Health Technology Assessment Studies Research Articles

Poor Rhinitis and Asthma Control Is Associated With Decreased Health-Related Quality of Life and Utilities: A MASK-air Study

BackgroundAllergic rhinitis (AR) and asthma may impact health-related quality-of-life. However, national estimates on the quality-of-life of patients with AR or asthma are lacking. ObjectiveTo provide estimates for utility scores and EQ-5D Visual Analog Scale (VAS) for patients with AR or asthma. MethodsWe conducted a cross-sectional study using direct patient data from the MASK-air® app on European MASK-air® users with self-reported AR or asthma. We used a multiattribute instrument (EQ-5D) to measure quality-of-life (as utility scores and EQ-5D VAS values). Mean scores were calculated per country and disease control level using multilevel regression models with post-stratification, accounting for age and sex biases. ResultsWe assessed data from up to 7905 MASK-air® users reporting a total of up to 82,737 days. For AR, utilities ranged from 0.86-0.99 for good control versus 0.72-0.85 for poor control; EQ-5D VAS levels ranged from 78.9-87.9 for good control versus 55.3-64.2 for poor control. For asthma, utilities ranged from 0.84-0.97 for good control versus 0.73-0.87 for poor control; EQ-5D VAS levels ranged from 68.4-81.5 for good control versus 51.4-64.2 for poor control. Poor disease control was associated with a mean loss of 0.14 utilities for both AR and asthma. For the same control levels, AR and asthma were associated with similar utilities and EQ-5D VAS levels. However, lower values were observed for asthma+AR when compared to AR alone. ConclusionPoor AR or asthma control are associated with reduced quality-of-life. The estimates obtained from mHealth data may provide valuable insights for health technology assessment studies.

Ethical soundness of health technology assessment reports in Islamic Republic of Iran.

Health technology assessment (HTA) is a conventional method for evaluating reasonable use of health technologies in many countries. To investigate the ethical soundness of HTA studies in Islamic Republic of Iran. All HTA reports published by the HTA office until 2020 were reviewed using the HTA Core Model and the Q-SEA questionnaires. We evaluated 91 reports for ethical soundness. The research question, literature search and inclusion/exclusion criteria were included in 91.2%, 83.5% and 82.4% of the HTA reports, respectively. Only 13.2% of the reports explicitly stated the objective of the analysis and 6.6% stated the ethics framework. Only 2.2%, 4.4%, 9.9%, 9.9%, 14.3%, and 2.2%, respectively, of the reports, complied with the completeness, bias, policy implications, other implications, conceptual clarification, and conflicting values. HTA reports in the Islamic Republic of Iran require coordinated and integrated framework acceptable to all stakeholders to ensure their compliance with sound ethical requirements.

Protocol for estimating the willingness-to-pay-based value for a quality-adjusted life year to aid health technology assessment in India: a cross-sectional study

IntroductionTo ensure that the evidence generated by health technology assessment (HTA) is translated to policy, it is important to generate a threshold value against which the outcomes of HTA studies...

HTA and Gastric Cancer: Evaluating Alternatives in Third- and Fourth-Line Patients.

Metastatic gastric cancer (mGC) represents an economic and societal burden worldwide. The present study has two aims. Firstly, it evaluates the benefits and the added value of the introduction of trifluridine/tipiracil (FTD/TPI) in the Italian clinical practice, defining the comparative efficacy and safety profiles with respect to the other available treatment options (represented by the best supportive care (BSC) and FOLFIRI (5-FU, irinotecan, and leucovorin) regimens). Secondly, it assesses the potential economic and organizational advantages for hospitals and patients, focusing on third- and fourth-line treatments. For the achievement of the above objective, a health technology assessment study was conducted in 2021, assuming the NHS perspective within a 3-month time horizon. The literature reported a better efficacy of FTD/TPI with respect to both BSC and FOLFIRI regimens. From an economic perspective, despite the additional economic resources that would be required, the investment could positively impact the overall survival rate for the patients treated with the FTD/TPI strategy. However, the innovative molecule would lead to a decrease in hospital accesses devoted to chemotherapy infusion, ranging from a minimum of 34% to a maximum of 44%, strictly dependent on FTD/TPI penetration rate, with a consequent opportunity to take on a greater number of oncological patients requiring drug administration for the treatment of any other cancer diseases. According to experts' opinions, lower perceptions of FTD/TPI emerged concerning equity aspects, whereas it would improve both individuals' and caregivers' quality of life. In conclusion, the results have demonstrated the strategic relevance related to the introduction of FTD/TPI regarding the coverage of an important unmet medical need of patients with metastatic gastric cancer who were refractory to at least two prior therapies, with important advantages for patients and hospitals, thus optimizing the clinical pathway of such frail patients.

Assistive Technologies and Quadriplegia: A Map Point on the Development and Spread of the Tongue Barbell Piercing

The barbell piercing can be used as an assistive device that allows people with severe disabilities, such as tetraplegia, to control their environments using the movement of the tongue. The human tongue can move rapidly and accurately, such that the tip can touch every tooth. Lingual control systems allow people with disabilities to take advantage of their residual skills for easier communication and to improve the control of mobility and the surrounding environment. The aim of this study was to conduct a narrative review of the development and dissemination of the assistive technologies based on tongue control by means of the barbell piercing. The design of the study was based on: (I) an overview of Pubmed complemented with other databases and Web searches (also institutional); (II) an organization according to a standardized checklist for narrative reviews; (III) an arrangement with four different perspectives: the trends in the scientific literature, technological evolution and categorization, dominant approaches, issues of incorporation into the health domain-such as acceptance, safety, and regulations. The results have highlighted: (1) that the volume of scientific productions, which started in this sector before the smartphone expansion, has not increased; (2) that it is possible to make a map point of the technological evolution and categorization; (3) that these assistive technologies have a high degree of acceptance and performance, especially when integrated with aid tools with mechatronics; (4) and the complexity of the regulatory framework in this area. The study, from a general point of view, highlighted the high potential of these systems and we suggest investing the energy into agreement tools for assistive technologies (AT)s, such as health technology assessment studies, comparative assessment analysis, or consensus conferences that could allow a better diffusion and use of ATs, including these systems.

Applying Multi-Criteria Decision Making (MCDM) in Health Technology Policy Making: Background, Current Challenges, and Path to Future

Introduction: The science of health technology policy-making has, in recent years, gone beyond merely conducting health technology assessment studies, systematic reviews or economic evaluations. In fact, sciences based on decision-making in operational research, such as multi-attribute and multi-objective decision-making methods, have been added to this field.
 Methods: Examining several prominent papers in the field of applying multi-criteria decision analysis to the science of health technology assessment, this study attempts to provide guidance for policy makers in the field of health technologies to acquaint them with the history, current challenges, and the future of this field.
 Results: Mathematical approaches based on multi-criteria decision analysis began to be used in the fields of health policy making and economics in 2006 and 2008. These approaches are still being completed to adapt to the field of health. The main challenges in this regard are the existence of attributes such as equity and ethical issues facing the use of technology in health systems. The quantitative assessment of such attributes is really demanding. It is also very difficult to weight the attributes in such a way that all the considerations regarding technology stakeholders can be taken into account.
 Conclusions: In general, the application of approaches from applied mathematics to the field of health technology policy making can help us clarify the prioritization process. At the same time, however, using the efforts made so far by researchers in this field from around the world, we have, to a large extent, been able to overcome the operational shortcomings in applying those approaches in the field of health.

Evaluation of telehomecare Studies in Patients with Chronic Heart Failure: A health Technology Assessment Study

Background: Heart failure (HF) is a major complication resulting from a variety of heart diseases. HF is an increasingly important issue, whose prevalence has doubled in the last two decades. This is due to increased life expectancy, treatment and prevention of other heart diseases, and increased life expectancy. Promoting self-care through tele homecare is an emerging strategy for managing chronic diseases.
 Objectives: The purpose of this study is to evaluate tele-care studies in patients with chronic heart failure (CHF). This is based evaluating the types of technologies used for patients in this method, effectiveness, cost-effectiveness and safety of these technologies based on the aspects of health technology assessment.
 Methods: PubMed, Scopus, Web of Science, Cochrane databases, HTA (Health Technology Assessment), NHS EED (National Health System Economic Evaluation Database), DARE (Database of Abstract of Reviews of Effects), Embase, and (Society for Information Display) SID were searched using medical subject heading (Mesh) keywords. Then, studies were evaluated by two people and disputed by a third party. The quality of the extracted studies was evaluated based on the (Risk of Bias) RoB 2.0 checklist. The difference between the mean and its standard deviation was calculated (which was used as the effect size). To analyze the results, meta-analysis of random effects was performed. In addition, the subgroup and meta-regression analysis were performed to discover possible sources of heterogeneity. Finally, studies were evaluated in terms of Health Problem and Current Use of the Technology (CUR), Description and technical characteristics of technology (TEC), safety (SAF), Clinical effectiveness (EFF), Costs and economic evaluation (ECO) of 9 Aspects of Health Technology Assessment (HTA). Studies were evaluated with respect to the long-distance care in patients with CHF. We approach the method through systematic review and meta-analysis based on the principles of PRISMA-P. This systematic review examined the effectiveness of long-distance care interventions in patients with CHF, compared with conventional care methods. In general, evaluation of studies extracted in this systematic review will try to identify, evaluate and combine the effects of tele-care in patients with HF using meta-analytical methods in the evidence. Evaluating studies conducted in the field of tele-care in patients with CHF will help us to better understand how these methods work in the management of chronic heart disease [effectiveness, safety and cost reduction] and determine which care interventions Distance is more effective in patients with HF based on their characteristics according to clinical outcomes and resource use.
 Conclusion: The results of this study can be used as a guide to provide valid evidence for the decision of senior managers of the Ministry of Health and large hospitals to use common technologies used in distance care for patients with CHF and other chronic diseases. This study will also provide a new understanding of the various studies that have been conducted to help patients with chronic failure by different types of remote care technologies in terms of effectiveness, safety, technology, and economic costs.

Hospital-Based Health Technology Assessment of Machine Perfusion Systems for Human Liver Transplantation

Based on published data, we have carried out a hospital-based health technology assessment of machine perfusion in adult liver transplantation using cold storage as a comparator, and within the perspective of a national health system-based hospital practice and disease-related group reimbursement policy. A systematic literature review on machine perfusion for adult liver transplantation was conducted exploring the Pubmed, CINAHL, Scopus, Embase, and Cochrane databases. The literature was analyzed with the intent to provide information on 6 dimensions and 19 items of the hospital-based health technology assessment framework derived from previous studies. Out of 705 references, 47 (6.7%) were retained for current analysis. Use of machine perfusion was associated with advantages over cold storage, i.e., a 10%–50% reduced risk for early allograft dysfunction, 7%–15% less ischemia reperfusion injury; 7%–50% fewer ischemic biliary complications, comparable or improved 1-year graft and patient survival, and up to a 50% lower graft discard rate. Hospital stay was not longer, and technical failures were anecdotal. Information on costs of machine perfusion is limited, but this technology is projected to increase hospital costs while cost-effectiveness analysis requires data over the transplant patient lifetime. No hospital-based health technology assessment study on machine perfusion in liver transplantation was previously conducted. From the hospital perspective, there is evidence of the clinical advantages of this novel technology, but strategies to counterbalance the increased costs of liver transplantation are urgently needed. Further studies should focus on the ethical, social, and organizational issues related to machine perfusion.

Latest developments and scope of Health Technology Assessment in India: Tapping into the future

Health Technology Assessment (HTA) is a multifaceted approach for informing policy by considering social, medical, economic and ethical aspects in a systematic and transparent manner. HTA is an important tool for decision-making, priority-setting and for resource allocation, leading to Universal Health Coverage (UHC). The importance of HTA becomes more pronounced in developing countries such as India. In this review, we have summarised the status and future scope of HTA in India after referring to the scientific literature available in the form of journal articles and government reports. HTA supports prioritisation of healthcare services to be included in UHC and the provision of affordable and quality healthcare services in India. India established ‘HTA in India’ (HTAIn) in January 2017 as a starting point in HTA activities and this centre conducts HTA studies of various methodologies upon receiving requests from the different central and state departments. HTA in India is a relatively new concept and the processes are not streamlined compared to countries where HTA is established. Although an HTA manual is present for guiding the HTA process in India, there is lack of clarity on the HTA information considered for translating evidence into policy or practice. Additionally, there is a dearth of individual capacity to undertake high quality HTA in the country. HTAIn initiative showcases India’s political commitment towards achieving UHC and for HTA. However, there is an imminent need to expand the role of the technical partners and regional resource hubs in capacity building in HTA by involving the private sector in HTA processes.

Development of an EQ-5D Value Set for India Using an Extended Design (DEVINE) Study: The Indian 5-Level Version EQ-5D Value Set

ObjectivesThis study aimed to develop the Indian 5-level version EQ-5D (EQ-5D-5L) value set, which is a key input in health technology assessment for resource allocation in healthcare. MethodsA cross-sectional survey using the EuroQol Group’s Valuation Technology was undertaken in a representative sample of 3548 adult respondents, selected from 5 different states of India using a multistage stratified random sampling technique. The participants were interviewed using a computer-assisted personal interviewing technique. This study adopted a novel extended EuroQol Group’s Valuation Technology design that included 18 blocks of 10 composite time trade-off (c-TTO) tasks, comprising 150 unique health states, and 36 blocks of 7 discrete choice experiment (DCE) tasks, comprising 252 DCE pairs. Different models were explored for their predictive performance. Hybrid modeling approach using both c-TTO and DCE data was used to estimate the value set. ResultsA total of 2409 interviews were included in the analysis. The hybrid heteroscedastic model with censoring at −1 combining c-TTO and DCE data yielded the most consistent results and was used for the generation of the value set. The predicted values for all 3125 health states ranged from −0.923 to 1. The preference values were most affected by the pain/discomfort dimension. ConclusionsThis is the largest EQ-5D-5L valuation study conducted so far in the world. The Indian EQ-5D-5L value set will promote the effective conduct of health technology assessment studies in India, thereby generating credible evidence for efficient resource use in healthcare.

Safety and Effectiveness of Lung Cancer Screening Using Low-dose Computed Tomography Scan in High-risk Individuals: A Comprehensive Review

Context: Lung cancer is the most important cause of cancer mortality. Given the incidence and mortality of this disease, the implementation of preventive interventions is necessary. Objectives: The present study investigated the effectiveness of one of the most important interventions of lung cancer screening with lowdose computed tomography (LDCT) in high-risk individuals.
 Evidence Acquisition: The present study was an applied study performed as a comprehensive review. For the assessment of safety, studies on the technical specifications of computed tomography scans and issues related to the safety of applying this device were searched using keywords in medical databases. For the evaluation of clinical effectiveness, a comprehensive review of health technology assessment studies, systematic review studies, and screening guidelines was performed.
 Results: Based on 15 studies extracted for the safety issue, the diagnosis of harmless tumors, false positives cases and Unnecessary invasive complementary interventions, and possible negative effects of radiation exposure are discussable safety issues. Based on the synthesis of 16 studies on effectiveness, lung cancer screening intervention using LDCT was determined to reduce lung cancer mortality by 15 - 20% and mortality from other causes by 0 - 6%. Additionally, the incidence of this disease in its upper stages decreases significantly.
 Conclusions: Lung cancer screening using LDCT does not threaten the health of individuals seriously and, in comparison to nonintervention is more clinically effective and will lead to a statistically significant reduction in lung cancer mortality and increase in the timely diagnosis of this disease.

OP318 Health Technology Assessment And Decision-Making Processes: The Purchase Of Magnetic Resonance Imaging Technology

IntroductionMedical devices play an essential role in health care, but they are also a leading causes of increasing healthcare expenditures. The purchase of technologies and the determination of how and when they should be used are among the most important decisions made by decision-makers, at the institutional level.The present research focuses on the Portuguese health system and sheds light on the characterization of decision-making process by those involved in Magnetic Resonance Imaging (MRI) purchases.MethodsTo characterize the decision-making process, results from forty questionnaires and twenty-seven semi-structured interviews with key decision-makers were merged, using a mixed method approach. To assess competences for decision-making, a questionnaire was applied, and Exploratory and Confirmatory Factorial Analysis conducted.ResultsCost and suppliers’ characteristics are seen as the most important indicators to guide decisions. The decision is undertaken by a committee, in a bottom-up process, characterized by a bounded rationality, influenced by intuition and a consultant decision-maker. The reasoning and justification for selection of the committee members is unclear. The decision process is considered to be bureaucratic, time-consuming and long. Patients are negatively perceived as stakeholders in the process. Few studies were performed (mostly related to the workload of the Radiology Department) to support the decision and no national or international health technology assessment (HTA) study was used in the process, to guide decisions. Decision-makers have limited knowledge and training in areas of decision-making in the areas of health informatics, health economics and especially HTA. This may limit their ability to truly understand the future implications of their purchase decisions.ConclusionsTo foster HTA in decision-making processes, recommendations are made, in particular, to: (i) establish an HTA in-house unit, able to carry out studies considering the hospital context and aiming to inform managerial local decisions (ii) promote a team comprised of technology assessment multidisciplinary researchers but also professionals from the health institution able to carry out HTA studies (iii) foster common languages and values to increase uptake of HTA studies.

Expectations for the Development of Health Technology Assessment in Brazil.

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts’ expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

A Health Technology Assessment in Maxillofacial Cancer Surgery by Using the Six Sigma Methodology.

Squamous cell carcinoma represents the most common cancer affecting the oral cavity. At the University of Naples “Federico II”, two different antibiotic protocols were used in patients undergoing oral mucosa cancer surgery from 2006 to 2018. From 2011, there was a shift; the combination of Cefazolin plus Clindamycin as a postoperative prophylactic protocol was chosen. In this paper, a health technology assessment (HTA) is performed by using the Six Sigma and DMAIC (Define, Measure, Analyse, Improve, Control) cycle in order to compare the performance of the antibiotic protocols according to the length of hospital stay (LOS). The data (13 variables) of two groups were collected and analysed; overall, 136 patients were involved. The American Society of Anaesthesiologist score, use of lymphadenectomy or tracheotomy and the presence of infections influenced LOS significantly (p-value < 0.05) in both groups. Then, the groups were compared: the overall difference between LOS of the groups was not statistically significant, but some insights were provided by comparing the LOS of the groups according to each variable. In conclusion, in light of the insights provided by this study regarding the comparison of two antibiotic protocols, the utilization of DMAIC cycle and Six Sigma tools to perform HTA studies could be considered in future research.

Application of DMAIC Cycle and Modeling as Tools for Health Technology Assessment in a University Hospital.

Background The Health Technology Assessment (HTA) is used to evaluate health services, manage healthcare processes more efficiently, and compare medical technologies. The aim of this paper is to carry out an HTA study that compares two pharmacological therapies and provides the clinicians with two models to predict the length of hospital stay (LOS) of patients undergoing oral cavity cancer surgery on the bone tissue. Methods The six Sigma method was used as a tool of HTA; it is a technique of quality management and process improvement that combines the use of statistics with a five-step procedure: “Define, Measure, Analyze, Improve, Control” referred to in the acronym DMAIC. Subsequently, multiple linear regression has been used to create two models. Two groups of patients were analyzed: 45 were treated with ceftriaxone while 48 were treated with the combination of cefazolin and clindamycin. Results A reduction of the overall mean LOS of patients undergoing oral cavity cancer surgery on bone was observed of 40.9% in the group treated with ceftriaxone. Its reduction was observed in all the variables of the ceftriaxone group. The best results are obtained in younger patients (−54.1%) and in patients with low oral hygiene (−52.4%) treated. The regression results showed that the best LOS predictors for cefazolin/clindamycin are ASA score and flap while for ceftriaxone, in addition to these two, oral hygiene and lymphadenectomy are the best predictors. In addition, the adjusted R squared showed that the variables considered explain most of the variance of LOS. Conclusion SS methodology, used as an HTA tool, allowed us to understand the performance of the antibiotics and provided variables that mostly influence postoperative LOS. The obtained models can improve the outcome of patients, reducing the postoperative LOS and the relative costs, consequently increasing patient safety, and improving the quality of care provided.

"Perspectives" in Health Technology Assessment.

This article considers 2 types of standard by which health technology assessment (HTA) studies should be judged: methodological and social. Methodological desiderata specify characteristics of a good quality analysis and should be met regardless of context. Transparency about an HTA study's perspective (eg, specifying whose costs and whose benefits from an intervention should be counted) is one such desideratum. Whether any particular perspective is the right one is, by contrast, contingent upon conditions in which the analysis is to be applied. A perspective ought always to be treated as context sensitive. Recently, it has been advocated that an HTA study's perspective should always be "societal" (ie, including consequences, good or bad, for anyone affected in any way by a technology's use). This article argues that this is a mistake, ethically attractive though it might appear.

Assessing the performance of health technology assessment (HTA) agencies: developing a multi-country, multi-stakeholder, and multi-dimensional framework to explore mechanisms of impact

BackgroundHealth technology assessment (HTA) agencies have an important role to play in managing the rising demands on health systems. However, creating and running such agencies potentially diverts resources from frontline services. A large number of studies address the question of ‘what is the impact of HTA?’. Several points of heterogeneity in this literature include: purpose of the study, definition of HTA, definition of impact, and scope and rigour of evaluations. Our study seeks to address several limitations in this literature. This study aims to explore the mechanisms of impact of an HTA agency. In doing so, we consider HTA as an institution rather than a knowledge product to build an impact evaluation framework from an international, multi-stakeholder and multi-dimensional perspective.MethodsWe conducted 9 key informant interviews with experts from the international HTA community. We addressed several questions, informed by existing frameworks of impact within the literature, to understand their perspectives on the mechanisms of impact of an HTA agency. We analyse data using logic modelling and impact mapping, as tools to understand and visualise mechanisms of change.FindingsOur impact mapping highlights several distinct, but not necessarily mutually exclusive, mechanisms through which the overall impact of an HTA agency is achieved. These are: the effective conduct of HTA studies; effective use of HTA in agenda-setting and policy formulation processes; effective engagement and external communications; good institutional reputation and fit within the healthcare and policy-making system; effective use of HTA as a tool for the negotiation of health technology prices; and the effective implementation of policy change regarding health technologies. We also identify indicators of these effects.ConclusionsOur findings and resulting evaluation framework complement and add to existing literature by offering a new perspective on the mechanisms by which HTA agencies generate impact. This new perspective considers HTA as an institution rather than a knowledge product, is international, multi-dimensional, and includes multi-stakeholder views. We hope the analysis will be useful to countries interested in managing HTA performance.

Psychometric Properties of the Patient Reported Outcomes Burdens and Experiences (PROBE) Questionnaire

Objective:To assess the psychometric properties of The Patient Reported Outcomes, Burdens and Experiences (PROBE) questionnaire.Methods: This study was a cross-sectional, multi-national study. Participants were enrolled if they were 10 years or older and patients with hemophilia A or B or people without bleeding disorder. Participants were invited through non-governmental hemophilia patient organizations in 17 countries between 04/08/2015 and 12/28/2015, and completed the PROBE questionnaire. The following psychometric properties: item responses, missing data, floor and ceiling effects, exploratory factor analysis, and internal consistency reliability were examined. A PROBE Score was derived and assessed for its convergent and known groups validity.Results: The study enrolled a total of 677 participants with median age of 40.0 (interquartile range 26.0 to 54.5) years, 71.9% male. Missing data was up to 2.5% for the section concerning patient reported outcomes (PROs). More than 15% of participants presented floor effect for all items but two, and a ceiling effect for two items. Factor analysis identified three factors explaining the majority of the variance. Cronbach's alpha coefficient indicated good internal consistency reliability (0.83). PROBE items showed moderate to strong correlations with corresponding EQ-5D-5L domains. The PROBE Score has a strong correlation (r=0.72) with EQ-5D-5L utility index score. The PROBE Score has a discriminative validity among known groups.Conclusions: The results of this study suggest that PROBE is a valid questionnaire for evaluating PROs in people with hemophilia, as well as control population. The discriminative property of PROBE will allow its use in future clinical trials, longitudinal studies, health technology assessment studies, routine clinical care or registries. DisclosuresSkinner:Baxalta, now part of Shire; Bayer; Bioverativ; CSL; Novo Nordisk, Roche and Sobi with administrative support provided by the US National Hemophilia Foundation: Research Funding; US National Hemophilia Foundation: Other: non-financial support ; US National Hemophilia Foundation: Other: non-financial support ; Baxalta, now part of Shire; Bayer; Bioverativ; CSL; Novo Nordisk, Roche and Sobi with administrative support provided by the US National Hemophilia Foundation: Research Funding. Curtis:Bioverativ: Research Funding; Bayer: Research Funding, Speakers Bureau; Baxter: Research Funding; CSL Behring: Research Funding; Gilead: Honoraria; Genentech: Honoraria, Research Funding; Novo Nordisk: Honoraria, Research Funding; Pfizer: Research Funding. Nichol:Bioverativ: Consultancy, Research Funding; Baxter: Research Funding; Genentech: Research Funding; Pfizer: Research Funding; Bayer: Research Funding; Novo Nordisk: Research Funding; CSL Behring: Research Funding; Merck: Consultancy. Noone:Baxalta, now part of Shire; Bayer; Bioverativ; CSL; Novo Nordisk, Roche and Sobi with administrative support provided by the US National Hemophilia Foundation: Research Funding. O'Mahony:US National Hemophilia Foundation: Other: non-financial support.

Safety and Efficacy of Remdesivir for the Treatment of Covid-19: A Rapid Review of Available Evidence

Context: Remdesivir is an antiviral drug manufactured by Gilead Sciences, Inc., in which in-vitro studies have been shown to work in COVID-19 patients. Although it’s not approved by pharmaceutical authorities and has not passed the first and second phases of clinical trials, it is prescribed on a trial basis for patients with Covid-19. In more than 20 countries, researchers are monitoring the results of using Remdesivir in clinical settings to see if it can be prescribed for larger populations if patients respond positively. Methods: This is a rapid review of the evidence for the potential effects of Remdesivir, which intended to create a policy guide. To do so, health technology assessment studies indexed in MEDLINE and Cochrane Library databases were searched using the keywords, including drug name and disease name, on April 21, 2020. In addition, references of retrieved studies were checked to ensure throughout the capture of the literature. Studies on the safety and efficacy of Remdesivir in Covid-19 patients, both in Persian or English, were included. To identify ongoing clinical trials in Iran and some countries, clinical trial registration systems were also searched. Results: In total 90 titles were identified, which after removing duplicates and applying inclusion criteria, 32 were included, all of which were published in 2020. 25 of them were review studies, mostly on treating Covid-19 disease, and some of them were dedicated to the effects of Remdesivir in treating the disease. However, no systematic review was found. Of the remaining studies, three were finished clinical trials, two of which evaluated the safety and efficacy of Remdesivir on mild, moderate, and severe Covid-19 compared to a placebo, and the third study compared Remdesivir with routine treatment. A cohort study on the efficacy of Remdesivir in compassionate use was also found. Also, two case reports of patients receiving Remdesivir and a letter-to- editor describing Remdesivir as an appropriate treatment for Covid-19 were identified. Moreover, registered clinical trials with different designs intended to investigate the safety and efficacy of Remdesivir in treating Covid-19 were extracted from clinical trial registration systems (Table 3). In total 15 protocols were found, which 13 were in primary stages. The other two were in phase three of clinical trials and aimed to investigate the effect of Remdesivir in treating patients with severe, moderate, or mild Covid-19. In the clinical trial registration system, it is mentioned that the first study is stopped prematurely due to the lack of a sufficient number of patients, and the second study is also suspended. Conclusions: Evidence on the safety and efficacy of Remdesivir in treating Covid-19 are very limited to make a decision. However, if registered trials are completed, enough evidence would be available to decide whether to accept or reject the Remdesivir. Since the effectiveness of Remdesivir is not clear yet, its prescription for Covid-19 patients has so far been limited to clinical trials, compassionate use, or emergency use.

OP141 Health Technology Assessment In India: Current Scenario And Way Forward

IntroductionIndia 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.MethodsEconomic 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.ResultsAfter 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.ConclusionsHTA 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.