To explore health technology assessment (HTA) in Thailand focusing on its institutionalization, key elements for HTA introduction, and HTA contribution to policy.

A review of literature covered a wide range of topics, including the institutionalization of HTA, elements of HTA introduction, and the role of HTA in policy decision making in Thai context. Additional information from the authors’ involvement in the policy decision-making process in Thailand was also considered.

HTA institutionalization comprises processes of introducing HTA, including evidence generation and use in policymaking, building capacity of HTA practitioners, organizations, system infrastructure, and collaborations. In Thailand, HTA has been formally integrated into coverage decisions, including in the development of the National List of Essential Medicines and the Universal Health Coverage Scheme benefits package. Contributing factors included political will and leadership, capacity building on HTA-related disciplines, adequate resources, technical expertise, and data. Conversely, challenges faced included the absence of a governing body and strategic plan for HTA systems development, a lack of formal mechanisms for mobilizing financial support, an inadequate number of HTA researchers in nonprofit institutes, and the rise in advanced biotechnologies.

HTA plays an important role in evidence-based healthcare decision making. However, key elements of HTA institutionalization need to be strengthened, especially governance structure and policy for HTA systems development, building and retaining capacity of HTA practitioners to meet demand, addressing the challenges of complex and highly innovative health interventions. Lessons learned from the Thai experience may be used as guidance for HTA institutionalization in other developing countries.

Before an intervention is publicly funded within the United Kingdom, the cost-effectiveness is assessed by the National Institute of Health and Care Excellence (NICE). The efficacy of an intervention across the patients’ lifetime is often influential of the cost-effectiveness analyses, but is associated with large uncertainties. We reviewed committee documents containing company submissions and evidence review group (ERG) reports to establish the methods used when extrapolating survival data, whether these adhered to NICE Technical Support Document (TSD) 14, and how uncertainty was addressed.

A systematic search was completed on the NHS Evidence Search webpage limited to single technology appraisals of cancer interventions published in 2017, with information obtained from the NICE Web site.

Twenty-eight appraisals were identified, covering twenty-two interventions across eighteen diseases. Every economic model used parametric curves to model survival. All submissions used goodness-of-fit statistics and plausibility of extrapolations when selecting a parametric curve. Twenty-five submissions considered alternate parametric curves in scenario analyses. Six submissions reported including the parameters of the survival curves in the probabilistic sensitivity analysis. ERGs agreed with the company's choice of parametric curve in nine appraisals, and agreed with all major survival-related assumptions in two appraisals.

TSD 14 on survival extrapolation was followed in all appraisals. Despite this, the choice of parametric curve remains subjective. Recent developments in Bayesian approaches to extrapolation are not implemented. More precise guidance on the selection of curves and modelling of uncertainty may reduce subjectivity, accelerating the appraisal process.

This systematic review aimed to identify criteria being used for priority setting for resource allocation decisions in low- and middle-income countries (LMICs). Furthermore, the included studies were analyzed from a policy perspective to understand priority setting processes in these countries.

Searches were carried out in PubMed, Embase, Econlit, and Cochrane databases, supplemented with pre-identified Web sites and bibliographic searches of relevant papers. Quality appraisal of included studies was undertaken. The review protocol is registered in International Prospective Register of Systematic Reviews PROSPERO CRD42017068371.

Of 16,412 records screened by title and abstract, 112 papers were identified for full text screening and 44 studies were included in the final analysis. At an overall level, cost-effectiveness 52 percent (n = 22) and health benefits 45 percent (n = 19) were the most cited criteria used for priority setting for public health resource allocation. Inter-region (LMICs) and between various approaches (like health technology assessment, multi-criteria decision analysis (MCDA), accountability for reasonableness (AFR) variations among criteria were also noted. Our review found that MCDA approach was more frequently used in upper middle-income countries and AFR in lower-income countries for priority setting in health. Policy makers were the most frequently consulted stakeholders in all regions.

Priority-setting criteria for health resource allocation decisions in LMICs largely comprised of cost-effectiveness and health benefits criteria at overall level. Other criteria like legal and regulatory framework conducive for implementation, fairness/ethics, and political considerations were infrequently reported and should be considered.

This article discusses how participatory technology appraisal as part of the Universal Coverage Scheme (UCS) in Thailand contributes to improving access to essential health services among vulnerable populations.

Document review was conducted on health technology appraisal approaches introduced by the UCS. The review involves health benefit proposals advanced by stakeholders and also meeting minutes of relevant working groups and committees published between 2010 and 2015.

From the establishment of the UCS participatory technology appraisal mechanism in 2010 until 2015, a total of 133 health interventions have been nominated. Some nominations highlight problems in access to care among vulnerable populations. As policy advocates continue to be involved in the latter stages of coverage decisions, they have opportunities to persuade policy makers and other stakeholders to agree to the rationales of their proposals. Some interventions were rejected because they did not meet value for money, affordability, and feasibility criteria; however, topic nominations from stakeholders as well as relevant deliberation throughout the technology appraisal processes have a potential to improve accessibility of health care among the disadvantaged.

Through participation in the UCS policy-making processes, key stakeholders are able to direct the attention of decision makers to significant gaps in access to services among vulnerable citizens, a health system problem rarely brought to discussion by policy elites and experts. The Thai experience reaffirms participatory technology appraisal as a supportive measure to providing universal health coverage.

A key discussion point during HTAi's 2018 Meeting was how Health Technology Assessment (HTA) practitioners might borrow ideas from other industries or academic areas. Organisational learning (OL) is the study of how individual knowledge is shared within an organisation to become institutional/group knowledge. There are several models of OL, all focusing on how tacit knowledge (abstract, personalised, hard to define, action-based) is converted to explicit knowledge (definable, concrete, fixed, information-based). Effective knowledge sharing is crucial to leveraging individual knowledge to drive innovation, efficiency and effectiveness. Information retrieval is a knowledge-intensive field, with many processes requiring both tacit and explicit knowledge. Ideas from OL demonstrate ways to improve practice by increasing knowledge sharing.

Nonaka & Takeuchi's (1994) SECI model describes the cyclical process by which knowledge is shared. The model includes 4 stages: socialisation (tacit-to-tacit), externalisation (tacit-to-explicit), combination (explicit-to-explicit) and internalisation (explicit-to-tacit). Each stage describes how knowledge sharing takes place and highlights ways to ameliorate these processes. Information retrieval involves many elements that require or benefit from knowledge sharing and both tacit and explicit knowledge is required.

In the SECI model the Socialisation stage is characterised by face-to-face learning. Peer reviewing of search strategies, open dialogue and team working are ways of facilitating this stage. The Externalisation stage is crucial to OL. This can be seen as the practice-into-research stage; the results of successful experimentation, for example with search filters. The Combination stage is the easiest to understand. Communities of practice and inter-organisational networks can widen knowledge sharing and help refine or increase detail of best practice. The Internalisation stage is the hardest to conceptualise or measure. The extent to which guidelines become adopted in individual practice is one way to gauge Internalisation.

Information retrieval practitioners could benefit from thinking about ways to improve knowledge sharing. Models of OL can be instructive in this regard.

Real-world evidence (RWE), derived from real-world data (RWD), is already used, to some extent, for health technology assessment (HTA) purposes. With the increased availability of RWD, there is potential for more widespread use but also challenges ensuring reliable RWE for HTA. Opportunities to overcome key challenges, identified at a scoping meeting, were discussed during the 2019 HTA international (HTAi) Global Policy Forum (GPF).

Reflection of discussions using Design Thinking (an interactive process aimed to solve complex problems) between seventy-three representatives from not-for-profit, for-profit organizations, and HTAi leadership. The discussions were informed by a background paper, and presentations from three invited keynote speakers and eleven GPF members.

Several options were listed for addressing the identified key challenges: quality and acceptability, governance and accountability, transferability, and informing decision making. The GPF emphasized that the HTA community should first understand what questions could be answered with RWE. Additionally, more clarity on methods, standards, streamlining RWD collection, data sharing across jurisdictions, replication of RWD, and expert analysis were mentioned as important priorities.

The HTA community is currently standing at a cross-road as it is not yet fully equipped to address these key challenges. It is, therefore, time for action. The community should start aligning on what is the best source of evidence according to purpose and how the data should be collected to create reliable evidence. It should also initiate the development of actions and guidance to properly develop and manage RWD/RWE to inform decision making across the technology lifecycle.

It is a challenge to stay up-to-date with the latest developments in information retrieval for health technology assessment (HTA). Summarized Research in Information Retrieval for HTA (SuRe Info) is a well-established open-access website with a selection of up-to-date key papers presented in summarized overviews. SuRe Info is maintained by the HTAi Interest Sub-Group on Information Resources; its main target group are information specialists. SuRe Info is updated twice a year by experienced information specialists. Publications on information retrieval methods are identified by running topic-specific search strategies in relevant databases. Publications fulfilling the SuRe Info inclusion criteria receive a structured abstract together with a brief critical appraisal prepared by one SuRe Info information specialist and checked by another. The key messages from the appraisals are summarized in topic-specific chapters.

The structure and work of SuRe Info is presented on the basis of the chapter “Value of using different search approaches”.

The chapter “Value of using different search approaches” was last updated in September 2018. It examines various alternative search approaches in bibliographic databases beyond the conventional Boolean search. According to this chapter, the most well-known approach, offering the most evidence, is citation searching (direct or indirect citation relationships). In contrast, little research has so far been conducted on other approaches such as full-text searches, automated retrieval methods or hand searching.

SuRe Info is an important resource for information specialists to keep up-to-date with the literature on information retrieval. In particular when information specialists work alone and not within a larger team, it is necessary to rely on collaboration projects such as SuRe Info.

The aim of this study is to determine whether the approach used in Australia to regulate mobile medical applications (MMA) is consistent with international standards and is suitable to address the unique challenges of these technologies.

The policies of members of the International Medical Device Regulator's Forum (IMDRF) were analyzed, to determine whether these regulatory bodies address IMDRF recommendations for the clinical evaluation of software as a medical device (SaMD). Case-studies of varying types of regulated MMAs in Australia and the United States were also reviewed to determine how well the guidance in the IMDRF's SaMD: Clinical Evaluation (2017) document was operationalized.

All included jurisdictions evaluated the effectiveness of MMAs and addressed the majority of the key sub-categories recommended in the IMDRF guidance document. However, safety principles concerning information security (cybersecurity) and potential dangers of misinformation (risk-classification) were generally not addressed in either the case-studies or in the policy documents of international regulatory bodies. Australia's approach was consistent with MMA regulation conducted internationally. None of the approaches used by global regulatory bodies adequately addressed the risk of misinformation from apps and the potential for adverse clinical consequences.

The risks posed by MMAs are mainly through the information they provide and how this is used in clinical decision-making. Policy in Australia and elsewhere should be adjusted to follow the IMDRF risk-classification criteria to address potential harms from misinformation. Australian regulatory information should also be updated so the harm posed by cybersecurity and connectivity can be comprehensively evaluated.

When developing a health technology that requires clinical studies, developers institute working relations with clinical investigators. In certain diseases areas, patients' representatives create their own advisory boards, which proved their utility in the early 90s, in particular for the development of products to treat HIV infection. Inspired by this model, where patients with a same disease join and meet with relevant developers and discuss all aspects of the research, the European Organisation for Rare Diseases (EURORDIS) proposes a new programme of such Community Advisory Boards for Rare Diseases (CAB).

For this programme, EURORDIS invites developers to sign a Charter of principles when engaging with patients, and provides guidelines on CABs, together with a mentoring programme for patients’ networks that are less experienced with the development and the evaluation of health technologies. CABs are driven by patients who set their agenda, who sign a Memorandum of Understanding with each developer, and who organise the sessions. Sessions typically last for two to four days during which different meetings with different developers can take place, or trainings. All meetings can take place under confidentiality arrangements, and minutes are written to keep track and to follow-up with all points discussed. Participants and agendas are made public

As of 2018, four CABs exist and operate (for tuberous sclerosis complex, for scleroderma, for cystic fibrosis, for Duchenne muscular dystrophy) and 18 others are in discussion with many due to start in 2019. Topics discussed cover the target population, the study feasibility, the endpoints including patient reported outcomes, the comparator choice and/or the acceptance of a placebo controlled trial, the quality of life, the practical aspects of the trials, and the identification of previously unknown or unmet patient needs/preferences. For products which are more advanced in their life-cycle, discussions can also cover compassionate use, pricing policy, relative efficacy etc.

This represents a well-structured programme for the engagement of patients, where collective thinking and exchange between different patients ensure high quality dialogue with developers and can inform HTA also.

AQuAS is gradually incorporating patient involvement in health technology assessment (HTA). We present two experiences conducted during 2018 and the different methods and approaches used. The aim is to reflect on learnings from those experiences to improve ways for increasing patient involvement with HTA at AQuAS.

We conducted two experiences using different quantitative and qualitative techniques (mix-methods approach). The first, a focus group discussion regarding the use of 3D-technologies for maxillofacial reconstruction with a selection of hospital patients that received maxillofacial reconstruction, which included the use of a quality-of-life retrospective self-assessment tool. The second, a sequence of email correspondence regarding cataract surgery technology (femtosecond laser-assisted cataract surgery (FLACS), in the context of an EUnetHTA Joint Assessment) with a patients’ association representative, to learn their opinion regarding the use of laser technology.

Main learnings were: (1) patients and associations have different levels of knowledge and expertise to consider when planning an HTA; (2) sharing experience and knowledge among peers (i.e. focus group) proved to have a positive impact on patients and worked as a resource for some to improve knowledge on their condition; (3) critiques were received regarding a specific Patient Reported Experience template for HTA patient involvement (iv) quality of life retrospective self-assessment tool provided unexpected positive and negative results.

Recent patient involvement in HTA at AQuAS proved to be useful to complement HTA reports. We believe that patients’ experiences and opinions can help decision-making regarding the use, disinvestment or incorporation of health technologies, contribute to the improvement of tools and survey accuracy and improve doctor-patient communication. Their involvement might be beneficial for them to gain more knowledge, share experiences, reflect on their health situation and improve communication with the professionals that treat them. Future patient-involvement in HTA is needed, e.g. considering the social perspective in economic evaluations or including patients in recommendation consensus panels.