Assessing Data Sources for Medicine Price Studies.

OBJECTIVES: There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed. METHODS: A targeted literature review was carried out. Dimensions discussed in literature as relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies. RESULTS: According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage. CONCLUSIONS: While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.

Assessment of Extent and Quality of Pharmacoeconomic Studies in India Using Quality of Health Economic Studies Score: A Targeted Literature Review.

OBJECTIVES: We assessed the quality of pharmacoeconomic studies conducted in India to report key areas of focus on the findings from the reviewed studies. METHODS: A targeted literature review was conducted using well-defined search strategy in PubMed to identify economic studies conducted in India from May 2017 to April 2022. Only economic evaluation studies were included, whereas trial-based cost analyses were excluded. The quality of included studies was assessed using the Quality of Health Economic Studies tool, which comprised 16 evaluation criteria related to objectives, source, funding, perspective, subgroup analysis, scales, and economic modeling related parameters. Based on scores (100 points), studies were rated as good (≥75), fair (50-74), and poor (≤49) quality. RESULTS: Search strategy provided 888 studies; 95 of these were economic studies, and 74 were included in the analysis. These 74 studies included budget impact analysis (n = 4), burden of illness (n = 8), cost-benefit analysis (n = 5), cost-consequences analysis (n = 1), cost-effectiveness analysis (n = 55), and cost-utility analysis (n = 1). The average quality score of studies was 64.08. Of the studies, 15 studies were rated as "good," 51 "fair," and 8 "poor." It was observed that primary outcome measures, stating negative outcomes, reporting bias, and implementing statistical and sensitivity analysis significantly affected the quality score. CONCLUSIONS: Most of the health economic studies conducted in India are of fair quality, and there is a need for standardization of guidelines and increase in number of Indian peer-reviewed health economics journals. A collaborative effort from pharma companies, policy makers, education experts, curriculum planners, and medical faculty is needed to promote quality economic studies.

How should we deal with patient heterogeneity in economic evaluation: a systematic review of national pharmacoeconomic guidelines.

OBJECTIVE: To review and analyze recommendations from national pharmacoeconomic guidelines with regard to acknowledging patient heterogeneity in economic evaluations. METHODS: National pharmacoeconomic guidelines were obtained through the ISPOR Web site. Guidance was extracted by using a developed data extraction sheet. Extracted data were divided into subcategories on the basis of consensus meetings. RESULTS: Of the 26 included guidelines, 20 (77%) advised to identify patient heterogeneity. Most guidelines (77%) provided general methodological advice to acknowledge patient heterogeneity, including justifications for distinguishing subgroups (65%), prespecification of subgroups (42%), or methodology to acknowledge patient heterogeneity (77%). Stratified analysis of cost-effectiveness was most commonly advised (20 guidelines; 77%); however, guidance on the specific application of methods was scarce (9 guidelines; 34%) and generally limited if provided. Guidance to present patient heterogeneity was provided by 15 guidelines (58%), most prominently to describe the definition (31%) and justification (31%) of subgroups. CONCLUSIONS: The majority of national pharmacoeconomic guidelines provide guidance on acknowledging patient heterogeneity in economic evaluations. However, because guidance is mostly not specific, its usefulness is limited. This may reflect that the importance of acknowledging patient heterogeneity is usually recognized while there is a lack of consensus on specific methods to acknowledge patient heterogeneity. We advise the further development of national pharmacoeconomic guidelines to provide specific guidance on the identification of patient heterogeneity, methods to acknowledge it, and presenting the results. We present a checklist that can assist in formulating these recommendations. This could facilitate the systematic and transparent handling of patient heterogeneity in economic evaluations worldwide.

[International reference prices and cost minimization analysis for the regulation of medicine prices in Colombia]. / Precios de referencia internacional y análisis de costo minimización para la regulación de precios de medicamentos en Colombia.

OBJECTIVES: To suggest a scheme of decision making on pricing for medicines that are part of Free Regulated Regime, a regulation way of the pharmaceutical pricing policy in Colombia. It includes two regulation tools: international reference prices and a cost minimization analysis methodology. METHODS: Following the current pricing policy, international reference prices were built with data from five countries for selected medicines, which are under Free Regulated Regime. The cost minimization analysis methodology includes selection of those medicines under Free Regulated Regime with possible comparable medicines, selection of comparable medicines, and treatment costs evaluation. RESULTS: As a result of the estimate of International Reference Prices, four medicines showed in the domestic pharmaceutical market a bigger price than the Reference Price. A scheme of decision-making was design containing two possible regulation tools for medicines that are part of Free Regulated Regime: estimate of international reference prices and cost minimization analysis methodology. This diagram would be useful to assist the pricing regulation of Free Regulated Regime in Colombia. CONCLUSIONS: As present results shows, international reference prices make clear when domestic prices are higher than those of reference countries. In the current regulation of pharmaceutical prices in Colombia, the international reference price has been applied for four medicines. Would be suitable to extend this methodology to other medicines of high impact on the pharmaceutical expenditure, in particular those covered by public funding. The availability of primary sources about treatment costs in Colombia needs to be improved as a requirement to develop pharmaco-economic evidence. SISMED is an official database that represents an important primary source of medicines prices in Colombia. Nevertheless, having into account that SISMED represents an important advantage of transparency in medicines prices, it needs to be improved in quality and data availability.

Conjoint analysis applications in health--a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.

BACKGROUND: The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards. OBJECTIVE: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health. METHODS: The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers. RESULTS: Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items. CONCLUSIONS: Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies.

Interpreting indirect treatment comparisons and network meta-analysis for health-care decision making: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 1.

Evidence-based health-care decision making requires comparisons of all relevant competing interventions. In the absence of randomized, controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best choice(s) of treatment. Mixed treatment comparisons, a special case of network meta-analysis, combine direct and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than a traditional meta-analysis. This report from the ISPOR Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on the interpretation of indirect treatment comparisons and network meta-analysis to assist policymakers and health-care professionals in using its findings for decision making. We start with an overview of how networks of randomized, controlled trials allow multiple treatment comparisons of competing interventions. Next, an introduction to the synthesis of the available evidence with a focus on terminology, assumptions, validity, and statistical methods is provided, followed by advice on critically reviewing and interpreting an indirect treatment comparison or network meta-analysis to inform decision making. We finish with a discussion of what to do if there are no direct or indirect treatment comparisons of randomized, controlled trials possible and a health-care decision still needs to be made.

Conducting indirect-treatment-comparison and network-meta-analysis studies: report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: part 2.

Evidence-based health care decision making requires comparison of all relevant competing interventions. In the absence of randomized controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for judiciously selecting the best treatment(s). Mixed treatment comparisons, a special case of network meta-analysis, combine direct evidence and indirect evidence for particular pairwise comparisons, thereby synthesizing a greater share of the available evidence than traditional meta-analysis. This report from the International Society for Pharmacoeconomics and Outcomes Research Indirect Treatment Comparisons Good Research Practices Task Force provides guidance on technical aspects of conducting network meta-analyses (our use of this term includes most methods that involve meta-analysis in the context of a network of evidence). We start with a discussion of strategies for developing networks of evidence. Next we briefly review assumptions of network meta-analysis. Then we focus on the statistical analysis of the data: objectives, models (fixed-effects and random-effects), frequentist versus Bayesian approaches, and model validation. A checklist highlights key components of network meta-analysis, and substantial examples illustrate indirect treatment comparisons (both frequentist and Bayesian approaches) and network meta-analysis. A further section discusses eight key areas for future research.

An overview of the characteristics and quality assessment criteria in systematic review of pharmacoeconomics.

BACKGROUND: The systematic review of economic evaluations plays a critical role in making well-informed decisions about competing healthcare interventions. The quality of these systematic reviews varies due to the lack of internationally recognized methodological evaluation standards. METHODS: Nine English and Chinese databases including the Cochrane Library, PubMed, EMbase (Ovid), NHS economic evaluation database (NHSEED) (Ovid), Health Technology Assessment (HTA) database, Chinese National Knowledge Infrastructure (CNKI), WangFang, VIP Chinese Science & Technology Periodicals (VIP) and Chinese Biomedical Literature Database (CBM) were searched. Two reviewers independently screened studies and extracted data. The methodological quality of the literature was measured with modified AMSTAR. Data were narrative synthesized. RESULTS: 165 systematic reviews were included. The overall methodological quality of the literature was moderate according to the AMSTAR scale. In these articles, thirteen quality assessment tools and 32 author self-defined criteria were used. The three most widely used tools were the Drummond checklist (19.4%), the BMJ checklist (15.8%), the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement (12.7%). Others included the Quality of Health Economic Studies (QHES), the Consensus on Health Economic Criteria (CHEC), the checklist of Center for Reviews and Dissemination (CRD), the Philips checklist, the World Health Organization (WHO) checklist, the checklist of Critical Appraisal Skills Program (CASP), the Pediatric Quality Appraisal Questionnaire (PQAQ), the Joanna Briggs Institute (JBI) checklist, Spanish and Chinese guidelines. The quantitative scales used in these literature were the QHES and PQAQ. CONCLUSIONS: Evidence showed that pharmacoeconomic systematic reviews' methodology remained to be improved, and the quality assessment criteria were gradually unified. Multiple scales can be used in combination to evaluate the quality of economic research in different settings and types.

Evaluation of quality of pharmacoeconomic studies involved in traditional Chinese medicine in China.

OBJECTIVES: The pharmacoeconomic studies of traditional Chinese medicine (TCM) are still in its infancy. Assessing the quality of pharmacoeconomic studies of TCM to improve the efficiency of health resource allocation and guide the rational use of medicine. METHODS: Four databases were searched from inception to January 2018. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies (QHES) were used to assess the reporting quality and methodological quality. STATA 12.0 and Meta analyst 3.13 were used to analyze the related data. RESULTS: A total of 178 studies were included. The methodological evaluation of the study found that the total score of QHES was 47.85 ± 8.09. The report quality evaluation results found that many studies did not report comprehensive information, such as lack of detailed reports on abstracts, study perspectives, time frames, discount rates, model selection, but the titles, study background and location, and health results, resource and cost estimates, analysis methods, and heterogeneity analysis are reported in more detail. Six of the ten stratification factors have statistically significant differences. CONCLUSION: The overall quality of pharmacoeconomic studies of TCM is low, and further standardization and improvement are needed to obtain reliable study results.

What do international pharmacoeconomic guidelines say about economic data transferability?

OBJECTIVES: The objectives of this article were to assess the positions of the various national pharmacoeconomic guidelines on the transferability (or lack of transferability) of clinical and economic data and to review the methods suggested in the guidelines for addressing issues of transferability. METHODS: A review of existing national pharmacoeconomic guidelines was conducted to assess recommendations on the transferability of clinical and economic data, whether there are important differences between countries, and whether common methodologies have been suggested to address key transferability issues. Pharmacoeconomic guidelines were initially identified through the ISPOR Web site. In addition, those national guidelines not included in the ISPOR Web site, but known to us, were also considered. RESULTS: Across 27 sets of guidelines, baseline risk and unit costs were uniformly considered to be of low transferability, while treatment effect was classified as highly transferable. Results were more variable for resource use and utilities, which were considered to have low transferability in 63% and 45% of cases, respectively. There were some differences between older and more recent guidelines in the treatment of transferability issues. CONCLUSIONS: A growing number of jurisdictions are using guidelines for the economic evaluation of pharmaceuticals. The recommendations in existing guidelines regarding the transferability of clinical and economic data are quite diverse. There is a case for standardization in dealing with transferability issues. One important step would be to update guidelines more frequently.

Methods for the collection of resource use data within clinical trials: a systematic review of studies funded by the UK Health Technology Assessment program.

BACKGROUND: The UK Health Technology Assessment (HTA) program funds trials that address issues of clinical and cost-effectiveness to meet the needs of the National Health Service (NHS). The objective of this review was to systematically assess the methods of resource use data collection and costing; and to produce a best practice guide for data capture within economic analyses alongside clinical trials. METHODS: All 100 HTA-funded primary research papers published to June 2009 were reviewed for the health economic methods employed. Data were extracted and summarized by: health technology assessed, costing perspective adopted, evidence of planning and piloting, data collection method, frequency of data collection, and sources of unit cost data. RESULTS: Ninety-five studies were identified as having conducted an economic analysis, of which 85 recorded patient-level resource use. The review identified important differences in how data are collected. These included: a priori evidence of analysts having identified important cost drivers; the piloting and validation of patient-completed resource use questionnaires; choice of costing perspective; and frequency of data collection. Areas of commonality included: the extensive use of routine medical records and reliance on patient recall; and the use of standard sources of unit costs. CONCLUSION: Economic data collection is variable, even among a homogeneous selection of trials designed to meet the needs of a common organization (NHS). Areas for improvement have been identified, and based on our findings and related reviews and guidelines, a checklist is proposed for good practice relating to economic data collection within clinical trials.

Data generalizability, data transferability, and the political economy of pharmacoeconomic guidelines.

OBJECTIVE: There are several methodological and practical issues surrounding the transferability of economic data that are important to address. A review of what national guidelines for economic evaluations say about transferability is important to understand the context in which transferability is currently practiced and discussed. Aim of this editorial is to discuss the results of a study reviewing the positions of various national guidelines in relation to the transferability and generalizability of data and the methods suggested for addressing issues of transferability presented in this issue. CONCLUSION: The recommendations on good research practices for dealing with aspects of transferability are filling an important gap. However, in order for the applied science of Pharmacoeconomics and Outcomes Research to make up for its epistemological aim and the aim of providing normative judgments, the methodological foundation of normative judgments has to be given the same importance as the methodological foundation the scientific community is seeking to establish as good research practices.

Good research practices for measuring drug costs in cost-effectiveness analyses: an international perspective: the ISPOR Drug Cost Task Force report--Part VI.

OBJECTIVE: The pharmacoeconomic guidelines available in the literature or promulgated in many countries are either vague or silent about how drug costs should be established or measured so an international comparison of cost-effectiveness analysis (CEA) results can be made. The objective of this report is to provide guidance and recommendations on how drug costs should be measured for CEAs done from an internationally comparative perspective. METHODS: Members of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force on Good Research Practices-Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) subgroup from several countries were experienced developers or users of CEA models, and worked in academia, industry, and as advisors to governments. They solicited comments on drafts from a core group of 174 external reviewers and more broadly, from the members of the ISPOR at the ISPOR 12th Annual International meeting and via the ISPOR Web site. RESULTS: Drug units should be standardized in terms of volume of active ingredient, regardless of packaging and dosing strength variations across countries. Drug costs should be measured in local currency per unit of active ingredient and should be converted to other currencies using sensitivity analyses of purchasing power parities (PPP) and exchange rates, whichever is more appropriate. When using drug prices from different years, the consumer price index for the local currency should be applied before the PPP and/or exchange rate conversion. CONCLUSION: CEA researchers conducting international pharmacoeconomic analysis should tailor the appropriate measure of drug costs to the international perspective, to maintain clarity and transparency on drug cost measurement in the context of international drug comparison and report the sensitivity of CEA results to reasonable cost conversions.

The transferability of valuing lost productivity across jurisdictions. differences between national pharmacoeconomic guidelines.

UNLABELLED: For at least two decades, there has been an intense debate on whether and how to include the value of lost productivity in economic evaluations. This debate is often reflected in pharmacoeconomic guidelines, which have been developed to indicate the methods and requirements for the design, execution, and reporting of economic evaluations in a particular country. OBJECTIVE: To examine what various national pharmacoeconomic guidelines recommend regarding the identification, measurement, and valuation of lost productivity. METHODS: First, the theoretical framework on how lost productivity can be identified, measured, and valued is described. Second, a summary sheet has been used to identify various pharmacoeconomic guidelines recommendations regarding the value of lost productivity. RESULTS: Twenty-two of the 30 guidelines identified recommend performing economic evaluations using the societal perspective. Nevertheless, even if the societal perspective is recommended, it is not always clear how the value of lost productivity should be taken into account. Most guidelines recommend including the costs of absenteeism from paid and/or unpaid work. In addition, although no agreement exists on how lost productivity should be valued, none of the guidelines recommended using the US panel approach for the valuation of lost productivity. DISCUSSION: The different recommendations hinder international transferability of the value of lost productivity. This difficulty is mainly caused by different recommendations regarding identification and valuation. These differences result from the debate and lack of consensus on including the value of lost productivity losses in economic evaluations. It will become easier to transfer data across jurisdictions if all data are reported transparently.

Good research practices for measuring drug costs in cost-effectiveness analyses: Medicare, Medicaid and other US government payers perspectives: the ISPOR Drug Cost Task Force report--Part IV.

OBJECTIVES: Public programs finance a large share of the US pharmaceutical expenditures. To date, there are not guidelines for estimating the cost of drugs financed by US public programs. The objective of this study was to provide standards for estimating the cost of drugs financed by US public programs for utilization in pharmacoeconomic evaluations. METHODS: This report was prepared by the ISPOR Task Force on Good Research Practices-Use of Drug Costs for Cost-Effectiveness Analysis Medicare, Medicaid, and other US Government Payers Subgroup. The Subgroup was convened to assess the methodological and practical issues confronted by researchers when estimating the cost of drugs financed by US public programs, and to propose standards for more transparent, accurate and consistent costing methods. RESULTS: The Subgroup proposed these recommendations: 1) researchers must consider regulation requirements that affect the drug cost paid by public programs; 2) drug cost must represent the actual acquisition cost, incorporating any rebates or discounts; 3) transparency with respect to cost inputs must be ensured; 4) inclusion of the public program's perspective is recommended; 5) high cost drugs require special attention, particularly when drugs represent a significant proportion of health-care expenditures for a specific disease; and 6) because of variations across public programs, sensitivity analyses for actual acquisition cost, real-world adherence, and generics availability are warranted. Specific recommendations also were proposed for the Medicare and Medicaid programs. CONCLUSIONS: As pharmacoeconomic evaluations for coverage decisions made by US public programs grows, the need for precise and consistent estimation of drug costs is warranted. Application of the proposed recommendations will allow researchers to include accurate and unbiased cost estimates in pharmacoeconomic evaluations.

[Indirect costs in health technology assessment]. / Koszty posrednie w ocenie technologii medycznych.

In the health technology assessment it is crucial to define the perspective of the analysis. When the societal perspective is chosen it is necessary to include all the costs incurred by the society, also the costs of lost productivity resulting from absence of sick employees from work or their reduced efficiency at work. The aim of this article is to present the notion of indirect costs, their importance in health technology assessment and the methods of calculation. The economic literature has been reviewed for the state of knowledge on indirect costs. Three methods of calculation are described: human capital method, friction cost method or health state valuation. Indirect costs in Western European countries can amount to more than half of total costs attributed to the illness and its treatment. In the literature there is no consensus regarding the proper method of indirect costs calculation. It is necessary to conduct further theoretical and empirical research in the area of indirect costs and enhance discussion among Polish pharmacoeconomists.

Interventional Pharmacoeconomics.

The increasing cost of health care is a major challenge around the world, but particularly in the United States. One reason for increased costs is the rapidly rising cost of oncology drugs. Potential solutions to this problem involve broad changes to health policy. However, an alternative solution is the development of lower-cost off-label treatment regimens, based on pharmacologic rationale, with significant potential economic impact. The pharmacologic and clinical properties of many drugs allow for a variety of different strategies. We describe this approach of interventional pharmacoeconomics and provide multiple individual examples.

Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers.

OBJECTIVE: To propose a set of guidelines for use by health care organizations in the United States that seek useful, comparative clinical information and economic analysis on pharmaceutical products to make sound drug purchasing decisions. PRACTICE INNOVATION: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system. PRACTICE SETTING: Intended for use by managed care organizations in the U.S. that purchase prescription drugs. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Not applicable. RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments-costs-outcomes, overall assessment, and bibliography and supporting materials.

[Educational standards of the Polish Pharmacoeconomic Society]. / Standardy Edukacyjne Polskiego Towarzystwa Farmakoekonomicznego.

The objective of creating Educational Standards of the Polish Pharmacoeconomic Society (Polish Chapter of the International Society for Pharmacoeconomics and Outcomes Research) was to define and establish a scope of knowledge and skills needed for people conducting and interpreting pharmacoeconomic analyses as well as health technology assessments. A Working Group of the Society identified target groups and divided the requirements into 3 groups: basic, intermediate and advanced. The document reflects conditions of the Polish healthcare and educational systems and is harmonized with international regulations in the field of pharmacoeconomics, outcomes research and health technology assessment. The standards may also serve as guidelines for educators in this area.