Health Technology Assessment Process Research Articles

Comparative Assessment of Reimbursement Recommendations by NICE and HAS for Oncology New Medicines Indicated for the Treatment of Solid Tumors from 2015 to 2021.

This study aimed to compare reimbursement recommendations by the British National Institute for Health and Care Excellence (NICE) and the French National Authority for Health (Haute Autorité de Santé; HAS) for oncology new medicines indicated for the treatment of solid tumors. Public assessment reports published on NICE and HAS Web sites between January 1, 2015, and December 31, 2021, describing appraisals for public reimbursement for oncology new medicines indicated for the treatment of solid tumors were searched and systematically reviewed. Biosimilars and generic drugs were excluded from the analysis. Overall, 119 public assessment reports published by NICE and 134 by HAS were identified, with 101 interventions assessed by both agencies. Of 101, 38 (38%) interventions received similar recommendations, 38 (38%) were recommended for different populations, and 25 (25%) were endorsed by one agency but rejected by the other. The main reason NICE would not recommend a drug was due to lack of cost-effectiveness, whereas HAS would primarily reject a drug on the grounds of insufficient clinical evidence. The major divergence between agencies is the key criterion used for reimbursement recommendations. NICE mainly considers cost-effectiveness, whereas HAS primarily focuses on the clinical value of interventions. This contributes to the variability in reimbursement recommendations and leads to differential access to oncology new medicines indicated for the treatment of solid tumors among patients in France, and England and Wales. Both the National Institute for Health and Care Excellence (NICE) and the National Authority for Health (Haute Autorité de Santé; HAS) have established formal health technology assessment (HTA) processes and offer universal public health care coverage. However, both agencies diverge in the weight given to different elements of evidence during HTA evaluations. NICE uses cost-effectiveness as key criterion for recommendations on drug reimbursement, while HAS mostly limits its assessment to clinical value.For oncology new medicines indicated for treating solid tumors between 2015 and 2021, recommendations differed 62% of the time between NICE and HAS, primarily due to the distinct key decision-making criteria each HTA agency uses.For 4 interventions not endorsed by NICE, HAS saw these drugs as providing a substantial enhancement in clinical value over existing treatments, potentially providing an edge in price negotiations. Conversely, NICE deemed these drugs as not delivering adequate value for money in comparison with current therapies.A key difference between the 2 agencies is HAS's insistence on methodological rigor in efficacy results, compared with NICE's more flexible approach, considering descriptive efficacy results in cost-effectiveness modeling.

Integration of real-world evidence from different data sources in health technology assessment.

Real-world evidence (RWE) is being increasingly used by a wide range of stakeholders involved in the therapeutic product lifecycle but remains underutilized in the health technology assessment (HTA) process. RWE aims to fill the current evidence gaps, reduce the uncertainty around the benefits of medical technologies, and better understand the long-term impact of health technologies in real-world conditions. Despite the minimal use of RWE in some elements of HTA, there has been a larger push to further utilize RWE in the HTA processes. HTA bodies, as other stakeholders, work towards developing more robust means to leverage RWE from various data sources in the HTA processes. However, these agencies need to overcome important challenges before the broader incorporation of RWE into their routine practice. This paper aims to explore the extensive integration of RWE utilizing diverse sources of RWD. We discuss the utilization of RWE in HTA processes, considering aspects such as when, where, and how RWE can be effectively applied. Additionally, we seek the potential challenges and barriers associated with the utilization of different data sources.

HEALTH TECHNOLOGY ASSESSMENT AS A TOOL FOR HEALTHCARE POLICY MAKING

Background. The article briefly describes the genesis of the concept of health technology assessment, which emerged in the 60s of the XX century. This was due to the emergence of technologies that gave rise to social, ethical, legal and political problems.
 Aim:To highlight the role of health technology assessment (HTA) in providing evidence-based information for health policy making. 
 Materials and methods. The object of the study was the information obtained from the relevant regulations and foreign and domestic literature sources describing the HTA process in terms of its impact on policy making.
 The basics of the HTA process and its purpose, which is to help develop safe and effective health care policies that focus on the needs of the patient and seek to achieve the best value for money, are established.
 Results. The list of factors that contribute to the use of HTA in health policy development, as well as the variety of models of real-world policy processes, is briefly reviewed. 
 It is emphasized that the interaction between policy makers and researchers, as well as the role of each party in the HTA process, especially the application of the results, depends on the social model of society. The introduction of a scientific approach inevitably leads to increased openness and accountability of government decisions and actions. In such a society, social and economic reforms become more successful. 
 Conclusion. It has been determined that the introduction of the HTA institute in Ukraine provides healthcare policy makers with a reliable resource for implementing healthcare reform.

Algorithms and heuristics of health technology assessments: A retrospective analysis of factors associated with HTA outcomes for new drugs across seven OECD countries

ContextPositive health technology assessment (HTA) outcomes can have important implications for equity, efficiency and timely patient access to novel therapies. Several outcomes and dimensions of benefit beyond utility feed into HTA processes. ObjectiveWe analyse a proprietary dataset of HTA outcomes in 7 countries, to (a) test whether HTA decision-making is grounded in welfarist or extra-welfarist approaches; and (b) empirically determine the factors associated with positive HTA outcomes, the time to achieve these and establish the magnitude of inter-country differences in assessment processes. MethodsData were extracted from publicly available HTA reports on drugs that received marketing authorisation between 2009 and 2018 (N = 1415). The outcomes of interest were the probability of positive HTA outcomes and the time-to-HTA outcome; these were examined with respect to clinical, regulatory, product- and disease-related, evidence uncertainty and contextual variables. Econometric models utilising survival analysis and multinomial logistic regression were specified. FindingsPositive HTA outcomes accounted for 87.3% of the sample (n = 1235), of which 71% (n = 1004) were restricted. Drugs with positive HTA outcomes were subject to clinical restrictions (n = 652, 46%), financial risk-sharing (n = 439, 31%) or had been rejected at least once (n = 282, 20%). Significant predictors of positive HTA outcomes were orphan drugs with cancer indications, high quality of evidence linked to clinical and economic evidence uncertainties which had been overcome, and contextual considerations, particularly innovativeness and unmet need. Comparative analyses revealed systematic differences between countries in their propensity to accept the same drugs, particularly oncology and orphan drugs. ConclusionsOur results are contextual and reinforce arguments in favour of explicitly accounting for social value judgements, establishing separate assessment frameworks for highly uncertain products, adopting risk mitigation strategies for novel therapies with early phase evidence, and sharing of HTA practices across settings. Lastly, HTA agencies have adopted an extra-welfarist approach to value assessment and resource allocation.

Evolving Use of Health Technology Assessment in Medical Device Procurement—Global Systematic Review: An ISPOR Special Interest Group Report

ObjectivesTo review the current academic evidence describing how data from health technology assessments (HTAs) informs procurement decisions for medical devices. MethodsA systematic literature review was performed to identify relevant studies and criteria used in medical device purchasing or procurement decisions. Included articles were screened for relevancy and risk of bias. The included studies were summarized qualitatively. ResultsA total of 292 studies were screened, of which 11 matched the inclusion criteria. Included studies’ geographies and HTA maturity varied. Some studies described hospital-level HTA processes, whereas others focused on national-level recommendations. Criteria for procurement decisions included standard HTA factors, such as efficacy, cost, cost-effectiveness, and budget impact; broader issues were also noted, including impact on the organization, ethical aspects, staff workload, and volume. There was little consideration of device-specific characteristics, such as life cycle, learning curve, or incremental technical innovation. Few decisions referred to HTA reports as part of the procurement decision; similarly, few HTA reports included a procurement perspective to help guide the procurement bodies. ConclusionsThere is minimal evidence that notes HTA influencing medical device procurement. Procurement bodies and hospitals may not be incentivized to publish their work and transparency could be improved; further research would better describe the link between HTA and procurement. Such research would enable the HTA agencies to meaningfully assess devices to target procurement bodies and allow device sponsors to prioritize evidence. This could limit redundancy, improve evidence, and ultimately promote savings to healthcare systems and expand access.

HTA74 HTA Processes for Medical Technologies across the World – Are All Hurdles the Same?

Explore health technology assessment (HTA) processes for medical technologies and evaluate similarities/differences by region.

EE495 Cost-Effectiveness of Pembrolizumab + Axitinib Versus Nivolumab + Ipilimumab As First-Line Treatment of Advanced Renal Cell Carcinoma in the Private Healthcare System in Brazil

In Brazil's Private Healthcare System, intravenous (IV) oncological drugs approved by the regulatory agency are automatically reimbursed. However, when the treatment involves an oral drug, it must go through the health technology assessment (HTA) process for reimbursement approval. In this context, we conducted a study to evaluate the cost-effectiveness of pembrolizumab (IV) + axitinib (oral) versus nivolumab (IV) + ipilimumab (IV) as first-line treatments in patients with advanced renal cell carcinoma (aRCC) at intermediate/poor IMDC (International Metastatic RCC Database Consortium) risk.

HTA5 Variation in Health Technology Assessments for Nivolumab Plus Chemotherapy Vs Chemotherapy in First-Line Gastric Cancer

Health technology assessments (HTAs) inform reimbursement decisions. International differences in HTA processes lead to international differences in patient access to new treatments. Using HTAs for nivolumab plus chemotherapy in first-line gastric cancer as an example, we quantified the variation in time to patient access and in the evaluation of benefits between different HTA agencies.

Perceptions and Attitudes Regarding Medical Device Development in Canada Among Canadian Innovators: A Qualitative Study.

The Canadian medical device industry presents unique challenges to innovators. However, little attention has been paid to exploring the distinct experience of Canadian medical device innovators in the literature. The objective of this study is to explore the experience of Canadian innovators in navigating this industry, with a focus on their perceptions and attitudes towards the use of health economic evaluation. Semi-structured interviews were conducted using virtual conferencing technology. All participants were C-level employees of small- and medium-sized enterprises (SMEs) with adequate knowledge of their company's overall strategy. Qualitative data were analyzed to reveal emerging themes. Interviews were performed with ten participants. Forty percent of participants rated themselves as having either minimal or basic knowledge of health economics. Thirty percent of participants had not pursued early economic evaluation of their device, while 90% rated health economics as being either "Quite important" or "Very important" to their company. The perception of increased barriers to successful device adoption in Canada relative to the USA was a prominent sentiment among participants, with 50% expressing discontentment with either the device approval process or health technology assessment process in Canada. Twenty percent stated that their primary target market involved the USA and/or other international jurisdictions. Canadian medical device innovators appear to understand the importance of health economic evaluation in the innovation process. However, they report difficulty with device approval and adoption, with some innovators focusing their efforts outside of Canada altogether. Further research should be directed toward understanding how to better support SMEs, given that they are a tremendous source of growth for the Canadian medical device industry.

Evaluation of Diversity of Clinical Trials Informing Health Technology Assessments in the United States: A 5-Year Analysis of Institute for Clinical and Economic Review Assessments

ObjectivesThis study aimed to evaluate the diversity of clinical trials informing assessments conducted by the Institute for Clinical and Economic Review. MethodsThis was a cross-sectional study of pivotal trials included in completed Institute for Clinical and Economic Review assessments over 5 years (2017-2021). Representation of racial/ethnic minority groups, females, and older adults was compared with the disease-specific and US population, using a relative representation cutoff of 0.8 for adequate representation. ResultsA total of 208 trials, evaluating 112 interventions for 31 unique conditions, were examined. Race/ethnicity data were inconsistently reported. The median participant-to-disease representative ratio (PDRR) for Blacks/African Americans (0.43 [interquartile range (IQR) 0.24-0.75]), American Indians/Alaska Natives (0.37 [IQR 0.09-0.77]), and Hispanics/Latinos (0.79 [IQR 0.30-1.22]) were below the adequate representation cutoff. In contrast, Whites (1.06 [IQR 0.92-1.2]), Asians (1.71 [IQR 0.50-3.75]), and Native Hawaiian/Other Pacific Islanders (1.61 [IQR 0.77-2.81]) were adequately represented. Findings were similar when compared with the US Census, except for Native Hawaiian/Pacific Islanders, which was substantially worse. Relative to all trials, a higher proportion of US-based trials adequately represented Blacks/African Americans (61% vs 23%, P < .0001) and Hispanics/Latinos (68% vs 50%; P = .047), but a lower proportion adequately represented Asians (15% vs 67%, P < .0001). Females were adequately represented in 74% of trials (PDRR: 1.02 [IQR 0.79-1.14]). Nevertheless, older adults were adequately represented in only 20% of trials (PDRR: 0.30 [IQR 0.13-0.64]). ConclusionsThe representation of racial/ethnic minorities and older adults was inadequate. Efforts are needed to enhance the diversity of clinical trials. Standardized and transparent evaluation of trial diversity should be part of the health technology assessment process.

Overview of Health Technology Assessment Processes for Time-Limited Recommendations

&#x0D; Several regulatory agencies have implemented processes to facilitate timely access to innovative therapies for patients with rare or life-threatening diseases with high unmet medical needs, typically with additional data-generation requirements to address important uncertainties in the existing evidence base at the time of regulatory approval. Many health technology assessment (HTA) agencies have adapted their processes to include time-limited recommendations (TLRs) for such therapies, which allows patients access to these medications while additional data are collected to verify the clinical efficacy, real-world effectiveness, or economic value of the new therapeutic. The objective of this Environmental Scan is to identify what HTA agencies have processes in place for TLRs and to describe these processes, if applicable.&#x0D; HTA agencies in North America, Europe, Australia, and New Zealand were considered for this report based on commonalities to the Canadian context in terms of geography and relevant regulatory or HTA and reimbursement processes. Seven HTA agencies (the National Institute for Health and Care Excellence, the Scottish Medicines Consortium, France’s Haute Autorité de Santé, the Dutch National Health Care Institute, the Italian Medicines Agency, the Belgium National Institute for Health and Disability Insurance, and the Australian Pharmaceutical Benefits Advisory Committee) that have implemented formal TLR processes, through managed entry agreements, special access funds, or other related programs were identified. Most TLR programs are referred to as managed access or entry agreements, but other types include interim acceptance, conditional inclusion, assessment contingent on additional evidence development, and additional specialized programs or pathways.&#x0D; TLRs are primarily used for promising (and sometimes high-cost) medicines intended to treat a condition with an important unmet medical need; some specify that the disease must be serious and life threatening (regardless of prevalence), others indicate that the process is used for orphan drugs intended to treat rare conditions, and others consider multiple criteria or do not have prerequisite criteria for eligible indications.&#x0D; Evidence generation requirements for TLRs vary across HTA agencies and are often dependent on the nature of the clinical and economic uncertainties identified in the initial assessment; sources include later follow-up from ongoing clinical trials, new clinical trials, real-world data, or a combination of both clinical and real-world studies. Additionally, most TLR processes have explicit maximum durations for the time-limited period, which range from 2 to 7 years across the included HTA agencies (although some allow for time adjustments or renewals); however, the French and Scottish HTA agencies determine the duration of the time-limited period on a case-by-case basis.&#x0D; Overall, this report provides an overview of HTA processes for TLRs across HTA agencies in Europe and Australia, many of which may be useful to inform the implementation of future TLR processes in Canada, as well as to refine existing ones.&#x0D;

Exploring the COVID-19 Pandemic’s Impact on the Health Technology Assessment Process of the National Commission for the Incorporation of Technologies Into the Brazilian Health System

ObjectivesThis study aimed to evaluate the impact of the COVID-19 pandemic on Brazilian health technology assessment processes based on public reports from the National Committee for Health Technology Incorporation (CONITEC). MethodsThis descriptive study analyzed CONITEC’s official reports on Brazil available on its website between 2018 and 2021 that aimed to propose recommendations for technologies to be incorporated into its public healthcare system. We used descriptive statistics covering the number of technologies and number of reports about drugs per year, objective, type of technology, demanding sector, and outcome before 2018 to 2019 and during the COVID-19 pandemic (2020-2021). Furthermore, we used logistic regression to explore any association between the final decision labeled as “incorporated” and the emergence of the COVID-19 pandemic. ResultsA total of 278 reports were analyzed. Approximately 85% (136 of 278), 79% (220 of 278), and 45% of the reports (125 of 278) were about drugs, for incorporation, and requested by the government, respectively. Moreover, 74 of 130 (57%) and 56 of 148 decisions (38%) were “incorporated” before and during the pandemic, respectively. No significant association was noted between incorporated decisions and the arrival of the COVID-19 pandemic for all technologies (odds ratio 1.43; 95% CI 0.84-2.46; P = .192) and for drugs (odds ratio 1.43; 95% confidence interval 0.81-2.53; P = .223) while adjusting for the type of technology and demandant. ConclusionsThe COVID-19 pandemic has brought many challenges, but it does not seem to have had a significant impact on the health technology assessment approval decisions of CONITEC in Brazil.

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment.

Artificial intelligence (AI) has attracted much attention because of its enormous potential in healthcare, but uptake has been slow. There are substantial barriers that challenge health technology assessment (HTA) professionals to use AI-generated evidence for decision-making from large real-world databases (e.g., based on claims data). As part of the European Commission-funded HTx H2020 (Next Generation Health Technology Assessment) project, we aimed to put forward recommendations to support healthcare decision-makers in integrating AI into the HTA processes. The barriers, addressed by the paper, are particularly focusing on Central and Eastern European (CEE) countries, where the implementation of HTA and access to health databases lag behind Western European countries. We constructed a survey to rank the barriers to using AI for HTA purposes, completed by respondents from CEE jurisdictions with expertise in HTA. Using the results, two members of the HTx consortium from CEE developed recommendations on the most critical barriers. Then these recommendations were discussed in a workshop by a wider group of experts, including HTA and reimbursement decision-makers from both CEE countries and Western European countries, and summarized in a consensus report. Recommendations have been developed to address the top 15 barriers in areas of (1) human factor-related barriers, focusing on educating HTA doers and users, establishing collaborations and best practice sharing; (2) regulatory and policy-related barriers, proposing increasing awareness and political commitment and improving the management of sensitive information for AI use; (3) data-related barriers, suggesting enhancing standardization and collaboration with data networks, managing missing and unstructured data, using analytical and statistical approaches to address bias, using quality assessment tools and quality standards, improving reporting, and developing better conditions for the use of data; and (4) technological barriers, suggesting sustainable development of AI infrastructure. In the field of HTA, the great potential of AI to support evidence generation and evaluation has not yet been sufficiently explored and realized. Raising awareness of the intended and unintended consequences of AI-based methods and encouraging political commitment from policymakers is necessary to upgrade the regulatory and infrastructural environment and knowledge base required to integrate AI into HTA-based decision-making processes better.

A qualitative study on the feasibility and acceptability of institutionalizing health technology assessment in Malawi

ObjectiveThe objective of this study was to assess the feasibility and acceptability of institutionalizing Health Technology Assessment (HTA) in Malawi.MethodsThis study employed a document review and qualitative research methods, to understand the status of HTA in Malawi. This was complemented by a review of the status and nature of HTA institutionalization in selected countries.Qualitative research employed a Focus Group Discussion (FGD ) with 7 participants, and Key Informant Interviews (KIIs) with12 informants selected based on their knowledge and expertise in policy processes related to HTA in Malawi.Data extracted from the literature was organized in Microsoft Excel, categorized according to thematic areas and analyzed using a literature review framework. Qualitative data from KIIs and the FGD was analyzed using a thematic content analysis approach.ResultsSome HTA processes exist and are executed through three structures namely: Ministry of Health Senior Management Team, Technical Working Groups, and Pharmacy and Medicines Regulatory Authority (PMRA) with varyingdegrees of effectiveness.The main limitations of current HTA mechanisms include limited evidence use, 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. KII and FGD results showed overwhelming demand for strengthening HTA in Malawi, with a stronger preference for strengthening coordination and capacity of existing entities and structures.ConclusionThe study has shown that HTA institutionalization is acceptable and feasible in Malawi. However, the current committee based processes are suboptimal to improve efficiency due to lack of a structured framework. A structured HTA framework has the potential to improve processes in pharmaceuticals and medical technologies decision-making.In the short to medium term, HTA capacity building should focus on generating demand and increasing capacity in cost-effectiveness assessments. Country-specific assessments should precede HTA institutionalization as well as recommendations for new technology adoptions.

Time From Marketing Authorization to Reimbursement of Medicines in Greece After the Introduction of the Health Technology Assessment Process From July 2018 to April 2022

ObjectivesThis study aimed to quantify the median time from marketing authorization (MA) to the inclusion of medicines in the reimbursement list after the introduction of the health technology assessment process in Greece. MethodsFrom July 2018 to April 2022, the Ministerial Decisions (MDs) and reimbursement lists, posted on the website of the Ministry of Health, were reviewed. The following information was collected for the medicines: the date that MDs and positive reimbursement lists were issued, the MA date, the date of the official price publication, and the type of the health technology assessment application. The time from MA to listing was calculated as the difference between the MA date and the date that the relevant reimbursement list was issued. ResultsDuring the study period, 93 MDs were issued, from which 79 (85%) were positive and 14 (15%) were negative. Focusing on medicines included in the positive list for the first time, the median time from MA to listing for the new molecules was found to be 34.8 (interquartile range 25.7-41.3) months. This time was statistically significantly shortened for fixed dose combinations (20.9 [15.3-45.4] months, P = .008), and biosimilars (23 [16.6-28.2] months, P = .001). For generics was 17.6 (interquartile range 10-30) months, statistically significantly lower than that of new molecules (P < .001). ConclusionsThe time from MA to the inclusion of medicines in the reimbursement list in Greece is significantly long, especially for innovative medicines. Thus, policy makers should consider this point to optimize and improve patients’ subsidized access.

Reimbursement Coverage Decision Making for Digital Health Technologies in South Korea: Does It Fit the Value Framework Used in Traditional Medical Technologies?

ObjectivesThe introduction of digital health technologies (DHTs) that have the potential to improve health outcomes and lower the costs of healthcare services has seen an explosion in recent years. Indeed, the expectation that these innovative technologies can ultimately fill a gap in the patient-healthcare provider model of care with the hope of bending the continuously increasing healthcare expenditure curve has not yet been realized in many countries including South Korea (from herein referred to as Korea). We examine reimbursement coverage decision making status for DHTs in South Korea. MethodsWe examine the regulatory landscape, health technology assessment process, and reimbursement coverage determination for DHTs in Korea. ResultsWe identified the specific challenges and opportunities for reimbursement coverage of DHTs. ConclusionsTo ensure DHTs can be used effectively in medical practice, a more flexible and nontraditional approach to assessment, reimbursement, and payment determination is required.

The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study

BackgroundFew antibiotics have entered the market in recent years despite the need for new treatment options. Some of the challenges of bringing new antibiotics to market are linked to the marketing authorization and health technology assessment (HTA) processes. Research shows great variation in geographic availability of new antibiotics, suggesting that market introduction of new antibiotics is unpredictable. We aimed to investigate regulatory authorities’ and HTA agencies’ role in developing non-financial incentives to stimulate antibiotic research and development (R&D).MethodsWe conducted individual, semi-structured, stakeholder interviews. Participants were recruited from regulatory authorities (EMA and FDA) and HTA agencies in Europe. Participants had to be experienced with assessment of antibiotics. The data were analyzed using a deductive and inductive approach to develop codes and identify key themes. Data were analyzed using thematic analysis including the constant comparison method to define concepts, and rival thinking to identify alternative explanations.ResultsWe found that (1) interpretation of key concepts guiding the understanding of what type of antibiotics are needed vary (2) lack of a shared approach on how to deal with limited clinical data in the marketing authorization and HTA processes is causing barriers to getting new antibiotics to market (3) necessary adaptations to the marketing authorization process causes uncertainties that transmit to other key stakeholders involved in delivering antibiotics to patients.ConclusionsA shared understanding of limited clinical data and how to deal with this issue is needed amongst stakeholders involved in antibiotic R&D, marketing authorization, and market introduction to ensure antibiotics reach the market before resistance levels are out of control. Regulatory authorities and HTA agencies could play an active role in aligning the view of what constitutes an unmet medical need, and direct new economic models towards stimulating greater diversity in the antibiotic armamentarium.

Inclusion of Environmental Spillovers in Applied Economic Evaluations of Healthcare Products

ObjectivesClimate change and environmental factors have an impact on human health and the ecosystem. The healthcare sector is responsible for substantial environmental pollution. Most healthcare systems rely on economic evaluation to select efficient alternatives. Nevertheless, environmental spillovers of healthcare treatments are rarely considered whether it is from a cost or a health perspective. The objective of this article is to identify economic evaluations of healthcare products and guidelines that have included any environmental dimensions. MethodsElectronic searches of 3 literature databases (PubMed, Scopus, and EMBASE) and official health agencies guidelines were conducted. Documents were considered eligible if they assessed the environmental spillovers within the economic evaluation of a healthcare product or provided any recommendations on the inclusion of environmental spillovers in the health technology assessment process. ResultsFrom the 3878 records identified, 62 documents were deemed eligible and 18 were published in 2021 and 2022. The environmental spillovers considered were carbon dioxide (CO2) emissions, water or energy consumption, and waste disposal. The environmental spillovers were mainly assessed using the lifecycle assessment (LCA) approach while the economic analysis was mostly limited to costs. Only 9 documents, including the guidelines of 2 health agencies presented theoretical and practical ways to include environmental spillovers into the decision-making process. ConclusionsThere is a clear lack of methods on whether environmental spillovers should be included in health economic evaluation and how this should be done. If healthcare systems want to reduce their environment footprint, the development of methodology which integrates environmental dimensions in health technology assessment will be key.

What, how and who: Cost-effectiveness analyses of COVID-19 vaccination to inform key policies in Nigeria.

While safe and efficacious COVID-19 vaccines have achieved high coverage in high-income settings, roll-out remains slow in sub-Saharan Africa. By April 2022, Nigeria, a country of over 200 million people, had only distributed 34 million doses. To ensure the optimal use of health resources, cost-effectiveness analyses can inform key policy questions in the health technology assessment process. We carried out several cost-effectiveness analyses exploring different COVID-19 vaccination scenarios in Nigeria. In consultation with Nigerian stakeholders, we addressed three key questions: what vaccines to buy, how to deliver them and what age groups to target. We combined an epidemiological model of virus transmission parameterised with Nigeria specific data with a costing model that incorporated local resource use assumptions and prices, both for vaccine delivery as well as costs associated with care and treatment of COVID-19. Scenarios of vaccination were compared with no vaccination. Incremental cost-effectiveness ratios were estimated in terms of costs per disability-adjusted life years averted and compared to commonly used cost-effectiveness ratios. Viral vector vaccines are cost-effective (or cost saving), particularly when targeting older adults. Despite higher efficacy, vaccines employing mRNA technologies are less cost-effective due to high current dose prices. The method of delivery of vaccines makes little difference to the cost-effectiveness of the vaccine. COVID-19 vaccines can be highly effective and cost-effective (as well as cost-saving), although an important determinant of the latter is the price per dose and the age groups prioritised for vaccination. From a health system perspective, viral vector vaccines may represent most cost-effective choices for Nigeria, although this may change with price negotiation.

Main Challenges of Incorporating Environmental Impacts in the Economic Evaluation of Health Technology Assessment: A Scoping Review

Health technology assessment (HTA) provides evidence-based information on healthcare technology to support decision making in many countries. Environmental impact is a relevant dimension of a health technology's value, but it has been poorly addressed in HTA processes in spite of the commitment that the health sector must have to contribute to mitigating the effects of climate change. This study aims to identify the state of the art and challenges for quantifying environmental impacts that could be incorporated into the economic evaluation (EE) of HTA. We performed a scoping review that included 22 articles grouped into four types of contribution: (1) concepts to draw up a theoretical framework, (2) HTA reports, (3) parameter designs or suitable indicators, and (4) economic or budgetary impact assessments. This review shows that evaluation of the environmental impact of HTAs is still very incipient. Small steps are being taken in EE, such as carbon footprint estimations from a life-cycle approach of technologies and the entire care pathway.