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.

Criteria for the procedural fairness of health financing decisions: a scoping review.

Due to constraints on institutional capacity and financial resources, the road to universal health coverage (UHC) involves difficult policy choices. To assist with these choices, scholars and policy makers have done extensive work on criteria to assess the substantive fairness of health financing policies: their impact on the distribution of rights, duties, benefits and burdens on the path towards UHC. However, less attention has been paid to the procedural fairness of health financing decisions. The Accountability for Reasonableness Framework (A4R), which is widely applied to assess procedural fairness, has primarily been used in priority-setting for purchasing decisions, with revenue mobilization and pooling receiving limited attention. Furthermore, the sufficiency of the A4R framework's four criteria (publicity, relevance, revisions and appeals, and enforcement) has been questioned. Moreover, research in political theory and public administration (including deliberative democracy), public finance, environmental management, psychology, and health financing has examined the key features of procedural fairness, but these insights have not been synthesized into a comprehensive set of criteria for fair decision-making processes in health financing. A systematic study of how these criteria have been applied in decision-making situations related to health financing and in other areas is also lacking. This paper addresses these gaps through a scoping review. It argues that the literature across many disciplines can be synthesized into 10 core criteria with common philosophical foundations. These go beyond A4R and encompass equality, impartiality, consistency over time, reason-giving, transparency, accuracy of information, participation, inclusiveness, revisability and enforcement. These criteria can be used to evaluate and guide decision-making processes for financing UHC across different country income levels and health financing arrangements. The review also presents examples of how these criteria have been applied to decisions in health financing and other sectors.

Community pharmacists' views about prescription medicine co-payments and potential implications for equitable access to medicines: a critical realist interpretation.

BACKGROUND: In many countries the community pharmacist's role includes collecting prescription medicine co-payments at the point of dispensing. This is a context which can provide unique insights into individuals' access to prescription medicines, as interactions with service users about out-of-pocket (OOP) expenses that may negatively affect a pharmacist's patient counselling role. Prior research has identified that OOP expenses for prescription medicines led to decreased treatment adherence. This study aims to understand the role of community pharmacists in the collection of co-payments for prescription medicines in one region of Aotearoa New Zealand, and the possible implications for equitable access to medicines. METHODS: This is a qualitative study using a case study research design. Data were collected through focus groups, individual interviews, and an electronic survey. Using a critical realist approach in thematic analysis, findings were categorised as Causal tendencies (the things that cause the events); Events (the things that community pharmacists experience); and Experiences (the perceptions and feelings of individual participants). RESULTS: Our analysis finds that the current profession of community pharmacy in Aotearoa New Zealand, is under strain. The results suggest that broader government policies, such as the pharmacist's role in delivering essential health services, the fairness of standard prescription co-payments, and the role of community pharmacists as gatekeepers, have a significant influence on the profession. In addition, the study found that individual community pharmacists have a unique position in the co-payment process, face power imbalances within their role, and the study indicates evidence of value judgements towards service users. CONCLUSIONS: This study is exploratory; however, its examination of the policy of prescription medicine co-payments from the perspective of community pharmacists, who play a vital role in both dispensing medicines and collecting prescription medicine co-payments, is novel. Despite prescription medicine co-payments being a routine part of pharmacists' role in many countries, it is a topic where there is limited published peer-reviewed literature. The study adds to existing evidence that funding models influence community pharmacists' role. In addition, this study identified value judgements about service users in relation to prescription medicine co-payments which may influence service users' health-seeking behaviour. In this setting, limited representation of at-risk populations in the community pharmacy profession may be a factor that negatively influence interactions between pharmacists and service users.

SARS-CoV-2 Prevalence in Malawi Based on Data from Survey of Communities and Health Workers in 5 High-Burden Districts, October 2020.

To determine early COVID-19 burden in Malawi, we conducted a multistage cluster survey in 5 districts. During October-December 2020, we recruited 5,010 community members (median age 32 years, interquartile range 21-43 years) and 1,021 health facility staff (HFS) (median age 35 years, interquartile range 28-43 years). Real-time PCR-confirmed SARS-CoV-2 infection prevalence was 0.3% (95% CI 0.2%-0.5%) among community and 0.5% (95% CI 0.1%-1.2%) among HFS participants; seroprevalence was 7.8% (95% CI 6.3%-9.6%) among community and 9.7% (95% CI 6.4%-14.5%) among HFS participants. Most seropositive community (84.7%) and HFS (76.0%) participants were asymptomatic. Seroprevalence was higher among urban community (12.6% vs. 3.1%) and HFS (14.5% vs. 7.4%) than among rural community participants. Cumulative infection findings 113-fold higher from this survey than national statistics (486,771 vs. 4,319) and predominantly asymptomatic infections highlight a need to identify alternative surveillance approaches and predictors of severe disease to inform national response.

National adaptation and implementation of WHO Model List of Essential Medicines: A qualitative evidence synthesis.

BACKGROUND: The World Health Organization Model List of Essential Medicines (WHO EML) has played a critical role in guiding the country-level selection and financing of medicines for more than 4 decades. It continues to be a relevant evidence-based policy that can support universal health coverage (UHC) and access to essential medicines. The objective of this review was to identify factors affecting adaptation and implementation of WHO EML at the national level. METHODS AND FINDINGS: We conducted a qualitative evidence synthesis by searching 10 databases (including CINAHL, Embase, Ovid MEDLINE, Scopus, and Web of Science) through October 2021. Primary qualitative studies focused on country-level implementation of WHO EML were included. The qualitative findings were populated in the Supporting the Use of Research Evidence (SURE) framework, and key themes were identified through an iterative process. We appraised the papers using the Critical Appraisal Skills Programme (CASP) tool and assessed our confidence in the findings using the Grading of Recommendations Assessment, Development and Evaluation working group-Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual). We screened 1,567 unique citations, reviewed 183 full texts, and included 23 studies, from 30 settings. Non-English studies and experiences and perceptions of stakeholders published in gray literature were not collected. Our findings centered around 3 main ideas pertaining to national adaptation and implementation of WHO EML: (1) the importance of designing institutions, governance, and leadership for national medicines lists (NMLs), particularly the consideration of transparency, coordination capacity, legislative mechanisms, managing regional differences, and clinical guidance; (2) the capacity to manage evidence to inform NML updates, including processes for contextualizing global evidence, utilizing local data and expert knowledge, and assessing budget impact, to which locally relevant cost-effectiveness information plays an important role; and (3) the influence of NML on purchasing and prescribing by altering provider incentives, through linkages to systems for financing and procurement and donor influence. CONCLUSIONS: This qualitative evidence synthesis underscores the complexity and interdependencies inherent to implementation of WHO EML. To maximize the value of NMLs, greater investments should be made in processes and institutions that are needed to support various stages of the implementation pathway from global norms to adjusting prescribed behavior. Moreover, further research on linkages between NMLs, procurement, and the availability of medicines will provide additional insight into optimal NML implementation. PROTOCOL REGISTRY: PROSPERO CRD42018104112.

Global access to COVID-19 vaccines: a scoping review of factors that may influence equitable access for low and middle-income countries.

OBJECTIVE: To identify the factors contributing to equitable access to COVID-19 vaccines for low and middle-income countries (LMIC). METHODS: We conducted a scoping review following the guidelines for Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and a five-stage framework for scoping studies. We performed systematic searches for published peer-reviewed literature in five databases: Medline, Embase, Web of Science, Global Index Medicus and COVID-19 Evidence Epistemonikos (August 2020, updated May 2021). RESULTS: Systematic selection according to predefined criteria resulted in the final inclusion of 45 peer-reviewed articles, with no limitations on study design or publication type. We derived four key factors that potentially influence equitable access to COVID-19 vaccines in LMICs: (1) collectively agreed global mechanisms or frameworks; (2) bilateral purchasing, contracting, and vaccine prices; (3) vaccine manufacturing that is supported by sharing know-how; and (4) countries' strength in implementing vaccination programmes. CONCLUSIONS: This scoping review highlights the ongoing challenges for the international community in ensuring equitable access to COVID-19 vaccines for LMICs. The literature suggests that vaccine manufacturing can influence the supply of vaccines, as can the role of patent holders who can influence global governance through their role in the distribution of COVID-19 vaccines. Our findings indicate that including the principles of equitable access throughout vaccine research and development, procurement, scale-up and distribution processes can support equitable access for LMICs. Advances made with mRNA vaccines may have additional benefits in relation to expanding the manufacturing of other vaccine. Finally, the exploration and scale-up of such capacities of LMICs are likely to prove to be a valuable investment, even after the pandemic.