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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
Sponsoring Austrian CME/ continuing medical education for physicians. A systematic analysis of the CME-Database
In recent years, the sponsorship of CME/ continuing medical education for physicians by the pharmaceutical and medical device industry is increasingly scrutinized. The question in this project was the scope of sponsoring in the Austrian CME-training. From the CME database of the Austrian Academy of doctors 13 medical fields (from a total of 56) were selected with the aim to analyse the number of events that were financially supported by manufacturer. The investigation shows that a sponsorship of at least 14.3% and at most 67.2% of the events took place. The sponsors are, as might be expected, pharmaceutical and medical product suppliers in the respective subject, mainly from "high-cost and / or high-volume" products.
Publication: Rapid Assessment 7a: https://eprints.aihta.at/1053
Contact: Claudia Wild
Vaccination against human papillomavirus (HPV). Decision-aid for young women and girls
In 2008 the German AOK-Bundesverband commissioned the LBI-HTA to develop a decision-aid on the vaccination against Human Papillomavirus (HPV) for young women and girls (online since June 2009). After smaller updates in 2010 and 2011, the updated, completely revised and partly new structured decision-aid went online in March 2015 (www.hpv-entscheidungshilfe.de).The first part of the decision aid contains information about the virus and HPV related diseases. The second part of the decision aid informs about the HPV-vaccine(s). Finally, the third part of the decision aid summarises information of parts I and II: eleven short information blocks can be rated according to the relevance for the decision (mainly pro or mainly contra vaccination or of no influence). In the present project report online contents are available in paper form for the first time. Hence, we were able to add country specific data for Austria and provide further, more detailed information (which has not been included in the online version due to complexity).
Publication: Decision Support Document No. 79: https://eprints.aihta.at/1050
Contact: Brigitte Piso
Horizon Scanning in Onkology - Reports
We are pleased to introduce our new HSO report.
DSD HSO No. 50
Nivolumab (Opdivo®) as single-agent first-line therapy for unresectable or metastatic melanoma
Hadron therapy in children: evidence synthesis for 15 paediatric tumours. Report based on Belgian (KCE) HTA report
A Belgian KCE-Assessment analysed – as an update of the 2007 report – the evidence for hadron therapy (proton and carbon ions) in 15 paediatric indications. Since 2015 the Austrian MedAustron started operating and the first patients are treated, the LBI -HTA has been involved in the Belgian report as external expert. Now the LBI -HTA wrote – due to the regional relevance – a German summary of the Belgian report.
In the assessment 21 clinical studies (non-randomized, non-controlled and mostly retrospective) were found. All studies showed serious methodological flaws. The conclusion therefore is that to date clinical data on PBT in all paediatric cancers under study are lacking as well as critical information on long-term effectiveness and harms.
Prospective comparative clinical trials in the field are urgently needed.
Publication: Decision Support Document Nr. 88: https://eprints.aihta.at/1049
Contact: Claudia Wild
Vasoprotectives: Efficacy and safety of capillary stabilising agents for venous insufficiency or haemorrhoidal diseases
The systematic review assessed the efficacy and safety of a treatment of chronic venous insufficiency (CVI) and haemorrhoidal diseases (HD) with capillary stabilising agents that are listed in the Austrian Code of Reimbursement.
A total of 56 studies were included for a data synthesis.
The majority of studies have shown that the symptoms and signs of CVI and HD can be reduced slightly with the agents (mostly when compared to placebo). Only minor side effects occurred.
However, the strength of the evidence of nearly all identified studies is low. Therefore, we cannot draw a final conclusion on the efficacy of capillary stabilising agents for the treatment of CVI and HD.
Publication: LBI-HTA Project report No. 79: https://eprints.aihta.at/1047
Contact: Stefan Fischer
PET/PET-CT Evidence for need based planning (in oncology indications)
In nearly all Western countries, HTA-reports on Positron Emission Tomography/PET imaging have been written in the last two decades. 155 only in the last 10 years (!) Hardly any other medical technology has undergone so many evaluations. This large abundance is ultimately an expression of an unfading uncertainty about the value of PET imaging in patient care. The (Austrian) HTA report has the intention of supplying decision support for evidence- and needs-based PET device planning. Results from 35 HTAs and recommendations from 7 medical societies have been taken into consideration in the HTA report.
Publication: LBI-HTA Project report No. 77: https://eprints.aihta.at/1045
Contact: Claudia Wild