HTA Organizations Research Articles

Why we should have more collaboration on HTA in Europe: the example of sofosbuvir

Results The results of the questionnaire showed that, 7 months after sofosbuvir received market authorisation, in 11 countries the assessment of the effectiveness sofosbuvir had not yet started, in nine it was ongoing and in seven it was completed. Of the 11 countries that had not started an assessment, five Eastern European countries reported that the MAH had not yet submitted an application for reimbursement of sofosbuvir. The analysis also showed that in the seven reports from different European HTA organisations several relative effectiveness assessment elements were in common.

A review of the health economic and resource utilization literature for the use of tigecycline treatment of complicated intra-abdominal infections

Objectives:Complicated intra-abdominal infections (cIAIs) infect deep soft tissues requiring surgical interventions and often result in decreased quality of life due to hospitalization. In addition to tigecycline, treatment of cIAI includes other drugs such as ceftriaxone, ciprofloxacin, imipenem, and levofloxacin. In this study, we conducted a literature review using publically-available databases focusing on the health economic and resource utilization estimates of tigecycline and the other agents as first-line treatment of cIAIs. Methods:The databases used in this systematic review included PubMed and 42 unique HTA organizations. Search terms included “tigecycline” in combination with “Health Economics,” “Resource Utilization,” “Cost-Effectiveness,” and “Length of Stay.” The search criteria excluded articles with the following characteristics: without abstracts, published over 10 years ago, or not in English. Articles were then determined for eligibility using four additional inclusion criteria: 1) Indication, 2) Bacteria Type, 3) Qualitative Assessment, 4) Technicality. Studies were analyzed independently and not pooled because this was not a meta-analysis. Results:After applying our filters to the search criteria, we identified 9 unique papers on the health economics and resource utilization of using tigecycline as first-line treatment of cIAIs. Though the health economic search resulted in only a few number papers on the cost-effectiveness of tigecycline, the messaging was consistent: tigecycline showed competitive clinical effectiveness and economic resource utilization versus several different comparators despite higher acquisition expenses. Several studies established that in terms of length of stay (LoS), total costs of hospitalization and other resource utilization parameters tigecycline was not inferior and thus the results do not favor one treatment over another.Conclusion:The health economics literature estimates tigecycline to have comparable total cost per patient with respect to comparators. The broad spectrum activity of the drug avoids inappropriate treatments which are associated with increased resource utilization and result in higher costs. In view of the alarming spread in antibiotic resistance, the addition of another treatment option offers a valuable tool to counteract a mono-culture of therapies applied against cIAIs.

Divergent evidence requirements for authorization and reimbursement of high-risk medical devices – The European situation

BackgroundUnsafe and dangerous medical devices have entered the European market during the last decade, raising public awareness. Consequently, regulatory processes and their requirements for evidence are under discussion. ObjectiveThis research aims to explore the authorization and reimbursement processes and associated evidence requirements for high-risk medical devices in four regions: Europe, the United States, Australia and Canada. MethodsA literature search in PubMed about the authorization and reimbursement processes in the four regions was performed. Seven high-risk medical devices were selected as examples, and their authorization and reimbursement status were analyzed. Information was extracted from publicly available summaries of the authorization agencies of the regions, from the Controlled Clinical Trial Database, supplemented by information from HTA and reimbursement organizations. ResultsThe evidence required for the authorization and reimbursement processes differs strongly in the four regions regarding the levels of methodology and scrutiny. All seven devices have been authorized in Europe, three in Australia, one in the USA, and one in Canada. Currently none of the devices is recommended for reimbursement in the regions except one, in the USA. Devices that have been authorized in more than one region show that authorization has been two to three years earlier in Europe. ConclusionHuge differences and gaps in the evidence required for market authorization and for reimbursement were observed, especially between the two processes (authorization and reimbursement) in Europe. To ensure the high quality and safe provision of medical devices, harmonization of requirements and transparency in processes are needed.

USING HEALTH TECHNOLOGY ASSESSMENT TO SUPPORT OPTIMAL USE OF TECHNOLOGIES IN CURRENT PRACTICE: THE CHALLENGE OF “DISINVESTMENT”

Health systems face rising patient expectations and economic pressures; decision makers seek to enhance efficiency to improve access to appropriate care. There is international interest in the role of HTA to support decisions to optimize use of established technologies, particularly in "disinvesting" from low-benefit uses. This study summarizes main points from an HTAi Policy Forum meeting on this topic, drawing on presentations, discussions among attendees, and an advance background paper. Optimization involves assessment or re-assessment of a technology, a decision on optimal use, and decision implementation. This may occur within a routine process to improve safety and quality and create "headroom" for new technologies, or ad hoc in response to financial constraints. The term "disinvestment" is not always helpful in describing these processes. HTA contributes to optimization, but there is scope to increase its role in many systems. Stakeholders may have strong views on access to technology, and stakeholder involvement is essential. Optimization faces challenges including loss aversion and entitlement, stakeholder inertia and entrenchment, heterogeneity in patient outcomes, and the need to demonstrate convincingly absence of benefit. While basic HTA principles remain applicable, methodological developments are needed better to support optimization. These include mechanisms for candidate technology identification and prioritization, enhanced collection and analysis of routine data, and clinician engagement. To maximize value to decision makers, HTA should consider implementation strategies and barriers. Improving optimization processes calls for a coordinated approach, and actions are identified for system leaders, HTA and other health organizations, and industry.

Istituti di Health Technology Assessment e portatori di interesse

Background The involvement of stakeholders (internal — third party payers, health care organisations and research centres, external — industry and patients, and clinicians) by HTA Organisations is hugely debated. On the one hand their participation may provide important information for the assessment process and could promote consensus over recommendations. On the other hand stakeholders’ involvement increases complexity in the decision-making process. The actual role of stakeholders and reasons for their different involvement in HTA organisations have not been deeply scrutinised so far. The aim of this paper is to investigate these two issues in six European countries, with a focus on those HTA organisations that assess medical devices (France, Germany, England, the Netherlands, Spain, and Sweden).

Measuring the influence of colleagues on a consultant team's use of breast conserving surgery

The aim of this study was to examine potential reasons why the use of breast conserving surgery (BCS) for breast cancer varies substantially between hospital teams in England, and in particular to examine whether colleague influence has a role in influencing BCS rates locally. Routinely collected Hospital Episode Statistics (HES) data relating to 420 surgical teams in England who performed more than ten breast cancer operations during the financial year 2006/07 were used to identify predictors of team BCS use. Team BCS rates (as a proportion of all types of breast excision surgery) were subject to a regression analysis that incorporated, as independent variables, a range of patient, organizational, and local demographic factors, as well as the BCS rate of colleagues working alongside them in the same hospitals(s). After adjusting for the effects of other variables, BCS use by colleagues working in the same hospital(s) was a significant predictor of a team's own BCS rate (standardized b = 0.224; p < .001), denoting a typical 3 percent increase in a team's BCS rate for every 10 percent increase in the BCS rate of colleagues. The practice of colleagues seems to have a measurable influence upon a surgical team's BCS usage. Guidance from HTA organizations can set national standards about the use of new techniques and innovations, but dissemination can be either slowed down or accelerated by the influence of local colleagues. A strategy of disseminating guidance through professional networks or "local champions" could be a powerful avenue for change.

Surgery versus sclerotherapy for the treatment of varicose veins

Varicose veins are a relatively common condition and account for around 54,000 in-patient hospital episodes per year. The two most common interventions for varicose veins are surgery and sclerotherapy. However, there is little comparative data regarding their effectiveness. To identify whether the use of surgery or sclerotherapy should be recommended for the management of primary varicose veins. Thirteen electronic bibliographic databases were searched covering biomedical, science, social science, health economic and grey literature (including current research). In addition, the reference lists of relevant articles were checked and various health services research-related resources were consulted via the internet. These included health economics and HTA organisations, guideline producing agencies, generic research and trials registers, and specialist sites. All studies that were described as randomised controlled trials comparing surgery with sclerotherapy for the treatment of primary varicose veins were identified. Two reviewers independently extracted and summarised data from the eligible studies using a data extraction sheet for consistency. All studies were cross-checked independently by the reviewers. A total of 2306 references were found from our searches, 61 of which were identified as potential trials comparing surgery and sclerotherapy. However, only nine randomised trials, described in a total of 14 separate papers, fulfilled the inclusion criteria. Fifty trials were excluded and one trial is ongoing and is due for completion in 2004. The trials used a variety of outcome measures and classification systems which made direct comparison between trials difficult. However, the trend was for sclerotherapy to be evaluated as significantly better than surgery at one year; after one year (sclerotherapy resulted in worse outcomes) the benefits with sclerotherapy were less, and by three to five years surgery had better outcomes. The data on cost-effectiveness was not adequately reported. There was insufficient evidence to preferentially recommend the use of sclerotherapy or surgery. There needs to be more research that specifically examines both costs and outcomes for surgery and sclerotherapy.