Objective:the aim of this study is to assess the accuracy, cost-effectiveness, and budget impact of the HLA-B27 test in diagnosis of axial spondyloarthritis to Brazilian Public Health System (SUS). Methods:A systematic review was conducted to assess the sensitivity and specificity of HLA-B27 compared to test ASAS or New York diagnostic criteria. Additionally, a cost-effectiveness analysis (a decision tree model coupled with a Markov model and effectiveness outcome of quality-adjusted life year (QALY)) and budget impact analysis were also developed. Costs were obtained in Brazilian currency and converted to dollars considering the PPP conversion factor. Results:Twenty-nine studies have shown that the sensitivity of the HLA-B27 test was 68% (95% CI: 67-69%) and the specificity was 88% (95% CI: 87-88%) (very low certainty of evidence to both outcomes) when compared with any comparator. The analysis of two studies showed that the combination of HLA-B27+clinical parameters still achieved sensitivity and specificity comparable to or greater than the combination of imaging and clinical parameters, or clinical parameters alone. When compared with clinical evaluation and clinical evaluation±imaging, the HLA-B27 test+clinical evaluation was close to the cost-effectiveness threshold ($17,628 per QALY) and dominated the comparator, respectively. Furthermore, incorporating HLA-B27 into the SUS would result in an increase in costs of $530,393 in 5-years of analysis (mean of six thousands/year eligible patients to HLA-B27). Conclusion:The findings supported the coverage of the HLA-B27 test in SUS, considering that test increases accuracy when associated with other diagnostic strategies and has the potential to be cost-effective or dominant.
Disinvestment in healthcare allows for strategic reallocation of resources from low-value care to higher-value areas, particularly in promoting clinical effectiveness, improving patient outcomes, and long-term cost savings. The Malaysian Health Technology Assessment Section (MaHTAS) is investigating the incorporation of a disinvestment framework into the health technology life cycle, in accordance with the Ministry of Health Malaysia's recent healthcare transformation strategy. Several health technology assessment (HTA) reports by MaHTAS have integrated concepts of health technology reassessment, with an emphasis on effectiveness and adverse effects. However, the need for additional funds and implementation strategies has impeded the impactful and timely execution of HTA recommendations. This article highlights ongoing efforts to promote disinvestment activities in the Malaysian healthcare system by raising early awareness and engaging with healthcare stakeholders during the planning phase. The journey from the possibility to the reality of implementing healthcare disinvestment initiatives in Malaysia requires addressing both facilitators and challenges. Facilitators identified include strong political will and the presence of global support for collaboration and knowledge sharing, among others. Some of the recognized challenges are getting the trust of the stakeholders, the need for additional funding to support disinvestment programs, and the lack of expertise as well as guideline to carry out the disinvestment process. By highlighting the steps taken and the strategic planning required, this article sheds light on the potential for disinvestment to enhance the efficiency and effectiveness of healthcare delivery in Malaysia, ultimately contributing to a more sustainable healthcare system.
Countries fundamentally base macro and micro decision making in the field of health on economic considerations, the budgetary impact of technologies being a major criterion. Nevertheless, the value of the technology of interest and its dimensions are more complex if we seek to take decisions based on the value itself. The use of structured and explicit approaches that require the assessment of multiple criteria that reflect the dimensions of this value may significantly improve the quality of the decision making. Multi-criteria decision analysis (MCDA) is a complementary decision-making tool that is able to systematically incorporate dimensions or domains such as ethical, organisational, legal, environmental and social considerations, as well as costs and benefits of medical interventions, together with the distinct perspectives of the interested parties. The objective of this article is to propose the implementation of analysis of non-core domains, in reports of Health Technology Assessment (HTA) agencies/units. To assess the scientific evidence on MCDA techniques a systematic review was conducted using structured searches in biomedical databases and websites of various HTA organisations. A consensus group was held using the nominal group technique and involving users of healthcare services, providers, managers and academics. Complementary, a survey was sent to HTA agencies to ascertain the degree of implementation of MCDA in their methods. 42 articles reporting the use of non-core criteria for the assessment of health technologies were included in the analysis. From these articles, a total of 216 non-core criteria were retrieved and categorised into domains by the researchers, and of these, 56 were classified as socioeconomic, 59 as organisational, 10 as legal, 8 as environmental and 47 as ethical, while 36 were considered to relate to other domains. The consensus group, based on the 216 non-core criteria obtained from the systematic review, proposed, and defined 26 criteria that participants considered necessary for decision making in healthcare. The consensus group did not consider that any of the domains should be given more weight than others or that any individual criteria should dominate. These approaches can serve as a framework of reference for a well-structured systematic discussion concerning the basis of individual criteria and the evidence supporting them.
Defining innovation in the field of medical devices can be extremely challenging due to the peculiarity of the products within this class. Short life-cycle, incrementality, learning curve effect, impact of the organizational setting, uncertainty of effect and level of evidence are only some of these aspects. A clear set of criteria to define innovation would be of paramount relevance in this field. Twelve criteria to define innovation were proposed to a multistakeholder panel within a consensus process. A Delphi method on two rounds was used to reach consensus. In total, 53 of the 93 (47%) invited panelists responded to the first round of the survey. Among them, 51 (96%) completed also the second round. At the first round, consensus was reached for four of the 12 proposed criteria. Three of the remaining eight criteria reached consensus at the second round. It was not possible to reach consensus for the remaining five criteria. The criteria that collected the highest scores (close to 100%) were from the clinical impact domain, namely the ability of the technology to offer significant advantages over existing alternatives in terms of improving relevant clinical outcomes, and the ability to address an unmet need defined in terms of unavailability of diagnosis/treatment alternatives. High levels of consensus (about 80%) were registered on criteria belonging to non-clinical domains of analysis and, in particular, the ability of the technology to introduce organizational benefits, and the ability of the technology to bring cost reduction providing the same clinical benefit of current alternatives.
Background: Atrial fibrillation (AF), which is associated with cryptogenic stroke, is the most common sustained arrhythmia in the general population. Because AF is asymptomatic and intermittent, its detection rate increases with the duration of monitoring. The objective of this study is to review the available evidence on the safety, efficacy, effectiveness and cost-effectiveness of AF diagnosis by prolonged monitoring with an implantable Holter monitor in adult patients with idiopathic or cryptogenic stroke of suspected cardioembolic origin, compared to conventional monitoring. Methods: Two independent reviewers performed a systematic review of the literature, identifying relevant studies through a structured search of Medline (Ovid), EMBASE, Web of Science and Cochrane Library and the databases of national and international health technology assessment agencies. The quality of the included studies was assessed with AGREE-II, AMSTAR-2 and CHEC. GRADE criteria were used to summarise the evidence Results: Four of the 211 papers identified were included: 1 clinical practice guideline, 2 systematic reviews, and 1 economic evaluation. The quality of the evidence reviewed was low. An implantable Holter monitor might be more effective in detecting AF than conventional monitoring. Serious adverse events were similar in both groups. The economic evaluation suggests that the technology is cost-effective. Conclusions: The available evidence suggests the diagnostic superiority of the implantable Holter monitor over the traditional Holter monitor. Due to the low quality of the evidence, further and higher quality studies on these technologies are needed before solid conclusions can be drawn.
