Expert Review of Pharmacoeconomics & Outcomes Research最新文献

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Evaluating the accuracy of extrapolated overall survival for pembrolizumab: a comparison with long-term observed data in the Australian reimbursement context.
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-04 DOI: 10.1080/14737167.2025.2478234
Francis C Dehle, Kevin Phan, Jerome Higgins, Kate Applegarth, Manoj Gambhir, Colman B Taylor
{"title":"Evaluating the accuracy of extrapolated overall survival for pembrolizumab: a comparison with long-term observed data in the Australian reimbursement context.","authors":"Francis C Dehle, Kevin Phan, Jerome Higgins, Kate Applegarth, Manoj Gambhir, Colman B Taylor","doi":"10.1080/14737167.2025.2478234","DOIUrl":"10.1080/14737167.2025.2478234","url":null,"abstract":"<p><strong>Background: </strong>Decisions about government funding for new medicines often rely on statistical models to predict how long patients will live (overall survival, OS) based on early trial data. This study compared the accuracy of these predictions for the cancer drug pembrolizumab, using models preferred by pharmaceutical companies (Sponsors) and the Pharmaceutical Benefits Advisory Committee (PBAC), compared to real-world long-term follow-up (LTFU) data.</p><p><strong>Research design and methods: </strong>We reviewed publicly available PBAC summary documents (PSDs) for all funding decisions on pembrolizumab up to November 2022. We included cases with at least three years of follow-up data and where at least 350 patients per year would be treated. We then compared survival predictions from PBAC and Sponsor models to actual survival data at two time points.</p><p><strong>Results: </strong>A total over 38 PSDs covering 15 indications, five met our criteria. Sponsor-preferred models underestimated real survival by 0.54% to 16.45%, while PBAC-preferred models underestimated survival by 1.20% to 24.21%.</p><p><strong>Conclusion: </strong>Results demonstrate that OS extrapolation methods used by both the Sponsor and PBAC tend to underestimate long-term survival outcomes for pembrolizumab indications, with PBAC-preferred methods being more conservative.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1-8"},"PeriodicalIF":1.8,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
New drug accessibility and budgetary impact in South Korea: policy challenges and implications.
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-02 DOI: 10.1080/14737167.2025.2487468
Se-Eun Hwang, Yoon-A Jang, Kyung-Min Lim, Ji-Won Jung, Jong Hyuk Lee
{"title":"New drug accessibility and budgetary impact in South Korea: policy challenges and implications.","authors":"Se-Eun Hwang, Yoon-A Jang, Kyung-Min Lim, Ji-Won Jung, Jong Hyuk Lee","doi":"10.1080/14737167.2025.2487468","DOIUrl":"10.1080/14737167.2025.2487468","url":null,"abstract":"<p><strong>Background: </strong>To compare the accessibility indicators for new drugs in South Korea with those in the United States, Europe, and Japan, and examine the structure of pharmaceutical expenditures in South Korea.</p><p><strong>Research design and methods: </strong>Patient accessibility and budget impacts of new drugs were analyzed using two independent datasets. Accessibility was evaluated for 171 drugs approved between 2013 and 2022 based on reimbursement rates, time to listing post-approval, and international comparisons. Budget impact analysis covered 226 new drugs listed from 2012 to 2021, assessing expenditure patterns with an emphasis on risk-sharing agreements and financial implications for the National Health Insurance budget.</p><p><strong>Results: </strong>Among the 171 new drugs approved between 2013 and 2022, 67.8% were reimbursed as of 1 January 2024. Approval-to-reimbursement timelines varied by drug type and pricing pathway, with drugs listed via the weighted average price pathway receiving faster reimbursement than those evaluated through pharmacoeconomic evaluation. Between 2012 and 2021, new drugs constituted 8.5% of total pharmaceutical expenditures, with oncology drugs incurring the highest annual expenditure per product. Expenditure on new drugs peaked in 2019 but declined thereafter.</p><p><strong>Conclusions: </strong>While South Korea has effectively controlled pharmaceutical expenditures, allocations for new drugs remain low compared to other major countries.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1-9"},"PeriodicalIF":1.8,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical and economic impact analysis of viscosupplementation with hylan G-F 20 versus hyaluronic acids and no viscosupplementation for the treatment of knee osteoarthritis in Colombia. 在哥伦比亚,补充粘胶蛋白g - f20与不补充透明质酸治疗膝关节骨性关节炎的临床和经济影响分析。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2024-12-30 DOI: 10.1080/14737167.2024.2442461
Eliana C Vásquez Melo, Pieralessandro Lasalvia, Lina Maria Gómez Espitia, Luz Karime Osorio Arango, Sergio Londoño, Angie Upegui
{"title":"Clinical and economic impact analysis of viscosupplementation with hylan G-F 20 versus hyaluronic acids and no viscosupplementation for the treatment of knee osteoarthritis in Colombia.","authors":"Eliana C Vásquez Melo, Pieralessandro Lasalvia, Lina Maria Gómez Espitia, Luz Karime Osorio Arango, Sergio Londoño, Angie Upegui","doi":"10.1080/14737167.2024.2442461","DOIUrl":"10.1080/14737167.2024.2442461","url":null,"abstract":"<p><strong>Background: </strong>Viscosupplementation is a viable alternative for managing knee osteoarthritis, showing potential to delay the need for total joint replacement in affected patients.</p><p><strong>Methods: </strong>We constructed an economic model that compared viscosupplementation with hylan G-F 20, with available hyaluronic acids, and no viscosupplementation over a 5-year period, from the perspective of the Colombian general health system. Time until total knee replacement, sourced from published literature, informed the model. Costs, including acquisition, administration, and knee replacement surgery, were sourced from the local drug prices database and the Ministry of Health's integral information system and expressed in USD.</p><p><strong>Results: </strong>Over 5 years, hylan G-F 20 demonstrated a total cost of USD$45,188,523 compared to hyaluronic acids (USD$50,247,826) and no viscosupplementation (USD$27,345,736). Hylan G-F 20 yielded 39,400 total knee replacement-free years, exceeding hyaluronic acid (30,741) and no viscosupplementation (4,280). Cumulative costs per surgery-free patient showed substantial savings, ranging from USD$1,158 to $6,847 for hylan G-F 20, compared to $1,164 to $74,662 for hyaluronic acid and $5,426 to $6,389 for no viscosupplementation.</p><p><strong>Conclusions: </strong>Hylan G-F 20 showed reduced cost per surgery-free patient compared to hyaluronic acids and no viscosupplementation, enhancing knee replacement-free years.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"527-534"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A perspective on the use of patient-reported experience and patient-reported outcome measures in ambulatory healthcare. 关于在门诊医疗中使用患者报告的经验和患者报告的结果措施的观点。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2025-01-17 DOI: 10.1080/14737167.2025.2451749
Ron D Hays, Denise D Quigley
{"title":"A perspective on the use of patient-reported experience and patient-reported outcome measures in ambulatory healthcare.","authors":"Ron D Hays, Denise D Quigley","doi":"10.1080/14737167.2025.2451749","DOIUrl":"10.1080/14737167.2025.2451749","url":null,"abstract":"<p><strong>Introduction: </strong>Patient-reported experience measures (PREMs) are patient reports about their healthcare, whereas patient-reported outcome measures (PROMs) are reports about their functioning and well-being regarding physical, mental, and social health. We provide a perspective on using PREMs and PROMs in ambulatory healthcare.</p><p><strong>Areas covered: </strong>We conducted a narrative review of the literature about using PREMs and PROMs in research and clinical practice, identified challenges and possibilities for addressing them, and provided suggestions for future research and clinical practice.</p><p><strong>Expert opinion: </strong>Substantial progress in using PREMs and PROMs has occurred during the last half-century. Collecting and reporting PREMs to clinicians in ambulatory care settings has improved communication with patients, diagnosis, and treatment, which may improve patients' health. Optimal use requires appropriate data analysis, minimizing implementation barriers, and facilitating interpretation of PREMs and PROMs in clinical practice. Also, formal structures and processes that include patient and family input into care improvement are needed (e.g. patient and family advisory councils as partners in co-design and coproduction of quality improvement). PREMs and PROMs have been used primarily in more affluent countries (e.g. the United States, Australia, United Kingdom, Netherlands, Japan, and Portugal), but this is expected to increase in many countries.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"441-449"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patients' health related quality of life after massive weight loss reconstruction in the Netherlands. 荷兰大规模减重重建后患者的健康相关生活质量。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2024-08-21 DOI: 10.1080/14737167.2024.2393328
Guus van Uittert, Maarten Hoogbergen, Charlotte Beaudart, Nannan Li, Mijke Boers, Mickaël Hiligsmann
{"title":"Patients' health related quality of life after massive weight loss reconstruction in the Netherlands.","authors":"Guus van Uittert, Maarten Hoogbergen, Charlotte Beaudart, Nannan Li, Mijke Boers, Mickaël Hiligsmann","doi":"10.1080/14737167.2024.2393328","DOIUrl":"10.1080/14737167.2024.2393328","url":null,"abstract":"<p><strong>Objectives: </strong>The present study aimed to evaluate the impact of undergoing massive weight loss reconstruction (MWR) on health-related quality of life (HR-QoL) in the Netherlands.</p><p><strong>Method: </strong>A retrospective study was performed among 131 Dutch bariatric patients, divided into two groups: an intervention group (93 patients who had undergone MWR) and a control group (38 patients who had not undergone MWR). HR-QoL was assessed by the validated BODY-q questionnaire. The sign test was used to measure the difference between the 0 and 12 months' measurements of HR-QoL in both groups, whereas multiple regression analysis was conducted to assess whether undergoing MWR significantly predicted participants' incremental HR-QoL.</p><p><strong>Results: </strong>Whereas the intervention group showed a significance improvement on all parameters of the BODY-q between 0 and 12 months (all parameters <i>p</i> < .001), the control group did not. The multiple regression analysis showed that having undergone a MWR significantly and positively predicted incremental HR-QoL on all scales on the BODY-q (all parameters <i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>The present study suggests a positive impact of MWR on the HR-QoL of bariatric patients.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"517-526"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Disparities in Respiratory Syncytial Virus Risk Factors, Diagnosis, and Outcomes in Adults by Race, Ethnicity, and Other Social Determinants of Health in the United States. 美国成人呼吸道合胞病毒危险因素、诊断和结局的差异,按种族、民族和其他健康社会决定因素划分
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2024-12-24 DOI: 10.1080/14737167.2024.2441867
Emily K Horn, Elizabeth M La, Meryem Bektas, Shahnaz Khan, Susan I Gerber
{"title":"Disparities in Respiratory Syncytial Virus Risk Factors, Diagnosis, and Outcomes in Adults by Race, Ethnicity, and Other Social Determinants of Health in the United States.","authors":"Emily K Horn, Elizabeth M La, Meryem Bektas, Shahnaz Khan, Susan I Gerber","doi":"10.1080/14737167.2024.2441867","DOIUrl":"10.1080/14737167.2024.2441867","url":null,"abstract":"<p><strong>Introduction: </strong>Respiratory syncytial virus (RSV) vaccination could improve health equity by protecting individuals who are disproportionally at increased risk of RSV infection and severe RSV-related outcomes. However, limited information is available about RSV-related disparities among United States (US) adults.</p><p><strong>Areas covered: </strong>We reviewed US-specific literature regarding disparities across adult populations in having risk factors for severe RSV disease (cardiopulmonary disease, diabetes, liver disease, kidney disease). We summarize available evidence regarding disparities in having or being diagnosed with RSV, as well as experiencing severe RSV-related health outcomes. Disparities are analyzed by race, ethnicity, socioeconomic status, and other social determinants of health.</p><p><strong>Expert opinion: </strong>RSV-related disparities are observed across all outcomes of interest, although RSV-specific data are limited in some cases. Racial and ethnic minority groups and socioeconomically disadvantaged populations are more likely to have risk factors for severe RSV disease, overall and at younger ages, yet individuals from these groups are more often underdiagnosed. Disparities in RSV-related hospitalizations, emergency department visits, and deaths are observed, especially among adults from racial and ethnic minority groups, of lower socioeconomic status, and in poorer or more crowded neighborhoods. Findings highlight the importance of RSV vaccination among these groups to improve health equity.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"459-471"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-effectiveness of toripalimab plus chemotherapy versus chemotherapy as first-line treatment for advanced non-small cell lung cancer in China: a societal perspective. 托帕利单抗联合化疗与化疗作为一线治疗晚期非小细胞肺癌在中国的成本效益:社会视角
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2025-01-15 DOI: 10.1080/14737167.2025.2451748
Dai Lian, Yi Yang, Yuling Gan, Dunming Xiao, Yuliang Xiang, Shan Jiang, Yuanyuan Gu, Yingyao Chen
{"title":"Cost-effectiveness of toripalimab plus chemotherapy versus chemotherapy as first-line treatment for advanced non-small cell lung cancer in China: a societal perspective.","authors":"Dai Lian, Yi Yang, Yuling Gan, Dunming Xiao, Yuliang Xiang, Shan Jiang, Yuanyuan Gu, Yingyao Chen","doi":"10.1080/14737167.2025.2451748","DOIUrl":"10.1080/14737167.2025.2451748","url":null,"abstract":"<p><strong>Background: </strong>To investigate the cost-effectiveness of toripalimab plus chemotherapy versus chemotherapy alone for advanced non-small cell lung cancer (NSCLC) patients from a societal perspective.</p><p><strong>Methods: </strong>A partitioned-survival model estimated the costs and cost-effectiveness of toripalimab plus chemotherapy versus standard chemotherapy for advanced NSCLC over 20 years. Clinical data were derived from the CHOICE-01 trial, and cost and utility inputs were gathered from Yaozh.com, expert interviews, and a nationwide hospital-based survey. Costs were reported in 2022 US dollars, and outcomes included quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs), with a 5% discount rate was applied. Sensitivity, subgroup, and scenario analyses verified the robustness of results.</p><p><strong>Results: </strong>Toripalimab plus chemotherapy resulted in 3.048 QALYs and a total cost of $60,813, with an ICER of $19,066 per QALY gained, below China's 3 times GDP per capita threshold ($38,223). Robustness is confirmed through sensitivity, subgroup and scenario analyses.</p><p><strong>Conclusions: </strong>Toripalimab plus chemotherapy is a cost-effective option for treatment-naive advanced NSCLC compared to chemotherapy alone, providing valuable evidence for clinical and reimbursement decision-making.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"587-596"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142947062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reimagining pharmacoeconomics in the age of artificial intelligence: opportunities, challenges, and future directions. 重新构想人工智能时代的药物经济学:机遇、挑战和未来方向。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2024-12-19 DOI: 10.1080/14737167.2024.2442466
Majid Ali
{"title":"Reimagining pharmacoeconomics in the age of artificial intelligence: opportunities, challenges, and future directions.","authors":"Majid Ali","doi":"10.1080/14737167.2024.2442466","DOIUrl":"10.1080/14737167.2024.2442466","url":null,"abstract":"","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"433-436"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medication adherence in rheumatoid arthritis: implications for cardiovascular disease risk and strategies to address in U.S. veterans. 类风湿关节炎的药物依从性:对美国退伍军人心血管疾病风险和策略的影响
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2025-01-20 DOI: 10.1080/14737167.2025.2451141
Isaac D Smith, Bryant R England, Neha J Pagidipati, Hayden Bosworth
{"title":"Medication adherence in rheumatoid arthritis: implications for cardiovascular disease risk and strategies to address in U.S. veterans.","authors":"Isaac D Smith, Bryant R England, Neha J Pagidipati, Hayden Bosworth","doi":"10.1080/14737167.2025.2451141","DOIUrl":"10.1080/14737167.2025.2451141","url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) is a systemic inflammatory disease associated with an increased risk of cardiovascular disease (CVD) and premature mortality. The risk of CVD is closely associated with RA disease activity, and achieving RA remission using disease-modifying anti-rheumatic drugs (DMARDs) can significantly mitigate this risk. However, despite the availability of highly effective DMARDs, many veterans fail to achieve sustained RA remission.</p><p><strong>Areas covered: </strong>We will discuss DMARD adherence in U.S. veterans with RA as it relates to RA disease activity and CVD risk, describe factors associated with DMARD non-adherence in individuals with RA, and discuss intervention strategies to improve DMARD adherence. For this review, the authors performed an extensive literature search using Embase, PubMed, Google Scholar, MEDLINE, Cochrane Library, Web of Science, and Duke University library resources.</p><p><strong>Expert opinion: </strong>Barriers to DMARD adherence in veterans with RA are multifactorial and include patient-related factors, systemic barriers, and suboptimal adherence screening practices. Additional research is needed to create validated screening tools for DMARD adherence, train rheumatology providers on how to assess DMARD adherence, develop effective interventions to promote veteran self-efficacy in DMARD management, and to learn how to sustainably utilize multidisciplinary resources to support DMARD adherence in veterans with RA.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"473-485"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142947064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Methodological standards for comparative effectiveness research: considerations for evidentiary review for medicare drug price negotiation. 比较有效性研究的方法标准:对医疗保险药品价格谈判证据审查的考虑。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-04-01 Epub Date: 2025-01-17 DOI: 10.1080/14737167.2025.2453503
Riddhi Doshi, Victoria Divino, Luke Greenwalt, Mitchell DeKoven
{"title":"Methodological standards for comparative effectiveness research: considerations for evidentiary review for medicare drug price negotiation.","authors":"Riddhi Doshi, Victoria Divino, Luke Greenwalt, Mitchell DeKoven","doi":"10.1080/14737167.2025.2453503","DOIUrl":"10.1080/14737167.2025.2453503","url":null,"abstract":"<p><strong>Introduction: </strong>The 2022 Inflation Reduction Act is expected to result in lower drug prices for Medicare beneficiaries in the United States (US). The Centers for Medicare & Medicaid Services (CMS) released the most recent draft guidance for the medicare drug price negotiation (DPN) program in May 2024.</p><p><strong>Areas covered: </strong>In August 2023, the list of 10 drugs selected for the DPN were published and the first round of negotiations are now complete. While the latest CMS guidance highlights the importance of considering study limitations, bias, uncertainty, and generalizability, there were scarce methodological guidelines provided for the comparative effectiveness research studies. We conducted searches on PubMed and reviewed resources from websites of regulatory authorities.</p><p><strong>Expert opinion: </strong>Broader domains of data quality, transparency, and methodology including study design, outcomes assessment, bias, confounding and uncertainty should be considered when developing methodological guidelines for evidence submitted for DPN. There is opportunity to align with and leverage existing guidelines published by federal and non-federal organizations in the US and globally while customizing the new guidance based on the specific requirements of DPN, keeping in mind CMS's interest in specific populations as well as health equity.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"451-457"},"PeriodicalIF":1.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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