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Background: Models incorporating long-term outcomes (LTOs) are not available to assess the health economic impact of attention-deficit/hyperactivity disorder (ADHD).Objective: Develop a conceptual modelling framework capable of assessing long-term economic impact of ADHD therapies.Methods: Literature was reviewed; a conceptual structure for the long-term model was outlined with attention to disease characteristics and potential impact of treatment strategies.Results: The proposed model has four layers: i) multi-state short-term framework to differentiate between ADHD treatments; ii) multiple states being merged into three core health states associated with LTOs; iii) series of sub-models in which particular LTOs are depicted; iv) outcomes collected to be either used directly for economic analyses or translated into other relevant measures.Conclusions: This conceptual model provides a framework to assess relationships between short- and long-term outcomes of the disease and its treatment, and to estimate the economic impact of ADHD treatments throughout the course of the disease. [ABSTRACT FROM AUTHOR]

Countries with expanding healthcare coverage (CEHCs) increasingly use external reference pricing (ERP) for pharmaceuticals. The ERP policies must aim to optimize efficiency, minimize disturbances, and maximize access to effective therapies for all patients. This research aims to deduce best practices for prudent ERP regulations from past experiences and currently applied policies and to guide policymakers in CEHCs in implementing robust ERP policies. The literature was reviewed for methods and effects of ERP for pharmaceuticals. Pharmaceutical pricing experts from Asia, the Middle East, Russia, and South Africa were surveyed for current approaches to ERP in their respective countries. Key determinants of ERP relate to scope, number, and choice of reference countries; price definitions; computation rules; frequency; and stringency of applying ERP. The scarce evidence shows that ERP seems to lead to narrower price windows with the risk of reducing prices in high-price countries and raising prices in low-price countries. Moreover, launch delays and indirect price effects are often observed. The ERP policies in CEHCs are often applied in isolation, not always in a consistent and transparent manner, neglecting its indirect effects. Policymakers should consider a set of requirements when introducing ERP, including clear definitions and decision criteria in full transparency. External reference pricing should inform and serve as a benchmark for pricing decisions, rather than being used as the sole pricing mechanism. External reference pricing is primarily a tool to support decisions regarding on-patent pharmaceuticals, and for off-patent products, competition may prove more effective in reducing prices than ERP. • Experience from countries with mature healthcare coverage systems using external reference pricing (ERP) indicates that prudent methods and regulations help to minimize potential negative impacts on availability of and access to pharmaceuticals. • The ERP regulations were surveyed and reported from 17 countries with expanding healthcare systems in Asia, the Middle East, Eastern Europe, and Africa. • Based on published reports, a set of parameters was identified, which should be considered by countries that are planning to introduce ERP or to revise the regulations for ERP in their environment. [ABSTRACT FROM AUTHOR]

Introduction: Trastuzumab, the standard treatment for HER-2 positive breast cancer, may be associated with access restrictions in countries with severe economic constraints. This study aimed to compare intravenous (IVT) and subcutaneous trastuzumab (SCT) forms and to explore the transferability of value propositions to Central and Eastern European (CEE) countries. Areas covered: After screening 376 abstracts, 42 articles were included in the final review. Statistical test results were rarely reported; therefore, the similarity of adverse event profiles of SCT and IVT could not be validated. Potential time savings for patients due to subcutaneous administration was not validated in CEE settings, where patient's waiting time for treatment administration is fairly long. Standard patient reported outcome instruments were rarely used to confirm the preference of patients/health care professionals to SCT over IVT. Moreover, feasibility of self/home administration of SCT, especially in case of concomitant intravenous chemotherapies, was not considered. Cost comparisons considered neither the patent expiry of IVT nor the incremental cost of potential differences in adverse events. Expert commentary: Potential benefits of SCT were not tested by any studies in CEE countries. The main policy objective should be to facilitate the uptake of multisource biologicals in lower income countries with access barriers. [ABSTRACT FROM AUTHOR]

Health technology assessment (HTA) is not simply a mechanistic technical exercise as it takes place within a specific institutional context. Yet, we know little about how this context influences the operation of HTA and its ability to influence policy and practice. We seek to demonstrate the importance of considering institutional context, using a case study of Hungary, a country that has pioneered HTA in Central and Eastern Europe. We conducted 26 in-depth, semi-structured interviews with public- and private-sector stakeholders. We found that while the HTA Department, the Hungarian HTA organisation, fulfilled its formal role envisaged in the legislation, its potential for supporting evidence-based decision-making was not fully realised given the low levels of transparency and stakeholder engagement. Further, the Department's practical influence throughout the reimbursement process was perceived as being constrained by the payer and policy-makers, as well as its own limited organisational capacity. There was also scepticism as to whether the current operational form of the HTA process delivered 'good value for money'. Nevertheless, it still had a positive impact on the development of a broader institutional HTA infrastructure in Hungary. Our findings highlight the importance of considering institutional context in analysing the HTA function within health systems. [ABSTRACT FROM AUTHOR]

Transparency is recognised to be a key underpinning of the work of health technology assessment (HTA) agencies, yet it has only recently become a subject of systematic inquiry. We contribute to this research field by considering the Polish Agency for Health Technology Assessment (AHTAPol). We situate the AHTAPol in a broader context by comparing it with the National Institute for Health and Care Excellence (NICE) in England. To this end, we analyse all 332 assessment reports, called verification analyses, that the AHTAPol issued from 2012 to 2015, and a stratified sample of 22 Evidence Review Group reports published by NICE in the same period. Overall, by increasingly presenting its key conclusions in assessment reports, the AHTAPol has reached the transparency standards set out by NICE in transparency of HTA outputs. The AHTAPol is more transparent than NICE in certain aspects of the HTA process, such as providing rationales for redacting assessment reports and providing summaries of expert opinions. Nevertheless, it is less transparent in other areas of the HTA process, such as including information on expert conflicts of interest. Our findings have important implications for understanding HTA in Poland and more broadly. We use them to formulate recommendations for policymakers. [ABSTRACT FROM AUTHOR]

Background: Decision makers in middle-income countries are using economic evaluations (EEs) in pricing and reimbursement decisions for pharmaceuticals. However, whilst many of these jurisdictions have local submission guidelines and local expertise, the studies themselves often use economic models developed elsewhere and elements of data from countries other than the jurisdiction concerned. The objectives of this study were to describe the current situation and to assess the challenges faced by decision makers in transferring data and analyses from other jurisdictions.Methods: Experienced health service researchers in each region conducted an interview survey of representatives of decision making bodies from jurisdictions in Asia, Central and Eastern Europe, and Latin America that had at least 1 year's experience of using EEs.Results: Representatives of the relevant organizations in twelve countries were interviewed. All twelve jurisdictions had developed official guidelines for the conduct of EEs. All but one of the organizations evaluated studies submitted to them, but 9 also conducted studies and 7 commissioned them. Nine of the organizations stated that, in evaluating EEs submitted to them, they had consulted a study performed in a different jurisdiction. Data on relevant treatment effect was generally considered more transferable than those on prices/unit costs. Views on the transferability of epidemiological data, data on resource use and health state preference values were more mixed. Eight of the respondents stated that analyses submitted to them had used models developed in other jurisdictions. Four of the organizations had a policy requiring models to be adapted to reflect local circumstances. The main obstacles to transferring EEs were the different patterns of care or wealth of the developed countries from which most economic evaluations originate.Conclusions: In middle-income countries it is commonplace to deal with the issue of transferring analyses or data from other jurisdictions. Decision makers in these countries face several challenges, mainly due to differences in current standard of care, practice patterns, or gross domestic product between the developed countries where the majority of the studies are conducted and their own jurisdiction. [ABSTRACT FROM AUTHOR]

Introduction: External price referencing (EPR) is applied frequently to control pharmaceutical prices. Our objective was to analyse how EPR is used in Middle Eastern (ME) countries and to compare the price corridor for original pharmaceuticals to non-pharmaceutical services not subjected to EPR.Methods: We conducted a survey on EPR regulations and collected prices of 16 patented pharmaceuticals and 14 non-pharmaceutical services in seven Middle Eastern (ME) countries. Maximum and minimum prices of each pharmaceutical and non-pharmaceutical technology were compared to mean prices in the countries studied by using market exchange rates. Influencing factors of pharmaceutical prices were assessed by multivariate linear regression analysis.Results: The average price corridor is narrower for pharmaceuticals (-39.8%; +35.9%) than for outpatient and hospital services (-81.7%; +96.3%).Conclusion: Our analysis revealed the importance of population size and EPR implementation on drug price levels; however, EPR results in higher pharmaceutical prices in lower-income countries compared to non-pharmaceutical services. [ABSTRACT FROM AUTHOR]

Abstract Objective This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. Methods A literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). Results The IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. Conclusions Emerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials. [ABSTRACT FROM AUTHOR]

The objective of this study is to quantify the value of a child born in 27 EU countries and Switzerland. The Human Capital (HC) approach was used to estimate the social benefit arising from an additional childbirth. The value of a newborn child was calculated by summing up the discounted value of all expected future gross earnings of the individual, including an imputed value for household production. The estimation takes into account life expectancy and the probability of being employed or in household production by age-groups. Input data was obtained from Eurostat and the Human Mortality Database. In 2012, the purchasing power parity adjusted present value (PV) of a newborn child was EUR 108.4 thousand in Bulgaria and EUR 803.6 thousand in Denmark. By applying the actual exchange rates, the difference between the lowest value (EUR 48.8 thousand in Bulgaria) and the highest value (EUR 1.1 million in Switzerland) was increased. The PV was highly sensitive to the discount rate. The fertility interventions are expected to gain popularities among other health priorities as a tool to counter generation ageing. However, in order to enhance fertility among other health priorities, policy-makers must take into account the full social value based on the local estimates. [ABSTRACT FROM AUTHOR]

Objectives To provide an overview about the current status of health technology assessment (HTA) implementation in Latin American countries and to identify long-term objectives considering regional commonalities. Methods We conducted a survey among participants of the 5th Latin American Future Trends Conference in October 2015. Thirty-seven respondents from eight Latin American countries provided insights about the current and preferred future status of HTA implementation related to human capacity building, HTA financing, process and organizational structure for HTA, scope of mandatory HTA, decision criteria, standardization of HTA methodology, mandating the use of local data, and international collaboration in HTA. Results Survey respondents reported insufficient human resources and public investment for HTA implementation. Organizational structure and legislation framework of HTA differ considerably across countries. According to survey respondents, in the future policymakers should rely more on the assessment of therapeutic value, cost-effectiveness, and budget impact criteria by applying explicit thresholds, potentially in a multicriteria decision analysis framework. HTA should not be restricted to policy decisions of new technologies but it should also be used for the revision of previous decisions. In addition, the quality and transparency of HTA have to be strengthened. Conclusions HTA plays an increasingly important role in Latin American countries. Each country needs to record its current implementation status and identify components for improvement. Duplication of efforts can be reduced if international collaboration is integrated into national HTA implementation. [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]

External price referencing (EPR) is applied more and more frequently worldwide by payers to control pharmaceutical prices. Together with the parallel trade of pharmaceuticals, EPR may result in lower pharmaceutical prices in higher-income countries and higher prices in lower-income countries, which implies that pharmaceutical expenditure grows more rapidly in the latter than in the former group. Our objective was to assess this hypothesis. We used hierarchical linear models on country-level panel data to show that-after controlling for compounding factors such as GDP, the proportion of the old-age population or life expectancy-the annual growth rate of pharmaceutical expenditure was 2.1% points larger in the lower- than in the higher-income members of the European Union between 2000 and 2008. This difference in trends became non-significant (0.6% points) after the onset of the global economic crisis. There was no significant difference between lower- and higher-income countries in the growth rate of non-pharmaceutical health expenditure in either period. Our results indirectly support the presence of price convergence of pharmaceuticals among European countries, and EPR and parallel trade may provide a reasonable explanation to the observed trend difference of pharmaceutical expenditure in the two groups of countries between 2000 and 2008. This higher growth rate of pharmaceutical expenditure put extra burden on public health care budgets in lower-income countries and resulted in disproportionately more cost-containment measures compared to higher-income countries after 2008. It remains to be seen whether the disappearance of the difference in trend growth rates due to special health policy interventions in countries with economic difficulties is temporary or permanent. [ABSTRACT FROM AUTHOR]