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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 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]

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]

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]

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]

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]

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]