International Society For Pharmacoeconomics And Outcomes Research Research Articles

Self-Efficacy to Manage Chronic Disease (SEMCD) scale: translation and evaluation of measurement properties for a swedish version

BackgroundReinforcing self-efficacy in patients is important in person-centered care; therefore, reliable and valid measures of a person’s self-efficacy is of clinical relevance. A questionnaire suitable for self-efficacy and patient engagement that is not limited to a particular condition is the Self-efficacy to Manage Chronic Disease (SEMCD). This study aims to evaluate the measurement properties of a Swedish translation of the SEMCD with a Rasch analysis.MethodsThe translation and cultural adaptation of the SEMCD was performed according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations. Self-reported data was collected from two cohorts: patients with pituitary tumors (n = 86) and patients on sick leave due to common mental disorders (n = 209). Measurement properties were evaluated with a Rasch analysis in RUMM2030.ResultsThe original six-item SEMCD did not fit to a unidimensional scale. Two items, item 5 and item 6, deviated both statistically and conceptually and were removed. A four-item solution, the SEMCD-4 with collapsed thresholds for mid-range response options, showed good targeting and unidimensionality, no item misfit, and a reliability of 0.83.ConclusionIn a Swedish context with a mix of patients with pituitary tumors or common mental disorders, SEMCD-4 showed satisfactory measurement properties. Thus, SEMCD-4 could be used to identify patient self-efficacy in long-term illnesses. This knowledge about patient self-efficacy may be of importance to tailor person-centered support based on each patient´s resources, needs and goals.

Cross-cultural adaptation of the CRS-PRO questionnaire into French

BackgroundChronic rhinosinusitis (CRS), encompasses many different clinical patterns with variable response to treatment. Precise criteria specifying disease severity and control are lacking in the current literature. Our aim was to perform a cross-cultural adaptation of the CRS-PRO, creating a French version for use as a routine questionnaire in the assessment of patients with CRS.MethodsThe CRS-PRO questionnaire was translated according to the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through a three-step procedure including a backward translation.ResultsSeven of 12 items were initially discordant between the three translators before achieving consensus (Step 1). Two of 12 items were discordant between the backward translation and the initial CRS-PRO version regarding the word “mucus”(Step 2). Step 3 allowed the creation of a French proof-read version of the CRS-PRO questionnaire. Thirty patients were included for initial validation, mean age of 49.2 ± 15 years and 63.3% (19/30) male. It took them 67 ± 23 s to complete the questionnaire without any patients requiring more than 2 min.ConclusionThis study presents the French version of the CRS-PRO questionnaire—an adapted, validated, and well-accepted instrument to evaluate the CRS symptoms in the French speaking population.

OP41 Facilitating Dialogue Of Real-World Evidence Use In Health Technology Assessment: Taxonomy Of Question/Data Source Pairings To Support A Registry Of Studies

IntroductionThis paper reports the results of the collaboration within the European initiative of new Reimbursement and aCCess Approaches (EUreccA) which is concerned with the use of real-world evidence (RWE) in health technology assessment (HTA) decision-making. The work grew from the observation of a large, very experienced group of HTA practitioners which found that the use of RWE varied depending on the type of question asked and the particulars of the data source(s) used. We set out to examine how RWE is used in HTA decision-making and to make proposals on its facilitation.MethodsLiterature reviews covering earlier reviews of RWE use, academic papers, and HTA agency websites were combined with case studies involving interviews with decision-makers in four countries (England, France, Italy, Sweden) to identify the circumstances of breakdown of RWE use and to build a categorization of the uses of RWE and associated difficulties. This evidence supported the creation of a taxonomy of pairings of data sources and the questions they were used to address. The face validity of the approach was tested at an advisory board of senior HTA practitioners.ResultsIn total, 27 questions were identified and 10 types of data source, giving 270 pairings. These pairings were linked to relevant methods guidance and to examples of their use, itemizing HTA issues and decisions made. Reports are being prepared for publication, covering the detail of the methods of the literature searches; methods of the country case studies; a description of the taxonomy; and guidance on governance.ConclusionsWhen using RWE in HTA decision-making, the detail of the particular data sources and question addressed matter. Recently, both the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Real-World Transparency Initiative have argued for a registry of the uses of RWE. The work described here offers a starting classification of the material that should be held in such a registry, and which in itself could be developed by the stakeholders, both agencies and companies, that use it, furthering trust and confidence.

Adaptation and Validation of the Spanish Version of Decisional Conflict Scale in People with Migraine in Spain.

We aimed to validate the Spanish version of the Decisional Conflict Scale (DCS) and analyze its psychometric properties in people with migraine. The DCS validation comprised two phases. First, a translation and cross-cultural adaptation following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practices: 1-preparation, 2-independent forward translation, 3-reconciliation, 4-back-translation, 5-harmonization, 6-clinical review, and 7-content validation in a group of migraine patients. Second, the analysis of the psychometric properties. The reliability or internal consistency of the DCS scale and subscales was assessed using Cronbach's α value. The item-subscale correlation was also evaluated. A floor and ceiling effects for DCS score was considered when at least 15% of respondents obtained DCS >90 (ceiling) or <10 (floor). The construct validity was studied through the correlation between the DCS subscales and by the correlation between the DCS and other questionnaires (Decision Self-Efficacy Scale [DSES] and 9-item Shared Decision-Making [SDM-Q-9]). Spearman's coefficients were estimated for the correlations. The cross-cultural adaptation was conducted on 17 patients who completed the questionnaire in a mean of 2.4 ±1.1 minutes. Generally, more than 75% of them considered that DCS items were adequate, easy to understand, and relevant. The psychometric properties were evaluated in a sample of n=128 patients. Accordingly, the internal consistency of DCS was high, with a Cronbach's α of 0.97 for the scale and between 0.87 to 0.96 for subscales. Also, a slight floor effect was observed, with 24.2% of patients having DCS scores <10. The correlation between subscales exceeded Spearman's coefficient of 0.7. Whereas the correlation between the DCS and the other questionnaires was generally moderate (Spearman's coefficient >0.4). The Spanish version (Spain) of the DCS has very acceptable psychometric properties (reliability and construct validity) and good potential for assessing decisional conflicts among migraine patients.

OP12 Findings From the 2022 International Society for Pharmacoeconomics and Outcomes Research Student Benefit Survey

The purpose of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) student benefit survey is to understand perceived benefits of student membership; identify suggested future membership benefits to improve student engagement; and identify drivers of a smooth transition from a student to a new professional member.

Validation of the French version of the ICHOM adult oral health standard set.

The ICHOM Adult Oral Health Standard Set (AOHSS) recently developed by the ICHOM Oral Adult Health Working Group is a standard set of outcomes designed for its collection in clinical practice in dental health. The outcome standard set is made up of clinical-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs). The purpose of this study was to translate and cross-culturally adapt the PROM section of the Standard Set in French for France to enable comprehensive evaluation of the patients' oral health quality of life in a French population. The questionnaire was translated following the guidelines of the International Society for Pharmacoeconomics and Outcome Research (ISPOR). We included patients consulting in a dentistry clinic (n = 127) and seeking dental care. The PROM and CROM data were collected from all patients. Both reliability and the internal consistency were evaluated. The ICHOM AOHSS was successfully translated into French. We sampled and surveyed 126 patients in a dentistry clinic in France using the French translation of the ICHOM AOHSS. Cronbach's α was calculated to measure the internal consistency. The resulting Cronbach's α was 0.8, indicating acceptable homogeneity. The French version of the ICHOM AOHSS shows acceptable psychometric properties in terms of reliability and internal consistency. This translation is suitable for its implementation in a French-speaking patient population.

Value Insider Season 1 Episode 5: What Other Aspects of Value May Be Relevant? (Societal Impact) [Podcast

What other aspects of value may be relevant? In this episode of the Value Insider podcast, host Mike Chambers speaks with Prof. Lou Garrison about the societal perspective on value of healthcare interventions. Prof. Garrison is Professor Emeritus in The Comparative Health Outcomes, Policy, and Economics institute (CHOICE) in the School of Pharmacy at the University of Washington. Lou is past president of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and he is currently co-chair of its Policy Outlook Committee. Going beyond the "conventional" elements of value assessment, Prof. Garrison highlights which additional impacts may be at play. He shares his concept of the "Value Flower", explaining elements such as insurance value and scientific spill-over.

Formulary Submissions: Value Claims, Protocols and Outcomes Based Contracting in Rare Disease.

Outcomes based payments contracting is in its infancy. The increased attention being given to rare disease place a premium on the ability to engage with payers to ensure that there is an analytical framework relevant to value claims contracting. Rare disease is not, of course, alone; many other chronic disease states may be suitable candidates and have been over the past 10 years or more. Rare disease, however stands apart: (i) the evidence base at product launch is limited; (ii) the therapy costs are often considered prohibitive; and (iii) the target patient population is small. At the same time, those seeking to implement an evidence-based engagement with health systems to support innovative rare disease interventions face a substantive technology assessment barrier. The focus in health technology assessment on assumption driven modeled cost-effectiveness simulations that support imaginary recommendations for cost-effective pricing and access is, however, an avoidable barrier. In the US, this barrier is the business model of the Institute for Clinical and Economic Review (ICER) and one endorsed by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Rare disease can be better served with other tools at our disposal with a proposed new start analytical framework in health technology assessment. The purpose of this brief note is to make the case that this proposed new start focused on single attribute value claims that meet the standards of normal science and fundamental evidence can not only dispense with the ICER imaginary modeling but, with a new start formulary submission package, integrate value claims with assessment protocols to set the stage for effective outcome-based contracting as the default standard for future payer negotiations.

Value Insider Season 1 Episode 3: How Does Budget Impact and Affordability in Healthcare Work? (BI and Affordability) [Podcast

How does budget impact and affordability in healthcare work? In this episode of the Value Insider podcast, host Mike Chambers speaks with Prof. Sean Sullivan about affordability and budget impact for the "payers" of healthcare interventions. Prof. Sullivan is Dean of the University of Washington School of Pharmacy. He is past president of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and served as chair of the health technology assessment (HTA) committee of US Health Insurer Premera Blue Cross, was part of the US Governmental Medicare coverage evidence committee and led the ISPOR Task Force on Methods for Conducting and Reporting Budget Impact Assessments. Prof. Sullivan explains how budget impact and affordability are intertwined and how this plays a role in decisions in the US, but also the rest of the world.

LIMB-Q Kids—German Translation and Cultural Adaptation

(1) Purpose: Lower limb deformities can have a severe impact on health-related quality of life (HRQL). LIMB-Q Kids is a new patient-reported outcome measure (PROM) aiming to elucidate the experience of 8–18-year-old patients before, during and after treatment, and to measure the different aspects of HRQL. The aim of this study was to translate and culturally adapt LIMB-Q Kids to German. (2) Methods: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were followed. Three forward translations, a backward translation, an expert panel meeting with eight participants, and twenty cognitive debriefing interviews led to the final German version of LIMB-Q Kids. (3) Results: In the forward translations, 4/159 items were difficult to translate, and 2/159 items in the backward translation differed from the original English version. Cognitive debriefing interviews with 20 patients identified 7/159 items that were difficult to comprehend/answer, and 2 of these items were changed. (4) Conclusions: Lower limb deformities can have a great impact on children, and it is important to measure and consider the impact on HRQL. In order to be able to use PROMs in different countries, conceptually equivalent translations and cultural adaptations should be performed in order to ensure comprehensibility. The final German version of LIMB-Q Kids is ready for use in an international field test.

3rd Annual International Pharmacoeconomic Forum Highlights.

3rd Annual International Pharmacoeconomic Forum Highlights.

Dutch translation and cultural adaptation of the LYMPH-Q, a new patient-reported outcome measure for breast cancer-related lymphedema

BackgroundThe LYMPH-Q Upper Extremity module is a new patient-reported outcome measure (PROM) developed to assess patient outcomes of breast cancer-related arm lymphedema (BCRL). Content for the LYMPH-Q Upper Extremity Module was developed from the extensive input of patients and experts in the field of breast surgery and breast cancer-related lymphedema. Rasch Measurement Theory analysis was used to assess psychometric properties. The aim of this study was to perform a Dutch translation and cultural adaptation of the LYMPH-Q Upper Extremity Module.MethodsThe translation process was performed in accordance with the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).The process included two forward translations, two back translations, and cognitive debriefing interviews with patients with BCRL.ResultsComparison of the two forward translations showed that the translations for most items (n = 60; 88.2%) were conceptually consistent between the two translators. Translations of the remaining items were reviewed and discussed until consensus was reached. Three items in the back translation had a different meaning when compared to the original English version and required re-translation. The resultant Dutch version of the LYMPH-Q was tested in a series of cognitive debriefing interviews with seven patients and showed good content validity.ConclusionsThe translation and cultural adaptation process resulted in a conceptually equivalent Dutch version of the LYMPH-Q Upper Extremity Module. This new PROM can now be used in clinical practice and research settings to evaluate outcomes in patients with BCRL.Level of evidence: Not gradable

OP2 Findings from the 2021 International Society for Pharmacoeconomics and Outcomes Research Student Interest Survey

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) student interest survey is distributed annually to active student ISPOR members. In this study, we describe the findings from the 2021 student interest survey.

Transcultural adaptation and validation of the Spanish version of the Global Pain Scale.

The aim of this study was to perform a cross-cultural adaption and validation of the Global Pain Scale (GPS) to produce a Spanish-language version (GPS-Sp) and to determine the psychometric properties of this instrument. The GPS was cross-culturally translated into Spanish following the guidelines of the International Society for Pharmacoeconomics and Outcomes Research. The initial study population was composed of 384 patients recruited from February to May 2021. All participants were aged at least 18 years and were currently experiencing pain. All gave signed informed consent to take part and completed the Brief Inventory-Sp and GPS-Spain questionnaires. Cronbach'sɑand test/retest reliability values were calculated and floor/ceiling effects analyzed. Construct validity was assessed by confirmatory factor analysis (CFA). The 370 patients included in the final analysis presented the following characteristics: 36.2% were male and 63.8% were female; mean age 42.6 (19-88) years; mean body mass index 24.99. Internal consistency was good. The Cronbach's ɑfor GPS-Sp was 0.86 and the intraclass correlation coefficient was 0.94 (95% CI; 0.87-0.97). Five main explanatory factors were identified by CFA, which produced the following values: RMSEA = 0.057; CFI = 0.807; GFI = 0.809; NFI = 0.763. No floor/ceiling effect was observed. The GPS-Sp is a valid, reliable and sensitive instrument for assessing pain in a Spanish-speaking population and could facilitate pain relief in this population.

Nothing to Cheer About: Endorsing Imaginary Economic Evaluations and Value Claims with CHEERS 22

One of the more unfortunate features of health technology assessment is the tenacity with which leaders in the field and organizations such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Institute for Clinical and Economic Review (ICER) cling to an evaluation framework that fails to meet the standards of normal science. Believers subscribe to a meme that is clearly non-science (metaphysics and pseudoscience) and one that should have been discarded over 30 years ago. Certainly, subscribing to an impossible belief is not unusual; indeed it may make the belief that much stronger. Yet the meme is non-sustainable; it is also pointless as the economic evaluation claims are non-evaluable. There is no acknowledgement of the standards of normal science or the limitations imposed by the axioms of fundamental measurement. The purpose of this commentary is to make the case that the recent release of the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 22) checklist is misleading; CHEERS 22 fails to address the manifest deficiencies in the approach to economic evaluations endorsed by ISPOR and ICER. Instead, it continues to promote economic evaluations in healthcare that invent evidence and non-empirically evaluable value claims. Given the widespread publicity that has accompanied the release of CHEERS 22, the purpose of this commentary is to detail the deficiencies in CHEERS 22 and propose an alternative framework for economic evaluation in health care to meet the information needs of formulary committees. This means abandoning the standards for economic evaluations that have dominated health technology assessment for 30 years, notably the key role assigned to the mathematically impossible quality adjusted life year (QALY). The proposed new start recommends single attribute evaluable value claims that meet ratio or interval measurement standards and are supported by evaluation protocols.

Economic evaluations for intensive care unit randomised clinical trials in Australia and New Zealand: Practical recommendations for researchers

ObjectivesEconomic evaluations of intensive care unit (ICU) interventions have specific considerations, including how to cost ICU stays and accurately measure quality of life in survivors. The aim of this article was to develop best practice recommendations for economic evaluations alongside future ICU randomised controlled trials (RCTs). Review methodsWe collated our experience based on expert consensus across several recent economic evaluations to provide best-practice, practical recommendations for researchers conducting economic evaluations alongside RCTs in the ICU. Recommendations were structured according to the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Task Force Report. ResultsWe discuss recommendations across the components of economic evaluations, including: types of economic evaluation, the population and sample size, study perspective, comparators, time horizon, choice of health outcomes, measurement of effectiveness, measurement and valuation of quality of life, estimating resources and costs, analytical methods, and the increment cost-effectiveness ratio. We also provide future directions for research with regard to developing more robust economic evaluations for the ICU. ConclusionEconomic evaluations should be built alongside ICU RCTs and should be designed a priori using appropriate follow-up and data collection to capture patient-relevant outcomes. Further work is needed to improve the quality of data available for linkage in Australia as well as developing costing methods for the ICU and appropriate quality of life measurements.

Nothing to Cheer About: Endorsing Imaginary Economic Evaluations and Value Claims with CHEERS 22.

One of the more unfortunate features of health technology assessment is the tenacity with which leaders in the field and organizations such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Institute for Clinical and Economic Review (ICER) cling to an evaluation framework that fails to meet the standards of normal science. Believers subscribe to a meme that is clearly non-science (metaphysics and pseudoscience) and one that should have been discarded over 30 years ago. Certainly, subscribing to an impossible belief is not unusual; indeed it may make the belief that much stronger. Yet the meme is non-sustainable; it is also pointless as the economic evaluation claims are non-evaluable. There is no acknowledgement of the standards of normal science or the limitations imposed by the axioms of fundamental measurement. The purpose of this commentary is to make the case that the recent release of the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 22) checklist is misleading; CHEERS 22 fails to address the manifest deficiencies in the approach to economic evaluations endorsed by ISPOR and ICER. Instead, it continues to promote economic evaluations in healthcare that invent evidence and non-empirically evaluable value claims. Given the widespread publicity that has accompanied the release of CHEERS 22, the purpose of this commentary is to detail the deficiencies in CHEERS 22 and propose an alternative framework for economic evaluation in health care to meet the information needs of formulary committees. This means abandoning the standards for economic evaluations that have dominated health technology assessment for 30 years, notably the key role assigned to the mathematically impossible quality adjusted life year (QALY). The proposed new start recommends single attribute evaluable value claims that meet ratio or interval measurement standards and are supported by evaluation protocols.

Treatment patterns and health care costs among patients with psoriatic arthritis treated with biologic or targeted synthetic disease-modifying antirheumatic drugs.

BACKGROUND: Biologic and targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies are used in management of psoriatic arthritis (PsA). Although previous studies have demonstrated that rates of adherence, persistence, discontinuation, and switching, as well as health care costs, are variable among treatments, limited published data exist on more recently approved therapies. OBJECTIVE: To describe adherence, persistence, discontinuation, reinitiation, switching, dosing patterns, and health care costs among PsA patients treated with biologics and tsDMARDs. METHODS: This was a real-world, retrospective administrative claims study. Adult PsA patients with at least 1 claim for an approved PsA biologic (adalimumab, certolizumab, etanercept, golimumab, infliximab, secukinumab, or ustekinumab) or tsDMARD (apremilast or tofacitinib) between January 1, 2015, and June 30, 2019, were selected from the IBM MarketScan administrative claims databases. The first claim for one of the study treatments determined the index date and drug cohort. Patients were required to be continuously enrolled in their health plans for 12 months before and after the index date and to have at least 1 claim with a diagnosis of PsA in the 12 months before or on the index date. Adherence (measured by proportion of days covered [PDC] and medication possession ratio [MPR]), persistence (< 60-day gap in treatment), discontinuation (> 90-day gap), reinitiation of index drug, switching, and dosing patterns for each index drug were assessed during the 12-month follow-up period. Health care costs were reported per patient per month (PPPM) during the 12-month follow-up and assessed after adjusting PsA treatment costs by the Institute for Clinical and Economic Review discount factors to account for discounts and rebates not usually reflected in claims data and by adherence. RESULTS: Overall, 6,674 patients met the selection criteria. The top 3 index drugs were adalimumab (37%), apremilast (26%), and etanercept (18%). Over 12 months of follow-up, 31%-59% of patients remained persistent on the index drug, whereas 35%-56% discontinued, 13%-29% switched to a different biologic or tsDMARD, and 3%-15% reinitiated the index therapy, depending on the index drug. The mean PDC ranged from 0.51 to 0.69 during the 12-month follow-up and 0.80 to 0.93 during the follow-up period before discontinuation. Dose values were largely consistent with prescribing information, with the exception of secukinumab. Index drug costs PPPM ranged from $2,361 (apremilast) to $6,528 for ustekinumab after adjustment for discounts and adherence. CONCLUSIONS: Results from this real-world analysis suggest that there is substantial variability in persistence, discontinuation, adherence, reinitiating, and switching patterns among the different biologic and tsDMARD treatment options for PsA patients. In addition, this study provides real-world cost data for biologics and tsDMARDs among patients with PsA. DISCLOSURES: This study was funded by Eli Lilly Inc., which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the development of the publication and maintained control over the final content. Murage, Malatestinic, Zhu, Atiya, Kern, Stenger, and Sprabery are employees and stockholders of Eli Lilly Inc. Princic and Park are employed by IBM Watson Health, which received funding from Eli Lilly Inc. to conduct this study. Ogdie has received consulting fees from Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Novartis, and Pfizer and has also received grant support from Pfizer, Novartis, and Amgen. Portions of these data have been presented in poster form at the virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020 and Congress of Clinical Rheumatology (CCR) West 2020 conferences.

Economic evaluations in fracture research an introduction with examples of foot fractures

IntroductionThe 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 studiesFour 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 AssessmentWhen 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 analysisTwo 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 analysisThe 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. ConclusionAlthough 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.

Economic burden of attention-deficit/hyperactivity disorder among adults in the United States: a societal perspective.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is associated with substantial clinical burden as individuals transition to adulthood, including higher rates of comorbidities, mortality, incarceration, and psychiatric hospitalizations than in individuals without ADHD. These higher rates likely contribute to substantial economic burden as well. OBJECTIVE: To provide a comprehensive evaluation of the economic burden associated with ADHD in the US adult population. METHODS: Direct health care costs were obtained by using claims data from the IBM MarketScan Research Databases (January 1, 2017, through December 31, 2018). Direct non-health care costs and indirect costs were estimated on the basis of the literature and government publications. Excess costs incurred by adults with ADHD during 2018 were evaluated from a societal perspective; per-patient costs were extrapolated to the national level. RESULTS: An estimated 8.7 million adults live with ADHD in the United States, resulting in a total societal excess cost attributable to ADHD of $122.8 billion ($14,092 per adult). Excess costs of unemployment ($66.8 billion; 54.4%) comprised the largest proportion of the total, followed by productivity loss ($28.8 billion; 23.4%) and health care services ($14.3 billion; 11.6%). CONCLUSIONS: ADHD in adults is associated with substantial economic burden. DISCLOSURES: This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka). The study sponsor contributed to and approved the study design, participated in the interpretation of data, and reviewed and approved the manuscript. Schein is an employee of Otsuka. Gagnon-Sanschagrin, Davidson, Kinkead, Cloutier, Guérin, and Lefebvre are employees of Analysis Group, Inc., a consulting company that provided paid consulting services to Otsuka to develop and conduct this study and write the manuscript. Adler has received research support from Shire/Takeda, Sunovion, and Otsuka; consulting fees from Bracket, Shire/Takeda, Sunovion, Otsuka, the State University of New York (SUNY), the National Football League (NFL), and Major League Baseball (MLB); and royalty payments (as inventor) from New York University (NYU) for license of adult ADHD scales and training materials. Childress has received research support from Allergan, Takeda/Shire, Emalex, Akili, Ironshore, Arbor, Aevi Genomic Medicine, Neos Therapeutics, Otsuka, Pfizer, Purdue, Rhodes, Sunovion, Tris, KemPharm, Supernus, and the US Food and Drug Administration; was on the advisory board of Takeda/Shire, Akili, Arbor, Cingulate, Ironshore, Neos Therapeutics, Otsuka, Pfizer, Purdue, Adlon, Rhodes, Sunovion, Tris, Supernus, and Corium; received consulting fees from Arbor, Ironshore, Neos Therapeutics, Purdue, Rhodes, Sunovion, Tris, KemPharm, Supernus, Corium, Jazz, and Tulex Pharma; received speaker fees from Takeda/Shire, Arbor, Ironshore, Neos Therapeutics, Pfizer, Tris, and Supernus; and received writing support from Takeda/Shire, Arbor, Ironshore, Neos Therapeutics, Pfizer, Purdue, Rhodes, Sunovion, and Tris. Part of the material in this study was presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2021 Virtual Meeting; May 17-20, 2021.