Pub Date : 2022-08-09eCollection Date: 2022-01-01DOI: 10.1080/20016689.2022.2106627
Wojciech Margas, Piotr Wojciechowski, Mondher Toumi
Background: Globally, healthcare has shouldered much of the socioeconomic brunt of the COVID-19 pandemic leading to numerous clinical trials suspended or discontinued.
Objective: To estimate the COVID-19 impact on the number of clinical trials worldwide.
Methods: Data deposited by 219 countries in the ClinicalTrials.gov database (2007-2020) were interrogated using targeted queries. A time series model was fitted to the data for studies ongoing, initiated, or ended between 2007 Quarter (Q) 1 and 2019 Q4 to predict the expected trials number in 2020 in the COVID-19 absence. The predicted values were compared with the actual 2020 data to quantify the pandemic impact.
Results: The ongoing registered trials number grew from 2007 Q1 (33,739) to 2019 Q4 (80,319). By contrast, there were markedly fewer ongoing trials in all four quarters of 2020 compared with forecasted values (1.6%-2.8% decrease). When excluding COVID-19-related studies, this disparity grew further (3.4%-5.8% decrease), to a peak of almost 5,000 fewer ongoing trials than estimated for 2020 Q2. The initiated non-COVID-19 trials number was higher than predicted in 2020 Q4 (9.9%).
Conclusions: This pandemic has impacted clinical trials. Provided that current trends persist, clinical trial activities may soon recover to at least pre-COVID-19 levels.
{"title":"Impact of the COVID-19 pandemic on the conduct of clinical trials: a quantitative analysis.","authors":"Wojciech Margas, Piotr Wojciechowski, Mondher Toumi","doi":"10.1080/20016689.2022.2106627","DOIUrl":"https://doi.org/10.1080/20016689.2022.2106627","url":null,"abstract":"<p><strong>Background: </strong>Globally, healthcare has shouldered much of the socioeconomic brunt of the COVID-19 pandemic leading to numerous clinical trials suspended or discontinued.</p><p><strong>Objective: </strong>To estimate the COVID-19 impact on the number of clinical trials worldwide.</p><p><strong>Methods: </strong>Data deposited by 219 countries in the ClinicalTrials.gov database (2007-2020) were interrogated using targeted queries. A time series model was fitted to the data for studies ongoing, initiated, or ended between 2007 Quarter (Q) 1 and 2019 Q4 to predict the expected trials number in 2020 in the COVID-19 absence. The predicted values were compared with the actual 2020 data to quantify the pandemic impact.</p><p><strong>Results: </strong>The ongoing registered trials number grew from 2007 Q1 (33,739) to 2019 Q4 (80,319). By contrast, there were markedly fewer ongoing trials in all four quarters of 2020 compared with forecasted values (1.6%-2.8% decrease). When excluding COVID-19-related studies, this disparity grew further (3.4%-5.8% decrease), to a peak of almost 5,000 fewer ongoing trials than estimated for 2020 Q2. The initiated non-COVID-19 trials number was higher than predicted in 2020 Q4 (9.9%).</p><p><strong>Conclusions: </strong>This pandemic has impacted clinical trials. Provided that current trends persist, clinical trial activities may soon recover to at least pre-COVID-19 levels.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2106627"},"PeriodicalIF":0.0,"publicationDate":"2022-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5e/80/ZJMA_10_2106627.PMC9367669.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40629559","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 : 2022-06-28eCollection Date: 2022-01-01DOI: 10.1080/20016689.2022.2094047
Clara Monleón, Hans-Martin Späth, Carlos Crespo, Claude Dussart, Mondher Toumi
Objectives: Deliberative processes in Health Technologies Assessment (HTA) result in recommendations that determine the reimbursement of medicines, diagnostics or devices. These processes are governed by explicit criteria, but are also influenced by implicit factors. The objective of this work was to identify the implicit factors influencing HTA deliberative processes in five European countries (France, Germany, Italy, Spain and the UK).
Methods: A systematic review of literature published between 2009 and 2019 was conducted. The search was performed in Pubmed, The Cochrane Database of Systematic Reviews, Google Scholar and Center for Reviews and Dissemination. The ISPOR database was searched manually.
Results: Out of 100 eligible publications, eight articles were selected for data extraction and analysis. The implicit factors in the HTA deliberative process most frequently mentioned in the identified literature are value judgments, biases, preferences and subjectivity. Five out of the eight articles highlight the need to further improve the transparency of the process, and three provide recommendations on how to address the influence of implicit factors on the HTA deliberative process through a framework.
Conclusion: Even in countries with a long HTA history, evidence on implicit factors is scarce. Some methods have been recommended for addressing these factors. Further research is required to characterize the implicit factors in the HTA deliberative process at a country level and explore potential ways to mitigate the influence of these factors on the HTA deliberative process.
{"title":"Systematic literature review on the implicit factors influencing the HTA deliberative process in Europe.","authors":"Clara Monleón, Hans-Martin Späth, Carlos Crespo, Claude Dussart, Mondher Toumi","doi":"10.1080/20016689.2022.2094047","DOIUrl":"10.1080/20016689.2022.2094047","url":null,"abstract":"<p><strong>Objectives: </strong>Deliberative processes in Health Technologies Assessment (HTA) result in recommendations that determine the reimbursement of medicines, diagnostics or devices. These processes are governed by explicit criteria, but are also influenced by implicit factors. The objective of this work was to identify the implicit factors influencing HTA deliberative processes in five European countries (France, Germany, Italy, Spain and the UK).</p><p><strong>Methods: </strong>A systematic review of literature published between 2009 and 2019 was conducted. The search was performed in Pubmed, The Cochrane Database of Systematic Reviews, Google Scholar and Center for Reviews and Dissemination. The ISPOR database was searched manually.</p><p><strong>Results: </strong>Out of 100 eligible publications, eight articles were selected for data extraction and analysis. The implicit factors in the HTA deliberative process most frequently mentioned in the identified literature are value judgments, biases, preferences and subjectivity. Five out of the eight articles highlight the need to further improve the transparency of the process, and three provide recommendations on how to address the influence of implicit factors on the HTA deliberative process through a framework.</p><p><strong>Conclusion: </strong>Even in countries with a long HTA history, evidence on implicit factors is scarce. Some methods have been recommended for addressing these factors. Further research is required to characterize the implicit factors in the HTA deliberative process at a country level and explore potential ways to mitigate the influence of these factors on the HTA deliberative process.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2094047"},"PeriodicalIF":0.0,"publicationDate":"2022-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ef/ee/ZJMA_10_2094047.PMC9267410.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40488927","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 : 2022-06-10DOI: 10.1080/20016689.2022.2082646
A. Millier, R. Supiot, K. Benyounes, V. Machuron, K. Le lay, M. Sivignon, C. Leboucher, C. Blein, F. Raffi
ABSTRACT Background Quantification of COVID-19 burden may be useful to support the future allocation of resources. Objective To evaluate the public health impact of COVID-19 in French ambulatory patients with at least one risk factor for severe disease. Study design A Markov model was used to estimate life years, costs, number of hospitalisations, number of deaths and long/prolonged COVID forms over a time horizon of 2 years. The hospitalisation probabilities were derived from an early access cohort, and the hospitalisation stay characteristics were derived from the French national hospital discharge database. Several scenario analyses were conducted. Results The number of hospitalisations reached 256 per 1,000 patients over the acute phase (first month of simulation), and 382 per 1,000 patients over 2 years. The number of deaths was 37 per 1,000 patients, and the number of long/prolonged COVID forms reached 407 per 1,000 patients. These translated into a reduction of 0.7 days of life per patient in the first month, with an associated cost of €1,578, and a reduction of 27 days of life over the time horizon, with an associated cost of €4,280. The highest burden was observed for patients over 80 years old, and those not vaccinated. The scenarios with a less severe situation or new treatments available showed a non-negligible burden reduction. Conclusion This study allowed us to quantify the considerable burden related to COVID-19 in infected patients, with at least one risk factor for severe form. Strategies with the ability to substantially reduce this burden in France are urgently required.
{"title":"Public health impact of COVID-19 in French ambulatory patients with at least one risk factor for severe disease","authors":"A. Millier, R. Supiot, K. Benyounes, V. Machuron, K. Le lay, M. Sivignon, C. Leboucher, C. Blein, F. Raffi","doi":"10.1080/20016689.2022.2082646","DOIUrl":"https://doi.org/10.1080/20016689.2022.2082646","url":null,"abstract":"ABSTRACT Background Quantification of COVID-19 burden may be useful to support the future allocation of resources. Objective To evaluate the public health impact of COVID-19 in French ambulatory patients with at least one risk factor for severe disease. Study design A Markov model was used to estimate life years, costs, number of hospitalisations, number of deaths and long/prolonged COVID forms over a time horizon of 2 years. The hospitalisation probabilities were derived from an early access cohort, and the hospitalisation stay characteristics were derived from the French national hospital discharge database. Several scenario analyses were conducted. Results The number of hospitalisations reached 256 per 1,000 patients over the acute phase (first month of simulation), and 382 per 1,000 patients over 2 years. The number of deaths was 37 per 1,000 patients, and the number of long/prolonged COVID forms reached 407 per 1,000 patients. These translated into a reduction of 0.7 days of life per patient in the first month, with an associated cost of €1,578, and a reduction of 27 days of life over the time horizon, with an associated cost of €4,280. The highest burden was observed for patients over 80 years old, and those not vaccinated. The scenarios with a less severe situation or new treatments available showed a non-negligible burden reduction. Conclusion This study allowed us to quantify the considerable burden related to COVID-19 in infected patients, with at least one risk factor for severe form. Strategies with the ability to substantially reduce this burden in France are urgently required.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48514010","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 : 2022-06-08DOI: 10.1080/20016689.2022.2078474
L. Fan, Yuanyuan Zhang, Peter Maguire, D. Muston, M. Monberg, J. R. Earla, A. Mihai, P. Gulati
ABSTRACT Background The economic impact of adverse events (AEs) for poly (ADP-ribose) polymerase inhibitors (PARPis) in ovarian or breast cancer has not been widely evaluated. Objective Compare PARPi-related AE management costs from a US payer perspective. Methods The frequency of treatment-related grade 3–4 AEs was obtained from published clinical trials of PARPis for the treatment of advanced ovarian cancer (AOC), platinum-sensitive recurrent ovarian cancer (PSROC), and metastatic breast cancer (MBC). AE management costs per patient (2020 USD) per treatment course were calculated by multiplying the AE unit costs by the frequency of AEs for each arm of each trial. Sensitivity analyses were conducted according to the lower and upper limits of the 95% confidence interval for AE rates and unit costs, respectively. Scenarios were also performed to explore the uncertainty of outcomes. Results Total AE management costs in AOC were: $3,904, olaparib; $5,595, olaparib plus bevacizumab; and $12,215, niraparib. In PSROC, total costs were: $3,894, olaparib; $6,001, rucaparib; and $11,492, niraparib, and in MBC: $3,574, olaparib; and $9,489, talazoparib. Hematological toxicities were the key drivers of AE management costs for PARPis. Conclusions The main AEs among PARPis were hematological. Olaparib was associated with lower AE costs compared to other PARPis.
{"title":"Cost comparison of adverse event management among breast and ovarian cancer patients treated with poly (ADP-ribose) polymerase inhibitors: analysis based on phase 3 clinical trials","authors":"L. Fan, Yuanyuan Zhang, Peter Maguire, D. Muston, M. Monberg, J. R. Earla, A. Mihai, P. Gulati","doi":"10.1080/20016689.2022.2078474","DOIUrl":"https://doi.org/10.1080/20016689.2022.2078474","url":null,"abstract":"ABSTRACT Background The economic impact of adverse events (AEs) for poly (ADP-ribose) polymerase inhibitors (PARPis) in ovarian or breast cancer has not been widely evaluated. Objective Compare PARPi-related AE management costs from a US payer perspective. Methods The frequency of treatment-related grade 3–4 AEs was obtained from published clinical trials of PARPis for the treatment of advanced ovarian cancer (AOC), platinum-sensitive recurrent ovarian cancer (PSROC), and metastatic breast cancer (MBC). AE management costs per patient (2020 USD) per treatment course were calculated by multiplying the AE unit costs by the frequency of AEs for each arm of each trial. Sensitivity analyses were conducted according to the lower and upper limits of the 95% confidence interval for AE rates and unit costs, respectively. Scenarios were also performed to explore the uncertainty of outcomes. Results Total AE management costs in AOC were: $3,904, olaparib; $5,595, olaparib plus bevacizumab; and $12,215, niraparib. In PSROC, total costs were: $3,894, olaparib; $6,001, rucaparib; and $11,492, niraparib, and in MBC: $3,574, olaparib; and $9,489, talazoparib. Hematological toxicities were the key drivers of AE management costs for PARPis. Conclusions The main AEs among PARPis were hematological. Olaparib was associated with lower AE costs compared to other PARPis.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46438093","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 : 2022-05-29DOI: 10.1080/20016689.2022.2080631
M. Nuijten, S. Capri
ABSTRACT Background In order to optimize positioning and associated drug price for both payer and investor, it is for a company essential to forecast the potential market access attractiveness for the new drug for different indications at the early onset of the clinical development program. This analysis must include the constraints from the perspective of the payer, but also the biotech companies, who require a minimum drug price to satisfy their investors. This paper aims to provide an Integrated Valuation Model for payer and investor, bridging concepts from health economics and economic valuation reflecting the perspectives of the payer and the investor for a drug in early clinical development phase. The concept is illustrated for a new hypothetical drug (Product X) in advanced breast cancer in 1-line, 2-line, and 3-line position. Methods The Integrated Valuation Model includes the outcomes of the budget impact model, pricing matrix model, and cost-effectiveness model reflecting the payer’s perspective. These models are interacted and linked with a discounted cash flow model in order to reflect also the economic value from the investor’s perspective. Results The maximum price in 1-line position is €269.7 for the payer and the minimum price is €14.7 for the investor, which are unit prices per administration corresponding with treatment regimens for the comparative treatments. In 2-line position, the maximum price is €274.1 for the payer and the minimum price for the investor increases to €184.5 for the investor because of the smaller market size in 2-line position, which leads to a smaller pricing corridor to satisfy both payer and investor. Consequently, Product X has market access attractiveness for both payer and investor in 1-line and 2-line position. However, the minimum price €942.7 in 3-line position for the investor is higher than the maximum price €283.3 for the payer, which means there is no market potential. Conclusion The practical strategic application of the Integrated Valuation Model is optimization of positioning and price of Product X. Hence, it can be a transparent tool in early-stage development of a compound based on upfront assessment of market access attractiveness for the payer and the investor.
{"title":"An integrated valuation model for payer and investor","authors":"M. Nuijten, S. Capri","doi":"10.1080/20016689.2022.2080631","DOIUrl":"https://doi.org/10.1080/20016689.2022.2080631","url":null,"abstract":"ABSTRACT Background In order to optimize positioning and associated drug price for both payer and investor, it is for a company essential to forecast the potential market access attractiveness for the new drug for different indications at the early onset of the clinical development program. This analysis must include the constraints from the perspective of the payer, but also the biotech companies, who require a minimum drug price to satisfy their investors. This paper aims to provide an Integrated Valuation Model for payer and investor, bridging concepts from health economics and economic valuation reflecting the perspectives of the payer and the investor for a drug in early clinical development phase. The concept is illustrated for a new hypothetical drug (Product X) in advanced breast cancer in 1-line, 2-line, and 3-line position. Methods The Integrated Valuation Model includes the outcomes of the budget impact model, pricing matrix model, and cost-effectiveness model reflecting the payer’s perspective. These models are interacted and linked with a discounted cash flow model in order to reflect also the economic value from the investor’s perspective. Results The maximum price in 1-line position is €269.7 for the payer and the minimum price is €14.7 for the investor, which are unit prices per administration corresponding with treatment regimens for the comparative treatments. In 2-line position, the maximum price is €274.1 for the payer and the minimum price for the investor increases to €184.5 for the investor because of the smaller market size in 2-line position, which leads to a smaller pricing corridor to satisfy both payer and investor. Consequently, Product X has market access attractiveness for both payer and investor in 1-line and 2-line position. However, the minimum price €942.7 in 3-line position for the investor is higher than the maximum price €283.3 for the payer, which means there is no market potential. Conclusion The practical strategic application of the Integrated Valuation Model is optimization of positioning and price of Product X. Hence, it can be a transparent tool in early-stage development of a compound based on upfront assessment of market access attractiveness for the payer and the investor.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42746475","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 : 2022-05-24eCollection Date: 2022-01-01DOI: 10.1080/20016689.2022.2077905
Flavia A Duarte, Carlos Gil Ferreira, Rodrigo Dienstmann, Bruno L Ferrari, Matheus Costa E Silva, Pedro Nazareth A Junior, Paulo Guilherme de O Salles, Paulo Henrique C Diniz
Background: Precision oncology has a prominent role in nonsquamous non-small cell lung cancer (nsNSCLC) treatment progress; however, its access in a real-world scenario might be limited.
Objective: To investigate the time spent in nsNSCLC molecular profile evaluation and its influence on clinical decisions.
Methods: nsNSCLC patients who underwent molecular testing in a private referral Brazilian center between November 2015 and February 2020 were identified. The interval from nsNSCLC diagnosis to the characterization of the molecular profile was determined. Other outcomes, focusing on the biomarker tissue journey, were also assessed.
Results: In this cohort (n = 78), the median time between the advanced nsNSCLC diagnosis and biomarker characterization was 40.5 days (range, 29.5-68.5). The median interval between the diagnosis and the test request was longer than the interval between the request and the results (respectively 29.0 versus 12.0 days; p < 0.001). At the treatment initiation, 51% (36/71) of the patients who received any systemic therapy did not have their driver mutations panel results available. But on these, 42% (15/36) had a targetable alteration identified later on. Among patients harboring a targetable alteration, only 46% (n = 13/28) received a tyrosine kinase inhibitor (TKI) as first-line therapy. The median time to the TKI initiation was even longer than the median time to all treatment initiation (92.0 versus 40.0 days).
Conclusions: Our data show a long median time from advanced nsNSCLC diagnosis and the availability of the biomarker testing in medical practice, which impacted the choice of a non-personalized therapy as the first-line.
背景:精准肿瘤学在非鳞状非小细胞肺癌(nsNSCLC)治疗进展中具有突出作用;然而，它在现实场景中的访问可能是有限的。目的:探讨nsNSCLC分子谱评估所需时间及其对临床决策的影响。方法:选取2015年11月至2020年2月期间在巴西一家私人转诊中心接受分子检测的nsNSCLC患者。确定了从nsNSCLC诊断到分子谱表征的时间间隔。其他结果，重点是生物标志物组织旅程，也进行了评估。结果:在该队列中(n = 78)，晚期nsNSCLC诊断和生物标志物鉴定之间的中位时间为40.5天(范围:29.5-68.5)。诊断和测试请求之间的中位数间隔时间比请求和结果之间的间隔时间长(分别为29.0天对12.0天;p n = 13/28)接受酪氨酸激酶抑制剂(TKI)作为一线治疗。TKI启动的中位时间甚至比所有治疗启动的中位时间更长(92.0天对40.0天)。结论:我们的数据显示，晚期nsNSCLC诊断的中位时间较长，医疗实践中生物标志物检测的可用性影响了非个性化治疗作为一线治疗的选择。
{"title":"Barriers in precision medicine implementation among Advanced Nonsquamous Cell Lung Cancer-patients: A Real-World Evidence Scenario.","authors":"Flavia A Duarte, Carlos Gil Ferreira, Rodrigo Dienstmann, Bruno L Ferrari, Matheus Costa E Silva, Pedro Nazareth A Junior, Paulo Guilherme de O Salles, Paulo Henrique C Diniz","doi":"10.1080/20016689.2022.2077905","DOIUrl":"https://doi.org/10.1080/20016689.2022.2077905","url":null,"abstract":"<p><strong>Background: </strong>Precision oncology has a prominent role in nonsquamous non-small cell lung cancer (nsNSCLC) treatment progress; however, its access in a real-world scenario might be limited.</p><p><strong>Objective: </strong>To investigate the time spent in nsNSCLC molecular profile evaluation and its influence on clinical decisions.</p><p><strong>Methods: </strong>nsNSCLC patients who underwent molecular testing in a private referral Brazilian center between November 2015 and February 2020 were identified. The interval from nsNSCLC diagnosis to the characterization of the molecular profile was determined. Other outcomes, focusing on the biomarker tissue journey, were also assessed.</p><p><strong>Results: </strong>In this cohort (<i>n</i> = 78), the median time between the advanced nsNSCLC diagnosis and biomarker characterization was 40.5 days (range, 29.5-68.5). The median interval between the diagnosis and the test request was longer than the interval between the request and the results (respectively 29.0 <i>versus</i> 12.0 days; <i>p</i> < 0.001). At the treatment initiation, 51% (36/71) of the patients who received any systemic therapy did not have their driver mutations panel results available. But on these, 42% (15/36) had a targetable alteration identified later on. Among patients harboring a targetable alteration, only 46% (<i>n</i> = 13/28) received a tyrosine kinase inhibitor (TKI) as first-line therapy. The median time to the TKI initiation was even longer than the median time to all treatment initiation (92.0 <i>versus</i> 40.0 days).</p><p><strong>Conclusions: </strong>Our data show a long median time from advanced nsNSCLC diagnosis and the availability of the biomarker testing in medical practice, which impacted the choice of a non-personalized therapy as the first-line.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2077905"},"PeriodicalIF":0.0,"publicationDate":"2022-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1b/4d/ZJMA_10_2077905.PMC9639562.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40454218","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 : 2022-04-05DOI: 10.1080/20016689.2022.2061241
Michelle Rydback, A. Hyder, G. Macassa, Clara Simonsson
ABSTRACT Pupose - This essay uses service marketing concept to discuss how domestic medical tourism (DMT) can contribute to healthcare equity in developed countries. Approach - The authors take up several vital issues. First, the potential benefits of DMT are outlined from a healthcare equity perspective; second, the challenges that DMT confronts in reaching its aim are identified; and finally, a few research areas are suggested. Finding - It is suggested that increased awareness about the healthcare service and proper service delivery are required to improve healthcare equity. Practical implication - This paper raises several research issues from service marketing to deal with delivery, communication, efficiency, and insurance practices regarding healthcare. Social implication - From a societal point of view, it explores how healthcare equity can be improved by DMT.
{"title":"Can domestic medical tourism contribute to healthcare equity? A commentary","authors":"Michelle Rydback, A. Hyder, G. Macassa, Clara Simonsson","doi":"10.1080/20016689.2022.2061241","DOIUrl":"https://doi.org/10.1080/20016689.2022.2061241","url":null,"abstract":"ABSTRACT Pupose - This essay uses service marketing concept to discuss how domestic medical tourism (DMT) can contribute to healthcare equity in developed countries. Approach - The authors take up several vital issues. First, the potential benefits of DMT are outlined from a healthcare equity perspective; second, the challenges that DMT confronts in reaching its aim are identified; and finally, a few research areas are suggested. Finding - It is suggested that increased awareness about the healthcare service and proper service delivery are required to improve healthcare equity. Practical implication - This paper raises several research issues from service marketing to deal with delivery, communication, efficiency, and insurance practices regarding healthcare. Social implication - From a societal point of view, it explores how healthcare equity can be improved by DMT.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41780510","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 : 2022-03-27DOI: 10.1080/20016689.2022.2057651
Yukiko Hashimoto, A. Hayashi, Takashi Tonegawa, L. Teng, A. Igarashi
ABSTRACT Background Although medical costs need to be controlled, there are no easily applicable cost prediction models of transfer to palliative care (PC) for terminal cancer patients. Objective Construct a cost-saving prediction model based on terminal cancer patients’ data at hospital admission. Study design Retrospective cohort study. Setting A Japanese general hospital. Patients A total of 139 stage IV cancer patients transferred to PC, who died during hospitalization from April 2014 to March 2019. Main outcome measure Patients were divided into higher (59) and lower (80) total medical costs per day after transfer to PC. We compared demographics, cancer type, medical history, and laboratory results between the groups. Stepwise logistic regression analysis was used for model development and area under the curve (AUC) calculation. Results A cost-saving prediction model (AUC = 0.78, 95% CI: 0.70, 0.85) with a total score of 13 points was constructed as follows: 2 points each for age ≤ 74 years, creatinine ≥ 0.68 mg/dL, and lactate dehydrogenase ≤ 188 IU/L; 3 points for hemoglobin ≤ 8.8 g/dL; and 4 points for potassium ≤ 3.3 mEq/L. Conclusion Our model contains five predictors easily available in clinical settings and exhibited good predictive ability.
{"title":"Cost-saving prediction model of transfer to palliative care for terminal cancer patients in a Japanese general hospital","authors":"Yukiko Hashimoto, A. Hayashi, Takashi Tonegawa, L. Teng, A. Igarashi","doi":"10.1080/20016689.2022.2057651","DOIUrl":"https://doi.org/10.1080/20016689.2022.2057651","url":null,"abstract":"ABSTRACT Background Although medical costs need to be controlled, there are no easily applicable cost prediction models of transfer to palliative care (PC) for terminal cancer patients. Objective Construct a cost-saving prediction model based on terminal cancer patients’ data at hospital admission. Study design Retrospective cohort study. Setting A Japanese general hospital. Patients A total of 139 stage IV cancer patients transferred to PC, who died during hospitalization from April 2014 to March 2019. Main outcome measure Patients were divided into higher (59) and lower (80) total medical costs per day after transfer to PC. We compared demographics, cancer type, medical history, and laboratory results between the groups. Stepwise logistic regression analysis was used for model development and area under the curve (AUC) calculation. Results A cost-saving prediction model (AUC = 0.78, 95% CI: 0.70, 0.85) with a total score of 13 points was constructed as follows: 2 points each for age ≤ 74 years, creatinine ≥ 0.68 mg/dL, and lactate dehydrogenase ≤ 188 IU/L; 3 points for hemoglobin ≤ 8.8 g/dL; and 4 points for potassium ≤ 3.3 mEq/L. Conclusion Our model contains five predictors easily available in clinical settings and exhibited good predictive ability.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"59990895","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 : 2022-01-24eCollection Date: 2022-01-01DOI: 10.1080/20016689.2022.2030559
Bhavneet Walia, Harshdeep Banga, David A Larsen
Overview In recent years, Physician Assistants (PAs) have become an increasingly important class of medical practioners in the USA (U.S.) healthcare system. After physicians, PAs and Nurse Practitioners are the most skilled among the commonly observed types of medical practitioners, having earned a Masters Degree from an accredited medical sciences program. Further, PAs perform many of the same tasks as physicians within the U.S. healthcare system. According to the American Association of Physician Assistants, PAs commonly: ‘Take medical histories; Conduct physical exams; Diagnose and treat illness; Order and interpret tests; Develop treatment plans; Prescribe medication; Counsel on preventive care; Perform procedures; Assist in surgery; Make rounds in hospitals and nursing homes; Do clinical research.’ [1] These tasks can either be transferred from physicians to PAs or completed in physician-PA teams. As such, PAs can act as substitutes or complements for physicians within U.S. healthcare and other healthcare systems. More specifically, PAs can work without day-to-day physician supervision while performing physician-like tasks or in teams in which they are directly supervised by physicians [2]. Given that their tasks are highly related to those of U.S. physicians, it is important to characterize trends in the role and scale of PAs in the U.S. healthcare system. The number of PAs is growing at a rapid rate in U.S. healthcare systems [3]. The number of employed PAs in the U.S. is expected to grow by 39,300 or 31.3% between 2019 and 2029. This growth rate is well above the average rate of labor growth in the healthcare industry. By comparison, the projected growth rate for U.S. physician and surgeon positions over the same time period is 3.6%, with a projected 27,300 new physician/surgeon positions over that time. Figure 1 shows the beginning of this projected trend. These projections suggest that the ratio of physicians to PAs will decrease from 6:1 in 2019 to 4.7:1 in 2029. This rapid change can be linked to structural shifts in the U.S. healthcare systems, including increased demand attributable partly to the Affordable Care Act of 2010, an increased market concentration of for-profit health institutions that seek to maximize profit partly by reducing labor costs, and a fairly-substantial average pay gap between physicians and PAs, among others. Presently, we consider whether this shift will create a tradeoff between health care access and quality within U.S. healthcare. In 2019, median physician pay in the U.S. was $208,000 compared to $115,390 for Pas [3]. Consequently, the cost savings from increasing the proportion of PAs relative to physicians are substantial. The BLS projects that the number of U.S. PAs and physicians combined will expand to 944,500 by 2029. If this expansion were to be conducted while preserving the 6:1 physician-to-PA ratio observed in 2019, it would cost approximately $1.38 trillion more systemwide at current salaries,
{"title":"Increased reliance on physician assistants: an access-quality tradeoff?","authors":"Bhavneet Walia, Harshdeep Banga, David A Larsen","doi":"10.1080/20016689.2022.2030559","DOIUrl":"https://doi.org/10.1080/20016689.2022.2030559","url":null,"abstract":"Overview In recent years, Physician Assistants (PAs) have become an increasingly important class of medical practioners in the USA (U.S.) healthcare system. After physicians, PAs and Nurse Practitioners are the most skilled among the commonly observed types of medical practitioners, having earned a Masters Degree from an accredited medical sciences program. Further, PAs perform many of the same tasks as physicians within the U.S. healthcare system. According to the American Association of Physician Assistants, PAs commonly: ‘Take medical histories; Conduct physical exams; Diagnose and treat illness; Order and interpret tests; Develop treatment plans; Prescribe medication; Counsel on preventive care; Perform procedures; Assist in surgery; Make rounds in hospitals and nursing homes; Do clinical research.’ [1] These tasks can either be transferred from physicians to PAs or completed in physician-PA teams. As such, PAs can act as substitutes or complements for physicians within U.S. healthcare and other healthcare systems. More specifically, PAs can work without day-to-day physician supervision while performing physician-like tasks or in teams in which they are directly supervised by physicians [2]. Given that their tasks are highly related to those of U.S. physicians, it is important to characterize trends in the role and scale of PAs in the U.S. healthcare system. The number of PAs is growing at a rapid rate in U.S. healthcare systems [3]. The number of employed PAs in the U.S. is expected to grow by 39,300 or 31.3% between 2019 and 2029. This growth rate is well above the average rate of labor growth in the healthcare industry. By comparison, the projected growth rate for U.S. physician and surgeon positions over the same time period is 3.6%, with a projected 27,300 new physician/surgeon positions over that time. Figure 1 shows the beginning of this projected trend. These projections suggest that the ratio of physicians to PAs will decrease from 6:1 in 2019 to 4.7:1 in 2029. This rapid change can be linked to structural shifts in the U.S. healthcare systems, including increased demand attributable partly to the Affordable Care Act of 2010, an increased market concentration of for-profit health institutions that seek to maximize profit partly by reducing labor costs, and a fairly-substantial average pay gap between physicians and PAs, among others. Presently, we consider whether this shift will create a tradeoff between health care access and quality within U.S. healthcare. In 2019, median physician pay in the U.S. was $208,000 compared to $115,390 for Pas [3]. Consequently, the cost savings from increasing the proportion of PAs relative to physicians are substantial. The BLS projects that the number of U.S. PAs and physicians combined will expand to 944,500 by 2029. If this expansion were to be conducted while preserving the 6:1 physician-to-PA ratio observed in 2019, it would cost approximately $1.38 trillion more systemwide at current salaries, ","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"10 1","pages":"2030559"},"PeriodicalIF":0.0,"publicationDate":"2022-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/dd/81/ZJMA_10_2030559.PMC8788342.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39865401","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 : 2022-01-10eCollection Date: 2022-01-01DOI: 10.1080/20016689.2021.2010961
Clément François, Nicola Germain, Renata Majewska, Vanessa Taieb, L Arthur Hewitt, Steven Kymes
Background: Symptoms of neurogenic orthostatic hypotension (nOH), including lightheadedness/dizziness, presyncope, syncope, and falls, can lead to impaired functional ability and reduced quality of life. Because the severity and frequency of nOH symptoms fluctuate, it may be difficult for patients to accurately quantify the effect of symptoms on their daily lives using available outcome measures. A new single-item instrument, the 'Good Day Bad Day,' was developed, and its psychometric validity was assessed in patients with nOH.
Methods: Data from a 6-month, prospective, observational cohort study of patients with nOH who were newly initiating droxidopa treatment were used. Patients were asked to quantify the number of good and bad days in the previous 7 days and responded to other validated patient-reported outcomes instruments. The concurrent and discriminant validities and the stability of the Good Day Bad Day instrument were assessed.
Results: A total of 153 patients were included in the analysis (mean [SD] age, 62.3 [17] years). Change in the number of good days moderately correlated with improvements in other patient-reported outcomes (rho value range, -0.38 to -0.61). When data were examined categorically (low vs high symptom severity), the mean number of good days was higher in subgroups representing low symptom severity across measures at 1, 3, and 6 months (all P ≤ 0.01).
Conclusions: The Good Day Bad Day instrument provided good discrimination at baseline and over time and may aid in assessment of the effects of nOH symptoms on patients.
{"title":"Psychometric validation of a patient-reported single-item assessment of 'Good Day Bad Day' in a neurogenic orthostatic hypotension population treated with droxidopa.","authors":"Clément François, Nicola Germain, Renata Majewska, Vanessa Taieb, L Arthur Hewitt, Steven Kymes","doi":"10.1080/20016689.2021.2010961","DOIUrl":"10.1080/20016689.2021.2010961","url":null,"abstract":"<p><strong>Background: </strong>Symptoms of neurogenic orthostatic hypotension (nOH), including lightheadedness/dizziness, presyncope, syncope, and falls, can lead to impaired functional ability and reduced quality of life. Because the severity and frequency of nOH symptoms fluctuate, it may be difficult for patients to accurately quantify the effect of symptoms on their daily lives using available outcome measures. A new single-item instrument, the 'Good Day Bad Day,' was developed, and its psychometric validity was assessed in patients with nOH.</p><p><strong>Methods: </strong>Data from a 6-month, prospective, observational cohort study of patients with nOH who were newly initiating droxidopa treatment were used. Patients were asked to quantify the number of good and bad days in the previous 7 days and responded to other validated patient-reported outcomes instruments. The concurrent and discriminant validities and the stability of the Good Day Bad Day instrument were assessed.</p><p><strong>Results: </strong>A total of 153 patients were included in the analysis (mean [SD] age, 62.3 [17] years). Change in the number of good days moderately correlated with improvements in other patient-reported outcomes (rho value range, -0.38 to -0.61). When data were examined categorically (low vs high symptom severity), the mean number of good days was higher in subgroups representing low symptom severity across measures at 1, 3, and 6 months (all <i>P</i> ≤ 0.01).</p><p><strong>Conclusions: </strong>The Good Day Bad Day instrument provided good discrimination at baseline and over time and may aid in assessment of the effects of nOH symptoms on patients.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"10 1","pages":"2010961"},"PeriodicalIF":0.0,"publicationDate":"2022-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2d/4e/ZJMA_10_2010961.PMC8757596.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39702402","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}
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