PharmacoEconomics Open最新文献

{"title":"A Cost Evaluation of COVID-19 Remote Home Monitoring Services in England.","authors":"Sonila M Tomini, Efthalia Massou, Nadia E Crellin, Naomi J Fulop, Theo Georghiou, Lauren Herlitz, Ian Litchfield, Pei Li Ng, Chris Sherlaw-Johnson, Manbinder S Sidhu, Holly Walton, Stephen Morris","doi":"10.1007/s41669-024-00498-3","DOIUrl":"10.1007/s41669-024-00498-3","url":null,"abstract":"<p><strong>Background: </strong>Remote home monitoring services emerged as critical components of health care delivery from NHS England during the COVID-19 pandemic, aiming to provide timely interventions and reduce health care system burden. Two types of service were offered: referral by community health services to home-based care to ensure the right people were admitted to the hospital at the right time (called COVID Oximetry@home, CO@h); and referral by hospital to support patients' transition from hospital to home (called COVID-19 Virtual Ward, CVW). The information collected for the oxygen levels and other symptoms was provided via digital means (technology-enabled) or over the phone (analogue-only submission mode). This study aimed to evaluate the costs of implementing remote home monitoring for COVID-19 patients across 26 sites in England during wave 2 of the pandemic. Understanding the operational and financial implications of these services from the NHS perspective is essential for effective resource allocation and service planning.</p><p><strong>Methods: </strong>We used a bottom-up costing approach at the intervention level to describe the costs of setting up and running the services. Twenty-six implementation sites reported the numbers of patients and staff involved in the service and other resources used. Descriptive statistics and multivariable regression analysis were used to assess cost variations and quantify the relationship between the number of users and costs while adjusting for other service characteristics.</p><p><strong>Results: </strong>The mean cost per patient monitored was lower in the CO@h service compared with the CVW service (£527 vs £599). The mean cost per patient was lower for implementation sites using technology-enabled and analogue data submission modes compared with implementation sites using analogue-only modes for both CO@h (£515 vs £561) and CVW (£584 vs £612) services. The number of patients enrolled in the services and the service type significantly affected the mean cost per patient.</p><p><strong>Conclusions: </strong>Our analysis provides a framework for evaluating the costs of similar services in the future and shows that the implementation of these services benefit from the employment of tech-enabled data submission modes.</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"739-753"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362405/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477168","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}

{"title":"Cost-Effectiveness of Vedolizumab as a First-Line Advanced Therapy Versus Adalimumab Treatment Sequences for Ulcerative Colitis in Italy.","authors":"Jonathan Salcedo, Daniel Hill-McManus, Chloë Hardern, Oyin Opeifa, Raffaella Viti, Ludovica Siviero, Antonio Saverio Roscini, Gennaro Di Martino","doi":"10.1007/s41669-024-00497-4","DOIUrl":"10.1007/s41669-024-00497-4","url":null,"abstract":"<p><strong>Background: </strong>Today, there are many treatment options available for the management of ulcerative colitis, creating challenges in selecting the most efficacious and cost-effective treatment sequences. Treatments in the anti-tumor necrosis factor alpha (TNFα) therapeutic class, as well as vedolizumab, are widely used and endorsed as first-line options according to treatment guidelines. The aim of this study was to compare treatment sequences involving vedolizumab and the anti-TNFα treatment adalimumab in terms of cost-effectiveness in the treatment of moderately to severely active ulcerative colitis in Italy.</p><p><strong>Methods: </strong>A cost-effectiveness model comparing treatment sequences within the Italian National Health Service in terms of costs and quality-adjusted life years (QALYs) with a lifetime horizon was developed. The analysis focused on the relative positioning of vedolizumab and adalimumab, leveraging the results of the landmark head-to-head VARSITY clinical trial as key inputs. The robustness of the results was investigated through a range of sensitivity and scenario analyses.</p><p><strong>Results: </strong>The strategy of vedolizumab as a first-line advanced therapy followed by adalimumab was associated with higher costs and health benefits compared with first-line adalimumab followed by vedolizumab. The incremental cost-effectiveness ratio was €16,146/QALY, which was found to be robust to changes to inputs associated with areas of high uncertainty.</p><p><strong>Conclusion: </strong>This economic evaluation estimated a 94% probability that vedolizumab as a first-line advanced therapy is cost-effective at a threshold of €33,004/QALY when compared with first-line adalimumab sequences. Using clinical trial evidence to inform the efficacy of second-line treatments estimated that the effectiveness of anti-TNFα treatments is not substantially reduced by vedolizumab exposure.</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"701-714"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141301202","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}

{"title":"Impact of Value-Driven Healthcare Strategies for Biosimilar Adoption: The Singapore Story.","authors":"She Hui Tan, Louise Gek Huang Goh, Benjamin Shao Kiat Ong, Darren Sze Guan Ng, Liang Lin, Raymond Chee Hui Ng, Bernard Yu-Hor Thong, Kwong Ng","doi":"10.1007/s41669-024-00491-w","DOIUrl":"10.1007/s41669-024-00491-w","url":null,"abstract":"<p><strong>Background: </strong>Healthcare sustainability is a global challenge. Various value-driven healthcare strategies have been implemented by Singapore's national health technology assessment (HTA) agency, the Agency for Care Effectiveness (ACE). Considering the high and growing expenditure on biologics, strategies have been implemented to drive the use of biosimilars. As Singapore has reached the 5-year mark since the subsidy listing of the first monoclonal antibody biosimilar infliximab, this review aimed to evaluate the impact of these strategies on the changes in adoption rates, utilisation, spending and cost savings for biosimilars in the public healthcare sector.</p><p><strong>Methods: </strong>A retrospective cross-sectional study was conducted using aggregated drug utilisation data from all public healthcare institutions. Five monoclonal antibodies with biosimilars, namely infliximab, adalimumab, trastuzumab, rituximab and bevacizumab, were included in this study. The outcomes evaluated were the monthly trends for utilisation volume, proportion attributed to biosimilar use, and drug spending up to December 2022. The simulated cost savings associated with biosimilar adoption were also reported.</p><p><strong>Results: </strong>After subsidy implementation, an upward trend in biosimilar use and proportion attributed to biosimilar adoption was observed, while spending reduced substantially. The adoption rate of most biosimilars reached more than 95% within 1 year of listing. Drugs with more than one approved biosimilar brand at the time of subsidy listing reported substantial price reductions of over 80%. Overall, spending for the five monoclonal antibodies have significantly reduced after biosimilar subsidy listing, with an estimated cumulative cost savings of $136 million over 5 years.</p><p><strong>Conclusion: </strong>Value-driven healthcare strategies implemented in Singapore's public healthcare institutions have contributed to high adoption rates of biosimilars and have improved affordable access through lower treatment costs. This in turn has led to significant cost savings to the healthcare system.</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"679-688"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362392/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748761","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}

{"title":"NICE's Pathways Pilot: Pursuing Good Decision Making in Difficult Circumstances.","authors":"Dawn Lee, Darren Burns, Ed Wilson","doi":"10.1007/s41669-024-00490-x","DOIUrl":"10.1007/s41669-024-00490-x","url":null,"abstract":"","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"645-649"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140868456","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}

{"title":"Psychometric Properties of the EQ-5D-5L in Patients with Alopecia Areata.","authors":"Andrew Lloyd, Daniel Aggio, Caleb Dixon, Ernest H Law, Thomas Price","doi":"10.1007/s41669-024-00504-8","DOIUrl":"10.1007/s41669-024-00504-8","url":null,"abstract":"<p><strong>Background: </strong>For many decision makers in Health Technology Assessment the EQ-5D-5L is the standard measure of health-related quality of life (HRQL). However, evidence has shown the limitations of the measure in certain disease areas, including dermatology. Alopecia areata (AA) is associated with a significant HRQL impact, partly due to the emotional impact of hair loss.</p><p><strong>Objectives: </strong>This study explores the psychometric properties of the EQ-5D-5L in people with AA in reference to the short-form 36 version 2 (SF-36v2), the Alopecia Areata Patient Priority Outcomes (AAPPO), the Severity of Alopecia Tool (SALT) and the Patient Global Impressions of Change (PGI-C).</p><p><strong>Methods: </strong>Data from participants with AA enrolled in the ALLEGRO-2b/3 trial (NCT03732807) of ritlecitinib were analysed. Participants completed the AAPPO measure (an AA-specific measure assessing emotional symptoms and activity limitations), PGI-C, EQ-5D-5L and SF-36v2 across 48-weeks of follow up. Extent of scalp hair loss was assessed using the SALT. Ceiling effects, known groups validity, convergent validity and responsiveness were examined. Known groups were defined by SALT score and a PGI-C defined response from baseline. Exploratory factor analysis was also performed.</p><p><strong>Results: </strong>Data were available from 612 adult participants. Ceiling effects were observed for the EQ-5D-5L (55.3-61.2%) and analyses suggested that the EQ-5D did not capture important differences between patients that the SF-36v2 did. The EQ-5D-5L very weakly correlated with SALT score, whereas the AAPPO correlated more strongly with the extent of hair loss. Compared with the EQ-5D-5L, the AAPPO was better able to discriminate between known groups defined by SALT and PGI-C. An exploratory factor analysis suggested that the EQ-5D-5L had limitations in content validity compared with the AAPPO.</p><p><strong>Conclusions: </strong>The EQ-5D-5L may not adequately measure the burden of AA on patients' HRQL. Insensitivity to the burden of AA suggests that the EQ-5D-5L may not measure treatment-related benefit with hair regrowth. Data from other measures could be considered if they are shown to be more relevant.</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"715-725"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141538330","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}

{"title":"ENTIMOS: Decision Support Tool Highlights Potential Impact of Non-intravenous Therapies for Multiple Sclerosis on Patient Care via Clinical Scenario Simulation.","authors":"Richard Nicholas, Erik Scalfaro, Rachel Dorsey, Zuzanna Angehrn, Judit Banhazi, Roisin Brennan, Nicholas Adlard","doi":"10.1007/s41669-024-00493-8","DOIUrl":"10.1007/s41669-024-00493-8","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Administration of intravenous (IV), high-efficacy treatments (HETs) for the treatment of multiple sclerosis (MS) poses a high resourcing and planning burden on infusion centres, resulting in treatment delays that may increase the risk of breakthrough disease activity. Simulation tools can be used to systematically analyse capacity scenarios and identify and better understand constraints, therefore enabling decision-makers to optimise patient care. We have previously applied ENTIMOS, a discrete event simulation model, to assess scenarios of patient flow and care delivery using real-life data inputs from the neurology infusion suite at Charing Cross Hospital London. The model predicted that, given current capacity and projected demand, patients would experience high-risk treatment delays within 30 months.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to address key healthcare challenges for MS patient care management as seen from a neurologist's perspective. We used ENTIMOS to predict the impact of several distinct and clinically plausible scenarios on patient waiting times at the same MS infusion suite and to quantify mitigation strategies needed to assure continuity of care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We used real-world experience of an expert neurologist to identify five clinical scenarios: (1) switching patients to a subcutaneous (SC) MS treatment of the same therapeutic agent, in the same hospital setting; (2) extending opening times to the weekend; (3) reducing the number of infusion chairs (to simulate social distancing measures applied during the coronavirus disease 2019 [COVID-19] pandemic); (4) increasing demand for infusions; and (5) increasing the scheduling approval time. Patient waiting time for next due infusion and time to high-risk treatment delays (≥ 30 days) were the main analysed model outputs. Previously published base case results were used as reference. All hypothetical scenarios were run over a 3-year horizon (with the exception of scenario 1, which was run over a 3- and 5-year horizon). Strategies to mitigate treatment delays were analysed and discussed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Switching 50% of patients to SC treatment of the same therapeutic agent administered in hospital postponed the predicted high-risk treatment delays to shortly beyond the 3-year simulation timeframe (month 38). Weekend opening reduced waiting times from 20 days to 4 days and prevented treatment delays, however, at elevated labour costs. Reducing the infusion chairs increased waiting time to 53 days on average and 86 days at the end of the simulation, leading to high-risk treatment delays within 6 months. An increased demand for infusions increased waiting time to 26 days on average and 47 days at the end of the simulation, leading to high-risk treatment delays within 22 months. Prolonged scheduling approval time did not reduce the waiting time, nor postpone the high-risk treatment delays.&lt;/p&gt;&lt;p&gt;&lt;stro","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"755-764"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141580453","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}

{"title":"Budget Impact Analysis of Olaparib for the Management of Patients with Homologous Recombination Repair (HRR)-Mutated Castration-Resistant Metastatic Prostate Cancer in Argentina.","authors":"Natalia Espinola, Constanza Silvestrini, Carla Colaci, Daniela Sugg, Carlos Rojas-Roque, Jesica Coelli, Federico Augustovski","doi":"10.1007/s41669-024-00508-4","DOIUrl":"10.1007/s41669-024-00508-4","url":null,"abstract":"<p><strong>Objectives: </strong>The aim of this study was to perform a budget impact analysis (BIA) of introducing olaparib treatment for adult patients with metastatic castration-resistant prostate cancer in Argentina.</p><p><strong>Methods: </strong>A BIA model was used to estimate the cost difference between the current scenario (without olaparib) and the new scenario (incorporation of olaparib) for a third-party payer over a 5-year time horizon. The budgetary impact is estimated at the national health system level and by healthcare sectors in Argentina. Input parameters were obtained from the literature and validated by local expert opinion. Direct medical costs were obtained from both the Institute for Clinical Effectiveness and Health Policy (IECS) unit cost database and public data in Argentina. The microcosting estimation was used for key variables of the analysis. All costs are reported in US dollars (US$) as for October 2022 (1 US$ = 152.59 Argentine pesos). One-way sensitivity analyses and scenario analyses were conducted to evaluate the model robustness.</p><p><strong>Results: </strong>The incorporation of olaparib, with a wholesale price per pack of US$3176, was associated with a weighted average of the budget impact per member per month (PMPM) of US$0.0191 for the national health system, being slightly higher than the estimated budgeted high impact threshold (US$0.0153). The PMPM budget impact for a 5-year average ranged between US$0.007 (public sector) and US$0.033 (private sector). The duration of treatment with olaparib was the most influential parameter in the budget impact results.</p><p><strong>Conclusions: </strong>The introduction of olaparib for the treatment of metastatic castration-resistant prostate cancer has a high budget impact for Argentina's health system. These findings are informative to support policy decisions aimed to expand the current treatment landscape for prostate cancer.</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"727-738"},"PeriodicalIF":2.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11362395/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601231","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}

{"title":"Whither Decision-Analytic Modelling-Based Economic Evaluation for Health Care Decision Making?","authors":"Rachael Maree Hunter, Matthew Franklin","doi":"10.1007/s41669-024-00492-9","DOIUrl":"10.1007/s41669-024-00492-9","url":null,"abstract":"","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"507-510"},"PeriodicalIF":2.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11252092/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849719","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}

{"title":"Public Health Impact and Cost-Effectiveness Analysis of 4-Component Meningococcal Serotype B Vaccination for Infants in France.","authors":"Gérard de Pouvourville, Manon Breau-Brunel, Véronique Loncle-Provot, Ekkehard Beck, Loïg Gaugain, Gaëlle Nachbaur, Céline Pribil","doi":"10.1007/s41669-024-00488-5","DOIUrl":"10.1007/s41669-024-00488-5","url":null,"abstract":"<p><strong>Background and objectives: </strong>In France, meningococcal serogroup B (MenB) is the most common serogroup causing invasive meningococcal disease (IMD) in infants and young children. Our objective was to illustrate the impact of model choices on health outcomes and the cost-effectiveness of infant vaccination with the multicomponent meningococcal serogroup B vaccine (4CMenB) versus no vaccine in France.</p><p><strong>Methods: </strong>A previously published dynamic transmission-based cost-effectiveness model was adapted for the French context using updated, French-specific demographic, epidemiological, and cost data. IMD incidence and long-term sequelae were derived through analysis of French healthcare and surveillance databases. A collective perspective over a 100-year time horizon was adopted, with a discount rate of 2.5%, reduced to 1.5% after the first 30 years. Deterministic and probabilistic sensitivity and scenario analyses were performed.</p><p><strong>Results: </strong>In the base case analysis, infant vaccination with 4CMenB avoided 3101 MenB IMD cases in infants aged < 1 year (- 54%) and 6845 cases in all age groups (- 21%). The estimated incremental cost-effectiveness ratio was €316,272/quality-adjusted life-year (QALY) but was highly sensitive to the types of sequelae included, MenB incidence, vaccine effectiveness parameters, and consideration of life-expectancy in IMD survivors (range: €65,272/QALY to €493,218/QALY).</p><p><strong>Conclusions: </strong>Using economic models compliant with French methodology guidelines, 4CMenB does not seem cost-effective; however, results are sensitive to model choices and 4CMenB immunization is an effective strategy to prevent MenB IMD cases and to improve quality of life and economic burden associated with MenB IMD treatment, especially with regard to long-term sequelae.</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"539-557"},"PeriodicalIF":2.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11252096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080591","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}

{"title":"A Systematic Review of Health-Related Quality of Life in Women with HER2-Positive Metastatic Breast Cancer Treated with Trastuzumab.","authors":"Sudewi Mukaromah Khoirunnisa, Fithria Dyah Ayu Suryanegara, Lisa Aniek de Jong, Didik Setiawan, Maarten Jacobus Postma","doi":"10.1007/s41669-024-00478-7","DOIUrl":"10.1007/s41669-024-00478-7","url":null,"abstract":"<p><strong>Background: </strong>Many trials of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer treatment with trastuzumab have provided evidence of improved clinical outcomes. This systematic review examined how a regimen that includes trastuzumab affects patients' health-related quality of life (HRQoL) during and after treatment.</p><p><strong>Methods: </strong>A systematic search for articles published up to February 2023 without restrictions of language or publication year was performed using the Pubmed, Embase, and Scopus databases. We included studies of women aged > 18 years with metastatic HER2-positive breast cancer treated with a trastuzumab-containing regimen. We assessed the quality of the studies using the Cochrane Risk of Bias (RoB) tool (2.0) for randomized controlled trials (RCTs) and the Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I) tool for cross-sectional studies. We used Microsoft Excel to extract and synthesize data, and documented the review procedure following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.</p><p><strong>Results: </strong>In total, eight studies compared 1104 trastuzumab-treated patients and 1003 non-trastuzumab-treated patients. Most studies were RCTs (n = 7) and one was a prospective observational study. All the included studies used the EORTC-QLQ-C30, EORTC-QLQ-BR23, FACT-B, or FACT-G questionnaires. During treatment, patients taking regimens that included trastuzumab showed clinical improvement in HRQoL, social functioning, and role functioning. After the treatment, patients' HRQoL profiles in the trastuzumab and chemotherapy arms were similar. However, trastuzumab (versus chemotherapy) treatment led to clinically improved functional status, role and physical functioning, and fatigue. The quality assessment revealed some concerns in most RCTs, with the risk of bias being high in two studies, low in one study, and moderate in the cross-sectional study.</p><p><strong>Conclusions: </strong>Trastuzumab-containing regimens administered to HER2-positive breast cancer patients at the metastatic stage evidenced beneficial effects on total HRQoL during and after treatment. Upon therapy cessation, patients' HRQoL scores for both interventions improved. Nevertheless, HRQoL profiles of patients treated with trastuzumab were more favorable, particularly for functional status, role functioning, physical well-being, and fatigue.</p><p><strong>Clinical trials registration: </strong>This review was registered in PROSPERO (registration number: CRD42021259826).</p>","PeriodicalId":19770,"journal":{"name":"PharmacoEconomics Open","volume":" ","pages":"511-524"},"PeriodicalIF":2.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11252097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140137061","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}