Topic identification, selection, and prioritization for health technology assessment in selected countries: a mixed study design.

BACKGROUND: There is limited evidence-informed guidance on TISP processes for countries where health technology assessment (HTA) is in a nascent phase. We aimed to explore the range of topic identification, selection and prioritization (TISP) processes and practices for HTA in selected countries and identify aspects relevant to emerging HTA systems. METHODS: This mixed design study included a systematic literature review, an electronic survey, and individual interviews. We conducted a systematic literature review with criteria that were developed a priori to identify countries deemed to have a recently formalized HTA system. Based on the literature review, a twenty-three item online survey was shared with the identified countries, we completed follow-up interviews with ten participants who have experience with HTA. We analyzed documents, survey responses and interview transcripts thematically to identify lessons related to TISP processes and practices. RESULTS: The literature review identified 29 nine candidate countries as having a "potential" recently formalized HTA system. Twenty-one survey responses were analyzed and supplemented with ten individual interviews. We found variation in countries' approaches to TISP - particularly between pharmaceutical and non-pharmaceutical interventions. Results indicate that TISP is heavily driven by policy makers, expert involvement, and to a lesser extent, relevant stakeholders. The use of horizon-scanning and early warning systems is uncommon. Interviewee participants provided further insight to the survey data, reporting that political awareness and an institutional framework were important to support TISP. TISP can be optimized by stronger national regulations and legislative structures, in addition to education and advocacy about HTA among politicians and decision-makers. In some settings regional networks have been useful, particularly in the development of TISP guidelines and methodologies. Additionally, the technical capacity to conduct TISP, and access to relevant local data were factors limiting TISP in national settings. Increased network collaboration and capacity building were reported as future needs. CONCLUSIONS: This study provides current insights into a topic where there is limited published peer reviewed literature. TISP is an important first step of HTA, and topics should be selected and prioritized based on local need and relevance. The limited capacity for TISP in settings where HTA is emerging may be supported by local and international collaboration to increase capacity and knowledge. To succeed, both TISP and HTA need to be embedded within national health care priority setting and decision-making. More in-depth understanding of where countries are situtated in formalizing the TISP process may help others to overcome factors that facilitate or hinder progress.

A systematic literature review of economic evaluation studies of interventions impacting antimicrobial resistance.

BACKGROUND: Antimicrobial resistance (AMR) is accelerated by widespread and inappropriate use of antimicrobials. Many countries, including those in low- and middle- income contexts, have started implementing interventions to tackle AMR. However, for many interventions there is little or no economic evidence with respect to their cost-effectiveness. To help better understand the scale of this evidence gap, we conducted a systematic literature review to provide a comprehensive summary on the value for money of different interventions affecting AMR. METHODS: A systematic literature review was conducted of economic evaluations on interventions addressing AMR. a narrative synthesis of findings was produced. Systematic searches for relevant studies were performed across relevant databases and grey literature sources such as unpublished studies, reports, and other relevant documents. All identified economic evaluation studies were included provided that they reported an economic outcome and stated that the analysed intervention aimed to affect AMR or antimicrobial use in the abstract. Studies that reported clinical endpoints alone were excluded. Selection for final inclusion and data extraction was performed by two independent reviewers. A quality assessment of the evidence used in the included studies was also conducted. RESULTS: 28,597 articles were screened and 35 articles were identified that satisfied the inclusion criteria. The review attempted to answer the following questions: (1) What interventions to address AMR have been the subject of an economic evaluation? (2) In what types of setting (e.g. high-income, low-income, regions etc.) have these economic evaluations been focused? (3) Which interventions have been estimated to be cost-effective, and has this result been replicated in other settings/contexts? (4) What economic evaluation methods or techniques have been used to evaluate these interventions? (5) What kind and quality of data has been used in conducting economic evaluations for these interventions? DISCUSSION: The review is one of the first of its kind, and the most recent, to systematically review the literature on the cost-effectiveness of AMR interventions. This review addresses an important evidence gap in the economics of AMR and can assist AMR researchers' understanding of the state of the economic evaluation literature, and therefore inform future research. Systematic review registration PROSPERO (CRD42020190310).

Economic Analysis of Border Control Policies during COVID-19 Pandemic: A Modelling Study to Inform Cross-Border Travel Policy between Singapore and Thailand.

With countries progressing towards high COVID-19 vaccination rates, strategies for border reopening are required. This study focuses on Thailand and Singapore, two countries that share significant tourism visitation, to illustrate a framework for optimizing COVID-19 testing and quarantine policies for bilateral travel with a focus on economic recovery. The timeframe is the month of October 2021, when Thailand and Singapore were preparing to reopen borders for bilateral travel. This study was conducted to provide evidence for the border reopening policy decisions. Incremental net benefit (INB) compared to the pre-opening period was quantified through a willingness-to-travel model, a micro-simulation COVID-19 transmission model and an economic model accounting for medical and non-medical costs/benefits. Multiple testing and quarantine policies were examined, and Pareto optimal (PO) policies and the most influential components were identified. The highest possible INB for Thailand is US $125.94 million, under a PO policy with no quarantine but with antigen rapid tests (ARTs) pre-departure and upon arrival to enter both countries. The highest possible INB for Singapore is US $29.78 million, under another PO policy with no quarantine on both sides, no testing to enter Thailand, and ARTs pre-departure and upon arrival to enter Singapore. Tourism receipts and costs/profits of testing and quarantine have greater economic impacts than that from COVID-19 transmission. Provided healthcare systems have sufficient capacity, great economic benefits can be gained for both countries by relaxing border control measures.

Is it the Right Topic? An Overlooked Stage in the Institutionalization of Health Technology Assessment.

Producing a Health Technology Assessment (HTA) is resource intensive, therefore, an explicit process for Topic Identification, Selection, and Prioritization (TISP) can optimize the use of limited resources to those HTA topics of national importance. TISP does not have to be complicated, however, a formalized process facilitates HTA recommendations that better align with local priorities. The comprehensiveness of TISP processes varies according to countries' needs and to the types of decisions HTA supports. There may be many relevant considerations for TISP, such as the resources available for allocation within the health system, the number of dedicated personnel to complete HTA, and the number of stakeholders and institutions involved in the decision-making process. In countries where HTA-supported decision-making is well-established, the process for TISP is usually formalized. In settings where HTA is emerging, relatively new, or where there may not be the necessary supporting institutional mechanisms, there is limited normative guidance on how to implement TISP. We argue that developing a clear process for TISP is key when institutionalizing HTA. Moreover, insights and experiences from more formalized HTA systems can provide valuable lessons. In this commentary we discuss three institutional aspects that we believe are vital to TISP: 1) Begin topic selection with a clear link to health system feasibility, 2) Ensure legitimacy and impact through transparent TISP processes, and 3) Include the public from the start to embed patient and public engagement throughout HTA.

How can health technology assessment support our response to public health emergencies?

Public health emergencies (PHEs), such as the COVID-19 crisis, are threats to global health and public order. We recommend that countries bolster their PHE responses by investing in health technology assessment (HTA), defined as a systematic process of gathering pertinent information on and evaluating health technologies from a medical, economic, social and ethical standpoint. We present examples of how HTA organizations in low- and middle-income countries have adapted to supporting PHE-related decisions during COVID-19 and describe the ways HTA can help the response to a PHE. In turn, we advocate for HTA capacity to be further developed globally and for increased institutional acceptance of these methods as a building block for preparedness and response to future PHEs. Finally, the long-term potential of HTA in strengthening health systems and embedding confidence and transparency into scientific policy should be recognized.

Factors associated with the opposition to COVID-19 vaccination certificates: A multi-country observational study from Asia.

BACKGROUND: There are ongoing calls to harmonise and increase the use of COVID-19 vaccination certificates (CVCs) in Asia. Identifying groups in Asian societies who oppose CVCs and understanding their reasons can help formulate an effective CVCs policy in the region. However, no formal studies have explored this issue in Asia. METHOD: The COVID-19 Vaccination Policy Research and Decision-Support Initiative in Asia (CORESIA) was established to address policy questions related to CVCs. An online cross-sectional survey was conducted from June to October 2021 in nine Asian countries. Multivariable logistical regression analyses were performed to identify potential opposers of CVCs. RESULTS: Six groups were identified as potential opposers of CVCs: (i) unvaccinated (Odd Ratio (OR): 2.01, 95% Confidence Interval (CI): 1.65-2.46); vaccine hesitant and those without access to COVID-19 vaccines; (ii) those not wanting existing NPIs to continue (OR: 2.97, 95% CI: 2.51-3.53); (iii) those with low level of trust in governments (OR: 1.25, 95% CI: 1.02-2.52); (iv) those without travel plans (OR: 1.58, 95% CI: 1.31-1.90); (v) those expecting no financial gains from CVCs (OR: 2.35, 95% CI: 1.98-2.78); and (vi) those disagreeing to use CVCs for employment, education, events, hospitality, and domestic travel. CONCLUSIONS: Addressing recurring public health bottlenecks such as vaccine hesitancy and equitable access, adherence to policies, public trust, and changing the narrative from 'societal-benefit' to 'personal-benefit' may be necessary and may help increase wider adoption of CVCs in Asia.

Monitoring and Evaluation of National Vaccination Implementation: A Scoping Review of How Frameworks and Indicators Are Used in the Public Health Literature.

An effective Monitoring and Evaluation (M&E) framework helps vaccination programme managers determine progress and effectiveness for agreed indicators against clear benchmarks and targets. We aimed to identify the literature on M&E frameworks and indicators used in national vaccination programmes and synthesise approaches and lessons to inform development of future frameworks. We conducted a scoping review using Arksey and O'Malley's six-stage framework to identify and synthesise sources on monitoring or evaluation of national vaccination implementation that described a framework or indicators. The findings were summarised thematically. We included 43 eligible sources of 4291 screened. Most (95%) were in English and discussed high-income (51%) or middle-income (30%) settings, with 13 in Europe (30%), 10 in Asia-Pacific (23%), nine in Africa (21%), and eight in the Americas (19%), respectively, while three crossed regions. Only five (12%) specified the use of an M&E framework. Most (32/43; 74%) explicitly or implicitly included vaccine coverage indicators, followed by 12 including operational (28%), five including clinical (12%), and two including cost indicators (5%). The use of M&E frameworks was seldom explicit or clearly defined in our sources, with indicators rarely fully defined or benchmarked against targets. Sources focused on ways to improve vaccination programmes without explicitly considering ways to improve assessment. Literature on M&E framework and indicator use in national vaccination programmes is limited and focused on routine childhood vaccination. Therefore, documentation of more experiences and lessons is needed to better inform vaccination M&E beyond childhood.

Operationalising Regional Cooperation for Infectious Disease Control: A Scoping Review of Regional Disease Control Bodies and Networks.

BACKGROUND: The rapid spread of the coronavirus disease 2019 (COVID-19) pandemic demonstrates the value of regional cooperation in infectious disease prevention and control. We explored the literature on regional infectious disease control bodies, to identify lessons, barriers and enablers to inform operationalisation of a regional infectious disease control body or network in southeast Asia. METHODS: We conducted a scoping review to examine existing literature on regional infectious disease control bodies and networks, and to identify lessons that can be learned that will be useful for operationalisation of a regional infectious disease control body such as the Association of Southeast Asian Nations (ASEAN) Center for Public Health Emergency and Emerging Diseases. RESULTS: Of the 57 articles included, 53 (93%) were in English, with two (3%) in Spanish and one (2%) each in Dutch and French. Most were commentaries or review articles describing programme initiatives. Sixteen (28%) publications focused on organisations in the Asian continent, with 14 (25%) focused on Africa, and 14 (25%) primarily focused on the European region. Key lessons focused on organisational factors, diagnosis and detection, human resources, communication, accreditation, funding, and sustainability. Enablers and constraints were consistent across regions/ organisations. A clear understanding of the regional context, budgets, cultural or language issues, staffing capacity and governmental priorities, is pivotal. An initial workshop inclusive of the various bodies involved in the design, implementation, monitoring or evaluation of programmes is essential. Clear governance structure, with individual responsibilities clear from the beginning, will reduce friction. Secure, long-term funding is also a key aspect of the success of any programme. CONCLUSION: Operationalisation of regional infectious disease bodies and networks is complicated, but with extensive groundwork, and focus on organisational factors, diagnosis and detection, human resources, communication, accreditation, funding, and sustainability, it is achievable. Ways to promote success are to include as many stakeholders as possible from the beginning, to ensure that context-specific factors are considered, and to encourage employees through capacity building and mentoring, to ensure they feel valued and reduce staff turnover.

'Science is only half of it': Expert perspectives on operationalising infectious disease control cooperation in the ASEAN region.

Governmental awareness of the potential spread of infectious disease, exemplified by the current Covid-19 pandemic, ideally results in collective action, as countries coordinate a response that benefits all, contributing expertise, resources, knowledge and experience to achieve a common public good. However, operationalising regional cooperation is difficult, with barriers including lack of political will, regional heterogeneity, and existing geopolitical issues. We interviewed 23 people with regional expertise focusing on Asia, Africa, the Americas and Europe. All interviewees held senior positions in regional bodies or networks or had significant experience working with them. Operationalisation of a regional infectious disease body is complex but areas interviewees highlighted-organisational factors (e.g. integration and harmonisation; cross-border issues; funding, financing and sustainability; capacity-building; data sharing); governance and diplomacy (e.g. building collaborations and partnerships; communication; role of communities; diplomacy; leadership; ownership; sovereignty; political commitment); and stakeholders and multilateral agreements-will help promote successful operationalisation. The international infectious disease community has learned valuable lessons from the Covid-19 pandemic, not least the necessity of pooling human, financial and technological resources, constructing positive working relationships with neighbours, and sharing data. Without this kind of regional cooperation, infectious diseases will continue to threaten our future, and the next pandemic may have even more far-reaching effects.

Multi-country collaboration in responding to global infectious disease threats: lessons for Europe from the COVID-19 pandemic.

Since 2005, the world has faced several public health emergencies of international concern arising from infectious disease outbreaks. Of these, the COVID-19 pandemic has had by far the greatest health and economic consequences. During these emergencies, responses taken by one country often have an impact on other countries. The implication is that coordination between countries is likely to achieve better outcomes, individually and collectively, than each country independently pursuing its own self-interest. During the COVID-19 pandemic, gaps in multilateral cooperation on research and information sharing, vaccine development and deployment, and travel policies have hampered the speed and equity of global recovery. In this Health Policy article, we explore how multilateral collaboration between countries is crucial to successful responses to public health emergencies linked to infectious disease outbreaks. Responding to future global infectious disease threats and other health emergencies will require the creation of stronger mechanisms for multilateral collaboration before they arise. A change to the governance of multilateral institutions is a logical next step, with a focus on providing equal ownership and leadership opportunities to all member countries. Europe can be an example and advocate for stronger and better governed multilateral institutions.

A protocol for a systematic literature review of economic evaluation studies of interventions to address antimicrobial resistance.

BACKGROUND: Antimicrobial resistance (AMR) is accelerated by the widespread and often indiscriminate use of antimicrobials in humans, animals, and the environment. In 2015, the World Health Organization recognised AMR as one of the top ten global health threats, due to its potential to neutralise humanity's advancements in western medicine by enabling the emergence of new strains of existing pathogens, many of which have no available treatments. Over the past decade, several countries, including those in low- and middle-income contexts, have started implementing interventions to tackle AMR. However, economic evidence regarding the cost-effectiveness of these interventions remains weak. To address this evidence gap, we will conduct a systematic literature review to provide a comprehensive summary on the value for money of different AMR interventions. METHODS: We aim to conduct a systematic literature review of all available economic evaluations on interventions addressing AMR and will provide a narrative synthesis of our findings. Systematic searches for relevant studies will be performed across all suitable databases as well as in grey literature sources such as unpublished studies, reports, and other relevant documents. All economic evaluation studies will be included as long as they report an economic outcome and have stated that the analysed intervention will reduce antimicrobial resistance or antimicrobial use in the abstract. Those studies reporting clinical endpoints alone will be excluded. Selection for final inclusion and data extraction will be performed by two independent reviewers. DISCUSSION: The review will be one of the first of its kind, and the most recent, to systematically review literature on the cost-effectiveness of AMR interventions, an important evidence gap in the economics of AMR. The findings will enable policy and decision-makers, particularly in resource-constrained settings, to better use available resources when selecting interventions to address AMR burdens, SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020190310.

Evaluating traditional and complementary medicines: Where do we go from here?

Traditional and complementary medicines are increasingly considered possible options for prevention and symptomatic treatment of the novel coronavirus, COVID-19. With renewed attention on these therapies from researchers and policy makers alike, the well-documented challenges of evaluating their safety and efficacy are once again of global concern. Between 2005 and 2018, the World Health Organization conducted a series of surveys, in which 88 percent of responding member states confirmed that their biggest challenge in traditional medicine was the need for technical guidance on research and evaluation. As a first step in pursuing this need, our commentary summarizes thirteen international and regional guidance documents by three broad categories on evaluating safety, efficacy, and product quality for market-based approval and distribution of these treatments. We highlight the paucity of updated international recommendations on these subjects and identify gaps that could inform the current evidence base. All available guidance note the need for evidence surrounding the efficacy of these treatments and practices but are also quick to caution against methodological difficulties in the conduct of such evaluations. Evidence suggests that improved evaluation methods on efficacy and effectiveness are crucial toward expanding future research into establishing the cost-effectiveness of these therapies, in the context of shifting acceptance, interest, and integration of traditional medicines into health systems, and as another step toward Universal Health Coverage.