India has introduced health technology assessment (HTA) as a tool for improving the allocation of health resources. The core mandate of HTA in India (HTAIn) is to undertake critical appraisal of available technologies, identify cost-effective interventions, and help the government pursue evidence-informed decisions regarding public health expenditures. We conducted a systematic review to assess economic evaluation studies published in the last four years from India.

Economic evaluations published from September 2015 to September 2019 were identified by searching various databases, including PubMed, Scopus, Embase, The Cochrane Library, and CINAHL according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Cost-effectiveness studies and HTAs reported or conducted in India were included. Two independent reviewers performed the final selection of studies by assessing the full-text articles and conducted the data extraction. Differences of opinions were resolved through discussion and mutual consensus.

After screening 2,837 articles, seventy met the inclusion criteria and were selected. The articles predominantly used secondary data (70%) to evaluate the cost effectiveness of an innovation. Among the technologies assessed, fifty-seven percent were curative in nature and most commonly addressed infectious diseases (27%), closely followed by non-communicable diseases, and maternal and child health. Principally, the cost effectiveness of a technology was expressed in terms of disability-adjusted or quality-adjusted life-years. Only two studies reported negative findings.

HTA can play a pivotal role in equipping policy makers and public health payers to make appropriate decisions for healthcare budget allocations when mapped with the true disease burden of the population. It is important to highlight negative results and to create a national repository of HTA studies to facilitate faster adoption of best practices in India.

Telemedicine uses information and communication technologies to provide services in the field where the distance is a critical factor. The aim of the present study is to describe the experience of a synchronous telemedicine between two hospitals in Spain and Angola.

This is a retrospective observational study of all synchronous telemedicine sessions conducted between the Hospital Nossa Senhora da Paz in Angola and the Vall d'Hebron University Hospital in Spain from January 2011 to December 2014.

Seventy-two cases were discussed in the telemedicine sessions. The average age of patients was 18.02 (SD 13.75) years and mostly women (54.38 percent). Reasons to discuss the cases were 46.47 percent doubts in the diagnosis and therapeutic management, 15.47 percent were purely formative cases, and only 8.45 percent treatment doubt. At the time of presentation, 29 percent of the patients were already diagnosed, 95 percent of whom with infectious disease diagnostic, and from the undiagnosed patients 36 percent presented a febrile syndrome.

This study shows the viability of synchronous telemedicine between European and African countries without an excessively sophisticated technology.

Various forms of outcomes-based or risk-sharing agreements have been implemented since early 2000s as a way of access to innovative medicinal products. This study aims to summarize the international experience of performance-based risk-sharing arrangements (PBRSAs) and identify the preconditions for a successful implementation of such schemes. Their implications for the Chinese healthcare market are discussed.

A systematic literature review (in PubMed) was conducted to review the evidence on the nature and performance of PBRSAs in the past 10 years. Grey literature was searched for reports in government websites of the countries in scope.

The search identifies 463 records from PubMed and 3 additional records from other sources. Thirty-one publications are included in the final review. The following preconditions were identified to support a successful implementation of PBRSAs: (1) Identify meaningful and feasible outcome measurements; (2) Establish an effective and efficient data collection infrastructure; (3) Control of the implementation costs; (4) Develop governance and administrative infrastructure to allow delisting and rebate/refund; (5) Clarify personal data protection issues.

The implementation of PBRSAs has proven to be challenging. Although the Chinese healthcare system is not yet well equipped to implement such schemes, some recent changes may pave the way to successful PBRSAs for particular innovative products.

Web-based and mobile health interventions, also called eHealth, have significant potential to deliver cost effective, quality health care. The present review maps common eHealth technology solutions for primary healthcare by evaluating their safety, efficacy, and effectiveness, and the challenges associated with their implementation in low-middle income countries (LMIC) in the last ten years.

A search of various electronic database was conducted, including PubMed, Scopus, and PsycINFO, to identify articles published between 2009 and 2019 that focused on the implementation of eHealth in the primary healthcare setting across LMICs. A total of 450 articles were screened and thirty-nine relevant articles were selected for review.

The thirty-nine included studies were classified into the following four categories: (i) assessment of intervention effects (n = 26); (ii) cost-benefit analysis (n = 4); (iii) systematic review (n = 5); and (iv) conceptual exploration of eHealth interventions (n = 4). The eHealth studies covered three domains: (i) non-communicable diseases; (ii) reproductive, maternal, newborn, and child health; and (iii) other health issues. The included eHealth technologies comprised mobile health (n = 27), telemedicine (n = 10), and information and communication technology (n = 2).

The majority of studies assessed eHealth technologies based on the following eight dimensions: safety, clinical effectiveness, technical aspects, acceptability, cost, ethical aspects, adaptability to local needs, and scalability. However, evidence on safety, cost effectiveness, and scalability were limited. The main implementation challenges identified were technology development and maintenance costs, the need for trained human resources, and acceptability among users. The methodologies and assessment frameworks of the studies were heterogeneous in nature, highlighting the need for a robust, standardized, and comprehensive framework for assessing eHealth technologies.

To alert policy makers early about emerging health technologies that could significantly impact the healthcare system at the clinical, financial and organizational levels, the Agency for Care Effectiveness (ACE) in Singapore established a horizon scanning system (HSS) in 2019. This paper describes the development of the ACE HSS and showcases its application with cell and gene therapy products as the first example.

A literature review of existing HSS methods, including the processes of the EuroScan International Network and other overseas horizon scanning agencies, was done to inform the development of our horizon scanning framework. The framework was first applied to the new and emerging cell and gene therapies.

Identification sources, filtration and prioritization criteria, and horizon scanning outputs for the HSS were developed in alignment to international best practices, with recommendations for technology uptake represented by a traffic light system. For the first horizon scanning exercise on cell and gene therapies, forty therapies passed the filtration step, of which eight were prioritized for further assessment. The few early reports developed were used to inform and prepare the healthcare system for their potential introduction, particularly in terms of the need to develop health and funding policies.

Early assessment of prioritized topics has provided support for strategic efforts within the Ministry of Health. Given that ACE's horizon scanning program is still in its infancy, the framework will continue to evolve to ensure relevance to our stakeholders so that it remains fit for purpose for our healthcare system.

The terminology used to describe community participation in Health Technology Assessment (HTA) is contested and frequently confusing. The terms patients, consumers, public, lay members, customers, users, citizens, and others have been variously used, sometimes interchangeably. Clarity in the use of terms and goals for including the different groups is needed to mitigate existing inconsistencies in the application of patient and public involvement (PPI) across HTA processes around the world.

We drew from a range of literature sources in order to conceptualize (i) an operational definition for the “public” and other stakeholders in the context of HTA and (ii) possible goals for their involvement. Draft definitions were tested and refined in an iterative consensus-building process with stakeholders from around the world.

The goals, terminology, interests, and roles for PPI in HTA processes were clarified. The research provides rationales for why the role of the public should be distinguished from that of patients, their families, and caregivers. A definition for the public in the context of HTA was developed: A community member who holds the public interest and has no commercial, personal, or professional interest in the HTA process

There are two distinct aspects to the interests held by the public which should be explicitly included in the HTA process: the first lies in ensuring democratic accountability and the second in recognising the importance of including public values in decision making.

The aim of this ethics analysis was to highlight the overt and covert value issues with regard to two health technologies (light therapy and vitamin D therapy), the health technology assessment (HTA) and the disease of seasonal affective disorder (SAD). The present ethics analysis served as a chapter of a full HTA report that aimed to assist decision makers concerning the two technologies.

First, we used the revised Socratic approach of Hofmann et al. to build overarching topics of ethical issues, and then, we conducted a hand search and a comprehensive systematic literature search on between 12 and 14 February 2019 in seven databases.

The concrete ethical issues found concerned vulnerability of the target population and the imperative to treat depressive symptoms for the sake of preventing future harm. Further disease-related ethical issues concerned the questionable nature of SAD as a disease, autonomy, authenticity, and capacity for decision making of SAD patients, and the potential stigma related to the underdiagnosis of SAD, which is contrasted with the concern over unnecessary medicalization. Regarding the interventions and comparators, the ethical issues found concerned their benefit-harm ratios and the question of social inequality. The ethical issues related to the assessment process relate to the choice of comparators and the input data for the selected health economic studies.

The concrete ethical issues related to the interventions, the disease, and the assessment process itself were made overt in this ethics analysis. The ethics analysis provided an (additional) value context for making future decisions regarding light and vitamin D therapies.

In 2017, the National Institute for Health and Care Excellence (NICE) and the National Health Service England established a program to identify Digitally Enabled Therapies (DET) that increase access to Improving Access to Psychological Therapies (IAPT) services. The aim was to determine whether DETs could improve service efficiency, and whether outcomes are at least as good as those achieved by NICE-recommended non-digital therapies.

An IAPT assessment briefing (IAB) was developed for each eligible DET. IABs included an assessment of content, technical standards, clinical effectiveness, and cost and resource impact. IABs were reviewed by the NICE IAPT expert panel to decide whether a DET is suitable for evaluation in IAPT services, needs further development, or is not suitable. Suitable DETs were evaluated for up to two years.

Of 154 DETs reviewed by the program, fourteen had IAB assessments. The high dropout rate was due to ineligible products or developer withdrawal. Of the fourteen IABs, five were recommended for evaluation, one was recommended for development, and eight were not recommended.

DETs can provide an alternative for patients who may not be able to access treatment. When establishing programs to review DETs, centers must consider the quality of the products submitted and, where necessary, make pragmatic decisions about assessment criteria.

Economic models play a central role in the decision-making process of the National Institute for Health and Care Excellence (NICE). Inadequate validation methods allow for errors to be included in economic models. These errors may alter the final recommendations and have a significant impact on outcomes for stakeholders.

To describe the patterns of technical errors found in NICE submissions and to provide an insight into the validation exercises carried out by the companies prior to submission.

All forty-one single technology appraisals (STAs) completed in 2017 by NICE were reviewed and all were on medicines. The frequency of errors and information on their type, magnitude, and impact was extracted from publicly available NICE documentation along with the details of model validation methods used.

Two STAs (5 percent) had no reported errors, nineteen (46 percent) had between one and four errors, sixteen (39 percent) had between five and nine errors, and four (10 percent) had more than ten errors. The most common errors were transcription errors (29 percent), logic errors (29 percent), and computational errors (25 percent). All STAs went through at least one type of validation. Moreover, errors that were notable enough were reported in the final appraisal document (FAD) in eight (20 percent) of the STAs assessed but each of these eight STAs received positive recommendations.

Technical errors are common in the economic models submitted to NICE. Some errors were considered important enough to be reported in the FAD. Improvements are needed in the model development process to ensure technical errors are kept to a minimum.

This paper aims to describe the clinical and regulatory aspects of new drugs and indications that were approved for lung, breast, prostate, and colorectal cancer, from 2016 to 2018, in order to provide health technology assessment trends in oncology.

Data were collected from the US Food and Drug Administration (FDA) online database for new medications and indications approved for the above-mentioned types of cancer. Data regarding clinical study characteristics and regulatory information were collected.

From 2016 to 2018, 53 percent of the FDA approvals of new drugs and indications for the most incident cancers were for oral protein kinase inhibitor monotherapy for advanced lung cancer. Since 2018, four drugs were approved as tumor-agnostic therapies. A biomarker was included in 72 percent of indications, and 58 percent of approvals were for targeted therapies, potentially heralding an end to research into conventional cytotoxic agents. A special designation for faster approval was granted in 78 percent of new approvals. The majority of the studies were open label randomized controlled trials (RCTs) (44 percent), followed by blind RCTs, single-arm clinical trials, and cohort studies. Only 14 percent of studies used overall survival as the primary end point; the vast majority used surrogate end points, and did not use patient-important outcomes. Three biosimilars were approved in the period.

Advanced lung cancer therapy, mainly targeted drugs, accounted for 53 percent of approvals. Special designations for faster approval were used in 78 percent of FDA approvals, and four drugs were approved for tumor-agnostic treatment—a new form of approval.

The newer cancer treatment technologies hold the potential of providing improved health outcomes at an additional cost. So it becomes obligatory to assess the costs and benefits of a new technology, before defining its clinical value. We assessed the cost-effectiveness of intensity-modulated radiotherapy (IMRT) as compared to 2-dimensional radiotherapy (2-DRT) and 3-dimensional radiotherapy (3D-CRT) for treating head and neck cancers (HNC) in India. The cost-effectiveness of 3-DCRT as compared to 2-DRT was also estimated.

A probabilistic Markov model was designed. Using a disaggregated societal perspective, lifetime study horizon and 3 percent discount rate, future costs and health outcomes were compared for a cohort of 1000 patients treated with any of the three radiation techniques. Data on health system cost, out of pocket expenditure, and quality of life was assessed through primary data collected from a large tertiary care public sector hospital in India. Data on xerostomia rates following each of the radiation techniques was extracted from the existing randomized controlled trials.

IMRT incurs an incremental cost of $7,072 (2,932–13,258) and $5,164 (463–10,954) per quality-adjusted life year (QALY) gained compared to 2-DRT and 3D-CRT, respectively. Further, 3D-CRT as compared to 2-DRT requires an incremental cost of $8,946 (1,996–19,313) per QALY gained.

Both IMRT and 3D-CRT are not cost-effective at 1 times GDP per capita for treating HNC in India. The costs and benefits of using IMRT for other potential indications (e.g. prostate, lung) require to be assessed before considering its introduction in India.

Quality-adjusted life-years (QALYs) and disability-adjusted life-years (DALYs) are commonly used in cost-effectiveness analysis (CEA) to measure health benefits. We sought to quantify and explain differences between QALY- and DALY-based cost-effectiveness ratios, and explore whether using one versus the other would materially affect conclusions about an intervention's cost-effectiveness.

We identified CEAs using both QALYs and DALYs from the Tufts Medical Center CEA Registry and Global Health CEA Registry, with a supplemental search to ensure comprehensive literature coverage. We calculated absolute and relative differences between the QALY- and DALY-based ratios, and compared ratios to common benchmarks (e.g., 1× gross domestic product per capita). We converted reported costs into US dollars.

Among eleven published CEAs reporting both QALYs and DALYs, seven focused on pharmaceuticals and infectious disease, and five were conducted in high-income countries. Four studies concluded that the intervention was “dominant” (cost-saving). Among the QALY- and DALY-based ratios reported from the remaining seven studies, absolute differences ranged from approximately $2 to $15,000 per unit of benefit, and relative differences from 6–120 percent, but most differences were modest in comparison with the ratio value itself. The values assigned to utility and disability weights explained most observed differences. In comparison with cost-effectiveness thresholds, conclusions were consistent regardless of the ratio type in ten of eleven cases.

Our results suggest that although QALY- and DALY-based ratios for the same intervention can differ, differences tend to be modest and do not materially affect comparisons to common cost-effectiveness thresholds.

Traditionally, health technology assessment (HTA) focuses on assessing the impact of pharmaceutical technologies on health and care. Resources are scarce and policy makers aim to achieve effective, accessible health care. eHealth innovations are increasingly more integrated in all healthcare domains. However, how eHealth is assessed prior to its implementation in care practices is unclear. To support evidence-informed policy making, this study aimed to identify frameworks and methods for assessing eHealth's impact on health care.

The scientific literature in five bibliographical databases was systematically reviewed. Articles were included if the study was conducted in a clinical setting, used an HTA framework and assessed an eHealth service. A systematic qualitative narrative approach was applied for analysis and reporting.

Twenty-one HTA frameworks were identified in twenty-three articles. All frameworks addressed outcomes related to the technical performance and functionalities of eHealth service under assessment. The majority also addressed costs (n = 19), clinical outcomes (n = 14), organizational (n = 15) and system level aspects (n = 13). Most frameworks can be classified as dimensional (n = 13), followed by staged (n = 3), hybrid (n = 3), and business modeling frameworks (n = 2). Six frameworks specified assessment outcomes and methods.

HTA frameworks are available for a-priori impact assessment of eHealth services. The frameworks vary in assessment outcomes, methods, and specificity. Demonstrated applicability in practice is limited. Recommendations include standardization of: (i) reporting characteristics of eHealth services, and (ii) specifying assessment outcomes and methods following a stepped-approach tailored to the functional characteristics of eHealth services. Standardization might improve the quality and comparability of eHTA assessments.

The purpose of this study was to evaluate the current state of health economic evaluations (HEEs) submitted by pharmaceutical companies to the Italian Medicines Agency (AIFA) as part of their pricing and reimbursement (P&R) dossiers, and to explore potential future actions in order to enhance their quality.

All company dossiers submitted from October 2016 to December 2018 were reviewed to select those containing pharmacoeconomic studies. The general characteristics of HEEs were described and their quality assessed based on a checklist adapted from Philips et al. (Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess. 2004;8: 1–158).

Of the 299 dossiers submitted to AIFA, 105 included one or more pharmacoeconomic studies, of which fifty-three were cost-effectiveness analyses. Overall, the compliance of the HEEs with the quality checklist was highly variable: some studies reached high methodological standards whereas others had serious flaws (mean 59.22 percent, range 19.35–90.32 percent). The main weaknesses were the unjustified exclusion of relevant alternatives, poor description and justification of model data and assumptions, and insufficient exploration of uncertainty and study validity. Non-homogeneity across studies was found in study perspectives, discount rates, methods for costing, estimating quality-adjusted life-years and conducting sensitivity analyses.

Based on the results of this study, the recommended actions for increasing the quality of HEEs within reimbursement submissions in Italy are twofold: first, to set methodological standards for conducting and reporting HEEs; second, to strengthen the internal assessment process, also through the acquisition of companies' models and re-evaluation of results. These actions will hopefully provide greater contribution to the evidence-based P&R decision making.

Ghana is in the process of formally introducing health technology assessment (HTA) for health decision making. Similar to other low- and middle-income countries, evidence suggests that the lack of data and human capacity is a major barrier to the conduct and use of HTA. This study assessed the current human and data capacity available in Ghana to undertake HTA.

As economic evaluation (EE) forms an integral part of HTA, a systematic review of EE studies undertaken in Ghana was conducted to identify the quality and number of studies available, methods and source of data used, and local persons involved. The literature search was undertaken in EMBASE (including MEDLINE), PUBMED, and Google Scholar. The quality of studies was evaluated using the Consolidated Health Economics Evaluation Reporting Standards. The number of local Ghanaians who contributed to authorship were used as a proxy for assessing human capacity for HTA.

Thirty-one studies were included in the final review. Overall, studies were of good quality. Studies derived their effectiveness, resource utilization and cost data mainly from Ghana. The most common source of cost data was from the National Health Insurance Scheme pricing list for medicines and tariffs. Effectiveness data were mostly derived from either single study or intervention programs. Sixty out of 199 authors were Ghanaians (30 percent); these authors were mostly involved in data collection and study conceptualization.

Human capacity for HTA in Ghana is limited. To introduce HTA successfully in Ghana, policy makers would need to develop more local capacity to undertake Ghanaian-specific HTA.

Disruptive telemedicine tools can help overcome the lack of specialized care and electroencephalographic (EEG) support for diagnosing and treating nervous system disorders such as epilepsy in remote communities. However, evidence on how such cloud-based platforms could enhance data-driven health care is limited. The utility of telemedicine-based apps to achieve EEG screening of communities in rural areas of Paraguay was investigated.

This descriptive study was carried out by the Telemedicine Unit of the Ministry of Public Health in collaboration with the Department of Biomedical Engineering and Imaging of the Health Science Research Institute in Paraguay and the Basque Country University in Spain to evaluate the utility of telediagnostic apps for EEG screening. For this purpose, the results obtained by tele-EEG apps implemented in nineteen public community hospitals were analyzed to determine the utility of the apps as epidemiological surveillance tools.

Among the 10,791 remote EEG studies performed, the most common reasons for the test included epileptic seizure (44%), headache (22%), seizure disorder (8%), follow up (6%), attention deficits in children (5%), cognitive impairment (4%), cranioencephalic trauma (3%), brain death (1%), history of seizure (0.9%), abnormal movements (0.7%), and behavioral disorders (0.5%).

The results showed that telemedicine apps can significantly enhance nationwide EEG screening by freeing up professional time and increasing productivity, improving access and equity, and reducing costs. However, before their systematic implementation a contextualization of the apps using the regional epidemiological profile must be performed.

While involving patients in health technology assessment (HTA) has become increasingly common and important around the world, little is known about the optimal methods of evaluating patients’ involvement (PI) in HTA. This scoping review was undertaken to provide an overview of currently available methods for the evaluation of PI, specifically the impact of PI on HTA recommendations.

A literature search was conducted using nine databases as well as a grey literature search of the websites of 26 organizations related to the conduct, practice or research of HTA to identify articles, reports and abstracts related to the evaluation of PI impact in HTA.

We identified 1,248 unique citations, six of which met our eligibility criteria. These six records (five articles, and one report) were all published after 2012. Four assessed the impact of patient experience submissions on final HTA recommendations; one evaluated the impact of direct involvement on HTA committees, and one assessed impact of multiple forms of involvement. Methods of evaluation included quantitative analyses of reimbursement decisions, qualitative interviews with those directly involved in an assessment, surveys of patient groups and committee members, and the review of HTA reports.

Quantitative evaluation of PI based on associations with funding decisions may not be feasible or fully capture the relevant impact of PI in the assessment of health technologies. Rather, a combination of both qualitative and quantitative strategies may allow for the most comprehensive assessment of the impact of PI on HTA recommendations when possible.