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                                  Current & archive

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                                  Re-orientation of the Austrian parent-child preventive care programme. Part XII: Economic evaluation of selected screenings during pregnancy

                                  In this report, we conducted an economic analysis of three screenings during pregnancy: testing of TSH as screening for hypothyroidism, urine culture as screening for asymptomatic bacteriuria and ultrasound screening for foetal anomalies.

                                  Over a three years period, the screening for hypothyroidism would save 2 million euros due to prevented preterm births. The costs for the screening for bacteriuria using urine culture are 1.17 million euros and the costs for the ultrasound screening would cost 337,800 euros, when 5 % of all pregnant women would be screened.

                                  Publlication: LBI-HTA Project report No. 91: https://eprints.aihta.at/1112/

                                  Contact: Stefan Fischer

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                                  2124

                                  Horizon Scanning in Onkology - Reports

                                  We are pleased to introduce our new HSO report.

                                  DSD HSO No. 64
                                  Palbociclib (Ibrance®) in combination with fulvestrant for the treatment of hormone-receptor-positive, HER2-negative advanced or metastatic breast cancer

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                                  Jb-2016

                                  Annual Report 2016 online

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                                  2123

                                  Horizon Scanning in Onkology - Reports

                                  We are pleased to introduce our new HSO report.

                                  DSD HSO No. 63
                                  Ixazomib (Ninlaro®) in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma (MM)

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                                  Fotolia-82745345-m1

                                  Supply mandates

                                  The definition of the “Best point of service (BPoS)” for all healthcare settings is a primary goal and shall be re-thought and set by the Austrian health reform. Against this background, part I of this report is based on definitions, models and approaches towards the potential content of a BPoS. The BPoS for the outpatient area at the conceptual level is discussed. In Part II, two concrete health interventions are presented alongside the evidence of the effectiveness and safety. Furthermore, the analysis shall involve organisational information regarding the service provision of a BPoS (using the “organisational domain” of the EUnetHTA core model).

                                  Publication: LBI-HTA Project report No. 88: https://eprints.aihta.at/1110/

                                  Contact: Brigitte Piso

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                                  Fotolia-71251055-m1

                                  Wearable cardioverter-defibrillator (WCD) therapy in primary and secondary prevention of sudden cardiac arrest in patients at risk

                                  Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. In Europe, there are about 350 000 out of hospital SCAs per year. Mostly, ventricular tachycardia and ventricular fibrillation are the underlying aetiology of SCA, which is claimed to be successfully treated by a novel defibrillation therapy, a wearable cardioverter defibrillator (WCD).

                                  This assessment, performed within the „European Network for Health Technology Assessment“ (EUnetHTA) Joint Action 3, aimed to provide valid data on clinical effectiveness and safety of the WCD. Furthermore, the project intended to elicit patients’ views on aspects regarding their cardiac disease and the WCD therapy as well as to identify neglected outcomes.

                                  According to the published data, no statement can be made about the device effectiveness – further research is needed. Studies suggest that the WCD could be a relatively safe intervention in the short to medium term. However, more data and more adequate reporting of (serious) adverse events are needed in order to establish the device safety. In particular, more data is needed for specific risk stratification of high risk patients in order to further narrow down the wide range of indications for WCD use.

                                  Publication: Decision Support Document No. 103: https://eprints.aihta.at/1109/

                                  Contact: Sabine Ettinger

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                                  Fotolia-49809344-m

                                  Outpatient cardiac rehabilitation. Part VII: economic evaluation

                                  In addition to the results of the prospective multicentre cohort study on the effectiveness of the outpatient cardiac phase III rehabilitation programme (see part VI), the aim of this report was to compare the costs that occur due to the treatment of cardiovascular diseases of patients who underwent an outpatient cardiac phase III rehabilitation programme (intervention group) and patients who did not receive this phase III (control group).

                                  The data of a total of 164 patients was analysed for this report. On average, the total costs that occurred for patients in the control group were 2,900 euros per patient and 5,099 euros per patient in the intervention group.

                                  Publication: LBI-HTA Project report No. 89: https://eprints.aihta.at/1102/

                                  Contact: Stefan Fischer

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                                  Fotolia-36479424-m

                                  Health Technology Assessments on Medical Devices in Europe

                                  In recent years, the European collaboration in health technology assessments (HTAs) on (high-risk) medical devices and procedures has become a major issue of consideration due to weak market authorization and efficacy/safety concerns. This research sought to ex­plore and synthesize the critical points and challenges in the assessment of medical devices in Europe discussed in publications and to analyze a number a selected European HTA reports.  

                                  The issues discussed in the recent literature can be summarized in five major critical points. The analyses of HTA reports on 10 selected high-risk medical devices revealed the amount of the redundancies in European HTA production: the number of reports per technology ranged between 5 and 22 reports over a time-span of 10-12 years; ranging between 1-6 reports of the same technology within the same year, sometimes even within the same country (language).

                                  The results strongly support the assumption that the resources of HTA institutes can be used more efficiently. The knowledge gained contributes to the conclusion that there is a need not only to collaborate across borders within the same year but also to build on each other´s assessments of the same technologies over years by using the same format, method, language.

                                  Publication: Rapid Assessment No. 12: https://eprints.aihta.at/1108/

                                  Contact: Claudia Wild

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                                  26

                                  Pharma: Disclosure of payments in Austria 2015

                                  In the last few years, payments from the pharmaceutical industry to physicians and medical institutions are increasingly critically questioned, since evidence suggests that those payments are influencing the the medical profession (e.g. in prescribing). To promote trust, the European Federation of Pharmaceutical Industries and Associations (EFPIA) responded with directives and regulations. The "Transparency Initiative" calls on member companies to disclose "monetary benefits to members of the professional circles and institutions" in year 2015. This information should be accessible to the general public at the respective websites of the pharmaceutical companies. The question that underlies this project report is the following: To what extent were Austrian physicians and medical institutions supported by pharmaceutical companies in 2015 and how transparent are they in the disclosure of the financial benefits? In a systematic analysis, the websites of all PHARMIG member companies (115) were searched for information on financial allocations to Austrian physicians and medical institutions in 2015. For a total of 69 out of 115 PHARMIG member companies, cash-based benefits were found in 2015. 20 pharmaceutical companies stated that they had not made any financial contributions; the rest of the companies did not provide feedback on request. A total of 104.1 million euros from PHARMIG member companies to doctors and medical institutions as well as to clinical research and application observations were made in Austria in 2015. Of this, clinical and post-marketing studies were financed with around 54 million euros (52% of the total financial expenditures), medical institutions and organizations received 27 million euros (26%) and medical doctors 22 million euros (22%). The results also show that Austrian pharmaceutical companies invested approximately 30 million euros in events (conferences, meetings), including the support of the events themselves, conference and participation fees as well as travel and accommodation costs. A total of 14 million euros was spent on services and advisory fees (e.g. lectures from doctors) and about 6 million euros for donations and funding. The disclosure of payments by pharmaceutical companies to doctors and medical institutions in Austria is an important step towards greater transparency, but is still at an initial stage. The evaluation of the data from 2015 shows that the actual willingness to disclose financial grants, especially from physicians, is low and the individual disclosure rate (name of the nominee) was only at an average of 21.9%. In contrast, the willingness to disclose payments from medical institutions by name (institutional) was significantly higher at 50.2%.

                                  Publication: Rapid Assessment No. 7d: http://eprints.aihta.at/1107/

                                  Contact: Philipp Petersen

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                                  2122

                                  Horizon Scanning in Onkology - Reports

                                  We are pleased to introduce our two new HSO reports.

                                  DSD HSO No. 61
                                  Atezolizumab (TecentriqTM) for the treatment of locally advanced and metastatic urothelial carcinoma

                                  DSD HSO No. 62
                                  Venetoclax (VenclextaTM) for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) with chromosome 17p deletion

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