scholarly journals MD1 Medical Devices: Timely Access and Reimbursement - Can National Health Technology Assessment Bodies Be Part of the Solution?

2016 ◽  
Vol 19 (7) ◽  
pp. A356
Author(s):  
R Macaulay ◽  
S Shaw
Keyword(s):  
Health Technology Assessment ◽  
National Health ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Timely Access

VP76 European Collaboration In Health Technology Assessment – Experiences And Possible Benefits

2017 ◽  
Vol 33 (S1) ◽  
pp. 184-185
Author(s):  
Julia Mayer ◽  
Sabine Ettinger ◽  
Anna Nachtnebel
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Medical Device ◽  
National Health ◽  
Medical Devices ◽  
Technology Assessment ◽  
Patient Involvement ◽  
Health Technology ◽  
Cross Border ◽  
European Collaboration

INTRODUCTION:Consistently high-quality health care is expected throughout Europe while concurrently, financial resources of member states are decreasing. National Health Technology Assessment (HTA) institutes are informing evidence-based reimbursement decisions in the national context, leading to redundancies in HTA production and tying up limited resources. Since 2006, the European Union project, the European Network for HTA (EUnetHTA) is aiming at enhancing the efficient use of HTA resources and facilitating transnational collaboration. Our aim is to present previous experience in joint assessment of medical devices. Furthermore, possible benefits of European collaboration for stakeholders will be discussed.METHODS:Processes and challenges of the completed EUnetHTA Joint Action (JA) 2 are summarized and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA JA 3 are described.RESULTS:Six rapid assessments of medical devices, focusing on the assessment of effectiveness and safety, were published during EUnetHTA JA 2. Challenges in European medical device assessment encompass the choice of topics, the time point of assessments and the lack of European standards for systematic patient involvement. Characteristics of medical devices, like learning curves, call for monitoring them throughout their lifecycle.The benefit of European collaboration for stakeholders is manifold: uncertainty with regard to actual added value of a technology is minimized through Early Dialogues; harmonized and transparent assessment processes increase the quality of reports; work division among HTA organizations allows a resource-efficient assessment of a bigger amount of technologies; patient involvement ensures consideration of patient relevant endpoints.The importance of cross-border collaboration in HTA is shown in the continuation of the EUnetHTA project, which aims to sustainably strengthen international collaboration even after expiration of EU-funding.CONCLUSIONS:European collaboration in medical device assessment can ensure cross-border health care and efficient cooperation of national health systems. The focus should be set on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for various stakeholders.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Healthcare Providers ◽  
Economic Assessment ◽  
Health Technology ◽  
Training Costs ◽  
Medical Technologies ◽  
The United Kingdom

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

OP51 Thrombectomy In France: A National Use Of European Network for Health Technology Assessment (EUnetHTA) Joint Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 24-24
Author(s):  
Huguette Lhuillier-Nkandjeu ◽  
Michèle Morin-Surroca
Keyword(s):  
Health Insurance ◽  
Ischaemic Stroke ◽  
Health Technology Assessment ◽  
National Health Insurance ◽  
National Health ◽  
Technology Assessment ◽  
Acute Ischaemic Stroke ◽  
Health Technology ◽  
List Type ◽  
European Network

INTRODUCTION:Mechanical thrombectomy (MT) is used in patients with acute ischaemic stroke due to occlusion of a proximal cerebral artery. Over the years endovascular techniques have been used to re-canalise blocked vessels, but are not currently reimbursed by National Health Insurance in France.The aim was to assess the efficacy and safety of MT in combination with intravenous tissue plasminogen activator (IV t-PA), or as an alternative to it, in adults with an acute ischaemic stroke who are not eligible for thrombolysis or in whom thrombolysis has failed; to support the reimbursement decision by National Health Insurance.METHODS:Within the scope of The European Network for Health Technology Assessment (EUnetHTA), a rapid assessment of “Endovascular therapy using devices for acute ischaemic stroke” was jointly produced with Haute Autorité de santé (HAS) as a reviewer.RESULTS:The EUnetHTA report provided a systematic review based on eight randomized controlled trials (RCT) for effectiveness and all available published data for safety.To produce its assessment, HAS has adapted the EUnetHTA report by: 1.Updating the systematic literature review including the latest published trials2.Retaining the subgroup analysis of the five most recent trials considered more relevant in the EUnetHTA report for the assessment of effectiveness3.Analysing specifically the different endovascular interventions studied in the five RCTs4.Taking into account contributions from stakeholders.CONCLUSIONS:This horizontal collaboration among European HTA doers has facilitated and shortened the assessment of the clinical benefit of this technology, confirming the relevance of EUnetHTA cooperation.This clinical assessment of thrombectomy is to be completed by the evaluation of its organizational impact in the management of acute ischemic stroke.

scholarly journals Which multi-attribute utility instruments are recommended for use in cost-utility analysis? A review of national health technology assessment (HTA) guidelines

2020 ◽  
Vol 21 (8) ◽  
pp. 1245-1257 ◽  
Author(s):  
Matthew Kennedy-Martin ◽  
Bernhard Slaap ◽  
Michael Herdman ◽  
Mandy van Reenen ◽  
Tessa Kennedy-Martin ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
National Health ◽  
Technology Assessment ◽  
Market Access ◽  
Health Technology ◽  
Cost Utility ◽  
Cost Utility Analysis ◽  
Utility Analysis ◽  
Disability Weights ◽  
Value Sets

Abstract Background Several multi-attribute utility instruments (MAUIs) are available from which utilities can be derived for use in cost-utility analysis (CUA). This study provides a review of recommendations from national health technology assessment (HTA) agencies regarding the choice of MAUIs. Methods A list was compiled of HTA agencies that provide or refer to published official pharmacoeconomic (PE) guidelines for pricing, reimbursement or market access. The guidelines were reviewed for recommendations on the indirect calculation of utilities and categorized as: a preference for a specific MAUI; providing no MAUI preference, but providing examples of suitable MAUIs and/or recommending the use of national value sets; and recommending CUA, but not providing examples of MAUIs. Results Thirty-four PE guidelines were included for review. MAUIs named for use in CUA: EQ-5D (n = 29 guidelines), the SF-6D (n = 11), HUI (n = 10), QWB (n = 3), AQoL (n = 2), CHU9D (n = 1). EQ-5D was a preferred MAUI in 15 guidelines. Alongside the EQ-5D, the HUI was a preferred MAUI in one guideline, with DALY disability weights mentioned in another. Fourteen guidelines expressed no preference for a specific MAUI, but provided examples: EQ-5D (n = 14), SF-6D (n = 11), HUI (n = 9), QWB (n = 3), AQoL (n = 2), CHU9D (n = 1). Of those that did not specify a particular MAUI, 12 preferred calculating utilities using national preference weights. Conclusions The EQ-5D, HUI, and SF-6D were the three MAUIs most frequently mentioned in guidelines. The most commonly cited MAUI (in 85% of PE guidelines) was EQ-5D, either as a preferred MAUI or as an example of a suitable MAUI for use in CUA in HTA.

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