Pub Date : 2024-07-01DOI: 10.1101/2024.06.30.24309745
Jeffrey Clement, Brad N Greenwood, John D'Arcy, Corey Angst
The Patient Protection and Affordable Care Act of 2010 led to the largest expansion of healthcare coverage since the instantiation of Medicare and Medicaid in 1965. Yet, limited attention has been given to the security aftereffects of the statute, specifically the potential for malfeasance in the form of consumer fraud and identity theft resulting from the vast influx of new patient data residing in various and highly dispersed sources. In this work, we fill this gap by exploiting the phased expansion of Medicaid into different states at different times. Using a difference in difference approach, we explore the data security-related aftereffects of the law. Results indicate a significant decrease in claims of consumer fraud after the expansion of Medicaid, with no robust effect on identity theft. In empirical extensions, we find a material drop in data breaches and compromised records after the expansion of Medicaid. Taken in sum, these findings suggest that the expansion of Medicaid had a consequential effect on the security of consumer data and created significant positive externalities for consumers.
{"title":"Expanding Risks: Medicaid Expansion and Data Security","authors":"Jeffrey Clement, Brad N Greenwood, John D'Arcy, Corey Angst","doi":"10.1101/2024.06.30.24309745","DOIUrl":"https://doi.org/10.1101/2024.06.30.24309745","url":null,"abstract":"The Patient Protection and Affordable Care Act of 2010 led to the largest expansion of healthcare coverage since the instantiation of Medicare and Medicaid in 1965. Yet, limited attention has been given to the security aftereffects of the statute, specifically the potential for malfeasance in the form of consumer fraud and identity theft resulting from the vast influx of new patient data residing in various and highly dispersed sources. In this work, we fill this gap by exploiting the phased expansion of Medicaid into different states at different times. Using a difference in difference approach, we explore the data security-related aftereffects of the law. Results indicate a significant decrease in claims of consumer fraud after the expansion of Medicaid, with no robust effect on identity theft. In empirical extensions, we find a material drop in data breaches and compromised records after the expansion of Medicaid. Taken in sum, these findings suggest that the expansion of Medicaid had a consequential effect on the security of consumer data and created significant positive externalities for consumers.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141522116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1101/2024.07.01.24309758
Anthony E Ades, Hugo Pedder, Annabel L Davies, Howard Thom, David M Phillippo, Beatrice Downing, Deborah M Caldwell, Nicky J. Welton
ABSTRACT Background: The treatment recommendation based on a Network Meta-analysis (NMA) is usually the single treatment with the highest Expected Value (EV) on an evaluative function. We explore approaches which recommend multiple treatments and which penalize uncertainty, making them suitable for risk-averse decision makers. Methods: We introduce Loss-adjusted EV (LaEV) and compare it to GRADE and three probability-based rankings. We define the properties of a valid ranking under uncertainty and other desirable properties of ranking systems. A two-stage process is proposed: the first selects treatments superior to the reference treatment; the second identifies those that are also within a Minimal Clinically Important Difference (MCID) of the best treatment. Decision rules and ranking systems are compared on stylized examples and 10 NMAs used in NICE Guidelines. Results: Only LaEV reliably delivers valid rankings under uncertainty and has all the desirable properties. In 10 NMAs comparing between 4 and 40 treatments, an EV decision maker would recommend 4-14 treatments, and LaEV 0-3 (median 2) fewer. GRADE rules give rise to anomalies, and, like the probability-based rankings, the number of treatments recommended depends on arbitrary probability cutoffs. Among treatments that are superior to the reference, GRADE privileges the more uncertain ones, and in 3/10 cases GRADE failed to recommend the treatment with the highest EV and LaEV. Conclusions: A two-stage approach based on MCID ensures that EV- and LaEV-based rules recommend a clinically appropriate number of treatments. For a risk-averse decision maker, LaEV is conservative, simple to implement, and has an independent theoretical foundation.
摘要背景：基于网络元分析（NMA）的治疗推荐通常是在评价函数上具有最高期望值（EV）的单一治疗。我们探讨了推荐多种治疗方法的方法，这些方法对不确定性进行惩罚，适合规避风险的决策者：我们介绍了损失调整 EV（LaEV），并将其与 GRADE 和三种基于概率的排名进行了比较。我们定义了不确定性下有效排名的属性以及排名系统的其他理想属性。我们提出了一个两阶段过程：第一阶段选择优于参考治疗的治疗方法；第二阶段确定那些与最佳治疗方法的最小临床重要差异（MCID）相同的治疗方法。结果显示，只有 LaEV 能可靠地得出最佳排名：结果：只有 LaEV 能在不确定情况下可靠地提供有效排名，并具有所有理想特性。在对 4 至 40 种治疗方法进行比较的 10 个 NMA 中，EV 决策者会推荐 4 至 14 种治疗方法，而 LaEV 会推荐 0 至 3 种治疗方法（中位数为 2）。GRADE 规则会产生异常现象，与基于概率的排名一样，推荐的治疗次数取决于任意的概率截止值。在优于参照物的治疗方法中，GRADE优先选择不确定性较高的治疗方法，在3/10的病例中，GRADE未能推荐EV和LaEV最高的治疗方法：结论：基于MCID的两阶段方法可确保基于EV和LaEV的规则推荐临床上适当数量的治疗。对于规避风险的决策者来说，LaEV是保守的，简单易行，并且有独立的理论基础。
{"title":"Treatment recommendations based on Network Meta-Analysis: rules for risk-averse decision-makers","authors":"Anthony E Ades, Hugo Pedder, Annabel L Davies, Howard Thom, David M Phillippo, Beatrice Downing, Deborah M Caldwell, Nicky J. Welton","doi":"10.1101/2024.07.01.24309758","DOIUrl":"https://doi.org/10.1101/2024.07.01.24309758","url":null,"abstract":"ABSTRACT\u0000Background: The treatment recommendation based on a Network Meta-analysis (NMA) is usually the single treatment with the highest Expected Value (EV) on an evaluative function. We explore approaches which recommend multiple treatments and which penalize uncertainty, making them suitable for risk-averse decision makers.\u0000Methods: We introduce Loss-adjusted EV (LaEV) and compare it to GRADE and three probability-based rankings. We define the properties of a valid ranking under uncertainty and other desirable properties of ranking systems. A two-stage process is proposed: the first selects treatments superior to the reference treatment; the second identifies those that are also within a Minimal Clinically Important Difference (MCID) of the best treatment. Decision rules and ranking systems are compared on stylized examples and 10 NMAs used in NICE Guidelines.\u0000Results: Only LaEV reliably delivers valid rankings under uncertainty and has all the desirable properties. In 10 NMAs comparing between 4 and 40 treatments, an EV decision maker would recommend 4-14 treatments, and LaEV 0-3 (median 2) fewer. GRADE rules give rise to anomalies, and, like the probability-based rankings, the number of treatments recommended depends on arbitrary probability cutoffs. Among treatments that are superior to the reference, GRADE privileges the more uncertain ones, and in 3/10 cases GRADE failed to recommend the treatment with the highest EV and LaEV.\u0000Conclusions: A two-stage approach based on MCID ensures that EV- and LaEV-based rules recommend a clinically appropriate number of treatments. For a risk-averse decision maker, LaEV is conservative, simple to implement, and has an independent theoretical foundation.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141505947","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-30DOI: 10.1101/2024.06.28.24309668
William B Wong, Irina Yermilov, Hannah Dalglish, Lori Bienvenu, Jonathan James, Sarah N Gibbs
Background: Alternative funding programs (AFPs) seek to reduce plan sponsor costs by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs [PAPs]) via an AFP vendor as a third-party). Objective: To describe patients' experiences and medication access with AFPs, which have not been explored previously. Methods: A survey instrument consisting of optional single- and multiple-choice questions with branching logic was administered to patients recruited from an online patient panel and a patient advocacy group who had experience with AFPs. The survey assessed patients' awareness of AFPs from their employers, experience with the PAP application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of any delay in access. All analyses were descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels. Results: In total, 227 patients were included in the final sample. Most patients (61%) first heard of the AFP as part of their health benefit when trying to obtain their medication. Up to 88% of patients reported being stressed owing to the medication coverage denial and the uncertainty of obtaining their medication. Over half of patients (54%) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for approximately 2 months (68.2 days); 24% reported the wait for the medication worsened their condition and 64% reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. Patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% vs 82%), while more patients with lower incomes (< $50,000 vs > $50,000) reported not receiving any medication (12% vs 5%). Conclusions: Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their health plan.
{"title":"A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs","authors":"William B Wong, Irina Yermilov, Hannah Dalglish, Lori Bienvenu, Jonathan James, Sarah N Gibbs","doi":"10.1101/2024.06.28.24309668","DOIUrl":"https://doi.org/10.1101/2024.06.28.24309668","url":null,"abstract":"Background: Alternative funding programs (AFPs) seek to reduce plan sponsor costs by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs [PAPs]) via an AFP vendor as a third-party). Objective: To describe patients' experiences and medication access with AFPs, which have not been explored previously. Methods: A survey instrument consisting of optional single- and multiple-choice questions with branching logic was administered to patients recruited from an online patient panel and a patient advocacy group who had experience with AFPs. The survey assessed patients' awareness of AFPs from their employers, experience with the PAP application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of any delay in access. All analyses were descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels. Results: In total, 227 patients were included in the final sample. Most patients (61%) first heard of the AFP as part of their health benefit when trying to obtain their medication. Up to 88% of patients reported being stressed owing to the medication coverage denial and the uncertainty of obtaining their medication. Over half of patients (54%) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for approximately 2 months (68.2 days); 24% reported the wait for the medication worsened their condition and 64% reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. Patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% vs 82%), while more patients with lower incomes (< $50,000 vs > $50,000) reported not receiving any medication (12% vs 5%). Conclusions: Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their health plan.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141522117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-28DOI: 10.1101/2024.06.27.24309551
Abhishek Pandey, Yang Ye, Chad R Wells, Burton H Singer, Alison P Galvani
Obesity is a major public health crisis in the United States (US) affecting 42% of the population, exacerbating a spectrum of other diseases and contributing significantly to morbidity and mortality overall. Recent advances in pharmaceutical interventions, particularly glucagon-like peptide-1 (GLP-1) receptor agonists (e.g., semaglutide, liraglutide) and dual gastric inhibitory polypeptide and glucagon-like peptide-1 (GIP/GLP-1) receptor agonists (e.g., tirzepatide), have shown remarkable efficacy in weight loss. However, limited access to these medications due to high costs and insurance coverage issues restricts their utility in mitigating the obesity epidemic. We quantify the annual mortality burden directly attributable to limited access to these medications in the US. By integrating hazard ratios of mortality across body mass index categories with current obesity prevalence data, combined with willingness to take the medication, observed adherence to and efficacy of the medications, we estimate the impact of making these medications accessible to all those eligible. Specifically, we project that with expanded access, over 43,000 deaths could be averted annually, including more than 12,000 deaths among people with type 2 diabetes. These findings underscore the urgent need to address barriers to access and highlight the transformative public health impact that could be achieved by expanding access to these novel treatments.
{"title":"Estimating the lives that could be saved by expanded access to weight-loss drugs","authors":"Abhishek Pandey, Yang Ye, Chad R Wells, Burton H Singer, Alison P Galvani","doi":"10.1101/2024.06.27.24309551","DOIUrl":"https://doi.org/10.1101/2024.06.27.24309551","url":null,"abstract":"Obesity is a major public health crisis in the United States (US) affecting 42% of the population, exacerbating a spectrum of other diseases and contributing significantly to morbidity and mortality overall. Recent advances in pharmaceutical interventions, particularly glucagon-like peptide-1 (GLP-1) receptor agonists (e.g., semaglutide, liraglutide) and dual gastric inhibitory polypeptide and glucagon-like peptide-1 (GIP/GLP-1) receptor agonists (e.g., tirzepatide), have shown remarkable efficacy in weight loss. However, limited access to these medications due to high costs and insurance coverage issues restricts their utility in mitigating the obesity epidemic. We quantify the annual mortality burden directly attributable to limited access to these medications in the US. By integrating hazard ratios of mortality across body mass index categories with current obesity prevalence data, combined with willingness to take the medication, observed adherence to and efficacy of the medications, we estimate the impact of making these medications accessible to all those eligible. Specifically, we project that with expanded access, over 43,000 deaths could be averted annually, including more than 12,000 deaths among people with type 2 diabetes. These findings underscore the urgent need to address barriers to access and highlight the transformative public health impact that could be achieved by expanding access to these novel treatments.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"136 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141522118","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Since vaccination policies were introduced in the healthcare sector in the province of Ontario, Canada, most establishments implemented vaccination or termination requirements, with most enforcing them to this day. Researchers have shown a strong interest in the perceived problem of vaccine hesitancy among healthcare workers, yet not in their lived experience of the policy or in their views on the impact of the policy on the quality of patient care in the province. Goal: To document the experience and views on mandated vaccination of healthcare workers in the province of Ontario, Canada. Methods: Between February and March 2024, we conducted a cross-sectional survey of Ontario healthcare workers, recruited through professional contacts, social media, and word-of-mouth. Findings: Most respondents, most with 16 or more years of professional experience, were unvaccinated, and most had been terminated due to non-compliance with mandates. As well, and regardless of vaccination status, most respondents reported safety concerns with vaccination, yet did not request an exemption due to their experience of high rejection rates by employers. Nevertheless, most unvaccinated workers reported satisfaction with their vaccination choices, although they also reported significant, negative impacts of the policy on their finances, their mental health, their social and personal relationships, and to a lesser degree, their physical health. In contrast, most respondents within the minority of vaccinated respondents reported being dissatisfied with their vaccination decisions, as well as having experienced mild to serious post vaccine adverse events, with about one-quarter within this group reporting having been coerced into taking further doses, under threat of termination, despite these events. Further, a large minority of respondents reported having witnessed underreporting or dismissal by hospital management of adverse events post vaccination among patients, worse treatment of unvaccinated patients, and concerning changes in practice protocols. Close to half also reported their intention to leave the healthcare industry. Discussion: Our findings indicate that in Ontario, Canada, mandated vaccination in the health sector had an overall negative impact on the well-being of the healthcare labour force, on patient care, on the sustainability of the health system, and on ethical medical practice. Our study should be reproduced in other provinces, as well as in other countries that adopted comparable policies. Findings from this and similar studies should be seriously considered when planning for future health emergencies, to protect health systems in crisis due to severe labour shortages, as well as the right to informed consent of healthcare workers and members of the public.
{"title":"Covid-19 vaccination decisions and impacts of vaccine mandates: A cross sectional survey of healthcare workers in Ontario, Canada","authors":"Claudia Chaufan, Natalie Hemsing, Rachael Moncrieffe","doi":"10.1101/2024.06.23.24309372","DOIUrl":"https://doi.org/10.1101/2024.06.23.24309372","url":null,"abstract":"Background: Since vaccination policies were introduced in the healthcare sector in the province of Ontario, Canada, most establishments implemented vaccination or termination requirements, with most enforcing them to this day. Researchers have shown a strong interest in the perceived problem of vaccine hesitancy among healthcare workers, yet not in their lived experience of the policy or in their views on the impact of the policy on the quality of patient care in the province. Goal: To document the experience and views on mandated vaccination of healthcare workers in the province of Ontario, Canada. Methods: Between February and March 2024, we conducted a cross-sectional survey of Ontario healthcare workers, recruited through professional contacts, social media, and word-of-mouth. Findings: Most respondents, most with 16 or more years of professional experience, were unvaccinated, and most had been terminated due to non-compliance with mandates. As well, and regardless of vaccination status, most respondents reported safety concerns with vaccination, yet did not request an exemption due to their experience of high rejection rates by employers. Nevertheless, most unvaccinated workers reported satisfaction with their vaccination choices, although they also reported significant, negative impacts of the policy on their finances, their mental health, their social and personal relationships, and to a lesser degree, their physical health. In contrast, most respondents within the minority of vaccinated respondents reported being dissatisfied with their vaccination decisions, as well as having experienced mild to serious post vaccine adverse events, with about one-quarter within this group reporting having been coerced into taking further doses, under threat of termination, despite these events. Further, a large minority of respondents reported having witnessed underreporting or dismissal by hospital management of adverse events post vaccination among patients, worse treatment of unvaccinated patients, and concerning changes in practice protocols. Close to half also reported their intention to leave the healthcare industry. Discussion: Our findings indicate that in Ontario, Canada, mandated vaccination in the health sector had an overall negative impact on the well-being of the healthcare labour force, on patient care, on the sustainability of the health system, and on ethical medical practice. Our study should be reproduced in other provinces, as well as in other countries that adopted comparable policies. Findings from this and similar studies should be seriously considered when planning for future health emergencies, to protect health systems in crisis due to severe labour shortages, as well as the right to informed consent of healthcare workers and members of the public.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"82 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141505948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-27DOI: 10.1101/2024.06.26.24309544
Esteban Rivera, Anne M Sydor, Robert Popovian
Background The Inflation Reduction Act′s Medicare Drug Price Negotiation Program allows the federal government to negotiate caps for select medications. These price caps may reduce revenue for the pharmacy benefit managers (PBMs) that negotiate the actual price paid for medicines in the US. To offset the resulting pressure on their profit margins, it is possible that PBMs would, in turn, increase patient′s out-of-pocket costs for medicines with capped prices. The model presented here evaluates how such increased out-of-pocket costs for the anticoagulants Eliquis (apixaban) and Xarelto (rivaroxaban) could impact patients financially and clinically. Methods Copay distributions for all 2023 prescription fills for Eliquis and Xarelto managed by the three largest PBMs were used to approximate current copay costs. Increased out-of-pocket costs were modeled as a shift of all Eliquis and Xarelto prescriptions to the highest copay tier. The known linear relationship between copay costs and treatment abandonment was used to calculate the potential resulting increase in treatment abandonment. Known rates of morbidity and mortality due to abandoning anticoagulants were used to estimate resulting increases in morbidity and mortality. Results If the three largest PBMs all shifted costs onto patients by moving all Eliquis and Xarelto prescriptions to the highest formulary tier, Tier 6, patients′ copay amount would increase by $235 to $482 million for Eliquis and $105 to $206 million for Xarelto. Such an increase could lead to 169,000 to 228,000 patients abandoning Eliquis and 71,000 to 93,000 abandoning Xarelto. The resulting morbidity and mortality could include up to an additional 145,000 major cardiovascular events and up to 97,000 more deaths. Conclusion The Medicare Price Negotiation Program could impact patients negatively if it causes PBMs to increase patients′ out-of-pocket costs for medicines. Policymakers should closely monitor changes in overall affordability, including all patient out-of-pocket expenditures, for medications in the program. Preemptive measures to ensure that the most vulnerable citizens are not placed in precarious situations leading to poorer health outcomes should be considered.
{"title":"Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?","authors":"Esteban Rivera, Anne M Sydor, Robert Popovian","doi":"10.1101/2024.06.26.24309544","DOIUrl":"https://doi.org/10.1101/2024.06.26.24309544","url":null,"abstract":"<strong>Background</strong>\u0000The Inflation Reduction Act′s Medicare Drug Price Negotiation Program allows the federal government to negotiate caps for select medications. These price caps may reduce revenue for the pharmacy benefit managers (PBMs) that negotiate the actual price paid for medicines in the US. To offset the resulting pressure on their profit margins, it is possible that PBMs would, in turn, increase patient′s out-of-pocket costs for medicines with capped prices. The model presented here evaluates how such increased out-of-pocket costs for the anticoagulants Eliquis (apixaban) and Xarelto (rivaroxaban) could impact patients financially and clinically. <strong>Methods</strong>\u0000Copay distributions for all 2023 prescription fills for Eliquis and Xarelto managed by the three largest PBMs were used to approximate current copay costs. Increased out-of-pocket costs were modeled as a shift of all Eliquis and Xarelto prescriptions to the highest copay tier. The known linear relationship between copay costs and treatment abandonment was used to calculate the potential resulting increase in treatment abandonment. Known rates of morbidity and mortality due to abandoning anticoagulants were used to estimate resulting increases in morbidity and mortality.\u0000<strong>Results</strong>\u0000If the three largest PBMs all shifted costs onto patients by moving all Eliquis and Xarelto prescriptions to the highest formulary tier, Tier 6, patients′ copay amount would increase by $235 to $482 million for Eliquis and $105 to $206 million for Xarelto. Such an increase could lead to 169,000 to 228,000 patients abandoning Eliquis and 71,000 to 93,000 abandoning Xarelto. The resulting morbidity and mortality could include up to an additional 145,000 major cardiovascular events and up to 97,000 more deaths.\u0000<strong>Conclusion</strong>\u0000The Medicare Price Negotiation Program could impact patients negatively if it causes PBMs to increase patients′ out-of-pocket costs for medicines. Policymakers should closely monitor changes in overall affordability, including all patient out-of-pocket expenditures, for medications in the program. Preemptive measures to ensure that the most vulnerable citizens are not placed in precarious situations leading to poorer health outcomes should be considered.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141531685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Worldwide, an estimated 71.1 million people are chronically infected with the Hepatitis C virus (HCV). The advent of direct-acting antivirals (DAAs) has made possible the definition of elimination targets by 2030. This study aimed to evaluate the effectiveness of a population-level health intervention to expand access to HCV treatment in the Tuscany Region, Italy.
{"title":"Evaluating the Effectiveness of a Population-Level Health Intervention to Increment HCV Treatment Coverage in Tuscany Region, Italy: An Interrupted Time Series Analysis","authors":"Chiara Seghieri, Luca Ceccarelli, Costanza Tortù, Lara Tavoschi","doi":"10.1101/2024.06.25.24309463","DOIUrl":"https://doi.org/10.1101/2024.06.25.24309463","url":null,"abstract":"Worldwide, an estimated 71.1 million people are chronically infected with the Hepatitis C virus (HCV). The advent of direct-acting antivirals (DAAs) has made possible the definition of elimination targets by 2030. This study aimed to evaluate the effectiveness of a population-level health intervention to expand access to HCV treatment in the Tuscany Region, Italy.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141522119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-20DOI: 10.1101/2024.06.19.24309148
Daivat Bhavsar, Laura Duffy, Hamin Jo, Cynthia Lokker, R. Brian Haynes, Alfonso Iorio, Ana Marusic, Jeremy Y. Ng
Background: Artificial intelligence (AI) chatbots are novel computer programs that can generate text or content in a natural language format. Academic publishers are adapting to the transformative role of AI chatbots in producing or facilitating scientific research. This study aimed to examine the policies established by scientific, technical, and medical academic publishers for defining and regulating the responsible authors' use of AI chatbots. Methods: This study performed a cross-sectional audit on the publicly available policies of 163 academic publishers, indexed as members of the International Association of the Scientific, Technical, and Medical Publishers (STM). Data extraction of publicly available policies on the webpages of all STM academic publishers was performed independently in duplicate with content analysis reviewed by a third contributor (September 2023 - December 2023). Data was categorized into policy elements, such as 'proofreading' and 'image generation'. Counts and percentages of 'yes' (i.e., permitted), 'no', and 'N/A' were established for each policy element. Results: A total of 56/163 (34.4%) STM academic publishers had a publicly available policy guiding the authors' use of AI chatbots. No policy allowed authorship accreditations for AI chatbots (or other generative technology). Most (49/56 or 87.5%) required specific disclosure of AI chatbot use. Four policies/publishers placed a complete ban on the use of AI tools by authors. Conclusions: Only a third of STM academic publishers had publicly available policies as of December 2023. A re-examination of all STM members in 12-18 months may uncover evolving approaches toward AI chatbot use with more academic publishers having a policy.
{"title":"Policies on Artificial Intelligence Chatbots Among Academic Publishers: A Cross-Sectional Audit","authors":"Daivat Bhavsar, Laura Duffy, Hamin Jo, Cynthia Lokker, R. Brian Haynes, Alfonso Iorio, Ana Marusic, Jeremy Y. Ng","doi":"10.1101/2024.06.19.24309148","DOIUrl":"https://doi.org/10.1101/2024.06.19.24309148","url":null,"abstract":"Background: Artificial intelligence (AI) chatbots are novel computer programs that can generate text or content in a natural language format. Academic publishers are adapting to the transformative role of AI chatbots in producing or facilitating scientific research. This study aimed to examine the policies established by scientific, technical, and medical academic publishers for defining and regulating the responsible authors' use of AI chatbots. Methods: This study performed a cross-sectional audit on the publicly available policies of 163 academic publishers, indexed as members of the International Association of the Scientific, Technical, and Medical Publishers (STM). Data extraction of publicly available policies on the webpages of all STM academic publishers was performed independently in duplicate with content analysis reviewed by a third contributor (September 2023 - December 2023). Data was categorized into policy elements, such as 'proofreading' and 'image generation'. Counts and percentages of 'yes' (i.e., permitted), 'no', and 'N/A' were established for each policy element. Results: A total of 56/163 (34.4%) STM academic publishers had a publicly available policy guiding the authors' use of AI chatbots. No policy allowed authorship accreditations for AI chatbots (or other generative technology). Most (49/56 or 87.5%) required specific disclosure of AI chatbot use. Four policies/publishers placed a complete ban on the use of AI tools by authors.\u0000Conclusions: Only a third of STM academic publishers had publicly available policies as of December 2023. A re-examination of all STM members in 12-18 months may uncover evolving approaches toward AI chatbot use with more academic publishers having a policy.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141505949","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-06DOI: 10.1101/2024.06.06.24308542
Peter C Gøtzsche, Karsten Juhl Jørgensen, Cochrane Breast Cancer Group
Background A variety of estimates of the benefits and harms of mammographic screening for breast cancer have been published and national policies vary. This is an update of a review previously updated 2013 and originally published 2001.
背景 对乳腺癌乳腺 X 线照相筛查的益处和危害有多种估计，各国的政策也不尽相同。本报告是对之前于2013年更新、最初于2001年发表的综述的更新。
{"title":"Screening for breast cancer with mammography","authors":"Peter C Gøtzsche, Karsten Juhl Jørgensen, Cochrane Breast Cancer Group","doi":"10.1101/2024.06.06.24308542","DOIUrl":"https://doi.org/10.1101/2024.06.06.24308542","url":null,"abstract":"<strong>Background</strong> A variety of estimates of the benefits and harms of mammographic screening for breast cancer have been published and national policies vary. This is an update of a review previously updated 2013 and originally published 2001.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"154 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141531686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-31DOI: 10.1101/2024.05.30.24308190
Stephen Allan, Stacey Rand, Ann-Marie Towers, Kaat De Corte, Freya Tracey, Elizabeth Crellin, Therese Lloyd, Rachael E Carroll, Sinead Palmer, Lucy Webster, Adam Gordon, Nick Smith, Gizdem Akdur, Anne Killett, Karen Spilsbury, Claire Goodman
Background To maintain good standards of care, evaluations of policy interventions or potential improvements to care are required. A number of quality of life (QoL) measures could be used but there is little evidence for England as to which measures would be appropriate. Using data from a pilot Minimum Data Set (MDS) for care home residents from the Developing resources And minimum dataset for Care Homes’ Adoption (DACHA) study, we assessed the construct validity of QoL measures and analysed factors associated with QoL. This was to demonstrate the value of the pilot MDS data and to provide evidence for the inclusion of QoL measures in a future MDS.
背景 为了保持良好的护理标准，需要对政策干预措施或潜在的护理改进措施进行评估。可以使用多种生活质量（QoL）测量方法，但在英格兰，几乎没有证据表明哪些测量方法是合适的。利用 "为护理院采用开发资源和最低数据集"（DACHA）研究中的护理院居民最低数据集（MDS）试点数据，我们评估了 QoL 测量的构建有效性，并分析了与 QoL 相关的因素。此举旨在证明 MDS 试点数据的价值，并为将 QoL 测量纳入未来的 MDS 提供证据。
{"title":"Factors associated with care home resident quality of life: Demonstrating the value of a pilot Minimum Data Set using cross-sectional analysis from the DACHA study","authors":"Stephen Allan, Stacey Rand, Ann-Marie Towers, Kaat De Corte, Freya Tracey, Elizabeth Crellin, Therese Lloyd, Rachael E Carroll, Sinead Palmer, Lucy Webster, Adam Gordon, Nick Smith, Gizdem Akdur, Anne Killett, Karen Spilsbury, Claire Goodman","doi":"10.1101/2024.05.30.24308190","DOIUrl":"https://doi.org/10.1101/2024.05.30.24308190","url":null,"abstract":"<strong>Background</strong> To maintain good standards of care, evaluations of policy interventions or potential improvements to care are required. A number of quality of life (QoL) measures could be used but there is little evidence for England as to which measures would be appropriate. Using data from a pilot Minimum Data Set (MDS) for care home residents from the Developing resources And minimum dataset for Care Homes’ Adoption (DACHA) study, we assessed the construct validity of QoL measures and analysed factors associated with QoL. This was to demonstrate the value of the pilot MDS data and to provide evidence for the inclusion of QoL measures in a future MDS.","PeriodicalId":501386,"journal":{"name":"medRxiv - Health Policy","volume":"28 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141258250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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