Comparing Two Approaches for Thyroidectomy: A Health Technology Assessment through DMAIC Cycle

Total thyroidectomy is very common in endocrine surgery and the haemostasis can be obtained in different ways across surgery; recently, some devices have been developed to support this surgical phase. In this paper, a health technology assessment is conducted through the define, measure, analyse, improve, and control cycle of the Six Sigma methodology to compare traditional total thyroidectomy with the surgical operation performed through a new device in an overall population of 104 patients. Length of hospital stay, drain output, and time for surgery were considered the critical to qualities in order to compare the surgical approaches which can be considered equal regarding the organizational, ethical, and security impact. Statistical tests (Kolmogorov–Smirnov, t test, ANOVA, Mann–Whitney, and Kruskal–Wallis tests) and visual management diagrams were employed to compare the approaches, but no statistically significant difference was found between them. Considering these results, this study shows that the introduction of the device to perform total thyroidectomy does not guarantee appreciable clinical advantages. A cost analysis to quantify the economic impact of the device into the practice could be a future development. Healthy policy leaders and clinicians who are requested to make decisions regarding the supply of biomedical technologies could benefit from this research.

How innovation can be defined, evaluated and rewarded in health technology assessment

Background What constitutes innovation in health technologies can be defined and measured in a number of ways and it has been widely researched and published about. However, while many countries mention it as a criterion for pricing or reimbursement of health technologies, countries differ widely in how they define and operationalise it. Methods We performed a literature review, using a snowballing search. In this paper, we explore how innovation has been defined in the literature in relation to health technology assessment. We also describe how a selection of countries (England, France, Italy, Spain and Japan) take account of innovation in their health technology assessment frameworks and explore the key methodologies that can capture it as a dimension of value in a new health technology. We propose a way of coming to, and incorporating into health technology assessment systems, a definition of innovation for health technologies that is independent of other dimensions of value that they already account for in their systems, such as clinical benefit. We use Spain as an illustrative example of how innovation might be operationalised as a criterion for decision making in health technology assessment. Results The countries analysed here can be divided into 2 groups with respect to how they define innovation. France, Japan and Italy use features such as severity, unmet need and therapeutic added value as indicators of the degree of innovation of a health technology, while England, Spain consider the degree of innovation as a separate and additional criterion from others. In the case of Spain, a notion of innovation might be constructed around concepts of `step-change’, `convenience’, `strength of evidence base’ and `impact on future research & development’. Conclusions If innovation is to be used as operational criteria for adoption, pricing and reimbursement of health technologies, the concept must be clearly defined, and it ought to be independent from other value dimensions already captured in their health technology assessment systems.

Health technology assessment-informed pricing negotiation in China: higher negotiated price for more effective targeted anticancer medicines?

Background In China, health technology assessment (HTA) has recently been adopted in pricing negotiation for medicine listing in the National Reimbursement Drug List. At present, how HTA is applied to inform the decision-making process remains underreported. In order to explore how the adoption of HTA was translated into listing and price negotiation results in light of the confidential nature of the negotiating process, this study aimed to compare the negotiated price and the clinical benefit of selected targeted anticancer medicines (TAMs) involved in the 2019 negotiation. Main text Among 16 TAMs successfully negotiated, only four TAMs representing four indication groups had appropriate reference medicines for comparison and were, therefore, included in the analysis. The price and clinical benefit of the four TAMs were compared against one or two reference medicines with the same initial indications. The sales prices for nine TAMs before and after the negotiation were extracted from the centralized medication procurement system. Clinical benefits were evaluated based on evidence from published articles and clinical guidelines. The results suggested that, despite the application of HTA, both rational and irrational decisions had been made about the reimbursement of TAMs in the 2019 negotiation, warranting further investigation. Conclusion While the development and adoption of HTA has seen significant progress in China, actions are needed to ensure that the adoption of HTA is effectively applied in decisions on the reimbursement of medicines.

Bridging health technology assessment and healthcare quality improvement using international consortium of health outcomes measurement standard sets

Objective Although health technology assessment (HTA) and healthcare quality improvement are distinct processes, a greater level of alignment in outcome measures used may increase the quality and efficiency of data collection. This study evaluates the agreement in outcome measures used in oncology for healthcare quality improvement and HTAs, and how these align to the International Consortium for Health Outcomes Measurement (ICHOM) standard sets. Methods We conducted a cross-sectional comparative analysis of ICHOM sets focusing on oncological indications and publicly available measures for healthcare quality and HTA reports published by the National Health Care Institute from the Netherlands and the National Institute for Health and Care Excellence from the United Kingdom. Results All ICHOM sets and HTAs used overall survival, whereas quality improvement used different survival estimates. Different progression estimates for cancer were used in HTAs, ICHOM sets, and quality improvement. Data on health-related quality of life (HRQoL) was recommended in all ICHOM sets and all HTAs, but selectively for quality improvement. In HTAs, generic HRQoL questionnaires were preferred, whereas, in quality improvement and ICHOM sets, disease-specific questionnaires were recommended. Unfavorable outcomes were included in all HTAs and all ICHOM sets, but not always for quality improvement. Conclusions Although HTA and quality improvement use outcome measures from the same domains, a greater level of alignment seems possible. ICHOM may provide input on standardized outcome measures to support this alignment. However, residual discrepancies will remain due to the different objectives of HTA and quality improvement.

Exploring facilitators and barriers to introducing health technology assessment: a systematic review

Objective This study aims to identify and codify the facilitators and barriers to help implementing partners institutionalize health technology assessment (HTA) successfully and navigate complex systems for health-related policy making. Methods We searched for peer-reviewed and gray literature articles examining HTA programs globally using six databases. Keywords used as a guide for capturing articles included “health technology assessment,” “barrier,” and “facilitator” and their synonyms. Search results were scrutinized for duplicates and screened through a review of titles and abstracts. A full-text review was conducted exploring articles’ coverage of twenty-seven evaluation criteria across four primary areas of interest: barriers/facilitators, motivations, guidelines, and institutional frameworks. Results A total of 18,599 records were identified for duplication check, title, and abstract review. A total of 1,594 articles underwent full-text review, leading to a final synthesis of 262 studies. We found that ninety-seven articles discussed barriers/facilitators, with fifty-three of those discussing local capacity and unavailable human resources. Out of the sixty-six articles discussing motivations, forty-two cited the interest in supporting the decision-making process for, and promoting, appropriate resource allocation. Of the sixty-one articles that discussed guidelines and institutional framework, twenty-one articles described HTA as an independent national unit, and sixteen described their HTA unit as a unit within the Ministry of Health (MOH). Conclusions This systematic review unpacks the dynamic and relevant contexts for understanding the HTA institutionalization process to help policy makers and practitioners achieve tangible progress in confronting the most critical issues facing priority setting and HTA institutionalization.

Opportunities to improve reporting of rapid response in health technology assessment

Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

Application of a health technology assessment framework to digital health technologies that manage chronic disease: a systematic review

Background As health services increasingly make investment decisions in digital health technologies (DHTs), a DHT-specific and comprehensive health technology assessment (HTA) process is crucial in assessing value-for-money. Research in DHTs is ever-increasing, but whether it covers the content required for HTA is unknown. Objectives To summarize current trends in primary research on DHTs that manage chronic disease at home, particularly the coverage of content recommended for DHT-specific and comprehensive HTA. Methods Medline, Embase, Econlit, CINAHL, and The Cochrane Library (1 January 2015 to 20 March 2020) were searched for primary research studies using keywords related to DHT and HTA domains. Studies were assessed for coverage of the most frequently recommended content to be considered in a nine domain DHT-specific HTA previously developed. Results A total of 178 DHT interventions were identified, predominantly randomized controlled trials targeting cardiovascular disease/diabetes in high- to middle-income countries. A coverage assessment of the cardiovascular and diabetes DHT studies (112) revealed less than half covered DHT-specific content in all but the health problem domain. Content common to all technologies but essential for DHTs was covered by more than half the studies in all domains except for the effectiveness and ethical analysis domains. Conclusions Although DHT research is increasing, it is not covering all the content recommended for a DHT-specific and comprehensive HTA. The inability to conduct such an HTA may lead to health services making suboptimal investment decisions. Measures to increase the quality of trial design and reporting are required in DHT primary research.

A Qualitative Study on the Feasibility and Acceptability of Establishing Health Technology Assessment (HTA) in a Low Income Country Setting: The Case of Malawi

BackgroundThe objective of this study was to assess the feasibility and acceptability of institutionalizing Health Technology Assessment (HTA) in Malawi focusing on the form, scope, capacity and financing requirements for a limited resource setting such as Malawi.MethodsThis study employed a desk review and qualitative research methods. An extensive literature review was conducted on relevant key policy documents, reports and publications to understand the status of HTA in Malawi. The study included one focus group discussion with 7 participants and 12 key informant interviews with key stakeholders selected purposely based on their knowledge and expertise in HTA. ResultsThe study found that partial or informal HTA processes exist and that HTA is practiced without a standardized framework. The partial HTA processes are executed through three structures; Ministry of Health Senior Management Team, Technical Working Groups and Pharmacy and Medicines Regulatory Authority (PMRA) with varying levels of effectiveness. The results revealed that lack of an institutional HTA creates severe shortfalls. This includes partial HTA mechanisms, limited evidence use, especially concerning cost-effectiveness, lack of a standardized framework for technology adoption, donor pressure, lack of resources for the HTA process and technology acquisition, laws and practices that undermine cost-effectiveness considerations. ConclusionInstitutionalizing HTA in Malawi is acceptable and feasible. The results suggest that any HTA institutionalization in the short to medium term could involve strengthening the capacity of PMRA to appraise Cost-effectiveness Analysis (CEAs) within academia and MOH health financing division. Furthermore, rather than creating new HTA institutions, country-specific assessments should precede any specific recommendations for new technology adoptions. A technical capacity in Academic institutions such as Health Economics and Policy Unit (HEPU) at Kamuzu University of Health Sciences (KuHes) can be developed either as “offshore” HTA capacity fully aligned to MOH and executing HTA evidence and knowledge management function in a sub-contractor capacity.Running HeadHealth technology assessment in Malawi