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Research and development investments for biologics independently developed by US biotechnology startups, 2017-2023. 2017-2023年美国生物技术创业公司自主研发的生物制剂研发投资。
IF 2.7
Health affairs scholar Pub Date : 2025-07-25 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf139
Ilina C Odouard, So-Yeon Kang, Jessica Mo, Gerard F Anderson, G Caleb Alexander
{"title":"Research and development investments for biologics independently developed by US biotechnology startups, 2017-2023.","authors":"Ilina C Odouard, So-Yeon Kang, Jessica Mo, Gerard F Anderson, G Caleb Alexander","doi":"10.1093/haschl/qxaf139","DOIUrl":"10.1093/haschl/qxaf139","url":null,"abstract":"<p><strong>Introduction: </strong>Despite policy interest in pharmaceutical innovation, little is known about the investment needed for venture capital-backed startups to develop innovative biologics, a growing segment of the pharmaceutical marketplace.</p><p><strong>Methods: </strong>In a cross-sectional analysis of Food and Drug Administration (FDA) drug approval data, investment deal records, and clinical trials data, we estimated the investment needed for a biotechnology startup company to independently develop a biologic approved by the US FDA with priority review, an indicator of innovation. To isolate a homogenous set of cases, the sample focused on independent drug development of 13 drugs by 9 biotechnology startup companies that retained ownership of the drug from the start of development to FDA approval without being acquired or licensing the product.</p><p><strong>Results: </strong>We found that the median investment per FDA-approved biologic was $304.1 million (IQR: $289.9-$790.3 million) in uncapitalized costs, accounting for the cost of failures.</p><p><strong>Conclusion: </strong>This estimate represents the direct drug R&D investment needed for independent development of innovative biologic products by biotechnology startup companies.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf139"},"PeriodicalIF":2.7,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Building on health care access for children in Spanish-language settings. 为西班牙语环境中的儿童提供保健服务。
IF 2.7
Health affairs scholar Pub Date : 2025-07-24 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf076
Rishika Selvakumar
{"title":"Building on health care access for children in Spanish-language settings.","authors":"Rishika Selvakumar","doi":"10.1093/haschl/qxaf076","DOIUrl":"10.1093/haschl/qxaf076","url":null,"abstract":"","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf076"},"PeriodicalIF":2.7,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12287690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
What drug characteristics explain the wide range of manufacturer rebates? 什么药物特性解释了制造商回扣的范围之广?
IF 2.7
Health affairs scholar Pub Date : 2025-07-15 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf132
Molly T Beinfeld, Fariel LaMountain, Glenn Phillips, Tom Hughes, Peter J Neumann, James D Chambers
{"title":"What drug characteristics explain the wide range of manufacturer rebates?","authors":"Molly T Beinfeld, Fariel LaMountain, Glenn Phillips, Tom Hughes, Peter J Neumann, James D Chambers","doi":"10.1093/haschl/qxaf132","DOIUrl":"10.1093/haschl/qxaf132","url":null,"abstract":"<p><strong>Introduction: </strong>Prescription drug list prices, often cited in policy discussions, do not account for rebates negotiated between manufacturers and payers.</p><p><strong>Methods: </strong>This study examines factors influencing rebates in the United States, focusing on specialty drugs-ie, high priced therapies (often biologics) for which payers issue specific coverage policies. Rebate data came from SSR Health and drug attributes from the Tufts Medical Center Specialty Drug Evidence and Coverage Database. We stratified rebate data by drug type and characteristics.</p><p><strong>Results: </strong>We identified 161 drugs found in SSR Health and SPEC as of December 2023. We found that rebates vary substantially across drugs (median of 27%, IQR 16%-53%). Biosimilar and originator drugs have the highest, most variable rebates (median of 71%, IQR 53%-79%), while rebates for cancer treatments and orphan drugs are lower (medians of 19% and 23%, respectively) and vary less (IQR of 12%-28% and 14%-29%, respectively). Drugs that face more competition from alternative options within the same therapeutic class, are self-administered, or received Food and Drug Administration approval further in the past have higher rebates.</p><p><strong>Conclusion: </strong>Our findings indicate that rebates are sizeable and vary along several dimensions, many relating to market competition, complicating policy discussions around drug pricing.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf132"},"PeriodicalIF":2.7,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290394/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A 10-year comparative analysis of medical and surgical specialty lobbying by physician professional organizations. 医师专业组织对内科和外科专业游说的10年比较分析。
IF 2.7
Health affairs scholar Pub Date : 2025-07-09 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf140
Max Bouvette, Stephanie Beveridge, Kirtana Kumar, Mehak Ali, Justin Dvorak, Nirmal Choradia, Ryan Nipp
{"title":"A 10-year comparative analysis of medical and surgical specialty lobbying by physician professional organizations.","authors":"Max Bouvette, Stephanie Beveridge, Kirtana Kumar, Mehak Ali, Justin Dvorak, Nirmal Choradia, Ryan Nipp","doi":"10.1093/haschl/qxaf140","DOIUrl":"10.1093/haschl/qxaf140","url":null,"abstract":"<p><strong>Introduction: </strong>Physician professional organizations (PPOs) engage in lobbying to advocate for their interests and influence health policy. However, trends in lobbying across specialties are not well characterized. Disproportionate spending across PPOs may affect the ability to shape healthcare legislation and ensure that all physician voices are represented.</p><p><strong>Methods: </strong>We analyzed publicly available lobbying data from OpenSecrets.org covering 2014-2023, adjusted to 2023 USD. A total of 109 PPOs were included. Physician professional organizations were categorized as medical (<i>n</i> = 68), surgical (<i>n</i> = 29), or overlapping (<i>n</i> = 12), based on whether they primarily represented medical specialties, surgical specialties, or both. Physician workforce data from the AAMC were used to calculate spending per-physician. Temporal trends were assessed using a Mann-Kendall test.</p><p><strong>Results: </strong>Median annual PPO lobbying spending was $71 million, with a significant downward trend (<i>P</i> < .01, tau = -.64). Expenditures included $32 million (45%) by medical PPOs, $12 million (16%) by surgical PPOs, and $27 million (39%) by overlapping PPOs. The median annual lobbying spending per-physician was $78.</p><p><strong>Conclusion: </strong>These findings suggest that PPOs have not sustained lobbying investments over time, particularly when accounting for the effects of inflation.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf140"},"PeriodicalIF":2.7,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12287694/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144710394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The potential for patient-reported data and narratives to improve quality during emergency department boarding. 病人报告的数据和叙述提高急诊住院质量的潜力。
IF 2.7
Health affairs scholar Pub Date : 2025-07-07 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf138
Kelly T Gleason, Kathryn M McDonald, Susan M Peterson, Diane Kuhn, Mark Schlesinger
{"title":"The potential for patient-reported data and narratives to improve quality during emergency department boarding.","authors":"Kelly T Gleason, Kathryn M McDonald, Susan M Peterson, Diane Kuhn, Mark Schlesinger","doi":"10.1093/haschl/qxaf138","DOIUrl":"10.1093/haschl/qxaf138","url":null,"abstract":"<p><p>Emergency department (ED) boarding, the holding of admitted patients in the ED due to unavailable inpatient beds, is a growing challenge linked to poorer patient outcomes. Traditional patient experience surveys, such as the ED Consumer Assessment of Healthcare Providers and Systems (ED CAHPS), exclude insights from boarded patients, whose experiences could inform quality improvement efforts. We collected data using the patient-reported outcomes to improve diagnostic experience in the ED instrument from all patients, whether discharged or admitted. Early findings show that longer ED stays correlate with lower patient-reported diagnostic quality scores, with the highest quartile of stay durations averaging 3.79 out of 5 compared to 4.10 in the lowest quartile. A separate nationwide survey of diagnostic experiences, which did not specifically ask about EDs or wait times, also highlighted the impact of long ED stays. Patient narratives emphasized the need for better communication during boarding, such as explaining the reasons for admission. These findings suggest that including boarded patients in ED CAHPS' sampling criteria and incorporating open-ended questions could provide valuable insights for improving ED boarding practices. This commentary emphasizes the value of patient-driven data in identifying actionable solutions to mitigate the challenges of ED boarding.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf138"},"PeriodicalIF":2.7,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12303624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The disability mismatch: the case for a comprehensive disability status measure. 残疾不匹配:综合残疾状态测量的案例。
IF 2.7
Health affairs scholar Pub Date : 2025-07-04 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf137
Scott D Landes, Bonnielin K Swenor, Jean P Hall, Anjali J Forber-Pratt, Nastassia Vaitsiakhovich, Kate Caldwell, Mihir Kakara, Deborah Lefkowitz, Andrew Myers, Susan J Popkin, Nicholas S Reed, Emily F Rothman, Maggie Salinger
{"title":"The disability mismatch: the case for a comprehensive disability status measure.","authors":"Scott D Landes, Bonnielin K Swenor, Jean P Hall, Anjali J Forber-Pratt, Nastassia Vaitsiakhovich, Kate Caldwell, Mihir Kakara, Deborah Lefkowitz, Andrew Myers, Susan J Popkin, Nicholas S Reed, Emily F Rothman, Maggie Salinger","doi":"10.1093/haschl/qxaf137","DOIUrl":"10.1093/haschl/qxaf137","url":null,"abstract":"<p><strong>Introduction: </strong>Current disability questions used in many US federal surveys exclusively measure disability as having 1 or more of 6 functional limitations. This strategy is at odds with who is disabled as some disabled people do not experience these limitations.</p><p><strong>Methods: </strong>Using data from a nationally representative survey of 2169 adults, this study describes the potential of a comprehensive disability status question to improve the measurement of disability.</p><p><strong>Results: </strong>Results from this study demonstrate that a comprehensive disability status question successfully identifies disabled people who both do, and do not, experience limitations.</p><p><strong>Conclusion: </strong>These findings suggest that a single comprehensive disability status question may provide a viable and more inclusive alternative to identifying the disabled population in US federal surveys.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf137"},"PeriodicalIF":2.7,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12290393/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144736383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Strategic pathways to International Classification of Diseases, 11th Revision, adoption in France and the United States. 《国际疾病分类第十一次修订版战略路径》在法国和美国获得通过。
Health affairs scholar Pub Date : 2025-07-01 DOI: 10.1093/haschl/qxaf099
Bastien Boussat, Robert Jakob, Laurent Boyer, Patrick S Romano
{"title":"Strategic pathways to International Classification of Diseases, 11th Revision, adoption in France and the United States.","authors":"Bastien Boussat, Robert Jakob, Laurent Boyer, Patrick S Romano","doi":"10.1093/haschl/qxaf099","DOIUrl":"10.1093/haschl/qxaf099","url":null,"abstract":"<p><p>The International Classification of Diseases, 11th Revision (ICD-11), developed by the World Health Organization, represents a transformative update to global health data classification systems. Building on the foundation of ICD-10, it introduces innovative features such as multilingual coding, advanced interoperability, postcoordination, and improved specificity, enabling better alignment with modern healthcare and digital information systems. This commentary explores the adoption pathways for ICD-11 in France and the United States, 2 countries with complex healthcare infrastructures and distinct implementation strategies. France's phased roadmap, led by the National Health Information Agency, prioritizes system readiness, workforce training, and pilot testing to ensure smooth integration with hospital information systems. In contrast, the United States, guided by the National Committee on Vital and Health Statistics, focuses on regulatory alignment, funding models, and system modifications to support a seamless transition. The manuscript underscores the critical role of academic research in refining ICD-11's applications, assessing its impact on healthcare quality, and optimizing tools for implementation. Drawing lessons from early adopters globally, we advocate for a coordinated, resource-driven approach to achieve full ICD-11 adoption within 5 years. This transition is poised to enhance health data accuracy, support clinical research, and improve population health outcomes worldwide.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf099"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12208713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144546650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retraction and replacement of: Strategic pathways to International Classification of Diseases, 11th Revision adoption in France and the United States. 撤回和替换:《国际疾病分类战略路径》第11次修订在法国和美国通过。
Health affairs scholar Pub Date : 2025-07-01 DOI: 10.1093/haschl/qxaf098
{"title":"Retraction and replacement of: Strategic pathways to International Classification of Diseases, 11th Revision adoption in France and the United States.","authors":"","doi":"10.1093/haschl/qxaf098","DOIUrl":"https://doi.org/10.1093/haschl/qxaf098","url":null,"abstract":"<p><p>[This retracts the article DOI: 10.1093/haschl/qxaf037.].</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf098"},"PeriodicalIF":0.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12208714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144546649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Geographical variation in physician supply and its relationship to utilization of care across older adults in the United States. 医生供应的地理差异及其与美国老年人护理利用的关系。
Health affairs scholar Pub Date : 2025-06-30 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf127
Mason Barnard, Jose F Figueroa, Jessica Phelan, E John Orav, Irene Papanicolas
{"title":"Geographical variation in physician supply and its relationship to utilization of care across older adults in the United States.","authors":"Mason Barnard, Jose F Figueroa, Jessica Phelan, E John Orav, Irene Papanicolas","doi":"10.1093/haschl/qxaf127","DOIUrl":"10.1093/haschl/qxaf127","url":null,"abstract":"<p><strong>Introduction: </strong>Scholars express concern that general practitioner shortages and specialist surpluses induce overspecialization, with overuse of costly specialist services and underuse of cost-effective primary care services. Yet few studies directly assess the relationship between physician supply and patient utilization. Given this gap, this paper examines the associations between physician supply, care utilization, and patient need and whether patients use more specialists in areas with lower primary care supply.</p><p><strong>Methods: </strong>Using a 20% sample of 2018 Medicare fee-for-service claims, this paper first assessed the correlation between county physician densities and county physician visits. It then modeled individual patient consumption of primary and specialty care services in relation to physician supply through linear regression, adjusting for health and demographics.</p><p><strong>Results: </strong>While county supplies of primary care practitioners (PCPs) and specialists were positively correlated, we found no correlation between local PCP supply and local primary care visits. We also found no evidence that patients substitute specialist care for primary care, even in areas with PCP shortages.</p><p><strong>Conclusion: </strong>These findings suggest that factors other than PCP supply play an important role in primary care underuse. Scholars should also consider how care models, limited gatekeeping, and excess consumption among well-resourced populations influence the distribution of primary care utilization.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf127"},"PeriodicalIF":0.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12248419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144628331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interventions that strengthen the care workforce: a realist synthesis review. 加强护理人员队伍的干预措施:现实主义综合审查。
Health affairs scholar Pub Date : 2025-06-28 eCollection Date: 2025-07-01 DOI: 10.1093/haschl/qxaf128
Christine Kelly, Lisette Dansereau, Ellie Jack, Salina Pirzada, Yuns Oh, Pranav Bhushan, Lorine Pelly, Janice Linton, Carey McCarthy, Giorgio Cometto
{"title":"Interventions that strengthen the care workforce: a realist synthesis review.","authors":"Christine Kelly, Lisette Dansereau, Ellie Jack, Salina Pirzada, Yuns Oh, Pranav Bhushan, Lorine Pelly, Janice Linton, Carey McCarthy, Giorgio Cometto","doi":"10.1093/haschl/qxaf128","DOIUrl":"10.1093/haschl/qxaf128","url":null,"abstract":"<p><strong>Introduction: </strong>Health systems depend on care workers to provide \"hands-on\" direct care with eating, dressing, and other needs, as well as indirect care with household tasks, meals, and transport. Care workers are in high demand to support growing populations who need help in daily life, yet they often fall outside of health human resource planning. Recruiting, supporting, and retaining the care workforce are urgent priorities for health workforce planners.</p><p><strong>Methods: </strong>This realist synthesis review asks: Which interventions strengthen the care workforce? We systematically identified 7396 peer-reviewed sources and 481 gray literature sources, with 151 included in the review.</p><p><strong>Results: </strong>The sources document a variety of interventions that strengthen the care workforce, with an emphasis on pre-service and ongoing training for care workers. There were ambitious interventions that aimed to support the care workforce on multiple fronts.</p><p><strong>Conclusion: </strong>Policy makers and researchers are encouraged to implement complex interventions that cover multiple factors simultaneously. We recommend focusing on legislative structures, educational oversight, and material working conditions, such as scheduling and pay, as highly promising avenues for strengthening the care workforce across multiple contexts.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"3 7","pages":"qxaf128"},"PeriodicalIF":0.0,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12247801/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144628332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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