Pub Date : 2024-10-24eCollection Date: 2024-10-01DOI: 10.1093/haschl/qxae119
Ravi Gupta, Jason Chernesky, Anna Lembke, David Michaels, Cecilia Tomori, Jeremy A Greene, G Caleb Alexander, Adam D Koon
It is widely recognized that pharmaceutical marketing contributed to the ongoing US opioid epidemic, but less is understood about how the opioid industry used scientific evidence to generate product demand, shape opioid regulation, and change clinician behavior. In this qualitative study, we characterize select scientific articles used by industry to support safety and effectiveness claims and use a novel database, the Opioid Industry Documents Archive, to determine notable elements of industry and non-industry documents citing the scientific articles to advance each claim. We found that 15 scientific articles were collectively mentioned in 3666 documents supporting 5 common, inaccurate claims: opioids are effective for treatment of chronic, non-cancer pain; opioids are "rarely" addictive; "pseudo-addiction" is due to inadequate pain management; no opioid dose is too high; and screening tools can identify those at risk of developing addiction. The articles contributed to the eventual normalization of these claims by symbolically associating the claims with scientific evidence, building credibility, expanding and diversifying audiences and the parties asserting the claims, and obfuscating conflicts of interest. These findings have implications for regulators of industry products and corporate activity and can inform efforts to prevent similar public health crises.
{"title":"The opioid industry's use of scientific evidence to advance claims about prescription opioid safety and effectiveness.","authors":"Ravi Gupta, Jason Chernesky, Anna Lembke, David Michaels, Cecilia Tomori, Jeremy A Greene, G Caleb Alexander, Adam D Koon","doi":"10.1093/haschl/qxae119","DOIUrl":"https://doi.org/10.1093/haschl/qxae119","url":null,"abstract":"<p><p>It is widely recognized that pharmaceutical marketing contributed to the ongoing US opioid epidemic, but less is understood about how the opioid industry used scientific evidence to generate product demand, shape opioid regulation, and change clinician behavior. In this qualitative study, we characterize select scientific articles used by industry to support safety and effectiveness claims and use a novel database, the Opioid Industry Documents Archive, to determine notable elements of industry and non-industry documents citing the scientific articles to advance each claim. We found that 15 scientific articles were collectively mentioned in 3666 documents supporting 5 common, inaccurate claims: opioids are effective for treatment of chronic, non-cancer pain; opioids are \"rarely\" addictive; \"pseudo-addiction\" is due to inadequate pain management; no opioid dose is too high; and screening tools can identify those at risk of developing addiction. The articles contributed to the eventual normalization of these claims by symbolically associating the claims with scientific evidence, building credibility, expanding and diversifying audiences and the parties asserting the claims, and obfuscating conflicts of interest. These findings have implications for regulators of industry products and corporate activity and can inform efforts to prevent similar public health crises.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 10","pages":"qxae119"},"PeriodicalIF":0.0,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500661/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515297","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}
Issues of workplace violence (WPV) in health care have garnered increasing attention due to the impact on the health care worker's well-being and retention. Yet, our understanding of whether and how WPV rates vary between health care facilities and occupations is limited, particularly information on growth over time. This information is needed to develop and target policies and interventions toward health care workers and settings most at risk. We examined trends in WPV among health care occupations and facilities over the past decade (2011-2021/2022), utilizing data from the Bureau of Labor Statistics' Survey of Occupational Injuries and Illness. Findings reveal a 30% increase in WPV across all health care facility types between 2011 and 2021/2022; however, there was no difference in the average rate of WPV for health care occupations over the same time period. The increase in WPV for health care facilities began long before the pandemic, suggesting larger systemic issues are likely driving WPV. Existing state and organizational efforts aim to mitigate WPV, yet targeted interventions are crucial. Understanding variations across occupations and facilities will inform tailored strategies to safeguard health care workers.
{"title":"Trends in workplace violence for health care occupations and facilities over the last 10 years.","authors":"Brianna Lombardi, Todd Jensen, Evan Galloway, Erin Fraher","doi":"10.1093/haschl/qxae134","DOIUrl":"10.1093/haschl/qxae134","url":null,"abstract":"<p><p>Issues of workplace violence (WPV) in health care have garnered increasing attention due to the impact on the health care worker's well-being and retention. Yet, our understanding of whether and how WPV rates vary between health care facilities and occupations is limited, particularly information on growth over time. This information is needed to develop and target policies and interventions toward health care workers and settings most at risk. We examined trends in WPV among health care occupations and facilities over the past decade (2011-2021/2022), utilizing data from the Bureau of Labor Statistics' Survey of Occupational Injuries and Illness. Findings reveal a 30% increase in WPV across all health care facility types between 2011 and 2021/2022; however, there was no difference in the average rate of WPV for health care occupations over the same time period. The increase in WPV for health care facilities began long before the pandemic, suggesting larger systemic issues are likely driving WPV. Existing state and organizational efforts aim to mitigate WPV, yet targeted interventions are crucial. Understanding variations across occupations and facilities will inform tailored strategies to safeguard health care workers.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 12","pages":"qxae134"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11630250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142815290","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}
Pub Date : 2024-10-23eCollection Date: 2024-11-01DOI: 10.1093/haschl/qxae136
Angela Liu, David Pittman, Gerard Anderson, Jianhui Xu
While many Medicare beneficiaries are enrolling in Medicare Advantage (MA), some beneficiaries may want to return to traditional Medicare and purchase Medigap, especially beneficiaries who have greater medical needs. Beyond minimal federal regulations, states impose additional regulations that impact Medigap affordability. Beneficiaries in some states have greater difficulty obtaining Medigap coverage because the states where they live allow Medigap insurers to experience rate the beneficiary, which can make Medigap insurance prohibitively expensive. We examined beneficiaries who received physician-administered drugs, which can be expensive and subject to high cost sharing, to see if disenrollment from MA for these beneficiaries was greater in states with Medigap consumer protection policy levels. In 2020, we find a 1.0% average baseline average probability of MA disenrollment. For beneficiaries who received a physician-administered drug in our sample, the probability of MA disenrollment is 3.7 (95% CI, 2.6-4.8; P < .001) percentage points higher in Medigap-guaranteed issue states compared with states with no protections. We find a greater association between MA disenrollment and Medigap protection policies with higher cost drugs. These findings suggest that beneficiaries who receive a high-volume and high-spending physician-administered drug are more likely to disenroll from MA back to traditional Medicare when Medigap is more affordable.
{"title":"Medigap-guaranteed issue associated with Medicare Advantage disenrollment for beneficiaries administered a part B drug.","authors":"Angela Liu, David Pittman, Gerard Anderson, Jianhui Xu","doi":"10.1093/haschl/qxae136","DOIUrl":"10.1093/haschl/qxae136","url":null,"abstract":"<p><p>While many Medicare beneficiaries are enrolling in Medicare Advantage (MA), some beneficiaries may want to return to traditional Medicare and purchase Medigap, especially beneficiaries who have greater medical needs. Beyond minimal federal regulations, states impose additional regulations that impact Medigap affordability. Beneficiaries in some states have greater difficulty obtaining Medigap coverage because the states where they live allow Medigap insurers to experience rate the beneficiary, which can make Medigap insurance prohibitively expensive. We examined beneficiaries who received physician-administered drugs, which can be expensive and subject to high cost sharing, to see if disenrollment from MA for these beneficiaries was greater in states with Medigap consumer protection policy levels. In 2020, we find a 1.0% average baseline average probability of MA disenrollment. For beneficiaries who received a physician-administered drug in our sample, the probability of MA disenrollment is 3.7 (95% CI, 2.6-4.8; <i>P</i> < .001) percentage points higher in Medigap-guaranteed issue states compared with states with no protections. We find a greater association between MA disenrollment and Medigap protection policies with higher cost drugs. These findings suggest that beneficiaries who receive a high-volume and high-spending physician-administered drug are more likely to disenroll from MA back to traditional Medicare when Medigap is more affordable.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 11","pages":"qxae136"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11538962/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591562","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}
Pub Date : 2024-10-23eCollection Date: 2024-11-01DOI: 10.1093/haschl/qxae133
Michelle S Rockwell, Sitaram Vangala, Jillian Rider, Beth Bortz, Kyle Russell, Marcos Dachary, Lauryn Walker, A Mark Fendrick, John N Mafi
Characterizing the value and equity of care delivered during the COVID-19 pandemic is crucial to uncovering health system vulnerabilities and informing postpandemic recovery. We used insurance claims to evaluate low-value (no clinical benefit, potentially harmful) and clinically indicated utilization of a subset of 11 ambulatory services within a cohort of ∼2 million Virginia adults during the first 2 years of the pandemic (March 1, 2020-December 31, 2021). In 2020, low-value and clinically indicated utilization decreased similarly, while in 2021, low-value and clinically indicated utilization were 7% higher and 4% lower, respectively, than prepandemic rates. Extrapolated to Virginia's population of insured adults, ∼$1.3 billion in spending was associated with low-value utilization of the 11 services during the study period, with 2021 spending rates 6% higher than prepandemic rates. During March 1, 2020-December 31, 2021, low-value and clinically indicated utilization were 15% and 16% lower, respectively, than pre-pandemic rates among patients with the greatest socioeconomic deprivation but similar to prepandemic rates among patients with the least socioeconomic deprivation. These results highlight widening healthcare disparities and underscore the need for policy-level efforts to address the complex drivers of low-value care and equitably redistribute expenditures to services that enhance health.
{"title":"Increased spending on low-value care during the COVID-19 pandemic in Virginia.","authors":"Michelle S Rockwell, Sitaram Vangala, Jillian Rider, Beth Bortz, Kyle Russell, Marcos Dachary, Lauryn Walker, A Mark Fendrick, John N Mafi","doi":"10.1093/haschl/qxae133","DOIUrl":"10.1093/haschl/qxae133","url":null,"abstract":"<p><p>Characterizing the value and equity of care delivered during the COVID-19 pandemic is crucial to uncovering health system vulnerabilities and informing postpandemic recovery. We used insurance claims to evaluate low-value (no clinical benefit, potentially harmful) and clinically indicated utilization of a subset of 11 ambulatory services within a cohort of ∼2 million Virginia adults during the first 2 years of the pandemic (March 1, 2020-December 31, 2021). In 2020, low-value and clinically indicated utilization decreased similarly, while in 2021, low-value and clinically indicated utilization were 7% higher and 4% lower, respectively, than prepandemic rates. Extrapolated to Virginia's population of insured adults, ∼$1.3 billion in spending was associated with low-value utilization of the 11 services during the study period, with 2021 spending rates 6% higher than prepandemic rates. During March 1, 2020-December 31, 2021, low-value and clinically indicated utilization were 15% and 16% lower, respectively, than pre-pandemic rates among patients with the greatest socioeconomic deprivation but similar to prepandemic rates among patients with the least socioeconomic deprivation. These results highlight widening healthcare disparities and underscore the need for policy-level efforts to address the complex drivers of low-value care and equitably redistribute expenditures to services that enhance health.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 11","pages":"qxae133"},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11549685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142635088","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}
Pub Date : 2024-10-21eCollection Date: 2024-10-01DOI: 10.1093/haschl/qxae122
William H Dow, Julia M Goodman, Paloma Lin, Paige Park
The United States does not have a federal policy offering employees paid leave. We study employer attitudes toward the Families First Coronavirus Response Act (FFCRA) federal emergency paid leave policies temporarily adopted during the COVID-19 pandemic to draw lessons for proposed permanent federal paid leave policies. We analyzed a 2021 survey of 300 San Francisco Bay Area employers to examine employers' experiences with paid sick leave (PSL) and paid family leave (PFL) policies during the COVID-19 pandemic, along with their attitudes regarding FFCRA paid leave. Most firms reported that it was not difficult to comply with or seek reimbursement for FFCRA leave. Nevertheless, most smaller firms did report difficulty in understanding policy details, and many reported being unaware of FFCRA paid leave availability. FFCRA paid leave was broadly popular among firms aware of it: 64% supported (9% opposed) the PSL provisions, and 52% supported (12% opposed) PFL. However, support for permanent extension dropped to just over 40%, despite this Bay Area sample having long familiarity with California's state paid leave policies. We conclude that federal pandemic paid leave offers a potential model that could be refined for future paid leave policies, but support is mixed.
{"title":"Learning from employer experiences with paid leave policy expansions during the COVID-19 pandemic.","authors":"William H Dow, Julia M Goodman, Paloma Lin, Paige Park","doi":"10.1093/haschl/qxae122","DOIUrl":"10.1093/haschl/qxae122","url":null,"abstract":"<p><p>The United States does not have a federal policy offering employees paid leave. We study employer attitudes toward the Families First Coronavirus Response Act (FFCRA) federal emergency paid leave policies temporarily adopted during the COVID-19 pandemic to draw lessons for proposed permanent federal paid leave policies. We analyzed a 2021 survey of 300 San Francisco Bay Area employers to examine employers' experiences with paid sick leave (PSL) and paid family leave (PFL) policies during the COVID-19 pandemic, along with their attitudes regarding FFCRA paid leave. Most firms reported that it was not difficult to comply with or seek reimbursement for FFCRA leave. Nevertheless, most smaller firms did report difficulty in understanding policy details, and many reported being unaware of FFCRA paid leave availability. FFCRA paid leave was broadly popular among firms aware of it: 64% supported (9% opposed) the PSL provisions, and 52% supported (12% opposed) PFL. However, support for permanent extension dropped to just over 40%, despite this Bay Area sample having long familiarity with California's state paid leave policies. We conclude that federal pandemic paid leave offers a potential model that could be refined for future paid leave policies, but support is mixed.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 10","pages":"qxae122"},"PeriodicalIF":0.0,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11493094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484126","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}
Pub Date : 2024-10-17eCollection Date: 2024-11-01DOI: 10.1093/haschl/qxae132
Erin L Duffy, Christopher Garmon, Loren Adler, Adam Biener, Erin Trish
The No Surprises Act banned surprise billing and established a final-offer arbitration system, independent dispute resolution (IDR), to resolve disagreements between health plans and providers. One factor that arbiters must consider in the IDR process is the qualifying payment amount (QPA), the median contracted rate for the same or similar service in the same market as computed by health plans. We analyzed public IDR data from 2023 for the most common disputed professional service: evaluation and management of a moderate to severe emergency medicine visit. Providers won 86% of cases, with mean decisions 2.7 times the QPA. Private equity-backed providers won more often and higher monetary awards than other providers. The mean QPA was 2.4 times Medicare payments. Disputes were dominated by a small group of health plans and providers, so payments may not reflect the overall market for emergency services.
{"title":"No Surprises Act independent dispute resolution outcomes for emergency services.","authors":"Erin L Duffy, Christopher Garmon, Loren Adler, Adam Biener, Erin Trish","doi":"10.1093/haschl/qxae132","DOIUrl":"10.1093/haschl/qxae132","url":null,"abstract":"<p><p>The No Surprises Act banned surprise billing and established a final-offer arbitration system, independent dispute resolution (IDR), to resolve disagreements between health plans and providers. One factor that arbiters must consider in the IDR process is the qualifying payment amount (QPA), the median contracted rate for the same or similar service in the same market as computed by health plans. We analyzed public IDR data from 2023 for the most common disputed professional service: evaluation and management of a moderate to severe emergency medicine visit. Providers won 86% of cases, with mean decisions 2.7 times the QPA. Private equity-backed providers won more often and higher monetary awards than other providers. The mean QPA was 2.4 times Medicare payments. Disputes were dominated by a small group of health plans and providers, so payments may not reflect the overall market for emergency services.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 11","pages":"qxae132"},"PeriodicalIF":0.0,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142559849","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}
Pub Date : 2024-10-15eCollection Date: 2024-11-01DOI: 10.1093/haschl/qxae131
Scott D Landes, Bonnielin K Swenor, Jean P Hall
The Washington Group Short Set (WGSS) questions are intended to measure the severity of disability and disability status in US federal surveys. We used data from the 2010-2018 National Health Interview Survey to examine the performance of the WGSS visual disability and hearing disability questions in capturing blindness and deafness. We found that the WGSS questions failed to capture 35.7% of blind adults and 43.7% of deaf respondents as having a severe disability, or, per their recommended cut point, as being disabled. Coupled with evidence demonstrating the poor performance of the WGSS questions in estimating the size of the overall disability population, we contend that results from this study necessitate a halt in the use of the WGSS questions to measure disability in US federal surveys.
{"title":"Performance of the Washington Group questions in measuring blindness and deafness.","authors":"Scott D Landes, Bonnielin K Swenor, Jean P Hall","doi":"10.1093/haschl/qxae131","DOIUrl":"10.1093/haschl/qxae131","url":null,"abstract":"<p><p>The Washington Group Short Set (WGSS) questions are intended to measure the severity of disability and disability status in US federal surveys. We used data from the 2010-2018 National Health Interview Survey to examine the performance of the WGSS visual disability and hearing disability questions in capturing blindness and deafness. We found that the WGSS questions failed to capture 35.7% of blind adults and 43.7% of deaf respondents as having a severe disability, or, per their recommended cut point, as being disabled. Coupled with evidence demonstrating the poor performance of the WGSS questions in estimating the size of the overall disability population, we contend that results from this study necessitate a halt in the use of the WGSS questions to measure disability in US federal surveys.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 11","pages":"qxae131"},"PeriodicalIF":0.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142560349","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}
Pub Date : 2024-10-15eCollection Date: 2024-10-01DOI: 10.1093/haschl/qxae130
[This corrects the article DOI: 10.1093/haschl/qxae098.].
[此处更正了文章 DOI:10.1093/haschl/qxae098]。
{"title":"Correction to: The state of health information organizations and plans to participate in the federal exchange framework.","authors":"","doi":"10.1093/haschl/qxae130","DOIUrl":"https://doi.org/10.1093/haschl/qxae130","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1093/haschl/qxae098.].</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 10","pages":"qxae130"},"PeriodicalIF":0.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11476905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484124","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}
Pub Date : 2024-10-14eCollection Date: 2024-10-01DOI: 10.1093/haschl/qxae121
[This corrects the article DOI: 10.1093/haschl/qxae103.].
[此处更正了文章 DOI:10.1093/haschl/qxae103]。
{"title":"Correction to: An increasing number of states filled Conrad 30 waivers for recruiting international medical graduates.","authors":"","doi":"10.1093/haschl/qxae121","DOIUrl":"https://doi.org/10.1093/haschl/qxae121","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1093/haschl/qxae103.].</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 10","pages":"qxae121"},"PeriodicalIF":0.0,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142484123","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}
Pub Date : 2024-10-10eCollection Date: 2024-12-01DOI: 10.1093/haschl/qxae129
Sandra Barbosu, Kirsten Axelsen, Stephen Ezell
This paper highlights the pressing need for updated, robust evidence to inform biopharmaceutical policy, particularly in light of recent initiatives such as the Inflation Reduction Act. Current estimates that inform such policies, including those from the Congressional Budget Office, rely on outdated data and models that fail to fully capture the complexities of modern investment decisions or the broader impact of policies on drug development in areas like oncology, rare diseases, and vaccines. Understanding how expectations of financial returns influence investment in all stages of drug development is critical for evaluating these policies' long-term effects on innovation. This piece reviews the current evidence on the relationship between financial returns and research and development investment and considers how this evidence is being used to shape biopharmaceutical policy. It also highlights gaps in data and methodology, emphasizing the need for better models that reflect real-world trade-offs, investment risks, and therapeutic area-specific impacts. Finally, this paper calls for improved access to federal and private data to better inform evidence-based policymaking and to study policy impact on investments in the next generation of medicines, particularly in emerging fields like gene and cell therapies, where the implications of policy decisions are not yet fully understood.
{"title":"Evidence to inform biopharmaceutical policy: call for research on the impact of public policies on investment in drug development.","authors":"Sandra Barbosu, Kirsten Axelsen, Stephen Ezell","doi":"10.1093/haschl/qxae129","DOIUrl":"10.1093/haschl/qxae129","url":null,"abstract":"<p><p>This paper highlights the pressing need for updated, robust evidence to inform biopharmaceutical policy, particularly in light of recent initiatives such as the Inflation Reduction Act. Current estimates that inform such policies, including those from the Congressional Budget Office, rely on outdated data and models that fail to fully capture the complexities of modern investment decisions or the broader impact of policies on drug development in areas like oncology, rare diseases, and vaccines. Understanding how expectations of financial returns influence investment in all stages of drug development is critical for evaluating these policies' long-term effects on innovation. This piece reviews the current evidence on the relationship between financial returns and research and development investment and considers how this evidence is being used to shape biopharmaceutical policy. It also highlights gaps in data and methodology, emphasizing the need for better models that reflect real-world trade-offs, investment risks, and therapeutic area-specific impacts. Finally, this paper calls for improved access to federal and private data to better inform evidence-based policymaking and to study policy impact on investments in the next generation of medicines, particularly in emerging fields like gene and cell therapies, where the implications of policy decisions are not yet fully understood.</p>","PeriodicalId":94025,"journal":{"name":"Health affairs scholar","volume":"2 12","pages":"qxae129"},"PeriodicalIF":0.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11631377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142815388","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}