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A health technology assessment (HTA) does not systematically account for the circumstances and needs of children and youth. To supplement HTA processes, we aimed to develop a child-tailored value assessment framework using a multicriteria decision analysis approach. We constructed a multicriteria-decision-analysis-based model in multiple phases to create the Comprehensive Assessment of Technologies for Child Health (CATCH) framework. Using a modified Delphi process with stakeholders having broad disciplinary and geographic variation (N = 23), we refined previously generated criteria and developed rank-based weights. We established a criterion-pertinent scoring rubric for assessing incremental benefits of new drugs. Three clinicians independently assessed comprehension by pilotscoring 9 drugs. We then validated CATCH for 2 childhood cancer therapies through structured deliberation with an expert panel (N = 10), obtaining individual scores, consensus scores, and verbal feedback. Analyses included descriptive statistics, thematic analysis, exploratory disagreement indices, and sensitivity analysis. The modified Delphi process yielded 10 criteria, based on absolute importance/relevance and agreed importance (median disagreement indices = 0.34): Effectiveness, Child-specific Health-related Quality of Life, Disease Severity, Unmet Need, Therapeutic Safety, Equity, Family Impacts, Life-course Development, Rarity, and Fair Share of Life. Pilot scoring resulted in adjusted criteria definitions and more precise score-scaling guidelines. Validation panelists endorsed the framework's key modifiers of value. Modes of their individual prescores aligned closely with deliberative consensus scores. We iteratively developed a value assessment framework that captures dimensions of child-specific health and nonhealth gains. CATCH could improve the richness and relevance of HTA decision making for children in Canada and comparable health systems. • Health technology assessment (HTA) methods for child health technologies are challenged by evidentiary limitations and incomplete consideration of the unique biological and social circumstances and needs of children and youth. Multicriteria decision analysis has emerged as an HTA tool for explicitly considering nonconventional values. • This article presents novel child-specific value assessment criteria based in societal preferences, which reflect the importance of family impacts and long-term flourishing of children beyond immediate health gains obtained through treatment. • A child-tailored multicriteria decision analysis approach facilitating HTA deliberations may broaden the normative lens through which child health technologies are evaluated, contributing to more comprehensive and relevant decision making. [ABSTRACT FROM AUTHOR]

To comprehensively identify and map an exhaustive list of value criteria for the assessment of next-generation sequencing/comprehensive genomic profiling (NGS/CGP), to be used as an aid in decision making. We conducted a systematic review to identify existing value frameworks (VFs) applicable to any type of healthcare technology. VFs and criteria were mapped to a previously published Latin American (LA) VF to harmonize definitions and identify additional criteria and or subcriteria. Based on this analysis, we extracted a comprehensive, evidence-based list of criteria and subcriteria to be considered in the design of a NGS/CGP VF. A total of 42 additional VFs were compared with the LA VF, 88% were developed in high-income countries, 30% targeted genomic testing, and 16% specifically targeted oncology. A total of 242 criteria and subcriteria were extracted; 227 (94%) were fully/partially included in the LA VF; and 15 (6%) were new. Clinical benefit and economic aspects were the most common criteria. VFs oriented to genomic testing showed significant overlap with other VFs. Considering all criteria and subcriteria, a total of 18 criteria and 36 individual subcriteria were identified. Our study provides an evidence-based set of criteria and subcriteria for healthcare decision making useful for NGS/CGP as well as other health technologies. The resulting list can be beneficial to inform decision making and will serve as a foundation to co-create a multistakeholder NGS/CGP VF that is aligned with the needs and values of health systems and could help to improve patient access to high-value technologies. • Value frameworks play a crucial role in enhancing transparency and facilitating informed decision making within the healthcare system. They serve as valuable guides, highlighting key dimensions that need evaluation when assessing various healthcare technologies. • Institute for Clinical Effectiveness and Health Policy recently developed a value framework for diagnostic technologies, based on a targeted systematic review and a participatory process with health technology assessment stakeholders in Latin America. • In this article, we report a systematic review to update the previous framework and develop a comprehensive evidence-based list of criteria and subcriteria that could be considered for creation of a next-generation sequencing/comprehensive genomic profiling-targeted value framework, as well as a starting point for value frameworks targeted to other health technologies. [ABSTRACT FROM AUTHOR]

The objective of this study was to evaluate the cost-utility of the Oxford, CoronaVac, and Janssen COVID-19 vaccines from the perspective of the Brazilian public health system. A total of 3 microsimulation models were constructed with individual data to evaluate the 3 vaccines. The simulation contains 7 transition states that are related to the natural history of the disease. The model with a daily cycle has a time horizon of 1 year and uses data from 289 days of the pandemic. The analysis was conducted from the perspective of the Brazilian public health system considering direct medical costs. For the model inputs, outpatient and hospital databases were used with information on treated patients stratified by age. Information on mortality was also stratified based on patients' age in the mortality database (SIM). The efficacy of vaccines to reduce the likelihood of patients becoming ill was evaluated independently for each vaccine. Information on the quality of life of patients in outpatient or hospital treatment and the sequelae resulting from the disease were extracted from the literature. The main outcome of the analysis was quality-adjusted life-years (QALYs). The vaccines showed incremental cost-utility ratios ranging from R$−23 161.3/QALY (Oxford) to R$17 757.85/QALY (CoronaVac). The older the population, the lower was the incremental cost-utility ratio. Given a willingness-to-pay threshold of R$17 586/QALY, all the vaccines were considered cost-effective in the probabilistic sensitivity analysis. The results of the analysis by age group can help in the preparation of a vaccination prioritization plan. • This is the first economic evaluation performed with COVID-19 vaccines from the perspective of the Brazilian public health system. • The analysis used real-world data on mortality and outpatient and hospital treatment, which represent the context of the first year of the pandemic in Brazil. • The study allowed for a comparison of the cost-utility ratios of 3 different vaccines used in Brazil, taking into account 3 age groups (<59, 60-75, and >75 years old), and demonstrating the impact of price and number of doses on the efficiency of health spending. [ABSTRACT FROM AUTHOR]

The focus on health maximisation in a healthcare economic evaluation (HEE) – that is health gains are of equal value regardless of the recipient– has significant implications as health systems attempt to address persistent and growing health inequities. This study aimed to systematically compare and contrast the equity principles of different health technology assessment (HTA) agencies and how equity is addressed in HEE guidelines. HTA agencies were identified through the ISPOR, GEAR, iDSI, HTAi, INAHTA, HTAsiaLink, and RedETSA websites in June 2021 and updated in August 2023. Agencies websites were then searched to retrieve HEE guidelines. The guidelines were grouped into two categories: well-established and newly-developed agency guidelines, based on whether or not they published their first guidelines before 2009. Data extracted summarised the methodological details in the reference cases, including specifics on how equity featured and in what role. In those agencies where equity did not feature explicitly in the HEE guidelines, an additional search of the agency website was undertaken to understand if equity featured in those agencies' decision-making frameworks. The study included 46 guidelines from 51 countries. Only 30% of the guidelines were explicit about the equity assumptions. Health equity (using a broad definition) was mentioned in 29 guidelines and 14 included a specific definition while only seven recommended specific methods to incorporate inequalities. Addressing equity concerns was usually suggested as an additional analyses rather than a key part of the assessment. It was unclear how equity was incorporated into decision-making processes. In addition, equity was mentioned in other guidance – such as decision-making frameworks - provided by five agencies that did not mention it in the HEE guidelines, and 7 of 14 topic selection criteria that were identified. Equity is given less attention than efficiency in HEE guidelines. This indicates that HTA agencies while subscribing to an extra-welfarist approach have a narrow evaluative space – focusing on maximising health and not considering the opportunity cost of the equity constraint. The omission of equity and the lack of systematic approaches in guidelines poses a threat to the international endeavours to reduce inequities. It is timely for HTA agencies to reconsider their positions on equity explicitly. • Equity mentioned in 29 of 46 guidelines of HTA bodies, only 13 give methods to address inequalities. • Equity assumptions underlying economic evaluations is explicit in 14 guidelines. • The guidelines place a greater emphasis on efficiency rather than fairness. • Explicit consideration of equity needed to help deliver equitable health outcomes. [ABSTRACT FROM AUTHOR]

The traditional health economic analysis is limited to estimating the impact on the treated patient. As vaccines are usually aimed at preventing infectious diseases, they may be associated with additional values for the non-treated wider population. Although there are valid reasons for treating vaccines differently, and a wide support for a broader perspective in the literature (i.e., beyond the net costs and health gain related to the outcome for the vaccinated individual), it remains unclear to what extent the Health Technology Assessment (HTA) agencies accept and apply a broader perspective. The purpose of this study is to examine and discuss what type of consequences are relevant for a health economic analysis of vaccines and which consequences are considered by HTA agencies. The study includes a strategic review of literature and HTA decisions in Sweden and other countries, online round-table discussions with stakeholders in Sweden, and a basic estimation of the value of a COVID-19 vaccination in Sweden. The study shows that, other than herd effect, broader economic consequences for the population are generally not included in the economic evaluation of vaccines. Also, all economic consequences for the treated patient (production loss) and caregiver (health loss) are not always considered. The perspective chosen can have a major impact on the outcome of the analysis. A vaccine for COVID-19 is estimated to provide a value of €744–€956 per dose when using a societal perspective including broader consequences for the population. Providing a complete and appropriate picture of the value of vaccination is of importance to allocate resources efficiently, to provide incentives for vaccine development, and to show the cost of delaying decisions to implement a new vaccine. [ABSTRACT FROM AUTHOR]

There is an alarming delay in Europe for anticancer medicines becoming accessible for children. Following a paediatric European Union marketing authorisation, national Health Technology Assessment (HTA) agencies evaluate effectiveness, and safety of medicines to support decision on their cost and reimbursement. This study (a SIOPE Access to Medicines project) aimed to evaluate how these HTA evaluations take place for anticancer medicines indicated for paediatric use in Europe and to explore where the delays for market access originate. We obtained HTA reports from the public domain for nine European countries for blinatumomab, dinutuximab beta and tisagenlecleucel. We evaluated the time elapsed between marketing authorisation for a paediatric indication and a national HTA decision and the nature of the decision. Out of 23 HTA decisions (four countries without blinatumomab report), 18 were positive, two with restrictions, three negative. For blinatumomab, tisagenlecleucel and dinutuximab beta, the median time to an HTA decision after regulatory approval for paediatric use was 353 days (range 193–751), 141 days (range 77–517) and 515 days (range 0–780), respectively, with variability between countries. Dinutuximab beta and tisagenlecleucel were first introduced in children, but did not result in shorter time to HTA decision. For blinatumomab, marketing authorisation followed 1008 days after the indication in adults, with HTA applications submitted a median of 167 days later, and a recommendation after 145 days. This study reveals ample variability in HTA decision making in nine European Union countries. Collaboration and alignment of required evidence is needed to facilitate robust scientific HTA assessments, also considering methodological challenges in paediatric oncology. • Health technology assessments of paediatric oncology drugs vary greatly within Europe. • The timing of HTA evaluation adds to the delay of patient access. • Differences between adult and paediatric trial methodology should be considered. • Multistakeholder collaboration between EMA, academia, pharmaceutical companies, patients advocates and HTAs is needed. [ABSTRACT FROM AUTHOR]

Introduction: The incidence of foot fractures is increasing. These types of fractures represent the most expensive group of diagnoses in the emergency department. Next to this, the need for economic evaluation studies is growing fast. The aim of this article is to provide healthcare professionals with an introduction to economic evaluation studies in the field of foot fractures.Types Of Economic Evaluation Studies: Four types of economic evaluation studies exist: cost-minimization analysis (CMA), cost-benefit analysis (CBA), cost-effectiveness analysis (CEA), and cost-utility analysis (CUA). An economic evaluation study can be either trial- or model-based.Cost Assessment: When assessing costs in an economic evaluation study, three steps need to be made: identification of costs, measurement of costs, and valuation of costs.Perspective Of Analysis: Two main perspectives exist in economic evaluation studies. When using a healthcare perspective, only the potential costs and benefits of an intervention for the healthcare sector are included. The societal perspective includes all potential costs, including societal costs.Synthesis Of Costs and Effects and Uncertainty Analysis: The level of cost-effectiveness can be objectively expressed using the incremental cost-effectiveness ratio (ICER). This measure can be plotted in a cost-effectiveness plane and can be compared with existing regional ceiling ratios.Conclusion: Although this article is not a guideline for economic evaluations, we do want to present five tips to consider when performing an economic evaluation. Firstly, when measuring resource use, consult the Database of Instruments for Resource Use Measurements (DIRUM) to find an appropriate instrument. Secondly, when measuring utility values, use the EuroQol questionnaire if possible. Thirdly, when setting up an economic evaluation study, consult the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) database for the appropriate pharmacoeconomic guidelines. Fourthly, consult international guidelines to decide which study design is most appropriate. Finally, when performing an economic evaluation, consult a heath technology assessment (HTA) specialist from the start to ensure methodological quality. [ABSTRACT FROM AUTHOR]

Background: The prescribing process for children with cancer is complex, and errors can occur at any step. As a result, many interventions have been used to reduce errors. However, few of them have been designed based on an understanding of the prescriber behaviour that can lead to errors. In order to design effective behaviour change interventions, it is important first to understand the prescribing process and identify prescriber behaviours that could be targeted for change.Objectives: To describe the prescribing process in a paediatric oncology ward and to identify prescriber behaviours during prescription writing that could be targeted to reduce errors.Methods: This study employed two sequential phases. First, the prescribing process was observed and then described using the hierarchical task analysis (HTA) method. Second, prescriber tasks identified from the HTA were analysed using the behaviour change wheel (BCW) approach to identify promising behaviours for change. These identified behaviours were prioritised based on information collected from four focus groups with prescribers and chart review of errors made in the ward.Results: The prescribing process was complex and involved multiple tasks performed in varying orders. Applying the BCW identified thirty-two candidate behaviours for potentially reducing prescribing errors. However, after prioritization, only two emerged as promising candidate behaviours for intervention: writing drug indications at the time of prescribing and using a pre-written order when ordering medications through electronic prescribing.Conclusions: This research suggests that two behaviours could be promising in reducing errors. Having identified these behaviours, future work could explore what needs to change with respect to individuals and their work environments to achieve the desired change in these identified behaviours. [ABSTRACT FROM AUTHOR]

Objectives: Immunization programs in low-income and middle-income countries (LMICs) are faced with an ever-growing number of vaccines of public health importance recommended by the World Health Organization, while also financing a greater proportion of the program through domestic resources. More than ever, national immunization programs must be equipped to contextualize global guidance and make choices that are best suited to their setting. The CAPACITI decision-support tool has been developed in collaboration with national immunization program decision makers in LMICs to structure and document an evidence-based, context-specific process for prioritizing or selecting among multiple vaccination products, services, or strategies.Methods: The CAPACITI decision-support tool is based on multi-criteria decision analysis, as a structured way to incorporate multiple sources of evidence and stakeholder perspectives. The tool has been developed iteratively in consultation with 12 countries across Africa, Asia, and the Americas.Results: The tool is flexible to existing country processes and can follow any type of multi-criteria decision analysis or a hybrid approach. It is structured into 5 sections: decision question, criteria for decision making, evidence assessment, appraisal, and recommendation. The Excel-based tool guides the user through the steps and document discussions in a transparent manner, with an emphasis on stakeholder engagement and country ownership.Conclusions: Pilot countries valued the CAPACITI decision-support tool as a means to consider multiple criteria and stakeholder perspectives and to evaluate trade-offs and the impact of data quality. With use, it is expected that LMICs will tailor steps to their context and streamline the tool for decision making. [ABSTRACT FROM AUTHOR]

Objectives: The availability of novel, more efficacious and expensive cancer therapies is increasing, resulting in significant treatment effect heterogeneity and complicated treatment and disease pathways. The aim of this study is to review the extent to which UK cancer technology appraisals (TAs) consider the impact of patient and treatment effect heterogeneity.Methods: A systematic search of National Institute for Health and Care Excellence TAs of colorectal, lung and ovarian cancer was undertaken for the period up to April 2020. For each TA, the pivotal clinical studies and economic evaluations were reviewed for considerations of patient and treatment effect heterogeneity. The study critically reviews the use of subgroup analysis and real-world translation in economic evaluations, alongside specific attributes of the economic modeling framework.Results: The search identified 49 TAs including 49 economic models. In total, 804 subgroup analyses were reported across 69 clinical studies. The most common stratification factors were age, gender, and Eastern Cooperative Oncology Group performance score, with 15% (119 of 804) of analyses demonstrating significantly different clinical outcomes to the main population; economic subgroup analyses were undertaken in only 17 TAs. All economic models were cohort-level with the majority described as partitioned survival models (39) or Markov/semi-Markov models. The impact of real-world heterogeneity on disease progression estimates was only explored in 2 models.Conclusion: The ability of current modeling approaches to capture patient and treatment effect heterogeneity is constrained by their limited flexibility and simplistic nature. This study highlights a need for the use of more sophisticated modeling methods that enable greater consideration of real-world heterogeneity. [ABSTRACT FROM AUTHOR]

Objectives: A recent debate in health economics and outcomes research community identified option value as one of the elements warranting consideration in the assessment of medical technologies. To conduct a scoping review of contributions on option value in the healthcare sector and identify relevant conceptual aspects and methods used to incorporate it in standard economic evaluations.Methods: A systematic search was conducted up to July 2020 to identify contributions from electronic bibliographic database and gray literature. Data on the proposed definitions of option value, theoretical implications of its use in economic evaluations, and methods used to estimate it were extracted and analyzed.Results: We found 57 eligible studies. Three different definitions emerged: insurance value, real option value, and option value of survival. Focusing on the latter (24 studies), we analyzed in depth 8 empirical applications across 7 therapeutic areas. The most relevant methodological challenges were on the perspective used in economic evaluations and how to robustly manage forecasting uncertainty, update cost-effectiveness thresholds, and avoid double-counting issues. For empirical studies assessing the total value of the technology, including option value, estimates ranged from +7% to +469% of its conventional value.Conclusions: This review synthesizes theoretical and empirical aspects on option value of healthcare technologies and proposes a terminology to distinguish 3 different concepts identified. Future work should focus primarily on agreeing on whether option value should be included in economic evaluations and, if so, on developing and validating reliable methods for its ex-ante estimation. [ABSTRACT FROM AUTHOR]

La prise en charge de la prééclampsie est bien codifiée en phase aigüe, mais le devenir des patientes en post-partum l'est bien moins. Pourtant, la prééclampsie est associée à un excès de risque de morbimortalité cardiovasculaire au long cours. Un parcours de soin a été créé au Centre Hospitalier Universitaire de Nantes pour évaluer à distance de l'accouchement les facteurs de risque cardiovasculaires des patientes ayant présenté une prééclampsie. Notre étude en présente les premiers résultats. Nous avons inclus 134 patientes entre octobre 2016 et janvier 2019 qui ont présenté une prééclampsie dans la région nantaise et qui ont bénéficié de ce dépistage dans l'année suivant leur accouchement. L'hypertension artérielle était persistante chez 28 patientes (20,9 %). Trente-quatre patientes étaient obèses (25,3 %) et un diabète a été diagnostiqué chez une patiente. L'hypertension artérielle était à prédominance diastolique, légère et dans plus d'un tiers des cas masquée (35,7 % de pression artérielle normale lors de la consultation mais élevée sur les mesures à domicile). Une hypertension artérielle secondaire (cause hormonale ou rénale) a été identifiée dans un tiers des cas (32,1 %). L'hypertension survenait plus souvent chez les patientes plus âgées (OR : 2,26 ; IC 95 % : 1,25- 4,11, p = 0,072), originaire d'Afrique sub-saharienne (OR : 11,52 ; IC 95 % : 2,67- 49,86, p = 0,01) et multipares (OR : 7,82 ; IC 95 % : 1,15- 53,21, p = 0,035). Ce parcours de soins permet donc de dépister et de prendre en charge précocement les facteurs de risque cardiovasculaire de ces jeunes femmes. The medical treatment of preeclampsia is well structured in its acute phase but the required follow-up with patients in post-partum is discussed. However, preeclampsia is associated with an increased risk of cardiovascular morbi-mortality in the long term. In order to optimize the post-partum treatment, a care program has been developed for these patients in the city of Nantes, France. This includes a check-up of the cardiovascular risks at a day hospital. Our study presents the first results of this program. The study included 134 patients who were diagnosed with preeclampsia between October 2016 and January 2019 in the Nantes area, France, and took part in the program within the year following their childbirth. A descriptive analysis was first carried out and then a multivariate logistic regression model was used to investigate the risk factors for persistent high blood pressure after preeclampsia. The study detected 28 cases of persistent hypertension (20.9%), 34 cases of obesity (25.3%) and 1 case of diabetes. Hypertension was predominantly diastolic, mild and sometimes masked (35.7%). In a third of the cases (32.1%), the hypertension was secondary. High blood pressure was found to be more frequent in older patients (OR: 2.26; 95% CI: 1.25-4.11, p = 0.072), patients from sub-Saharan Africa (OR: 11.52; 95% CI: 2.67-49.86, p = 0.01) and multiparous patients (OR: 7.82; 95% CI: 1.15-53.21, p = 0.035). The study confirmed that this care program enables an earlier detection and therefore treatment of the cardiovascular risk factors of these young women. [ABSTRACT FROM AUTHOR]

• There is need for HTA capacity building by establishing postgraduate trainings in Romania. • Funding for HTA should be a delicate balance between public and private resources. • Primarily local data should be used for developing HTA evidence for decision-making. • Findings indicate the need for improving the methodological framework of HTA activities. Health Technology Assessment (HTA) is a complex approach increasingly used worldwide to make transparent and evidence-based reimbursement decisions for health technologies. This study aims to describe the present environment and future prospects of HTA implementation in Romania based on the opinion of a wide range of national stakeholders. A survey was conducted using a questionnaire already applied previously to design HTA roadmaps for middle-income countries. Survey responses were collected from two sites. First, responses were collected among the participants of the National Conference of Pharmacoeconomics and Health Management in October 2017 at Brasov. Second, a purposive sampling was applied to contact HTA professionals from public organizations from October 2017 to February 2018. According to the respondents there is need for HTA capacity building by establishing postgraduate trainings in Romania. The funding for HTA should be a delicate balance between public and private resources. A national HTA body with the involvement of academic institutions was the preferred organizational structure. Results indicate that the quality assurance tools such as a methodological guideline or a critical appraisal checklist should be applied and the HTA process should be transparent. Respondents emphasized the importance of using primarily local data in certain categories for developing HTA evidence for decision-making. Our study indicates the need to improve the educational and methodological framework of HTA activities and to consider the transferability of international evidence in Romania, which can contribute to improve the efficiency of the health system. [ABSTRACT FROM AUTHOR]

Objectives: Universal healthcare coverage in low- and middle-income countries requires challenging resource allocation decisions. Health technology assessment is one important tool to support such decision making. The International Decision Support Initiative worked with the Ghanaian Ministry of Health to strengthen health technology assessment capacity building, identifying hypertension as a priority topic area for a relevant case study.Methods: Based on guidance from a national technical working group of researchers and policy makers, an economic evaluation and budget impact analysis were undertaken for the main antihypertensive medicines used for uncomplicated, essential hypertension. The analysis aimed to address specific policy questions relevant to the National Health Insurance Scheme.Results: The evaluation found that first-line management of essential hypertension with diuretics has an incremental cost per disability-adjusted life-year avoided of GH¢ 276 ($179 in 2017, 4% of gross national income per capita) compared with no treatment. Calcium channel blockers were more effective than diuretics but at a higher incremental cost: GH¢ 11 061 per disability-adjusted life-year avoided ($7189 in 2017; 160% of gross national income per capita). Diuretics provide better health outcomes at a lower cost than angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or beta-blockers. Budget impact analysis highlighted the potential for cost saving through enhanced price negotiation and increased use of better-value drugs. We also illustrate how savings could be reinvested to improve population health.Conclusions: Economic evaluation enabled decision makers to assess hypertension medicines in a Ghanaian context and estimate the impact of using such evidence to change policy. This study contributes to addressing challenges associated with the drive for universal healthcare coverage in the context of constrained budgets. [ABSTRACT FROM AUTHOR]

India is a diverse land with different cultures, social norms, castes, religions, faiths, languages, politics, and a complex healthcare system. As a step to enhance healthcare, the government of India announced a move toward universal health coverage to increase accessibility and affordability of health-related services. Recently, there has been an introduction of health technology assessment (HTA) in India to help inform evidence-based decision making in cases of limited resources and budgets. Nevertheless, there are challenges related to biased decision making, an unregulated healthcare framework, and the lack of data and capacity that will (directly or indirectly) affect the use of HTA in India. For HTA to be successful in India and in similar low- and middle-income countries, it is important that the decision makers acknowledge these challenges and embrace differences in ideologies, cultures, and politics instead of ignoring them. Drawing lessons from countries with well-developed HTA bodies may help, but these need to be modified for the country-specific context. Ensuring quality and transparency is key to building trust in medical decision making. Improved coordination at all levels of healthcare is vital to ensure the long-term success of HTA in India. This is challenging but achievable by spreading awareness among stakeholders and achieving moderate health-sector regulation that can combat corruption. HTA will prosper in India if it incorporates cultural and institutional diversity, alongside tackling socioeconomic inequalities. [ABSTRACT FROM AUTHOR]

• There were 47 biosimilars approved by the European Medicines Agency (EMA) between 2006 and September 2018. • In the same period, only 14 reimbursement dossiers from marketing authorisation holders were submitted for biosimilars in Slovakia. • The Slovak health budget could save €28.26-€39.56 million per year if biosimilars with marketing authorisations were available in the Slovak market. • Proactive strategies and policies should be implemented with the aim of increasing the availability and penetration of biosimilars. • The current knowledge and perception among clinicians in Slovakia regarding biosimilars in comparison with original biologics is unknown. The aim of this study was to review legislative provisions for the reimbursement of biosimilars, assess the impact of the implemented regulations on access to biosimilars, and to calculate the lost opportunity for savings due to the limited availability of biosimilars in Slovakia. The Slovak legislation concerning the reimbursement of biosimilars was reviewed. The reimbursement dossiers of medicines, health technology assessments and appraisals, justification of the reimbursement decisions, final reimbursement decisions and all aspects of the appeal mechanisms are transparently published on the website of the Slovak Ministry of Health (http://kategorizacia.mzsr.sk/Lieky), and these were used for this analysis. Only 14 reimbursement dossiers were submitted for biosimilars between 2006 and September 2018 in Slovakia. In 2016 and 2017, no reimbursement dossiers were submitted. The results, based on data provided by wholesalers who are legally obliged to deliver information to the State Institute for Drug Control, showed that the Slovak health budget could save €28.26-€39.56 million per year if biosimilars with marketing authorisations were available in the Slovak market, and a 25–35% decrease in price compared with that of biological medicinal products. Our findings show that proactive strategies and policies should be implemented to increase availability and penetration of biosimilars on the Slovak pharmaceutical market to reduce societal losses that are caused by the lack of biosimilar medicines availability. [ABSTRACT FROM AUTHOR]

The relevance of studies focusing on patient satisfaction becomes imperative for patients with cancer, who often face major changes in their lifestyles. Their perceived uncertainty in illness and their personal experiences with the services received are crucial factors for a qualitatively adequate assistance. To assess the determinants of patient satisfaction, using a sample of 306 Bulgarian oncology outpatients. The hypotheses tested concern the extent to which patient satisfaction depends on the uncertainty in illness; the patients' assessment of technical and interpersonal skills of nurses and medical staff; the information provision; and some organizational aspects. Patients were asked to answer a questionnaire composed of internationally validated scales assessing the determinants of patient satisfaction (measured through the European Organization for Research and Treatment of Cancer), uncertainty in illness (assessed through the Mishel Uncertainty in Illness Scale), and patients' health status (assessed through the EuroQol 5-dimensional questionnaire and the visual analogue scale). An ordered logit model was run, using the level of overall patient satisfaction as a dependent variable. This is one of the first studies carried out in Bulgaria for oncology patient satisfaction of subjective factors related to the frailty of the oncology patient status such as age, self-assessed health-related quality of life, and uncertainty in illness. Nevertheless, other determinants, reflecting the quality of the care provided, also have an impact on patient satisfaction, namely, the assessment of the nonmedical personnel, the perception of medical technical skills, and the access to a medical center. Results stress the relevance of reducing uncertainty in illness in patients with cancer by implementing a satisfactory patient-physician relationship in the management of the disease. • The aim of this article was to elicit patient satisfaction and identify its principal determinants in the oncology hospital setting in Bulgaria. • The level of patient satisfaction appears to be fairly high in comparison with the international evidence. Most of the determinants of overall patient satisfaction found in this study are in line with the existing international literature. • This study enriches the existing knowledge because it is one of the first to be carried out in Bulgaria. • The results suggest that patients should be involved in the treatment as health coproducers. [ABSTRACT FROM AUTHOR]

Singapore has a robust health care system that is well known for delivering good health outcomes. In the public health care sector, subsidies and financial assistance are provided for drugs listed on the Standard Drug List and Medication Assistance Fund. Additional financing mechanisms are also available to provide further support for patients in need. With new technologies entering the market at high costs, health technology assessment (HTA) is playing an increasingly important role to inform their relative value and determine how best to allocate finite health care resources to ensure long-term sustainability of the health care system. National HTA efforts are currently focused on informing subsidy decision making and improving patient access to cost-effective drugs. The Agency for Care Effectiveness (ACE) was established in 2015 to support the Ministry of Health Drug Advisory Committee make evidence-based recommendations for the public funding of drugs. Standardized HTA methods and processes have been developed in line with international best practice to ensure that ACE's evaluations are conducted in a consistent and robust manner. Since ACE's establishment, subsidies are now provided earlier within a drug's life cycle, and value-based pricing has led to more cost-effective prices being negotiated with companies to improve affordability for patients and the public health care system. To achieve greater impact, Singapore needs to expand its HTA capacity beyond subsidy decision making and drive appropriate care in a sustainable manner for future generations. [ABSTRACT FROM AUTHOR]

Background: Proportional hazards (PH) is an assumption often made by researchers, despite evidence of nonproportionality in a significant proportion of clinical trials. In the presence of non-PH, the interpretation of hazard ratios, medians, and landmark survival as summary measures of treatment effect can become problematic. Several recent studies have recommended restricted mean survival time (RMST) as an alternative metric for survival analysis, particularly where non-PH may apply.Objectives: To determine the current approaches of health technology assessment (HTA) agencies to value assessment in the presence of non-PH, and the extent to which RMST is accepted as an alternative measure of treatment benefit.Methods: Methodological guidelines published by 10 HTA agencies were reviewed to establish recommended approaches for presenting survival benefit from clinical trials. Published HTA reports for 23 oncology agents approved by the US Food and Drug Administration and the European Medicines Agency since 2014 were reviewed to determine how guidelines are implemented in practice and identify instances where the PH assumption was tested and RMST analyses reported.Results: Testing for non-PH is not widely incorporated into HTA except by the UK National Institute for Health and Care Excellence. RMST is used infrequently but has been used in a number of countries, particularly by agencies that focus on cost effectiveness.Conclusions: HTA agencies vary in their approaches to non-PH. Most do not routinely check the PH assumption. RMST has played a role in assessing clinical benefit within HTA, although not consistently within countries (across drugs) or across countries (for the same drug). [ABSTRACT FROM AUTHOR]

• Holistic health technology assessment is required for optimal scoping/evaluation. • Considering stakeholders' values is key to plan the assessment of any intervention. • Reasons for overridden alerts & barriers/facilitators are as vital as clinical data. • Technological approaches are not enough to prevent medication errors. • Solutions for the whole/integrated process are needed. Lately, Health Technology Assessment (HTA) has narrowed its scope to analyses of mainly clinical and economic benefits. Recent challenges emphasize the need for holistic assessments to obtain accurate recommendations for decision-making considering empirical facts and stakeholder's values. VALIDATE approach considers stakeholder's views and empirical facts allowing for more comprehensive HTAs. This study frames the assessment for clinical decision support systems (CDSS) using VALIDATE. A systematic review of the literature was conducted to gather evidence on the CDSS's effectiveness and published stakeholder perspectives. Considering the retrieved information, semi-structured interviews with stakeholders were conducted to uncover issues around CDSSs such as problem definition regarding the occurrence of medication errors, judgement of existing preventive methods and previous experiences with CDSSs, background theories regarding thoughts on future impact and personal beliefs, and barriers/facilitators for implementation. When including multi-stakeholder views, reasons different from the literature are shown to interfere with CDSS acceptance/implementation, such as: i) Occurrence of ME (no traceability of medication taken/poor patient empowerment), ii) Technology as a tool to prevent ME (insufficient if only implemented at one point-of-care), iii) Previous experiences with CDSSs (low CDSSs development due to drug prescription being lastly digitalized in hospitals) and iv) CDSSs metrics (data inputted should be measured to control CDSSs performance). Including multi-stakeholders views in scoping technology evaluation brings added value and new information for the assessment, resulting in more comprehensive assessment; otherwise, it can lead to inaccurate information resulting in inaccurate decisions on if, when and how to adopt CDSS. Including varied stakeholders into health technology assessment provides a deeper understanding of what value can a technology bring in. The present study develops a framework to assess clinical decision support systems (CDSS) considering different stakeholders. They were interviewed to understand their perspective on different parts of the problem CDSSs try to solve (medication errors) and the solution itself (CDSSs). Some reasons on the interviews were different from the literature published so far, that are shown to hinder CDSS acceptance/implementation, such as: no traceability of medication taken/poor patient empowerment, CDSSs being insufficient if only implemented at one point-of-care, low CDSSs development due to drug prescription being lastly digitalized in hospitals and CDSS metrics (data inputted should be measured to control CDSSs performance). This approach can improve both implementation chances and posterior assessment of CDSSs. [ABSTRACT FROM AUTHOR]

Hypertension is responsible for 8.5 million deaths from stroke, ischemic heart disease and other vascular and kidney diseases. In Algeria, hypertension (HTN) is the most common chronic disease with an estimated prevalence of 23,6%. The PACT II study is a national, observational, descriptive, cross-sectional, multicenter and non-interventional study of therapeutic strategy, conducted in Algeria on hypertensive patients treated for at least 3 months, followed by 100 specialists or general practitioners. The primary objective is to describe the hypertension management in Algeria through the distribution of patients treated for HTN through predefined levels of arterial pressure (AP) reached under treatment. 2000 eligible patients were recruited in the study. 63.5% and 36.4% of patients were female and male respectively. The average age was 62.4 years ± 10.7. The most affected age group (65.2%) was between 55 to 75 years old. Most of the patients had an elevated blood pressure (BP) with 49.30 % at level III AP (130 – 139 mmHg of SBP or 80 – 89 mmHg of DBP), with 49.6% for diabetic patients and 48.8% for non-diabetic patients, then followed by 20.35% at the level IV AP (140 – 159 mmHg of SBP or 90 – 99 mmHg of DBP) with 21.4% for diabetic and 18.3% for non-diabetic patients. Also, 47.32% were at AP level III in patients with Renal failure. Regarding the achievement of the BP target, it was 17.4% for the overall population with 18,3% for diabetic's patients and only 12.64% for Renal failure patients. Additionally, the risk of cardiovascular disease (CVD) was at very high level for most patients, corresponding to 38,4 % of the overall study population. At last, PACT II study data were collected on analysis of blood pressure levels in the overall population and in cardiovascular risk (CVR) population groups such as diabetes (65%), sedentary lifestyle (53%), dyslipidemia (50%), obesity (44%), and renal failure (11.3%). PACT II has made it possible to update national data relating to hypertension in Algeria. It confirmed the low level of achievement of the BP target, even if the average arterial pressure level obtained was acceptable in 76% patients with a BP level which was lower than 140 mmHg for SBP and less than 90 mmHg for DBP. Many efforts must be made, according to WHO recommendations, to improve the management of hypertensive patients and BP control in Algeria. [ABSTRACT FROM AUTHOR]

There has been continuous development in the field of health technology assessment (HTA) owing to the added value of HTA in supporting healthcare reimbursement decisions. Collaboration and engagement among countries in Asia has been carried out to share experiences and learning on the barriers and factors facilitating the implementation and use of HTA in policy making. A symposium on the topic of Health Technology Assessment (HTA): Selecting the Highest Value Care was held on January 10, 2019 at the National University of Singapore, during which 3 major challenges confronting HTA development in Asia were identified. The symposium also offered possible ways to overcome the challenges. • Countries in Asia increasingly recognize and adopt health technology assessment (HTA) in setting priorities for healthcare. Nevertheless, 2 common challenges can be identified, namely, lack of infrastructure and technical capacity to cope with the increasing demand for HTA, and the inadequate involvement of stakeholders in the HTA process. • Solutions identified at the HTA symposium in Singapore to overcome these challenges were that countries should implement a tailored and transparent mechanism for using HTA, promote existing HTA capacity, and strengthen the understanding of HTA among the stakeholders. • Health technology assessment symposia such as the one organized in Singapore provide a platform for countries to share knowledge and challenges, and bring different views to build into something greater and overcome the challenges. Such symposia should be organized regularly. [ABSTRACT FROM AUTHOR]

Slovak law sets clear rules and timelines in the process of approving the price and reimbursement of drugs. During the last decade, the Ministry of Health adopted several cost-containment measures in the price and reimbursement policy. The most effective measures were the implementation of the external referencing of drug prices in 2008 and the reimbursement law in 2011. The new act introduced several regulations such as making stricter rules for the referencing of prices, setting cost per quality-adjusted life-year threshold, and defining new rules for the setting of reimbursements. On one side, implementation of these measures helped to achieve visible cost savings, but, on the other side, cost-containment policies have had some unintended consequences. In recent years, Slovakia has been facing a decreased availability of drugs because of parallel exports. As a result of the government’s effort, Slovakia is the only country in the European Union that implemented a legal ban on the re-export of medicines. During the decade before 2011, many innovative drugs were included in the reimbursement system. Because of stricter legal conditions introduced in 2011, there has been a gradual shift in reimbursing innovative drugs from the standard reimbursement system to reimbursement by way of exceptions of health insurance companies. Recently, there has been an ongoing discussion on possible changes to the reimbursement law. [ABSTRACT FROM AUTHOR]

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population’s health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system’s needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes. [ABSTRACT FROM AUTHOR]

Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation. [ABSTRACT FROM AUTHOR]

The objective of this article is to show the relationship between socio-cultural factors and the state of health of hypertension subjects followed at the Regional Hospital Center of Sokodé -Togo.. Based on a prospective cross-sectional study carried out in 2021, with 84 hypertensive patients admitted to the Regional Hospital Center of Sokodé (Togo) during this period. Data were collected using a questionnaire and processed by SPSS software..The results highlight four main socio-cultural factors related to the state of health of hypertension subjects followed at the Regional Hospital Center of Sokodé (Togo): Loneliness, conflicting relationships, ignorance of hypertension risk factors and the feeling of lack of socio-economic support. Taking socio-cultural factors into account in therapeutic responses is essential to avoid decompensation in hypertension subjects at the Regional Hospital Center of Sokodé (Togo). [ABSTRACT FROM AUTHOR]

Health care budgets in high-income countries are having issues coping with unsustainable growth in demand, particularly in the hospital setting. Despite this, implementing tools systematising priority setting and resource allocation decisions has been challenging. This study answers two questions: (1) what are the barriers and facilitators to implementing priority setting tools in the hospital setting of high-income countries? and (2) what is their fidelity? A systematic review using the Cochrane methods was conducted including studies of hospital-related priority setting tools reporting barriers or facilitators for implementation, published after the year 2000. Barriers and facilitators were classified using the Consolidated Framework for Implementation Research (CFIR). Fidelity was assessed using priority setting tool's standards. Out of thirty studies, ten reported program budgeting and marginal analysis (PBMA), twelve multi-criteria decision analysis (MCDA), six health technology assessment (HTA) related frameworks, and two, an ad hoc tool. Barriers and facilitators were outlined across all CFIR domains. Implementation factors not frequently observed, such as 'evidence of previous successful tool application', 'knowledge and beliefs about the intervention' or 'external policy and incentives' were reported. Conversely, some constructs did not yield any barrier or facilitator including 'intervention source' or 'peer pressure'. PBMA studies satisfied the fidelity criteria between 86% and 100%, for MCDA it varied between 36% and 100%, and for HTA it was between 27% and 80%. However, fidelity was not related to implementation. This study is the first to use an implementation science approach. Results represent the starting point for organisations wishing to use priority setting tools in the hospital setting by providing an overview of barriers and facilitators. These factors can be used to assess readiness for implementation or to serve as the foundation for process evaluations. Through our findings, we aim to improve the uptake of priority setting tools and support their sustainable use. • Healthcare demand is unsustainably growing in the hospital setting. • Priority setting and resource allocation tools' implementation is challenging. • Barriers and facilitators to implementation are critical for uptake. • Fidelity does not necessarily determine implementation. • Implementation factors should be considered aiming for sustainability. [ABSTRACT FROM AUTHOR]

The market success of a medical product depends on its commercial viability, yet this may be hard to predict during the development process of medical devices. This paper aims to determine if applying the Headroom method combined with return on investment (ROI) analysis allows for estimation of the potential commercial viability of one therapeutic and five diagnostic devices. The devices were targeted at different disease areas. Information regarding the maximum additional health benefit that could be obtained with the new device, the estimated production price and expected sales volume was gathered from literature and expert opinions. A willingness-to-pay threshold for one additional Quality-Adjusted Life Years of €30,000 was assumed for Headroom calculation. The analysis showed that the device with the highest estimated headroom per unit was RAPAI: a computed tomography photo-acoustic instrument for imaging inter-phalangeal joints (€1,645,120), followed by CBPM: continuous blood pressure measurement device (€922,440), Home Brain Monitoring (HBM) device (€750,000), a portable point-of-care (POC-CKD) device (€36,250), and the IHP: injectable healing plasters (€22,100). The devices with the highest estimated ROI were RAPAI (€14,951,200), and POC-CKD (€14,100,000), followed by HBM (€9,450,000), CBPM (€8,624,400), and IHP (€7,050,000). Overall, RAPAI is expected to have the highest potential commercial viability and HBM and IHP the lowest. The presented combined method is feasible, useful, and informative to help assess the potential commercial viability of medical devices under development. It might be an answer to the growing need of performing value-based pricing of devices replacing currently dominating cost-plus pricing approach. [ABSTRACT FROM AUTHOR]

Résumé Introduction La prévalence importante de l’hypertension artérielle (HTA) en entreprise a conduit une entreprise à Bouaké (centre de la Côte d’Ivoire) a rajouté l’électrocardiogramme (ECG) au bilan de santé annuel de son personnel depuis 2010. Matériels et méthodes Il s’agit d’une étude rétrospective par l’analyse des commentaires du cardiologue sans relecture de 855 ECG télétransmis de 2010 à 2015 à Bouaké. Les principales anomalies retrouvées depuis 2010 ont fait l’objet d’une télésurveillance jusqu’en 2015. Résultats En moyenne, 142,5 ECG ont été télétransmis par an. L’âge moyen était de 42,3 ans ± 8,7. Le pourcentage d’anomalies ECG moyen était de 60,8 % contre 56 % en 2010 et 53 % 2015. Il y avait 10,17 % de patients hypertendus. Les anomalies ECG les plus retrouvées étaient le bloc de branche droit incomplet (BBDI) avec 13,92 % et l’hypertrophie ventriculaire gauche (HVG) dans 13,85 % des cas. Le taux moyen de progression de ces anomalies était de 29 % pour le BBDI et de 18 % pour l’HVG. Discussion Le nombre important de BBDI est en rapport avec l’âge de la population d’étude qui est relativement jeune. L’HVG avec un taux de progression de 18 % retrouvée dans cette population où l’on dénombre 10,17 % d’HTA est un paramètre clinique important à surveiller dans le temps. Conclusion La télésurveillance de certains paramètres ECG tels que l’HVG chez ce groupe de travailleurs et particulièrement chez les patients hypertendus est un élément important dans la prise en charge de l’HTA. Summary Introduction The high prevalence of hypertension in businesses led a firm in Bouake (center of Ivory Coast) to add the electrocardiogram (ECG) to the annual check-up of its staff since 2010. Materials and methods This retrospective study analyzed comments from the cardiologist without any reinterpretation of the 855 ECGs teletransmitted from 2010 to 2015 to Bouaké. The major anomalies found since 2010 were monitored until 2015. Results On average, 142.5 ECGs were teletransmitted per year. The mean age was 42.3 ± 8.7 years. The percentage of mean ECG anomalies was 60.8% versus 56% in 2010 and 53% in 2015. There were 10.17% of hypertensive patients. The more recurrent ECG anomalies were incomplete right bundle branch blocks (IRBBB) with 13.92% and left ventricular hypertrophy (LVH) in 13.85% of cases. The average rate of progression of these anomalies was 29% for IRBBB and 18% for LVH. Discussion The large number of IRBBBs is related to the age of the relatively young study population. LVH with a growth rate of 18% was found in this population where 10.17% of hypertensive case were counted as an important clinical parameter worth monitoring over time. Conclusion Remote monitoring of certain ECG parameters such as LVH in this group of workers, especially in hypertensive patients, is an important element to take into account in the management of hypertension. [ABSTRACT FROM AUTHOR]

Background China is investing considerably in health care reforms to address issues in its health care system. An example is access to innovative drugs, which remains challenging because it is largely dependent on patient self-pay. Recognizing this, the government has invested considerably in its basic medical insurance. As health care expenditure increases, there are growing concerns on budget control. Several health policy tools have been discussed recently such as health technology assessment, international reference pricing, and hospital budget control tools, which can be viewed as addressing the affordability concerns of the government budget. China has also listed her health outcomes goals in “Healthy China 2020” initiative. Objectives This article aimed to discuss the “fit-for-purpose” of these tools to address budget concerns and support China in reaching her health outcomes goals. Methods The findings are informed by a panel discussion at ISPOR Asia Pacific 2014, literature review, and authors’ experience. This review looks at the current developments in China and the considerations and implications for using these tools by drawing experiences from countries where they are used. Results These tools are generally used in countries with advanced health care systems. China’s health care spending is still below that of countries with advanced health care systems and below World Health Organization recommendation. Conclusions China has not yet reached the “critical mass” necessary for the effective use of these tools. As China continues its health care reforms, increase in health care spending to balance the health needs of the population would be key. [ABSTRACT FROM AUTHOR]

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• Positive impacts of HTA implementation transcends the negative impacts. • There are high expectations of what HTA can offer for MICs. • HTA is expected to support the implementation of universal health coverage. • HTA can be supportive to control the health care budget in selected areas. • No clear evidence if HTA can generate savings at the health care system level. Building an efficient health technology assessment (HTA) system requires significant effort and political commitment, in addition to human and financial resources. Expectations of what HTA can offer to middle-income countries (MICs) are continuously rising, which drives health policymakers to raise the question of whether HTA could help secure the financial sustainability needed to implement universal health coverage. In this study, we explored the impact HTA adoption may have on the countries and its impact on health system objectives, as well as transferability of benefits and drawbacks observed in higher-income to middle-income countries. We utilized secondary data from a systematic literature review and primary data by disseminating a survey among local stakeholders in three MICs across three continents to capture their perspective on the impact of HTA implementation from a local context. It was evident from the results of both the literature review and survey that the positive impacts of HTA implementation outweigh the negative impacts. Most of the reviewed literature discussed the impact of HTA on the intermediate objectives of the health finance policy in relation to the broad health system goals. According to the survey respondents, the most evident benefit of HTA implementation is improving the transparency and accountability of healthcare decisions. Overall, HTA implementation can introduce a myriad of benefits to healthcare systems in MICs as well. Our findings show that while HTA implementation may have the potential to generate cost savings in specific areas, there is no guarantee that HTA can generate savings at the macro level. Health technologies (medicines, devices, and interventions) are rapidly increasing in complexity and cost. Health Technology Assessment (HTA) guides healthcare decision-makers in choosing the most suitable, effective, affordable, and acceptable health technology to invest limited healthcare resources. However, healthcare decision-makers in middle-income countries (MICS) are still uncertain about whether adopting HTA would help them achieve the financial sustainability needed to achieve universal health coverage. we sought to gather evidence on how HTA has affected the health systems of countries that have already adopted it by reviewing published research reports. In addition, healthcare decision-makers from three MICs were questioned about their perception of how HTA implementation will affect their country's health system. found that the positive effects of HTA implementation outweigh the negative ones; specifically, the transparency and accountability of decisions are improved. However, although HTA implementation may generate cost savings in specific areas, it may not significantly contribute to overall financial sustainability. [ABSTRACT FROM AUTHOR]

Human error identification and subsequent prioritization are the foremost tasks involved in HRA. In this study a methodology is developed for performing these tasks with an application to overhead crane operations. The application of the present methodology will help to understand how the risk associated with the human errors propagates through different hierarchy levels. The methodology provides a framework for quantifying the risk of different human errors using the experts’ subjective opinions only. The incorporation of fuzzy VIKOR technique enables us develop a ranking mechanism for the failure modes where the individual constituent components are non-commensurable in nature. The developed ranking mechanism helps the decision makers in optimal allocation of safety critical resources, used for risk mitigation purposes. [ABSTRACT FROM AUTHOR]

Résumé L’HTA dans la hyalinose segmentaire et focale(HSF) est fréquente et est responsable de la progression de la maladie. Elle peut être une circonstance de découverte de la HSF ou une complication du syndrome néphrotique. Objectifs Déterminer la prévalence de l’HTA chez les patients ayant une HSF diagnostiquée en Tunisie et de décrire le profil des patients ayant une HSF hypertendus par rapport aux non-hypertendus. Patients et méthodes Nous avons réalisé une étude multicentrique et rétrospective portant sur 116 cas de HSF confirmés par l’examen histologique, recueillies par les 5 centres de néphrologie en Tunisie. Résultats La prévalence de l’HTA chez nos patients était de 41 % avec une prédominance féminine et un âge moyen des patients de 36,34 ans ± 15,71. La tension artérielle systolique moyenne chez les hypertendus était de 153,18 mmHg. Le syndrome néphrotique était impur par l’HTA dans 14,50 %. Les patients hypertendus étaient plus obèses. La protéinurie était plus intense chez les patients normotendus par rapport aux hypertendus avec une protéinurie moyenne de 5,67 ± 4,51 g/24 h avec une différence non significative. L’insuffisance rénale était significativement plus présente chez les patients hypertendus. Les lésions vasculaires étaient présentes à la biopsie rénale dans 39,45 % chez les sujets hypertendus associées à une insuffisance rénale dans 58,50 %. Le traitement étiopathogénique de la HSF reposait essentiellement sur la corticothérapie à pleine dose. Conclusion L’HTA est souvent présente dans la HSF et sa prise en charge doit être précoce afin de ralentir la progression de la maladie rénale chronique. Hypertension in focal segmental glomerulosclerosis is frequent and responsible for the progression of the disease. It could be a circumstance of the diagnosis of FSG or a complication of the nephrotic syndrome. Purpose To determine the prevalence of hypertension among patients with FSG diagnosed in Tunisia and to describe the profile of patients with FSG having hypertension in contrast with who do not. Patients and methods It was a retrospective multicentric study based on 116 patient files having FSG located in 5 specialized centers in Tunisia. Results The prevalence of hypertension among our patients was 41%, with a feminine predominance, their mean age was 36.34 ± 15.71 years. The systolic blood pressure among the patients with hypertension was 153.18 mmHg. The nephrotic syndrome was impure due to hypertension in 14.5% of the cases. The patients affected by hypertension were more obese. Proteinuria was higher among those not having hypertension than those with it, who score an average value of 5.67 ± 4.51 g/24 h, with an insignificant difference. Serum creatinine at presentation was significantly higher among patients with hypertension. Vascular lesions were present at the renal biopsy among 39.45% of patients affected by hypertension, associated with renal failure in 58.50% of patients. The etiopathogenic treatment of FSG was essentially based on steroids full dose. Conclusion Hypertension is often present in FSG and its’ treatment must be as soon as possible in order to slow the progression of kidney chronic disease. [ABSTRACT FROM AUTHOR]

Résumé Introduction Au cours de la sclérodermie systémique, l’hypertension artérielle est redoutée car elle est souvent annonciatrice d’une atteinte rénale grave. L’objectif de notre étude était d’identifier la fréquence de l’hypertension artérielle et de préciser ses étiologies au cours de cette affection. Patients/méthodes Notre étude était prospective. De janvier 2008 à mai 2012, nous avons inclus tout patient, âgé de plus de 16 ans qui présentait une sclérodermie systémique répondant aux critères de classification de Leroy et Medsger modifiée. La prise de la pression artérielle était systématique et l’hypertension artérielle était définie par une PAS/PAD supérieure à 140/90 mmHg. Résultats Nous avons colligé 60 patients. Il s’agissait de 50 femmes et de 10 hommes d’un âge moyen de 41,1 ans ± 13,03. L’hypertension artérielle était notée chez 16 patients (26,7 %) d’un âge moyen de 48,8 ans ± 13,21. Il s’agissait de neuf sclérodermies systémiques cutanées diffuses, de six sclérodermies cutanées limitées et d’un cas de sclérodermie sine scleroderma. La recherche étiologique de l’HTA avait conclu à une cause rénale chez douze patients. Il s’agissait de cinq crises rénales sclérodermiques (CRS), trois néphropathies vasculaires, quatre insuffisances rénales chroniques (IRC) dont trois terminales et une IRC modérée. Une HTA dite « essentielle » était notée chez quatre patients. L’HTA était le signe majeur ayant révélé les cinq cas de CRS. Ces patients avaient bénéficié d’un traitement antihypertenseur et d’une épuration extra rénale. Discussion L’HTA est fréquente au cours de la sclérodermie systémique. Nos données se rapprochent de la littérature quant à sa fréquence et sa gravité. Conclusion L’HTA est un signe d’alarme majeur qu’il ne faut en aucun cas négliger, qu’elle soit de novo ou d’aggravation secondaire. Sa prise en charge doit être très précoce sous peine de mettre en jeu le pronostic vital en particulier au cours de la CRS. Purpose In systemic sclerosis, hypertension is feared because it is often heralding severe renal impairment. The objective of our study was to identify the frequency of arterial hypertension and clarify its etiologies in this condition. Patients/methods Our study was prospective. From January 2008 to May 2012, we have included all patients over the age of 16 years which featured a systemic scleroderma meeting the criteria for classification of Leroy and Medsger modified. Blood pressure was systematic and hypertension was defined as a greater than 140/90 mmHg PAS/PAD. Results We have collected 60 patients. It was 50 women and 10 men with an average age of 41.1 ans ± 13.03. Arterial hypertension was noted in sixteen patients (26.7%) with an average age of 48.8 years ± 13.21. It was nine diffuse cutaneous systemic scleroderma of six limited cutaneous scleroderma and one case of scleroderma sine scleroderma. Etiologic research hypertension had concluded to a renal cause in 12 patients. It was five scleroderma renal crisis (SRC), three vascular nephropathies, four chronic kidney failure (CKD) including three terminals and a moderate CKD. An ‘essential’ so-called HTA was observed in four patients. Hypertension was a major sign that reported five cases of SRC. These patients had received treatment anti hypertensive and renal extra cleansing. Discussion Hypertension is common in systemic scleroderma. Our data approximates of literature when its frequency and severity. Conclusion Hypertension is a major warning sign that under no circumstances should overlook it or novo or secondary aggravation. Its support must be very early under penalty to put at stake the life-threatening in particular during the CRS. [ABSTRACT FROM AUTHOR]

Objectives To compare processes and timings of regulatory and subsidized access systems for medicines across seven jurisdictions within the Asia-Pacific region. Methods A questionnaire was developed focusing on regulatory and health technology assessment–based subsidized access processes and timings in each of the seven surveyant’s jurisdictions. Results Australia and Thailand are the only two jurisdictions that formally allow the subsidized access evaluation process to be conducted in parallel with the regulatory evaluation process. Australian, Japanese, Korean, New Zealand, and Taiwanese systems afford broad coverage, whereas Chinese and Thai systems provide limited coverage for medicines under patent. Subsidized access systems for all jurisdictions except Thailand have an associated patient co-payment for each medicine/prescription. The biggest disparity across the study group relates to time from regulatory submission to subsidized access of patented medicines—ranging from just over 1 year (Japan) to a minimum of 5 years (China). Conclusions There is consistency across the seven jurisdictions studied in relation to regulatory and subsidized patient access processes—that is, regulatory approval is required before subsidized access review; subsidized access coverage is broad; and the cost of medicine subsidization is offset, in part, by patient co-payments. Although local differences will always exist in relation to budget and pricing negotiation, there may be efficiencies that can be applied across systems to improve time to subsidized access. Closer understanding of regulatory and subsidized access systems can lead to best-practice sharing and, ultimately, timely access and better health outcomes for patients. [ABSTRACT FROM AUTHOR]

Access to medicines treating rare diseases ('orphan medicines') has proven challenging due to high prices and clinical uncertainty. To optimise market access to these medicines, some healthcare systems are implementing specialised pathways and/or processes during marketing authorisation (MA) and/or health technology assessment (HTA). Comparing one setting where these medicines are classed as "orphan" (Scotland) to another where they considered "non-orphan" (Canada), this study aims to explore whether the presence of specialised pathways and processes at MA and HTA levels is associated with more favourable funding recommendations and faster time to market access. A matched sample of 116 medicine-indication pairs with MA approval from 2001 to 2019 in Europe and Canada was identified, and publicly available sources were used for data extraction. Descriptive statistics were used for data analysis. All medicines were commercially marketed in both countries, except one instance in Scotland. In Scotland, more orphan medicines (68.1%) had a favourable HTA recommendation than in Canada (60.4%), while Canada issued more negative HTA recommendations (20.7%) than Scotland (15.5%). Low levels of agreement on HTA recommendations and the main reasons driving recommendations were found between settings. In both countries, medicines with specialised MA approval were less likely to receive negative HTA recommendations than medicines with standard MA. Time to market access was faster in Canada than Scotland, though medicines with specialised MA approval had slower timelines than medicines with standard MA approval in both countries. However, it is unclear whether the presence of orphan designation and HTA specialised processes alone could result in favourable funding recommendations without accounting for other healthcare system-related factors and differences in the decision-making processes across settings. Holistic approaches and better alignment of evidentiary requirements across regulators are needed to optimise access to orphan medicines. • Canada approved more orphan medicines through specialised pathways than Scotland. • Less negative HTA outcomes for medicines with specialised MA in both countries. • Less negative HTA recommendations for orphan medicines in Scotland than Canada. • Low levels of agreement in HTA for orphan medicines between Scotland and Canada. • Time to market access occurred considerably faster in Canada than Scotland. [ABSTRACT FROM AUTHOR]

Objectives We aimed to compare the use of cost-effectiveness analysis and cost-utility analysis in health technology assessment in Poland. Methods We analyzed all the submissions (155) made to the Polish Agency for Health Technology Assessment in the period 2007 to 2011, with 316 intervention-comparator comparisons reporting incremental cost-effectiveness ratios (ICERs) or incremental cost-utility ratios (ICURs). We compared ICERs and ICURs when both were reported (31%), determined factors associated with reporting one or the other, and tested the precision of their assessment. Results In 13% of the cases, ICER and ICUR led to different decisions (were on opposite sides of the willingness-to-pay threshold). Cost-effectiveness analyses were more frequently performed in oncology, offering at the same time more favorable results. It was also more frequent for longer time-horizon models, although then ICER values were on average higher. Conclusions In Poland, cost-utility analysis is a usual approach of increasing popularity. Interestingly, although assessing ICUR requires additional assumptions, it is estimated more precisely (reported ranges of values in sensitivity analyses are narrower), especially in oncology. ICER and ICUR disagree more often than previously shown in literature. There seem to be no clear signs of biases in submissions (selecting whether to present ICER or ICUR on the basis of their values), but the current study is limited because only the values presented by manufacturers in the submission are available. [ABSTRACT FROM AUTHOR]

Abstract: As part of the global trend to address the constrained resources for population health care coverage, the concepts of pharmacoeconomics (PE) and health technology assessment (HTA) have been introduced to Asia in the last decade. Medicines are just one of numerous types of innovative technologies developed to address unmet medical need. Many of these medicines receive a great deal of attention because of their potential impact on limited health care budgets. There are a few key challenges for using PE and HTA in making informed decisions regarding the value of a given new health care technology in an Asian country. These challenges include 1) recognizing the multidimensional aspects of PE and HTA, which can include both health care and political considerations; 2) involving stakeholders (with a focus on patients) in decision making; 3) balancing short- and long-term overall benefits of innovative medicines; and 4) giving consideration to specific local cultural and health care characteristics. [Copyright &y& Elsevier]

Copyright of Archives of Cardiovascular Diseases is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Fire onboard passenger ships is a major hazard not only for the personnel, passengers, and the environment, but also for the vessel itself. Therefore, the response actions carried out by crewmembers after a fire has been detected onboard a passenger vessel are of outermost importance. SAFEMODE project aims to promote contemporary safety thinking through a collection of carefully selected Human Factors (HFs) Fact Sheets that includes the most-known HFs techniques for accident investigations, to help accident investigators and safety managers within maritime organisations. Therefore, this paper proposes to apply two of the above-mentioned Fact Sheets, namely Hierarchical Task Analysis (HTA) and Human Error Assessment and Reduction Technique (HEART). Hence, this paper initially demonstrates how HTA can be applied to model the human response actions to a fire onboard a passenger vessel, and secondly, it utilises a systematic human error reduction and prediction approach, namely HEART, to predict and quantify which errors are likely to occur. Results from this paper reveal that six human response errors are most likely to occur, with a Human Error Probability of 0.16 according to the HEART analysis. Finally, this paper also suggests remedial measures to mitigate each error identified. • This paper applies the HTA and HEART techniques. • Human actions for fire detection on passenger vessels. • Six human response errors are most likely to occur. • Suggestion of remedial measures to mitigate each error are proposed. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Health care decision making, assessment, and procurement of medicines is a complex, human resource–demanding, and time-consuming process. A thorough evaluation of all factors involved is necessary to optimize the process. The objective of this study was to describe and analyze the current stage of health technology assessment (HTA) in Cyprus. Methods: Literature research and private communication with all involved parties and competent authority. Moreover, data, decisions, and recommendations of the Drug’s Committee were used. Results: Cyprus is a latecomer in this field. HTA has entered a growing phase after the 2007 reform. It has not reached its full potential, and the current state is applicable only to the public sector, because of the nonexistence of a national health system. Therefore, this poses both a great challenge and a great barrier considering maximization of the value of money spent and health access equity. Conclusions: There is definitely enough space and clear necessity for further dissemination, and early successes indicate that steps should be taken toward the introduction of an HTA procedure that will cover both private and public sectors. The introduction of a national health system will further enhance the uptake of HTA, optimize the process, and use the common knowledge strategy for evidence-based decision making. [Copyright &y& Elsevier]

Abstract: Introduction: Hypertension in black is more frequent with early onset and clinically more severe. The blood pressure control and the decrease of global cardiovascular risk are two main goals of the treatment of hypertension. The objectives of this study were to determine the proportion of uncontrolled hypertension in hypertensive patients followed as outpatients and to investigate the factors associated with poor control. Patients and methods: This is a descriptive cross-sectional study including 456 hypertensive patients known and followed as outpatients. Blood pressure measurement was performed between 8am and 12noon both arms in the supine position, after a compliance averaging 8minutes of rest. We searched for conventional cardiovascular risk factors (age superior or equal to 45years for men and superior or equal to 55 for women, physical inactivity, overweight/obesity, smoking, diabetes and dyslipidemia) and calculated the global cardiovascular risk according to the Framingham model. Was regarded as uncontrolled high blood pressure SBP superior or equal to 140mmHg and/or DBP superior or equal to 90mmHg. Univariate analysis and multivariate logistic regression (using SPSS program version 17) were conducted to look for factors associated with poor blood pressure control. Results: We recruited 456 hypertensive patients including 259 women (56.8%). Modifiable cardiovascular risk factors also hypertension were dominated by dyslipidemia (29.8%) and diabetes (24.6%). The global cardiovascular risk calculated using the Framingham model was low in 21.3%, moderate in 34.0%, high in 24.8% and very high in 19.9% of cases. The proportion of uncontrolled hypertension was 54.2% (n =247 including 126 women and 121 men). This poor blood pressure control was associated (multivariate analysis) at age superior or equal to 60years, low socioeconomic status, high to very high cardiovascular risk, antihypertensive monotherapy, treatment duration superior or equal to 10years, an associated treatment and non-compliance therapy. Conclusion: More than half of hypertensive patients in our study were not adequately controlled on antihypertensive therapy. Factors of poor control were age superior or equal to 60years, low socioeconomic status, high to very high cardiovascular risk, antihypertensive monotherapy, treatment duration superior or equal to 10years, an associated treatment and non-compliance therapy. [Copyright &y& Elsevier]

Abstract: Compared to continuous wave (CW) ultrasound, pulsed wave (PW) ultrasound has been shown to result in enhanced sonochemical degradation of octylbenzene sulfonate (OBS). However, pulsed ultrasound was investigated under limited pulsing conditions. In this study, pulse-enhanced degradation of OBS was investigated over a broad range of pulsing conditions and at two ultrasonic frequencies (616 and 205kHz). The rate of OBS degradation was compared to the rate of formation of 2-hydroxyterephthalic acid (HTA) following sonolysis of aqueous terephthalic acid (TA) solutions. This study shows that sonication mode and ultrasound frequency affect both OBS degradation and HTA formation rates, but not necessarily in the same way. Unlike TA, OBS, being a surface active solute, alters the cavitation bubble field by adsorbing to the gas/solution interface of cavitation bubbles. Enhanced OBS degradation rates during pulsing are attributed to this adsorption process. However, negative or smaller pulse enhancements compared to enhanced HTA formation rates are attributed to a decrease in the high-energy stable bubble population and a corresponding increase in the transient bubble population. Therefore, sonochemical activity as determined from TA sonolysis cannot be used as a measure of the effect of pulsing on the rate of degradation of surfactants in water. Over relatively long sonolysis times, a decrease in the rate of OBS degradation was observed under CW, but not under PW conditions. We propose that the generation and accumulation of surface active and volatile byproducts on the surface and inside of cavitation bubbles, respectively, during CW sonolysis is a contributing factor to this effect. This result suggests that there are practical applications to the use of pulsed ultrasound as a method to degrade surface active contaminants in water. [Copyright &y& Elsevier]

The growth of health technology assessment (HTA) internationally is currently reflected in the growing membership of the International Network of Agencies for Health Technology Assessment. Many national and regional HTA institutions emerged in the 1980s and 1990s, and more recently, HTA has emerged in newly industrialized countries and in European Union member states in transition. Health technology assessment activities are becoming an increasingly important part of health care culture, with the appearance of HTA units in hospitals and hospital departments. This article provides a brief overview of who conducts HTA internationally and looks at how HTA is conducted and how this information is used. To highlight the different structures, processes, and methods available, a portion of this article is dedicated to describing different approaches that have been observed with respect to the assessment of computed tomographic colonography in North America for population-based colorectal cancer screening. [Copyright &y& Elsevier]

Copyright of Archives of Cardiovascular Diseases is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Komplementaere und Integrative Medizin is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)