radiofrequency denervation for sacroiliac and facet joint pain
                                  https://eprints.aihta.at/1096/
                                • DSD 100: Upper airway stimulation for moderate-to-severe sleep apnea
                                  https://eprints.aihta.at/1097/
                                • DSD 101: Magnetic sphincter augmentation device (MSAD) in patients with gastroesophageal reflux disease (GERD)
                                  https://eprints.aihta.at/1098/

                                +1 Update:

                                • DSD 24/Update 2016:

                                  Percutaneous transluminal coronary angioplasty (PTCA) with drug-eluting balloon (DEB)
                                  https://eprints.aihta.at/1093/

                                 

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                                Screening, diagnostics and indication for occupational therapy in children and adolescents with Developmental Coordination Disorder

                                Developmental Coordination Disorder (DCD) is characterized by a severe developmental impair­ment of the motor coordination, which is not solely caused by mental retardation or specific neurological damage. DCD approximately affects 5 to 6% of school children. It may cause significant difficulties in activities of daily living and lead to consequences in adulthood. Children and adolescents with DCD are primarily referred to paediatric occupational therapists and physiotherapists. The report addresses the research questions, which recommendations on DCD (for screening, diagnostic testing, indication and form of therapy) are provided in evidence-based guidelines, which differentiation criteria between occupational therapy and other forms of treatment are discussed and which of the recommended tools can be introduced in Austria with regard to language (German) and standardization/ adaption (central Europe). Depending on the research question, literature was identified by a systematic and/ or manual search. A population based screening for DCD is not recom­mended due to the lack of sufficiently sensitive screening tools. For DCD diagnosis, all information sources recommend the use of standardized assessment tools. However, currently there is no gold standard available. Of 85 identified assessment tools, 12 have been translated into German and standardised/ adapted for Central Europe. Recommended interventions for children and adolescents with DCD should target the individual activity- and participation-level of the affected person. Differentiation criteria for various forms of therapy could not be identified.

                                Publication: Decision Support Document No. 96: https://eprints.aihta.at/1092/

                                Contact: Brigitte Piso

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                                Drugs in Oncology: an overview of benefit and refund practices in Europe

                                Austria belongs to those countries that adopt new cancer drugs not only early and fast, but use them also widely. In 2009, the LBI-HTA launched the program “Horizon Scanning in Oncology” (HSO) in order to enable evidence based decisions on the use of cancer drugs and estimations on implications for the health care budget in Austria. Since then numerous (n=59) early assessments of new cancer drugs were published. This review shall provide an overview of all approved cancer drugs 2009–2015 by the European Medicines Agency (EMA) and the knowledge on patient-benefit at time of approval and will analyse which policies for high-prized cancer drugs are applied in other (European) countries.

                                At the time of approval by EMA, for 26 (23%) of 73 cancer drugs between 2009 and 2015 no information about the two endpoints overall survival (OS) and progression free survival (PFS) was available. For 37 (45%) of cancer drugs, OS was increased up to 3 months, and for 14 (13%) up to 5.8 months in relation to the comparator. The benefit assessments in various countries (Germany, England, Norway, Belgium, Netherlands, Canada) differ in the point in time carried out (before/ after approval), in methods used (only clinical benefit assessment or additional cost-effectiveness analysis), the publication of results (degree of transparency) and the binding character of recommendations (from purely informational to binding). In a comparison of national benefit assessments of cancer drugs 14 drugs in 15 indications, including also some drugs that are in the Austrian MEL-catalogue, have been assessed consistently negative (not recommended). 16 drugs in 22 indications have been assessed consistently positive (recommended). Assessments with (binding) recommendations, health economical evaluations, “Managed-Entry Agreements” and “Value-based pricing” are approaches identifying cancer drugs with the highest benefit and acceptable costs with transparent and traceable methods.

                                Publication: Rapid Assessment No. 8: https://eprints.aihta.at/1091/

                                Contact: Nicole Grössmann, Claudia Wild

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                                B0005622

                                Opportunities and strategies to drive appropriate use of MRI in Austria. Part 2

                                Magnetic resonance imaging (MRI) is an essential component of medical care. Currently, however, the appropriateness of diagnostic imaging is increasingly debated. In a first report we identified via database screening, literature review and interviews with stakeholders recommendations against the use of MRI and opportunities and strategies to drive appropriate imaging relevant to the Austrian context. In the second part we aim to provide additional information (on evidence base, guideline recommendations, diagnostic algorithms/decision support tools and products) on already identified recommendations regarding a set of indications selected by a working group of HVB and WKÖ.

                                Publication: LBI-HTA Project report No. 80b: https://eprints.aihta.at/1090/

                                Contact: Agnes Kisser

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                                2120

                                Horizon Scanning in Onkology - Reports

                                We are pleased to introduce our new HSO report.

                                DSD HSO No. 59
                                Afatinib (Giotrif®) in patients with non-small cell lung cancer (NSCLC) who are refractory to erlotinib/gefitinib and afatinib monotherapy

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                                Involvement of Citizen and Patients in HTA-Processes – International Experiences and Good Practice Examples

                                There is consensus among HTA-experts that the involvement of patient and citizen perspectives can valuably complement health technology assessment (HTA) processes. Since the 1990s, scientific papers about different forms and models of participation have been published. Until now sound (cost-) benefit assessments are missing.

                                The project aims to summarize internationally published models, methods and experiences in a systematic overview. Furthermore it intends to identify and describe obstacles, facilitating factors and learnings for HTA in Austria by using examples of selected countries and models of good practice.

                                Publication: LBI-HTA Project report No. 86: https://eprints.aihta.at/1088/

                                Contact: Claudia Wild

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                                2119

                                Horizon Scanning in Onkology - Reports

                                We are pleased to introduce our two new HSO reports.

                                DSD HSO No. 57
                                Ofatumumab (Arzerra®) as maintenance therapy in patients with relapsed chronic lymphocytic leukaemia (CLL)

                                DSD HSO No. 58
                                Pembrolizumab (Keytruda®) in previously treated advanced non-small cell lung cancer (NSCLC)

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                                Thrombectomy for ischemic stroke: Patient characteristics, structural requirements and (differential) diagnostics

                                The results of recent studies suggest that mechanical thrombectomy combined with standard care is superior to standard care alone for the treatment of ischemic stroke in selected patients. The intention of this paper is to show under which circumstances and for which patients the mechanical thrombectomy could be a viable option for the treatment of stroke patients. Additionally, thrombectomy devices will be presented. Recent guidelines, systematic reviews, recent randomized controlled trials (RCTs) and information published by the manufacturers have been examined for this purpose. There is only evidence on the basis of RCTs for the efficacy of stent retriever available. At least noninvasive vascular imaging should be conducted prior the thrombectomy. The mechanical thrombectomy could be an option for patients with contraindications against systemic lysis and could allow treatment after 4.5 hours after symptoms onset. The number of potentially eligible patients is reduced because in all recent RCTs exclusively patients with anterior circulation occlusion have been treated. Additional patient selection criteria (e.g. NIHSS Score above a specific value) further limit this number.

                                Publication: Decision Support Document No. 95: https://eprints.aihta.at/1084/

                                Contact: Robert Emprechtinger

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