Formal Health Technology Assessment Research Articles

A situational and stakeholder analysis of health technology assessment in Zimbabwe.

Systematic priority setting is necessary for achieving high-quality healthcare using limited resources in low- and middle-income countries. Health technology assessment (HTA) is a tool that can be used for systematic priority setting. The objective of this study was to conduct a stakeholder and situational analysis of HTA in Zimbabwe. We identified and analyzed stakeholders using the International Decision Support Initiative checklist. The identified stakeholders were invited to an HTA workshop convened at the University of Zimbabwe. We used an existing HTA situational analysis questionnaire to ask for participants' views on the need, demand, and supply of HTA. A follow-up survey was done among representatives of stakeholder organizations that failed to attend the workshop. We reviewed two health policy documents relevant to the HTA. Qualitative data from the survey and document review were analyzed using thematic analysis. Forty-eight organizations were identified as stakeholders for HTA in Zimbabwe. A total of 41 respondents from these stakeholder organizations participated in the survey. Respondents highlighted that the HTA was needed for transparent decision making. The demand for HTA-related evidence was high except for the health economic and ethics dimensions, perhaps reflecting a lack of awareness. Ministry of Health was listed as a major supplier of HTA data. There is no formal HTA agency in the Zimbabwe healthcare system. Various institutions make decisions on prioritization, procurement, and coverage of health services. The activities undertaken by these organizations provide context for the institutionalization of HTA in Zimbabwe.

OP174 Health Technology Assessment And Economic Evaluations For A Genomic Strategy In Italy

IntroductionThe challenge to health systems is sustainability, not only in the economic and financial sense of compatibility of spending with allocated resources, but also in terms of equity in access to services and care, quality, safety, innovation and research, that is, in terms of the effectiveness of the right to health. Some countries, such as Italy, do not have formal health technology assessment (HTA) or other similar processes that take into account views outside the decision maker.MethodsIn the Italian national context, there is currently no single tariff for the reimbursability and pricing of genomic technologies. In fact, although genomic tests have been in clinical practice for many years now, to date they have not yet been included in the LEA (Minimum healthcare provision), especially in view of the fact that a defined and transparent process for updating the Essential Levels of Care has been operational since 2018. With the goal of structuring guidelines for the adaptability of economic evaluations to currently available and developing genomic technologies, a literature review was conducted.ResultsThe literature review showed that there are some methodological and practical issues that need to be carefully considered when designing and conducting economic evaluations of genomic tests. In more detail, five key concepts were identified in order to implement the most comprehensive economic evaluation of the technologies under study: the PICO model, the survey perspective, the costs included in the analysis, the effectiveness analysis, the time horizon, and the discount rate.ConclusionsAdequate definition of these concepts appears to be of paramount importance in view of the fact that genomic testing may have important consequences for future generations as well. For the purpose of sustainability of access of genomic technologies, the use of Budget Impact Analysis (BIA) is recommended in all analysis settings being essential for the regulator to tie access to its available budget capacity.

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.

Genuine policy learning is fundamental: the journey of the United Arab Emirates toward the establishment of health technology assessment.

The launch of innovative technologies has been credited with significant improvements in health indicators, but it comes at a high financial impact, and the value of certain innovations may not be well documented. Health technology assessment (HTA) is a universally established process to assess the incremental value of innovations. Despite its acknowledged value, almost one-third of the countries around the globe have not established yet a formal HTA in their health systems. The UAE is one of the pioneering countries worldwide in adopting innovative health technologies. This emphasizes the importance of exploring the key elements in the UAE's journey toward the establishment of HTA. Our study aims to articulate an academic insight that can support the ongoing endeavors to establish the HTA in the UAE. This case study was guided by an analytical framework. Data was collected from document review and semistructured interviews, then analyzed by applying the codebook thematic analysis technique. The findings outline multiple facilitators and challenges in the perspective process, as they show a multidimensional interlink between all identified elements. Markedly, leveraging the role of specialized academia and building HTA genuine knowledge are the areas that need the most attention. The originality of this research is associated with analyzing the three health policy pillars: the context, actors, and content in a prospective HTA establishment process. The main practical implications generated from this study are supporting global health organizations, HTA policy entrepreneurs, and academics in improving their strategies and designing more effective HTA policy learning programs.

OP28 Health Technology Assessment: A Situation Analysis Of Zimbabwe

IntroductionWith ever increasing burden of disease and limited resources, health technology assessment (HTA) is required for efficient resources allocation and priority setting in healthcare. The objective of this study was to establish the baseline HTA evidence generation and use in Zimbabwe.MethodsIn 2019, we convened a stakeholder workshop on HTA at the University of Zimbabwe. Presentations on HTA processes, current healthcare reimbursement model, priority setting in the Ministry of Health and selection of medicines into the treatment guidelines, were done by the experts. We adapted the Health Intervention and Technology Assessment Program questionnaire for situational analysis of HTA introduction at national level and administered it among the workshop participants. We report the baseline information on HTA situation, the need, demand and supply of HTA in Zimbabwe obtained from the presentations and responses from workshop participants.ResultsA total of 33 participants attended the workshop. Participants indicated that there is no formal HTA agency or process in Zimbabwe. The selection of medicines into treatment guideline is determined by disease burden, safety, efficacy and cost data, and it is done by a group of experts. The Association of Healthcare Funders of Zimbabwe (AFHOZ) reported that private healthcare funders use resource-based relative value scale system to determine tariffs and reimbursement levels. The regulator requires safety, efficacy and product quality data for the registration of medicines. Transparency in decision-making, registration of heath technology and formulation of essential medicines and treatment guidelines were reported as the major needs of HTA. The major users of HTA outputs were reported as medicines regulator, AFHOZ and Ministry of Health. Key suppliers of HTA evidence are academic and clinical research institutions and healthcare workers. Lack of training in health economics was cited as the major challenge to supply of HTA evidence.ConclusionsThere is a need to institute a formal, systematic and transparent processes of determining value of health technologies.

Are We Ready for a New Approach to Comparing Coverage and Reimbursement Policies for Medical Nutrition in Key Markets: An ISPOR Special Interest Group Report

ObjectivesHealthcare policy makers should ensure optimal patient access to medical nutrition (MN) as part of the management of nutrition-related disorders and conditions. Questions remain whether current healthcare policies reflect the clinical and economic benefits of MN. The objective of this article is to characterize coverage and reimbursement of MN, defined as food for special medical purposes/medical food for a diverse set of countries, including Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Italy, Japan, The Netherlands, Singapore, Spain, United Kingdom, and United States. MethodsData sources included published literature and online sources. ISPOR’s Nutrition Economics Special Interest Group developed a data collection form to guide data extraction that included reimbursement coverage, years that reimbursement policies were established, and presence of a formal health technology assessment (HTA) for MN technologies. ResultsReimbursement coverage of MN technologies varied across the countries that were reviewed. All but 3 countries limited coverage to specific formulations of products, regardless of demonstrated clinical benefit. The year that reimbursement policies were established varied across countries (ranging from 1984 to 2017), and only 4 countries regularly update policies. France and Brazil are the only countries with a formal HTA process for MN technologies. ConclusionsMost countries have limited MN reimbursement, have not updated reimbursement policies, and lack HTA for MN technologies. These limitations may lead to suboptimal access to MN technologies where they are indicated to manage nutrition-related disorders and conditions, with the potential of negatively affecting patient and healthcare system outcomes.

Health Technology Assessment in Support of National Health Insurance in South Africa.

South Africa has embarked on major health policy reform to deliver universal health coverage through the establishment of National Health Insurance (NHI). The aim is to improve access, remove financial barriers to care, and enhance care quality. Health technology assessment (HTA) is explicitly identified in the proposed NHI legislation and will have a prominent role in informing decisions about adoption and access to health interventions and technologies. The specific arrangements and approach to HTA in support of this legislation are yet to be determined. Although there is currently no formal national HTA institution in South Africa, there are several processes in both the public and private healthcare sectors that use elements of HTA to varying extents to inform access and resource allocation decisions. Institutions performing HTAs or related activities in South Africa include the National and Provincial Departments of Health, National Treasury, National Health Laboratory Service, Council for Medical Schemes, medical scheme administrators, managed care organizations, academic or research institutions, clinical societies and associations, pharmaceutical and devices companies, private consultancies, and private sector hospital groups. Existing fragmented HTA processes should coordinate and conform to a standardized, fit-for-purpose process and structure that can usefully inform priority setting under NHI and for other decision makers. This transformation will require comprehensive and inclusive planning with dedicated funding and regulation, and provision of strong oversight mechanisms and leadership.

POSC272 How Does the Japanese CE-HTA Compare with ROW?

In Japan, since April 2019 selected pharmaceutical products and medical devices have required health technology assessment (HTA) of their cost-effectiveness (CE) by the Central Social Insurance Medical Council (Chuikyo), from which list-price adjustments are made. This formal HTA process was implemented in response to unsustainable healthcare costs, with Japan having some of the highest drug costs outside the US. This research aims to compare the CE outcomes of the first two pharmaceutical products that have been assessed in Japan (Fluticasone/umeclidinium/vilanterol [Trelegy] and Tisagenlecleucel [Kymriah]) with other CE markets.

Mentoring as a potential means to assist consumer representatives contribute effectively to the assessment of health technologies in Australia: a pragmatic review.

This project was implemented on behalf of the Health Technology Assessment (HTA) Consumer Consultative Committee (CCC) to explore training to support and retain new consumer representatives to participate effectively in HTA committees. These committees are key parts of the Australian Government's health system. Currently, there is no training available to them, specific to their roles in HTA committees. Hypothesizing that mentoring is appropriate, the project team undertook a literature review to identify definitions of mentoring, its benefits, skills requirements, resources, examples of best practice, and how mentoring might support consumer representatives in formal health technology assessment committee structures. A rapid review was commenced by the project team and fifty-seven articles were identified and read independently. Following discussion, the team revised its approach as there was little evidence to assess and drew upon thirty-five articles where elements of mentoring were described. Discussion was followed by a thematic qualitative analysis exploring mentoring models. The project team agreed that features of mentoring programs were necessary to design a mentoring program under the headings of definitions, mentors' qualities, benefits of training, resources, other considerations, and evaluation. These assist the design of a pilot project to test mentoring's effectiveness. Mentoring may assist consumers working in the health technology area to develop their skills and competencies and contribute to representing the needs of health consumers in the approval of applications. A pilot mentoring program is currently being designed and will run with one mentor and one mentee in an HTA committee.

Resident Perspectives 56–3

Resident Perspectives 56–3

PMU59 GLOBAL OUTCOMES-BASED CONTRACTING TRENDS IN THE US AND EUROPE OVER THE PAST 5 YEARS

As global spending on medicines continues to escalate, healthcare markets are experiencing increased pressure to improve patient access to highly effective, yet costly therapies. Outcomes-based contracts (OBCs) have been implemented as a sustainable solution to the rising cost of healthcare. Variation in healthcare system infrastructure, market priorities and the existence of formal health technology assessment bodies, may account for the differences in approaches to outcomes-based contracting between the US and EU.

OP123 A Cost-Effectiveness Registry For Prioritization In Emerging Markets

IntroductionDecision-makers in low- and middle-income countries (LMICs) often must prioritize health spending without quantitative benchmarks for the value of their purchases. The Tufts Global Health Cost-Effectiveness Analysis (GH CEA) Registry (healtheconomicevaluation.org/GHCEARegistry/) is a freely-available, curated and standardized dataset designed to address this need.MethodsAll indexed English-language articles published between 1995 and 2017 are currently included in the GH CEA Registry. Studies are limited to those reporting cost-effectiveness in terms of cost per disability-adjusted life years (DALYs) averted, a commonly-employed metric in global health. Abstracted data include intervention type, comparator(s), country, funding source, study characteristics (e.g., perspective, time horizon), primary study findings, sensitivity analyses, and disaggregated data on costs and DALYs. Study quality is assessed using a numerical scoring system (from 1-7, higher scores indicating better quality) based on accuracy of findings and comprehensive reporting of methods and results.ResultsTo date, 620 articles have been included in the GH CEA Registry. Among LMICs, studies have been conducted primarily in Sub-Saharan Africa (41 percent) or South Asia (34 percent), have focused on communicable diseases (67 percent), and have involved immunization, educational, or pharmaceutical interventions (67 percent). As a priority-setting example, seven percent of interventions from higher-quality studies (ratings of 5 or higher) were reported to be cost-saving (i.e., lower costs and greater DALYs than standard care), two-thirds of which involved primary disease prevention (e.g., immunization, educational or behavioral interventions).ConclusionsThe GH CEA Registry is a new tool for decision-makers in LMICs, particularly those without a formal health technology assessment infrastructure but with a remit for providing access to essential, cost-effective health interventions. New functions are under development, including league tables for priority ranking, a repository for shared models, and tools for enhancing transferability between settings.

2471. The State of Cost-Utility Analyses in Vaccines: A Systematic Review

BackgroundEconomic evaluations are a major consideration of public health decisions on vaccine programs. Given the growth in the number of published cost-utility analyses of vaccines, we sought to better understand global trends in these studies by describing trends in growth, quality, and study findings in the published literature over time.MethodsWe reviewed published economic evaluation of vaccines using the Tufts CEA Registry, a comprehensive database of 5,546 published healthcare related cost-utility analyses. Descriptive data from eligible publications were screened and summarized by reviewers, who also perform an assessment of the quality of each study. We described studied vaccines, their geographic distribution, author affiliation, funding sources, quality and results.ResultsThere were 379/5,546 articles examining the cost-effectiveness of vaccines published in the CEA registry between 1980 and 2017. The United States (n = 121), Canada (n = 36), the Netherlands (30), and the UK (n = 29) were the largest publishers, accounting for 57% of total publications. Overall, publications covered 12 therapeutic categories of vaccines, with HPV vaccine-related articles accounting for the largest proportion of articles (25%; n = 94). While the majority of study authors reported academic affiliations (n = 300), most studies were funded by industry (n = 120) and government (n = 94). Most studies reported favorable findings, and 16% of articles (n = 60) reported cost-savings against comparator interventions. The median ICER of all vaccine cost-effectiveness analyses was approximately $22,182 USD/quality-adjusted life year. The mean quality rating of all vaccine articles was 4.7/7, and was consistent across funding sources and vaccine type.ConclusionThe publication of cost-utility analyses of vaccines has steadily increased over time. Given the impact of these studies on clinical practice and public health policy, more trained researchers and peer-review processes are needed to utilize this information, especially in jurisdictions that do not have a formal health technology assessment process for vaccines.This study is funded by Sanofi Pasteur.Disclosures All Authors: Sanofi Pasteur: Employee, Salary.

Cost-effectiveness of interventions to control cardiovascular diseases and diabetes mellitus in South Asia: a systematic review

ObjectivesMore than 80% of cardiovascular diseases (CVD) and diabetes mellitus (DM) burden now lies in low and middle-income countries. Hence, there is an urgent need to identify and implement the...

OP108 From Essential Medicines List To Health Technology Assessment, And From Reimbursement To Pricing Decision-Making

Introduction:All health systems are challenged by finite resources to address unlimited demand for services. In many countries priority-setting and resource-allocation decision-making has been inconsistent and unstructured. In these cases, the lack of coherence between limitless promise and limited resources leads to implicit and covert rationing through waiting lines, low quality, inequities, and other mechanisms. Over the past decades, different countries have established specialized health technology assessment (HTA) organizations aimed at better informing health care policies and clinical practice. Although the first technology assessment institution, although not exclusively health related, was the Office for Technology Assessment (OTA) in the U.S. in the 1970s, HTA is not yet current nationwide practice. Nevertheless, there are more than fifty agencies in operation in over thirty countries to assist systematic priority setting, especially in high income countries. The cases of Ukraine, Colombia and U.S. represent different features of the need for systematic priority setting. Ukraine is moving from National essential medicines lists (EML) to more dynamic HTA use to update its publicly funded benefits package; Colombia established a few years ago nationwide HTA, but is currently attempting to use HTA for Pricing and Reimbursement since healthcare coverage is so heavily contested by judicialization. Nevertheless, even in countries where formal HTA activities are ongoing, and in most low and middle income countries, rationing still occurs as an ad hoc, haphazard series of non-transparent choices that reflect the competing interests of governments, payers and other stakeholders. Henceforth, there is the opportunity to closely review why the state of development for HTA varies so much according to setting.Methods:Retrospective policy analysis considering common motivators for the implementation of HTA; the agenda setting model of the three streams (problems, policy and politics) for policy action ; and qualitative approaches for the inception of HTA are being used in these three cases.Results:Through a qualitative approach, ten “drivers” previously emerged with the ability to help or hinder HTA development in Colombia were used to assess the difference of HTA development in the USA and Ukraine (i.e. availability and quality of data, implementation strategy, cultural aspects, local capacity, financial support, policy/political support, globalization, stakeholder pressure, health system context, and usefulness perception). Policy/political and financial support, stakeholder pressure, cultural aspects and health system context were the most prominent drivers to induce or prevent institutional development of HTA in different countries.Conclusions:Common motivators, similar drivers and context specific characteristics are all influential for the implementation of HTA at the national level. Policy/political and financial support, stakeholder pressure, cultural aspects and health system context preliminarily seemed the most prominent drivers to induce or prevent institutional development of HTA in different countries. Henceforth, methods and processes matter, as well as the political economy for HTA. Further research is needed to test these preliminary findings.

Early Insights from Commercialization of Gene Therapies in Europe.

After years of research and development, gene therapies are now becoming a commercial reality with several products approved by European regulatory authorities [...].

CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE

The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Strengthening and implementing health technology assessment and the decision-making process in the Region of the Americas.

ABSTRACT Objective. Health technology assessment (HTA) has been adopted by countries in order to improve allocative efficiency in their health systems. This study aimed to describe and analyze the HTA decision-making process in the Region of the Americas. Methods. A literature review was done to better understand the HTA situation in the Region. Also, in 2014 and 2015, individuals responsible for conducting HTA in countries of the Americas were identified and received a questionnaire on HTA and the decision-making process. Results. A total of 46 questionnaire responses were obtained, from 30 countries. The respondents were similar in terms of their institutions, main funding sources, and technology types assessed. Of the 46 respondents, 23 (50%) work for their respective ministry of health. Also, 36 (78%) undertake and/or coordinate HTA through coverage and reimbursement/pricing decisions and other HTA-related activities, while 24 (52%) use HTA for emerging technologies. While some countries in the Region have created formal HTA units, there is a weak link between the HTA process and decision-making. Most of the countries with recognized HTA institutions are members of the Health Technology Assessment Network of the Americas (RedETSA). Despite the advances in the Region overall, most countries in Central America and the Caribbean are still at the early stages of implementing HTA to support decision-making. Conclusions. Many countries in the Americas have benefited from the exchange and capacity-building opportunities within RedETSA. However, there are still many challenges to overcome in the Region in terms of the discussion and creation of HTA-related policies.

The cost-effectiveness of bevacizumab for the treatment of advanced ovarian cancer in Canada.

The overall survival (os) analysis of the icon7 trial demonstrated that frontline ovarian cancer patients with a high risk of progression (stage iii suboptimally debulked, and stage iii or iv with unresectable disease) benefited from the addition of bevacizumab to standard chemotherapy compared with standard chemotherapy alone. The objective of the present study was to investigate the cost-effectiveness, from a Canadian publicly funded perspective, of adding bevacizumab to frontline treatment of ovarian cancer at high risk of progression. An area-under-the-curve, Markov-structured model was used to estimate the cost-effectiveness of the treatments. Long-term progression-free survival (pfs) and os were extracted from the icon7 trial (subgroup at high risk of relapse) and extrapolated by parametric time-to-event functions over a time horizon of 10 years. Canadian pfs health state utility values were obtained from the EQ-5D (EuroQoL Group, Rotterdam, Netherlands) questionnaires in the icon7 high-risk patient population. Canadian post-progression utility values were consistent with those for other gynecologic cancers. Cost inputs were informed by public sources. An annual 5% efficacy and cost discount rate was applied. A probabilistic sensitivity analysis and one-way sensitivity analyses were conducted. Ovarian cancer patients at high risk of progression receiving bevacizumab plus standard chemotherapy experienced a mean incremental quality-adjusted life year (qaly) gain of 0.374 years. At an additional cost of $35,901.54, the incremental cost-effectiveness ratio (icer) for the addition of bevacizumab to standard chemotherapy, relative to standard chemotherapy alone, was $95,942 per qaly. No formal health technology assessment willingness-to-pay threshold exists in Canada. However, at a threshold of $100,000 per qaly, bevacizumab in addition to chemotherapy is a cost-effective alternative for ovarian cancer patients who are at high risk of progression (stage iii suboptimally debulked, and stage iii or iv with unresectable disease). Using the $100,000 per qaly threshold in a probabilistic sensitivity analysis, it was determined that, compared with standard chemotherapy, the addition of bevacizumab to chemotherapy is cost-effective in 56% of tested scenarios.

Centrally Inserted External Catheters and Totally Implantable Ports for the Delivery of Chemotherapy: A Systematic Review and Meta-Analysis of Device-Related Complications

This systematic review and meta-analysis aimed to evaluate the risks of complications (infectious and non-infectious) including the need for device removal associated with centrally inserted external catheters compared with totally implantable ports in patients undergoing chemotherapy. Relevant major electronic databases were searched from inception to December 2012. All randomized controlled trials (RCT) and observational studies that compared centrally inserted external catheters with totally implantable ports in patients undergoing chemotherapy were included in the systematic review. Meta-analysis was carried out to estimate the odds ratios of device-associated complications, including infection, non-infectious complications and device removal associated with external catheters relative to implantable ports. Overall, five RCTs and 25 observational studies were included in the study. The studies were heterogeneous, and included adults and children, with different types of cancer, undergoing chemotherapy. Based on the pooled estimates from included studies, external catheters were associated with approximately a three to four-fold increase in the risks of infections, non-infectious complications and device removal compared implantable ports. The findings of this study showed that totally implantable ports are superior to external catheters in terms of catheter-associated complications. However, a formal health technology assessment on the clinical and cost-effectiveness of the use of implantable ports compared with external catheters is needed to inform policy makers of the relative value of investing in totally implantable devices compared with external catheters.