Expert Review of Pharmacoeconomics & Outcomes Research最新文献

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The cost-utility analysis of adding ocrelizumab to the treatment plan for primary progressive multiple sclerosis in Iran. 在伊朗原发性进展型多发性硬化症治疗方案中加入奥克立珠单抗的成本效用分析。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-01-01 Epub Date: 2024-08-08 DOI: 10.1080/14737167.2024.2388818
Ali Darvishi, Ramin Abdi Dezfouli, Zohreh Ghasemian, Ali Akbari Sari, Mohammad Hossein Harirchian, Rajabali Daroudi
{"title":"The cost-utility analysis of adding ocrelizumab to the treatment plan for primary progressive multiple sclerosis in Iran.","authors":"Ali Darvishi, Ramin Abdi Dezfouli, Zohreh Ghasemian, Ali Akbari Sari, Mohammad Hossein Harirchian, Rajabali Daroudi","doi":"10.1080/14737167.2024.2388818","DOIUrl":"10.1080/14737167.2024.2388818","url":null,"abstract":"<p><strong>Background: </strong>This study evaluates the cost-effectiveness of adding ocrelizumab to supportive care for primary progressive multiple sclerosis (PPMS) in Iran.</p><p><strong>Research design and methods: </strong>Using a lifetime horizon from the payer's perspective, we developed a decision analytic model with Expanded Disability Status Scales (EDSS) as Markov health states while taking transition probabilities and treatment effects into account. Data were sourced from clinical trials and other literature. The target population was PPMS patients receiving either supportive care or ocrelizumab. We assessed cost- effectiveness through total costs, quality-adjusted life-years (QALYs), and the incremental cost- effectiveness ratio (ICER). Sensitivity analyses addressed uncertainties.</p><p><strong>Results: </strong>The addition of ocrelizumab to supportive care provided an incremental gain of 0.89 QALYs and an additional cost of US$76,771.34, resulting in an ICER of US$86,220.35 compared to supportive care, which is 5.2 times Iran's GDP per capita (US$16,557). Thus, ocrelizumab is not cost-effective at the threshold of one time GDP per capita. However, the probability of cost-effectiveness increases at higher thresholds. Sensitivity analyses confirmed the robustness of the results.</p><p><strong>Conclusion: </strong>While ocrelizumab is not cost-effective at the threshold of one-time GDP per capita, its clinical benefits are significant. Formulating healthcare policies for high-cost medications with low alternatives like ocrelizumab is essential.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"71-80"},"PeriodicalIF":1.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878555","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
Budget impact and cost per responder analysis of upadacitinib for the treatment of moderate to severe atopic dermatitis from the perspective of the social security and the private sector in Argentina. 从阿根廷社会保障和私营部门的角度分析奥达帕替尼治疗中重度特应性皮炎的预算影响和每应答者成本。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-01-01 Epub Date: 2024-08-30 DOI: 10.1080/14737167.2024.2394124
Natalia Espinola, Federico Rodríguez Cairoli, Carlos Rojas-Roque, Paula Carolina Luna, Diego Kanevsky, Valeria Migliazza, Andrés Pichon-Riviere
{"title":"Budget impact and cost per responder analysis of upadacitinib for the treatment of moderate to severe atopic dermatitis from the perspective of the social security and the private sector in Argentina.","authors":"Natalia Espinola, Federico Rodríguez Cairoli, Carlos Rojas-Roque, Paula Carolina Luna, Diego Kanevsky, Valeria Migliazza, Andrés Pichon-Riviere","doi":"10.1080/14737167.2024.2394124","DOIUrl":"10.1080/14737167.2024.2394124","url":null,"abstract":"<p><strong>Objectives: </strong>Our study assessed the budget impact and cost per responder of upadacitinib15mg and 30 mg for moderate to severe atopic dermatitis (MS-AD) treatment from social security and private health sector perspective in Argentina.</p><p><strong>Methods: </strong>A budget impact model was adapted to depict clinical and economic aspects of treatment over a 5-years horizon time. Scenario analyses and deterministic sensitivity analyses were performed. A 16-weeks cost per responder model was adapted based on a network meta-analysis. Primary analyses assessed the cost per Eczema Area and Severity Index 50, 75 and 90 at week 16.</p><p><strong>Results: </strong>The inclusion of upadacitinib 15 mg and 30 mg in the biological treatment mix for MS-AD was associated with an average budget saving per-member per-month ofU$S0.062 (social security) and U$S0.064 (private sector). Percentage of patients with access to treatment, acquisition cost of upadacitinib 30 mg and prevalence of MS-AD were the most influential parameters in the budget impact results. At week 16, upadacitinib 30 mg was associated with the lowest number needed to treat and the lowest cost per responder for all outcomes.</p><p><strong>Conclusion: </strong>The introduction of upadacitinib in MS-AD treatment was associated with modest savings for the social security and private payer budget in Argentina.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"101-111"},"PeriodicalIF":1.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035576","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
Acceptability and willingness to pay for a hypothetical HIV vaccine in Brazil and the implications: a cross-sectional study. 巴西对假定的艾滋病疫苗的接受度和支付意愿及其影响:一项横断面研究。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-01-01 Epub Date: 2024-07-26 DOI: 10.1080/14737167.2024.2384543
Vinícius Gonçalves Nogueira, Edna Afonso Reis, Brian Godman, Antony Paul Martin, Isabella Piassi Dias Godói
{"title":"Acceptability and willingness to pay for a hypothetical HIV vaccine in Brazil and the implications: a cross-sectional study.","authors":"Vinícius Gonçalves Nogueira, Edna Afonso Reis, Brian Godman, Antony Paul Martin, Isabella Piassi Dias Godói","doi":"10.1080/14737167.2024.2384543","DOIUrl":"10.1080/14737167.2024.2384543","url":null,"abstract":"<p><strong>Introduction: </strong>The Human Immunodeficiency Virus (HIV) is one of the greatest public health challenges still facing communities worldwide, and until this moment, no vaccine is available for its prevention. In Brazil, the Rio de Janeiro State has stood out regarding the prevalence of this disease. As a result, an important state to consider the Willingness to Pay (WTP) for a hypothetical HIV vaccine to help with future pricing.</p><p><strong>Methods: </strong>A cross-sectional study was conducted to assess the acceptability and WTP of individuals from Rio de Janeiro State for a hypothetical HIV vaccine with a 70% efficacy.</p><p><strong>Results: </strong>600 individuals were interviewed and the acceptability for this hypothetical vaccine was 77.2%. In addition, 452 participants were eligible for the WTP analysis and would accept a WTP US$79.37 (400 BRL) for this vaccine, a higher value than that found in another study (200 BRL) conducted in the Northern region of Brazil under the same methodological conditions.</p><p><strong>Conclusion: </strong>Economic studies such as WTP can contribute to discussions regarding the prices and specifications for future vaccines, particularly for a HIV vaccine in countries such as Brazil with over 5,000 municipalities spread across regions with diverse characteristics and challenges in terms of socioeconomic, epidemiological and cultural differences.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"91-100"},"PeriodicalIF":1.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758090","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
Burden of non-motor symptoms of Parkinson's disease: cost-of-illness and quality-of-life estimates through a scoping review. 帕金森病非运动症状的负担:通过范围审查估算疾病成本和生活质量。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2025-01-01 Epub Date: 2024-08-19 DOI: 10.1080/14737167.2024.2390042
Frank van der Meer, Jesper Jorgensen, Mickael Hiligsmann
{"title":"Burden of non-motor symptoms of Parkinson's disease: cost-of-illness and quality-of-life estimates through a scoping review.","authors":"Frank van der Meer, Jesper Jorgensen, Mickael Hiligsmann","doi":"10.1080/14737167.2024.2390042","DOIUrl":"10.1080/14737167.2024.2390042","url":null,"abstract":"<p><strong>Introduction: </strong>Parkinson's Disease (PD) is a progressive, chronic neurodegenerative disease, representing significant economic and social burdens. It is typically defined by motor symptoms (MSs), however, this does not reflect the full patient burden. Non-motor symptoms (NMSs) are increasingly recognized as central characteristics of PD. However, they still lack recognition in research. Therefore, this study aims to identify relevant NMSs, their prevalence, and the effect they have on Quality-of-Life (QoL) and Cost-of-Illness (COI). Secondly, it aims to identify gaps in the current body of knowledge and propose possible ways future research could bridge those gaps.</p><p><strong>Methods: </strong>The study employed a scoping review, identifying 60 records for inclusion, using PubMed and Web of Science. It included studies from Spain or Italy, including data on People with Parkinson's Disease. A comparative analysis was performed using Microsoft Excel.</p><p><strong>Results: </strong>It showed that the body of evidence relevant to NMSs, their prevalence, QoL, and COI is limited, or that estimates vary to an extent where interpretation is difficult.</p><p><strong>Conclusion: </strong>Most studies suffer from generalization, representation, and standardization issues, stemming from their designs and methodological decisions. Although the findings of this study should be interpreted with caution, several recommendations are made for future research.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"17-27"},"PeriodicalIF":1.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975487","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
Is the shift in treatment patterns towards new, more expensive drugs still driving the increase in pharmaceutical expenditure? A decomposition analysis of expenditure data in Sweden 1990-2022. 治疗模式转向新的、更昂贵的药物是否仍在推动药品支出的增加?1990-2022年瑞典支出数据的分解分析。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-12-18 DOI: 10.1080/14737167.2024.2439482
Marie-Catherine Schaller, Ulf-G Gerdtham, Johan Jarl
{"title":"Is the shift in treatment patterns towards new, more expensive drugs still driving the increase in pharmaceutical expenditure? A decomposition analysis of expenditure data in Sweden 1990-2022.","authors":"Marie-Catherine Schaller, Ulf-G Gerdtham, Johan Jarl","doi":"10.1080/14737167.2024.2439482","DOIUrl":"10.1080/14737167.2024.2439482","url":null,"abstract":"<p><strong>Background: </strong>Pharmaceutical expenditures (PE) are increasing worldwide, raising concerns about sustainability. However, the current price index provides an incomplete picture of this trend due to the rapid introduction of new drugs on the market.</p><p><strong>Objective: </strong>The aim of this study is to decompose PE into their components and investigate the development in Sweden from 1990 to 2022.</p><p><strong>Methods: </strong>The PE index was broken down into separate indices for price, quantity, and a residual. The residual reflects changes in expenditure driven by shifts in drug treatment patterns.</p><p><strong>Results: </strong>PE increased by 227% during the study period. The decomposition showed that this increase was mainly driven by the residual (215%). Drug quantity increased by 105%, while the relative prices decreased by 50%. When dividing the whole study period into three 11-year-subperiods, the increase in real drug expenditure, drug quantity, and the residual was the highest from 1990 to 2000.</p><p><strong>Conclusions: </strong>The finding that the residual is the main driver indicates that the increase in PE is due to the introduction of and shift to more expensive pharmaceutical treatments, while existing treatments tend to become cheaper. Further research is needed to determine whether newer, more expensive drugs are indeed worth the extra cost.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1-10"},"PeriodicalIF":1.8,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794407","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
Economic cost of hemodialysis and peritoneal dialysis under public-private partnership in a public tertiary care centre of Puducherry, India. 印度普杜切里公立三级保健中心公私伙伴关系下血液透析和腹膜透析的经济成本。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-12-18 DOI: 10.1080/14737167.2024.2439515
Vanjavakam Sahithya, Parthibane Sivanantham, Jeyanthi Anandraj, Sreejith Parameswaran, Sitanshu Sekhar Kar
{"title":"Economic cost of hemodialysis and peritoneal dialysis under public-private partnership in a public tertiary care centre of Puducherry, India.","authors":"Vanjavakam Sahithya, Parthibane Sivanantham, Jeyanthi Anandraj, Sreejith Parameswaran, Sitanshu Sekhar Kar","doi":"10.1080/14737167.2024.2439515","DOIUrl":"10.1080/14737167.2024.2439515","url":null,"abstract":"<p><strong>Background: </strong>India faces over 220 000 lakh new kidney failure cases annually, requiring approximately 34 million dialysis sessions, creating a significant economic burden on the healthcare system. This study estimates the costs of providing hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD) under a Public-Private Partnership (PPP) in a tertiary hospital.</p><p><strong>Methods: </strong>Economic health system costs (October 2021-2022) were estimated using a bottom-up approach. Resources consumed were identified, measured, and valued. Capital costs were annualized and discounted at 3%. Sensitivity analysis assessed the impact of variations in input costs.</p><p><strong>Results: </strong>The total annual economic cost for HD (<i>n</i> = 103) under PPP was INR 32 611 618 (USD 393 432), and for CAPD (<i>n</i> = 12) was INR 4 103 781 (USD 49 509). The annual cost per beneficiary for HD and CAPD was INR 316 618 (USD 3820) and INR 341 979 (USD 4126), respectively. Unit cost per HD session was INR 1856 (USD 22) and per CAPD exchange was INR 323 (USD 4).</p><p><strong>Conclusion: </strong>This study provides detailed costs of HD and CAPD services under PPP, offering insights for expanding dialysis services under the Pradhan Mantri National Dialysis Programme and supporting cost-effectiveness analysis for resource allocation.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1-7"},"PeriodicalIF":1.8,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794401","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 studies of brexu-cel for relapsed/refractory B-cell acute lymphoblastic leukemia and mantle cell lymphoma: a systematic review. brexus -Cell治疗复发/难治性b细胞急性淋巴细胞白血病和套细胞淋巴瘤的成本-效果研究:一项系统综述。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-12-13 DOI: 10.1080/14737167.2024.2438631
Asmita Priyadarshini Khatiwada, Ahmed Mostafa Ahmed Kamel, Nathorn Chaiyakunapruk, Surachat Ngorsuraches
{"title":"Cost-effectiveness studies of brexu-cel for relapsed/refractory B-cell acute lymphoblastic leukemia and mantle cell lymphoma: a systematic review.","authors":"Asmita Priyadarshini Khatiwada, Ahmed Mostafa Ahmed Kamel, Nathorn Chaiyakunapruk, Surachat Ngorsuraches","doi":"10.1080/14737167.2024.2438631","DOIUrl":"10.1080/14737167.2024.2438631","url":null,"abstract":"<p><strong>Introduction: </strong>This systematic review aims to explore the existing evidence on the cost-effectiveness of brexu-cel across different international jurisdictions.</p><p><strong>Methods: </strong>A systematic search of articles on Embase, Medline, Econlit, Web of Science, Scopus, gray literature, and a manual search of HTA reports was done until 24 June 2024. Original English articles and reports from different countries assessing the cost-effectiveness of brexu-cel in relapsed/refractory acute lymphoblastic leukemia (R/R ALL) and mantle cell lymphoma (R/R MCL) were included. This review was registered in the Open Science Framework (OSF) registry.</p><p><strong>Results: </strong>Of the 149 records, 22 articles underwent full-text review after the title and abstract screening, five met the inclusion criteria along with seven HTA reports from Australia, Canada, Scotland, and England. The CEA studies were from the US, England, Canada, and Italy, with varying perspectives, mainly adopting a partitioned survival model and lifetime horizons. The model input data from the ZUMA-2 and ZUMA-3 trials were used for brexu-cel, with comparisons from their respective trials or literature.</p><p><strong>Conclusion: </strong>Brexu-cel was found cost-effective in all the CEA studies and an HTA report from Scotland, but the other HTA agencies reported uncertainties around the cost-effectiveness of brexu-cel for R/R ALL and R/R MCL.</p><p><strong>Registration: </strong>Open Science Framework. (Reg doi: https://doi.org/10.17605/OSF.IO/JZU6Y).</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1-13"},"PeriodicalIF":1.8,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779730","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
Valuing quality of life for economic evaluations in cancer: navigating multiple methods. 癌症经济评估中的生活质量估价:驾驭多种方法。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-12-01 Epub Date: 2024-08-20 DOI: 10.1080/14737167.2024.2393332
Carrie-Anne Ng, Richard De Abreu Lourenco, Rosalie Viney, Richard Norman, Madeleine T King, Nancy Kim, Brendan Mulhern
{"title":"Valuing quality of life for economic evaluations in cancer: navigating multiple methods.","authors":"Carrie-Anne Ng, Richard De Abreu Lourenco, Rosalie Viney, Richard Norman, Madeleine T King, Nancy Kim, Brendan Mulhern","doi":"10.1080/14737167.2024.2393332","DOIUrl":"10.1080/14737167.2024.2393332","url":null,"abstract":"<p><strong>Introduction: </strong>Utility values offer a quantitative means to evaluate the impact of novel cancer treatments on patients' quality of life (QoL). However, the multiple methods available for valuing QoL present challenges in selecting the most appropriate method across different contexts.</p><p><strong>Areas covered: </strong>This review provides cancer clinicians and researchers with an overview of methods to value QoL for economic evaluations, including standalone and derived preference-based measures (PBMs) and direct preference elicitation methods. Recent developments are described, including the comparative performance of cancer-specific PBMs versus generic PBMs, measurement of outcomes beyond health-related QoL, and increased use of discrete choice experiments to elicit preferences. Recommendations and considerations are provided to guide the choice of method for cancer research.</p><p><strong>Expert opinion: </strong>We foresee continued adoption of the QLU-C10D and FACT-8D in cancer clinical trials given the extensive use of the EORTC QLQ-C30 and FACT-G in cancer research. While these cancer-specific PBMs offer the convenience of eliciting utility values without needing a standalone PBM, researchers should consider potential limitations if they intend to substitute them for generic PBMs. As the field advances, there is a greater need for consensus on the approach to selection and integration of various methods in cancer clinical trials.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1101-1114"},"PeriodicalIF":1.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141999675","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
Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review. 对高风险医疗器械上市后证据生成方案的监管观点:系统综述。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-12-01 DOI: 10.1080/14737167.2024.2431234
Jesús Aranda, Agnieszka Dobrzynska, Maria Piedad Rosario-Lozano, Juan Carlos Rejón-Parrilla, David Epstein, Juan Antonio Blasco-Amaro
{"title":"Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review.","authors":"Jesús Aranda, Agnieszka Dobrzynska, Maria Piedad Rosario-Lozano, Juan Carlos Rejón-Parrilla, David Epstein, Juan Antonio Blasco-Amaro","doi":"10.1080/14737167.2024.2431234","DOIUrl":"https://doi.org/10.1080/14737167.2024.2431234","url":null,"abstract":"<p><strong>Introduction: </strong>The new European Medical Device Regulation has raised the bar for the clinical evaluation of medical devices to gain marketing authorization by Notified Bodies (NBs) regarding certificates of conformity in Europe. Restrictions applied for High-risk medical devices (HRMD) may require further evidence generation. Some other jurisdictions apply similar schemes that may be useful to the European Union. This systematic review focused on extracting lessons from similar schemes worldwide to the European context.</p><p><strong>Methods: </strong>A systematic review of peer-reviewed and gray literature was performed based on 'Device approval' and 'conditional approval' keywords. Databases such as Medline, Embase, and WoS retrieved documents assessed with the AMSTAR-2 checklist. A descriptive and narrative analysis was conducted detailed in CRD42023431233 - PROSPERO.</p><p><strong>Results: </strong>We obtained eight documents where conditional approvals for High-risk medical devices in the United States of America, China, and Canada were subject to generate further evidence. In Europe, NBs impose restrictions or limitations to certificates of conformity instead.</p><p><strong>Conclusion: </strong>Further development of policies, supporting access to HRMD subject to further evidence generation, would help Europe in further defining the appropriate situations for the application of determined regulatory routes, to enhance access to HRMD with promising evidence and further evidence development.</p><p><strong>Registration: </strong>PROSPERO (CRD42023431233).</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1-15"},"PeriodicalIF":1.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767615","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 dapagliflozin plus standard treatment compared to standard therapy for the management of chronic kidney disease in Colombia. 在哥伦比亚,达帕格列净加用标准疗法与标准疗法治疗慢性肾病的成本效益比较。
IF 1.8 4区 医学
Expert Review of Pharmacoeconomics & Outcomes Research Pub Date : 2024-12-01 Epub Date: 2024-07-24 DOI: 10.1080/14737167.2024.2382976
Pieralessandro Lasalvia, Eliana C Vásquez M, Jose Javier Arango Álvarez, Paola Garcia-Padilla
{"title":"Cost-effectiveness of dapagliflozin plus standard treatment compared to standard therapy for the management of chronic kidney disease in Colombia.","authors":"Pieralessandro Lasalvia, Eliana C Vásquez M, Jose Javier Arango Álvarez, Paola Garcia-Padilla","doi":"10.1080/14737167.2024.2382976","DOIUrl":"10.1080/14737167.2024.2382976","url":null,"abstract":"<p><strong>Background: </strong>The DAPA-CKD study showed that dapagliflozin added to standard treatment reduced the risk of chronic kidney disease progression, and death from renal or cardiovascular causes compared to placebo.</p><p><strong>Objective: </strong>Assess the cost-effectiveness of dapagliflozin and standard treatment versus standard treatment alone for chronic kidney disease within the Colombian health system.</p><p><strong>Methods: </strong>We employed a Markov model based on the DAPA-CKD study, tailored to the Colombian scenario. The model forecasted hospitalizations for heart failure, overall and cardiovascular mortality, and chronic kidney disease progression over a 10-year horizon with a 5% discount rate.</p><p><strong>Results: </strong>Dapagliflozin combined with standard treatment is a cost-effective intervention in treating stage 2-4 CKD. In the base case, the ICER was US $5,366, below 1 GDP (US $6.558) per capita. This was consistent in the sensitivity analyses.</p><p><strong>Conclusion: </strong>Our study showed that dapagliflozin, when combined with standard treatment, is cost-effective against standard treatment alone, aligning with Colombia's willingness-to-pay threshold.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"1133-1143"},"PeriodicalIF":1.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751486","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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