{"title":"Health technology assessment reports for oncology medications in Canada from 2018 to 2025: methodological critiques on manufacturers' submissions and a comparison between manufacturers and Canada's Drug Agency (CDA) analyses.","authors":"Sepideh Mardani Jadid, Mobina Dokhaei, Naeemeh Dini, Masoud Tajadod, Dorsa Azizi Khezri, Kimia Hariri, Mitchell Levine, Fatemeh Mirzayeh Fashami","doi":"10.1080/14737167.2026.2632265","DOIUrl":"10.1080/14737167.2026.2632265","url":null,"abstract":"<p><strong>Objective: </strong>Providing an analytical framework to evaluate critiques by Canada's Drug Agency (CDA) and to compare the manufacturers' economic analyses versus CDA's reanalyses for oncology medications.</p><p><strong>Methods: </strong>We reviewed CDA oncology reports from 2018 to 2025. Clinical data and methodological critiques were compared between submissions receiving positive versus negative recommendations.</p><p><strong>Results: </strong>Positive recommendations were significantly more frequent in submissions that included randomized trials (90.1% vs. 61.9%), trials with a control arm (90.8% vs. 65.4%), and trials incorporating phase III or phase IV evidence (79.6% vs. 41.9%) (<i>p</i> < 0.001). Although CDA was generally receptive to indirect treatment comparisons (ITC), studies using naïve ITC (73.0% for naïve ITC vs. 88.1% for others, <i>p</i> = 0.031) or matching-adjusted indirect comparison (MAIC) (75.0% for MAIC vs. 91.2% for other ITCs, <i>p</i> = 0.009) had significantly lower rates of positive recommendations. When comparing submissions with positive versus negative recommendations, certain critiques were significantly more frequent in the latter. These included not having enough evidence available (82.2% vs. 100%, <i>p</i> = 0.011), and using surrogate outcomes (23.9% vs. 51.6%, <i>p</i> = 0.002).</p><p><strong>Conclusion: </strong>Using MAIC or naïve ITC, submitting a dossier that includes limited clinical evidence, and surrogate outcomes are associated with a negative recommendation.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"451-463"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146178553","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}
{"title":"Economic and humanistic burden of chronic liver diseases in the United States.","authors":"Javeria Khalid, Yinan Huang, Rajender R Aparasu","doi":"10.1080/14737167.2026.2634760","DOIUrl":"10.1080/14737167.2026.2634760","url":null,"abstract":"<p><strong>Background: </strong>Little is known about the healthcare burden of Chronic liver disease (CLD) post-introduction of newer antiviral therapies for hepatitis. Therefore, this national study examined healthcare expenditures, productivity loss, and health-related quality of life (HRQoL) of patients with CLD.</p><p><strong>Methods: </strong>This retrospective, cross-sectional analysis utilized the 2014-2021 Medical Expenditure Panel Survey involving patients with CLD ≥18 years. Two-part model was employed to estimate incremental direct medical costs. Multivariable models were used to evaluate missed workdays and HRQoL.</p><p><strong>Results: </strong>Annually, 1.63 million patients (95%CI=1.47-1.81) were diagnosed with CLD, with a prevalence of 0.59%. The mean annual incremental healthcare expenditure attributable to CLD was $11,711 (95%CI=$6,867.048-$16,555.36). Patients with CLD have 0.12 (95%CI=0.09-0.15) more missed workdays, translating into a national productivity loss of $51.6 million. Additionally, HRQoL was significantly lower in CLD patients, with mean differences of -3.72 (95%CI = -4.6 to -2.84) for physical component summary score and -1.83 (95%CI = -2.68 to -0.97) fore mental component summary score.</p><p><strong>Conclusions: </strong>CLD was associated with a significant healthcare burden, as evidenced by healthcare expenditure, productivity loss, and HRQoL. Therefore, concerted efforts are needed to improve the prevention and management of CLD to reduce the disease burden.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"379-387"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146219055","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}
Stijn B Peeters, Frederick W Thielen, Ben F M Wijnen
{"title":"Developing, updating and validating DepMod 2.0: an R-based decision-analytic model for the cost-effectiveness of depression interventions.","authors":"Stijn B Peeters, Frederick W Thielen, Ben F M Wijnen","doi":"10.1080/14737167.2026.2634764","DOIUrl":"10.1080/14737167.2026.2634764","url":null,"abstract":"<p><strong>Background: </strong>Depression imposes a substantial clinical and economic burden, and evaluating the cost-effectiveness of prevention and treatment strategies is essential for informed mental health policy. The original DepMod model was developed to support such evaluations, but evolving evidence and modeling standards have created the need for an updated version.</p><p><strong>Research design and methods: </strong>This study introduces DepMod 2.0, an updated health-economic Markov model for depression. The model was recalibrated using recent epidemiological data on incidence, prevalence, population size, and severity distribution. In addition, DepMod was transitioned from an Excel-based implementation to an open-source R package, providing both a stand-alone R function and an interactive Shiny interface. Model validation includes assessment using the TECH-VER checklist, validation against population-level reference parameters, and comparison with outcomes from the original DepMod model.</p><p><strong>Results: </strong>DepMod 2.0 produced outcomes consistent with published reference values and the original model, supporting its technical validity. Differences observed in prevention scenarios, were attributable to updated epidemiological inputs, including higher prevalence and a greater proportion of severe cases.</p><p><strong>Conclusions: </strong>DepMod 2.0 is an updated and validated R-based model that supports economic evaluation of depression prevention and treatment strategies across diverse healthcare settings.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"443-450"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343921","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}
Aziz Rezapour, Mohsen Rezaeian, Saeed Bagheri Faradonbeh, Mohammad Barzegar, Ali Zareh Askari, Hamid Pourasghari, Mohammad Mehdi Peighambari, Aghdas Souresrafil
{"title":"Economic evaluation of percutaneous patent foramen ovale closure versus medical therapy in patients with a cryptogenic stroke: a systematic review.","authors":"Aziz Rezapour, Mohsen Rezaeian, Saeed Bagheri Faradonbeh, Mohammad Barzegar, Ali Zareh Askari, Hamid Pourasghari, Mohammad Mehdi Peighambari, Aghdas Souresrafil","doi":"10.1080/14737167.2026.2626572","DOIUrl":"10.1080/14737167.2026.2626572","url":null,"abstract":"<p><strong>Introduction: </strong>A patent foramen ovale (PFO) closure reduces the risk of recurrent cryptogenic ischemic strokes in young to middle-aged patients. We aimed to review the studies on the cost-effectiveness of percutaneous closure of a PFO in comparison to medical therapy in the prevention of cryptogenic strokes in patients with a PFO.</p><p><strong>Methods: </strong>This systematic review searched PubMed, EMBASE, Web of Science, Cochrane, and Scopus from 1990 to 2025.</p><p><strong>Results: </strong>Twelve articles qualified for inclusion. Closed PFOs resulted in a quality-of-life gain of 3.25 to 4.55 years for most countries. According to the study, the incremental cost-effectiveness ratio per year of life gained was between $3,882.54 and $248,590. Percutaneous closure of the PFO has been found to be cost-effective compared to medical therapy in most countries, with the exception of Argentina.</p><p><strong>Conclusions: </strong>On the basis of the results of the present study, percutaneous closure of the PFO was cost-effective compared to medical therapy in preventing a cryptogenic stroke in patients with a PFO. A majority of studies were conducted in countries with high incomes. Further studies on the cost-effectiveness of percutaneous closure of the PFO are required in low- and middle-income countries.</p><p><strong>Registration: </strong>PROSPERO (CRD42024544835).</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"339-349"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146112721","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}
Conghui Kou, Huina Wu, Lihui Liu, Xifeng Zhao, Jing Nie
{"title":"Cost-effectiveness analysis of rezivertinib and gefitinib in patients with EGFR-mutated advanced non-small cell lung cancer.","authors":"Conghui Kou, Huina Wu, Lihui Liu, Xifeng Zhao, Jing Nie","doi":"10.1080/14737167.2026.2626573","DOIUrl":"10.1080/14737167.2026.2626573","url":null,"abstract":"<p><strong>Background: </strong>Epidermal growth factor receptor (EGFR) mutations represent the primary driver alterations in advanced non-small cell lung cancer (NSCLC). Rezivertinib has emerged as a promising targeted therapy for EGFR-mutated NSCLC. This study aimed to evaluate the cost-effectiveness of rezivertinib versus gefitinib as first-line treatment in Chinese patients with EGFR-mutated advanced NSCLC.</p><p><strong>Research design and methods: </strong>A cost-effectiveness analysis was conducted using a 10-year Markov model based on data from the REZOR clinical trial (NCT03866499). Primary outcomes included total costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).</p><p><strong>Results: </strong>Rezivertinib demonstrated superior clinical outcomes with a mean QALY of 2.14 compared to 1.79 for gefitinib. However, rezivertinib incurred higher treatment costs ($43390.34 vs $31202.03). The ICER of $35,215.97 per QALY for rezivertinib falls below the willingness-to-pay (WTP) threshold ($40334, three times the per capita GDP), confirming its cost-effectiveness. Sensitivity analysis revealed that rezivertinib had a 71.5% probability of being cost-effective versus 28.5% for gefitinib. Threshold analysis established cost-effective pricing thresholds for rezivertinib ($605.02 at 3×GDP per capita, $408.66 at 1.5×GDP per capita).</p><p><strong>Conclusions: </strong>Rezivertinib demonstrates significantly better cost-effectiveness compared to gefitinib for first-line treatment of EGFR-mutated advanced NSCLC in China.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"389-395"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146104364","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}
André Soares Motta-Santos, Kenya Valéria Micaela de Souza Noronha, Leonardo Costa Ribeiro, Jeffrey Gow, Khorshed Alam, Mônica Viegas Andrade
{"title":"The pharmaceutical market: a transdisciplinary description of concepts and their implications.","authors":"André Soares Motta-Santos, Kenya Valéria Micaela de Souza Noronha, Leonardo Costa Ribeiro, Jeffrey Gow, Khorshed Alam, Mônica Viegas Andrade","doi":"10.1080/14737167.2026.2613683","DOIUrl":"10.1080/14737167.2026.2613683","url":null,"abstract":"<p><strong>Introduction: </strong>The pharmaceutical industry has delivered innovative therapies that substantially improved health outcomes. However, concerns persist regarding high drug prices and delays in the entry of competitors. This article provides a comprehensive and transdisciplinary overview of the pharmaceutical market. References were identified and selected from Medline, Lilacs, Embase, and Google Scholar until thematic saturation. Particular attention is devoted to the market for monoclonal antibodies (mAbs), given their high prices and expanding commercial relevance.</p><p><strong>Areas covered: </strong>The industry is heavily dependent on innovation, with firms investing significant resources in risky R&D and charging high prices for new technologies. Although companies justify elevated prices based on R&D expenditures, additional market dynamics also sustain high pricing. Operating under imperfect competition, pharmaceutical products often exhibit characteristics of merit and credence goods, while practices such as evergreening and reverse payments reinforce market power. Patients' willingness to pay, especially for life-saving treatments, remains high despite limited understanding of expected outcomes due to informational asymmetry.</p><p><strong>Expert opinion: </strong>Drug prices reflect the interaction of market structure, R&D investment, licensing arrangements, and patient behavior. Biopharmaceuticals entail added complexity and cost. Monopolistic or oligopolistic conditions can result in suboptimal pricing and unmet demand, highlighting the need for stronger regulatory oversight.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"325-338"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910605","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}
Emilie Theisen Honore, Thomas Le Fevre, Andrew Pavelyev, Ugne Sabale, Christian Grønhøj, Vincent Daniels
{"title":"Impact of an expanded male catch-up HPV vaccination program on the clinical and economic burden of HPV-associated diseases in Denmark: a modeling study.","authors":"Emilie Theisen Honore, Thomas Le Fevre, Andrew Pavelyev, Ugne Sabale, Christian Grønhøj, Vincent Daniels","doi":"10.1080/14737167.2026.2626567","DOIUrl":"10.1080/14737167.2026.2626567","url":null,"abstract":"<p><strong>Background: </strong>Denmark's publicly funded routine HPV vaccination program has included boys born from 2005 onward, leaving earlier birth cohorts of young men potentially unprotected.</p><p><strong>Methods: </strong>A published deterministic dynamic transmission metapopulation model was adapted to evaluate the impacts of a 3-year male catch-up vaccination program on the cases, deaths, and costs of HPV-associated diseases in Denmark over a 100-year time horizon. Routine gender-neutral HPV vaccination of adolescents with a nonavalent vaccine was modeled with and without a male catch-up program, at 4 catch-up vaccination coverage rates (VCRs) from 40% to 70%.</p><p><strong>Results: </strong>Adding a temporary catch-up program for men born in 1997-2005 was projected to avert 253 HPV-associated cancer cases and 89 deaths at a VCR of 40%. Increasing coverage to 70% was estimated to avert 359 cases and 128 deaths. Catch-up vaccination may be considered cost-effective at all modeled VCRs, with incremental cost-effectiveness ratios of €35,584-35,755 per quality-adjusted life year compared to routine adolescent vaccination alone.</p><p><strong>Conclusions: </strong>Expanding Denmark's male catch-up HPV vaccination program to include all men born in 1997-2005 would reduce the burden of HPV-associated cancers and diseases and may represent a cost-effective public health strategy.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"397-406"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146124286","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}
Doris K Hansen, Xiaoxiao Lu, Omar Castaneda Puglianini, Eileen Zhang, Saad Z Usmani, Rameet Sachdev, Matthew Perciavalle, Denise De Wiest, Stephen Huo, Seina Lee, Zaina P Qureshi, Sundar Jagannath
{"title":"Comparative cost per responder analysis of ciltacabtagene autoleucel and real-world standard of care therapy in patients with lenalidomide-refractory multiple myeloma.","authors":"Doris K Hansen, Xiaoxiao Lu, Omar Castaneda Puglianini, Eileen Zhang, Saad Z Usmani, Rameet Sachdev, Matthew Perciavalle, Denise De Wiest, Stephen Huo, Seina Lee, Zaina P Qureshi, Sundar Jagannath","doi":"10.1080/14737167.2026.2634771","DOIUrl":"10.1080/14737167.2026.2634771","url":null,"abstract":"<p><strong>Background: </strong>Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T-cell therapy currently approved for relapsed/refractory multiple myeloma (RRMM). This study aimed to assess the value of cilta-cel against a real-world standard of care (RW-SoC) basket using a novel cost per responder (CPR) model.</p><p><strong>Research design and methods: </strong>The model was aligned with the patient population in the CARTITUDE-4 trial and incorporated progression-free survival (PFS), post-progression survival (PPS), and death states. The base-case analysis was conducted from a mixed US payer perspective with a 36-month time horizon, and modeled outcomes included the total cost per treated patient, total cost per complete responder, and cost per month during PFS.</p><p><strong>Results: </strong>In the base-case analysis, total cost per treated patient over 36 months was estimated to be lower for cilta-cel ($792,243) compared with RW-SoC ($815,023), with the difference driven predominantly by the lower costs for cilta-cel over the PPS period. Total costs per complete responder and per month during PFS were $1,070,599 and $25,203 for cilta-cel compared with $5,101,186 and $38,018, respectively, for RW-SoC.</p><p><strong>Conclusions: </strong>The CPR model suggests that cilta-cel offers substantial clinical and economic benefit for patients with RRMM compared with RW-SoC therapies.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"369-378"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147282840","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}
Rosa Acevedo Saladín, Sandra Orsini Peña, Pieralessandro Lasalvia
{"title":"Cost consequence minimization and budget impact model for introducing the fully liquid combined acellular hexavalent vaccine into the Dominican Republic's expanded immunization plan.","authors":"Rosa Acevedo Saladín, Sandra Orsini Peña, Pieralessandro Lasalvia","doi":"10.1080/14737167.2025.2610735","DOIUrl":"10.1080/14737167.2025.2610735","url":null,"abstract":"<p><strong>Background: </strong>This study evaluates the economic impact of incorporating a fully liquid combined acellular hexavalent vaccine within Expanded Program on Immunizations (EPI) of the Dominican Republic (DR).</p><p><strong>Research design and methods: </strong>A cost-consequence analysis model was conducted comparing two different vaccination schemes in 1 year. Inputs and costs were extracted from both official and literature sources. Two vaccination schedules were assessed: 3 + 0 and 3 + 1. Additionally, a 5-year budget impact analysis evaluated the implications of introducing the hexavalent vaccine into the EPI. The analysis was performed from both a third-party payer and considering productivity losses. (1 USD = 55.67, 2023).</p><p><strong>Results: </strong>The hexavalent vaccine resulted in an increase in total costs of 43.1% and 57.9% for the 3 + 0 and 3 + 1 scenarios. Vaccine acquisition costs drove this increase. However, adverse events, logistics cost and productivity losses were reduced by 51.87%-74.87%, 38.20%-49.23%, and 28.5%-44.9% (3 + 0-3 + 1) respectively. The budget impact analysis showed an overall budget increase of 61.7% and 80.2% with a 37.5% and 50% reduction in total vaccine doses administered, for the 3 + 0 and 3 + 1 scenarios.</p><p><strong>Conclusion: </strong>The incorporation of the hexavalent vaccine increases spending but reduces adverse events, logistics cost, and productivity losses, supporting modernization of the DR immunization program.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"351-360"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156604","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}
Vijay Kumar Chattu, Anthony Scaffeo, Sujatha Alla, Harini Sriraman
{"title":"How do we approach integrating digital endpoint studies into health technology assessment?","authors":"Vijay Kumar Chattu, Anthony Scaffeo, Sujatha Alla, Harini Sriraman","doi":"10.1080/14737167.2026.2616382","DOIUrl":"10.1080/14737167.2026.2616382","url":null,"abstract":"<p><strong>Introduction: </strong>The integration of digital endpoints into Health Technology Assessment (HTA) marks a significant advancement in modern healthcare evaluation, especially in the context of post-pandemic growth in telehealth and remote patient monitoring.</p><p><strong>Areas covered: </strong>Digital endpoints, which are defined by their use of sensor-generated data collected in non-clinical settings, provide a comprehensive, real-time view of patient health. This enhances the precision of HTA by uncovering nuanced aspects of disease burden and improving the evaluation of health technologies. Examples of digital endpoints include smartphone-based diagnostics for cognitive impairment and wearable devices that measure the impact of diseases, such as nocturnal activity in patients with sickle cell disease. Earlier diagnoses, and cost reductions in drug discovery, their integration into HTA faces challenges- data privacy, standardization, and methodological validation.</p><p><strong>Expert opinion: </strong>This paper explores the potential of digital endpoints to revolutionize HTA by enabling more dynamic and patient-centered evaluations, underscoring the need for established frameworks and standards to guide their effective incorporation. Initiatives such as the Digi-HTA process and the Digital Endpoints Ecosystem and Protocols (DEEP) highlight emerging frameworks that could shape the future of digital health assessments, ultimately enhancing healthcare decision-making and policy. Collaborative efforts across healthcare, technology, and regulatory bodies are essential to overcome these barriers.</p>","PeriodicalId":12244,"journal":{"name":"Expert Review of Pharmacoeconomics & Outcomes Research","volume":" ","pages":"317-324"},"PeriodicalIF":1.5,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145948674","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}