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Horizon Scanning in Onkology - Reports
We are pleased to introduce our new HSO report.
DSD HSO No. 55
Pembrolizumab (Keytruda®) for the treatment of advanced melanoma
Transcatheter implantable devices for mitral valve repair in adults with chronic mitral valve regurgitation (Mitraclip®, Carillon®, NeoChord DS1000)
Mitral valve regurgitation (MR) or mitral insufficiency is a common disease esp. among the elderly. MR may be acute or chronic, depending on the underlying pathology: accordingly, it must be distinguished between primary (degenerative) MR (DMR) and secondary (functional) MR (FMR). Since recent years new minimally invasive procedures are available for inoperable or high-risk patients. This assessment examines the question of efficacy and safety of mitral valve repair using minimally invasive procedures such Mitraclip® for inoperable patients with DMR or FMR; Carillon® inoperable patients with FMR; NeoChord DS 1000 for operable patients with DMR to answer.
Two of the evaluated medical devices, NeoChord DS1000 and CARILLON® are still at an early stage of development. The MitraClip® however, was already implanted worldwide in around 23,000 patients before results of a comparative study has been published.
Publication: Decision Support Document No. 93: https://eprints.aihta.at/1075/
Contact: Claudia Wild
Balloon Eustachian Tuboplasty for the treatment of Eustachian tube dysfunction - German short version and update of the correspondent EUnetHTA assessment
Balloon Eustachian Tuboplasty (BET) is a minimally invasive treatment option for patients with chronic tube dysfunction which involves passing a balloon catheter into the Eustachian tube. Currently, there are 2 CE marked products on the market for BET: the Bielefelder Ballonkatheter/TubaVent® produced by Spiggle & Theis and the AERATM produced by Acclarent Inc./Johnson & Johnson.
This report, which is based on a EUnetHTA assessment published in February 2015, aims to compare the effectiveness and safety of BET in patients aged >12 years with tympanostomy and medication.
Publication: Decision Support Document No. 91: https://eprints.aihta.at/1073/
Contact: Julia Mayer
Sponsoring of Patientinitiatives in Austria. Systematic Analysis
As part of the professionalization of patients organizations and the expansion of their activities (eg. awareness campaigns, advisory services for patients and their relatives, etc.) the need for financial resources is also increasing. This need is often covered by pharmaceutical and medical device manufacturers. This report analysed the extent of financial support for patient organizations from pharmaceutical companies in Austria. 24 of 115 PHARMIG member companies have declared donations to patient organization for the year 2014. A total of € 1,145.718.- grants were given. Most grants (63%) were given to four fields of diseases: neurology, haemato-oncology, rheumatology and haemophilia.
Publication: Rapid Assessment No 7b: https://eprints.aihta.at/1072
Contact: Claudia Wild
Outpatient neurological rehabilitation: goal attainment in stroke patients. Systematic review.
In the Austrian rehabilitation plan aims for outpatient rehabilitation have been defined. These can be summarised as a higher flexibility of the therapy plan, a higher participation into the living environment, a higher activation of the self-help capability, a better re-integration into the work process and a better cooperation with aftercare units. Aim of this report (a master´s thesis) is to analyse, if outpatient stroke patients are able to achieve these goals. 7 observational pre-post studies (4 with control group) fulfilled the inclusion criteria. For the domains ‘functionality’ and ‘participation’ most of the studies found positive effects. The heterogeneity of instruments led to different results in the domain ‘satisfaction’. Positive trends could be observed for the domain ‘re-integration into the work process’. Finally, none of the studies reported results for the domain ‘aftercare’. Overall, the risk of bias of included studies has to be rated as high. We did not aim at comparing different rehabilitation settings. Future studies should aim at the further standardisation of instruments, the randomized allocation of patients to the rehabilitation settings and the investigation of patients’ expectations and needs.
Publication: Decision Support Document No. 92: https://eprints.aihta.at/1071
Contact: Brigitte Piso
Horizon Scanning in Onkology - Reports
We are pleased to introduce our four new HSO reports.
DSD HSO No. 52
Carfilzomib (Kyprolis®) for patients with relapsed multiple myeloma who have received one to three prior lines of therapy
DSD HSO No. 53
Nivolumab (Nivolumab BMS®) for the second-line therapy of metastatic squamous non-small cell lung cancer
Biodegradable stents for the treatment of refractory or recurrent benign oesophageal stenosis
Biodegradable ("resorbable") esophageal stents to treat benign refractory and/ or recurrent esophageal strictures were recently developed as alternatives to self-expanding metal stents (SEMS) and self-ex¬pandierenden plastic stent (SEPS). Only one product - the SX-ELLA stent Esophageal Degradable ™ BD - holds CE marking (since 2007) on the European market. Only a few studies of very low quality were available for the assessment of efficacy and safety. Currently, the biodegradable esophageal stents is an experimental procedure in an early stage of use.
Publication: Decision Support Document Nr. 89: https://eprints.aihta.at/1067/
Contact: Claudia Wild
Background Analysis for National HTA Strategy for Lithuania: Focus on Medical Devices
Health policy goals in Lithuania until 2020 include increasing transparency, cost-effectiveness and rational use of resources. Despite repeated initiatives, a systematic application of HTA is so far not in place in Lithuania. In the context of a EU funded project we formulated a HTA-Strategy for Lithuania (https://eprints.aihta.at/1064). For this we undertook a background analysis of the Lithuanian healthcare system, together with local partners. We locally conducted 19 expert interviews with stakeholders. In addition a systematic search of the literature was made for HTA strategy papers, complemented by hand searches. The recommendations developed for Lithuania (and activities proposed) based on this analytical report are published in a separate document, the HTA-Strategy for Lithuania (https://eprints.aihta.at/1064).
More generally it was found that the regulatory environment is essential for the role of HTA. HTA’s impact is greatest, when conducted for supporting concrete decisions. Timely HTAs of good quality with clear messages are important. Not only HTA products themselves require transparency, also the entire HTA process (from topic selection to implementation) demands it for ultimate acceptability of the method. HTA needs to be independent from health policy and from providers (professions, industry) in order to be respected, which also requires a stable funding-basis for HTA.
Publication: Decision Support Document No. 90: https://eprints.aihta.at/1063
Contact: Claudia Wild
HTA-Strategy for Lithuania
The HTA-Strategy for Lithuania was formulated based on a thorough analysis of the Lithuanian health care system (“Background Analysis for National HTA Strategy for Lithuania - Focus on Medical Devices”: https://eprints.aihta.at/1063). It aims to boost the use of HTA-information in Lithuania. Its goals are to support the establishment of both a framework to promote, enforce and facilitate the uptake of HTA and of the necessary organizational structures for the timely, efficient and good-quality provision of HTA-information.
Recommendations and short/ medium/ long terms suggestions for implementation activities are presented for four strategic objectives: regulatory embedding and ensuring legitimacy of HTA; organization of HTA; quality assurance of HTA; capacity building for HTA.
A change of culture (in decision making) takes time. The ultimate success of the HTA-Strategy for Lithuania will be for its health sector stakeholders to increasingly take ownership of the HTA process. In the meantime the HTA-Strategy for Lithuania proposes that raising awareness for HTA works best by successfully realizing “flagship projects” that increase the quality of patient services, decrease inappropriate or even harmful interventions or create savings that can be reinvested for other services.
Publication: Decision Support Document No. 90a: https://eprints.aihta.at/1064
Contact: Claudia Wild
Evaluation of individual medical procedures 2015 - Reports
We are pleased to introduce our new reports.
Decision Support Documents 2015:
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DSD 81: Fully bioresorbable scaffolds for coronary artery disease
https://eprints.aihta.at/1060 -
DSD 82: Transcatheter mitral valve-in-valve implantation (TMViVI)
https://eprints.aihta.at/1058 -
DSD 83: Endovascular embolization of unruptured intracranial aneurysms with flow diverters
https://eprints.aihta.at/1054 -
DSD 84: Defibrotide for the treatment and prophylaxis of hepatic veno-occlusive disease
https://eprints.aihta.at/1061 -
DSD 85: Intrastromal corneal implants for ectatic corneal disorders
https://eprints.aihta.at/1055 -
DSD 86: Sphenopalatine Ganglion (SPG) stimulation of patients with therapy-resistant cluster headache
https://eprints.aihta.at/1062 -
DSD 87: Injectable bulking agents for faecal incontinence
https://eprints.aihta.at/1059
+2 Updates:
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DSD 44/ 2nd Update 2015: Percutaneous left atrial appendage closure for the prevention of thromboembolic events in patients with atrial fibrillation
https://eprints.aihta.at/1056
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DSD 68/ 1st Update 2015: Percutaneous transluminal angioplasty (PTA) of periphery arteries with drug-eluting balloon (DEB)
https://eprints.aihta.at/1057
