Journal of market access & health policy最新文献

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Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers. 澳大利亚逆行全肩关节置换术的创新技术:对患者、决策者和制造商的市场准入挑战和影响。
Journal of market access & health policy Pub Date : 2023-01-01 DOI: 10.1080/20016689.2022.2154420
Mutsa Gumbie, Michelle Costa, Michael Erb, Gnanadarsha Dissanayake
{"title":"Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers.","authors":"Mutsa Gumbie,&nbsp;Michelle Costa,&nbsp;Michael Erb,&nbsp;Gnanadarsha Dissanayake","doi":"10.1080/20016689.2022.2154420","DOIUrl":"https://doi.org/10.1080/20016689.2022.2154420","url":null,"abstract":"<p><strong>Purpose: </strong>The success of reverse total shoulder arthroplasty (RTSA) has expanded its use for a broader range of shoulder indications worldwide. Evidence regarding the relative efficacy and long-term safety of medical technologies used in RTSA is subjected to rigorous assessment. Nonetheless, substantial challenges impede market access for innovative shoulder implant technologies for RTSA in Australia, resulting in delayed patient access.</p><p><strong>Approach: </strong>This paper addresses the key challenges associated with generating evidence for the health technology assessments of innovative medical technologies for RTSA that are required for access to the Australian market. The transition to value-based care requires establishing a benchmarking reference that incorporates patient-reported outcome measures (PROMs) and combines revision outcomes with additional clinical outcomes to increase patient cohort sizes. Establishing the benchmark would require agreement on the outcome measures to be collected for each indication, and investment in reporting patient-reported outcomes for RTSA to the national orthopaedic registry.</p><p><strong>Implications for practice: </strong>The need for increased flexibility in developing evidence for health technology assessment of RTSA medical technologies is required. Optimised approaches for benchmarking RTSA require extensive stakeholder discussions, including the agreement on evidence requirements and follow-up periods, selection of clinical outcomes, as well as pre-operative and post-operative PROMs as a value assessment.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"11 1","pages":"2154420"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/78/51/ZJMA_11_2154420.PMC9731581.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10332679","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}
引用次数: 0
Patient perceptions of copay card utilization and policies. 患者对共同支付卡使用和政策的看法。
Journal of market access & health policy Pub Date : 2023-01-01 DOI: 10.1080/20016689.2023.2254586
Dimika Cavalier, Bridget Doherty, Gabrielle Geonnotti, Aarti Patel, Wesley Peters, Steven Zona, Lisa Shea
{"title":"Patient perceptions of copay card utilization and policies.","authors":"Dimika Cavalier,&nbsp;Bridget Doherty,&nbsp;Gabrielle Geonnotti,&nbsp;Aarti Patel,&nbsp;Wesley Peters,&nbsp;Steven Zona,&nbsp;Lisa Shea","doi":"10.1080/20016689.2023.2254586","DOIUrl":"https://doi.org/10.1080/20016689.2023.2254586","url":null,"abstract":"<p><strong>Background: </strong>Copay cards are intended to mitigate patient out-of-pocket (OOP) expenses. This qualitative, exploratory focus group study aimed to capture patient perceptions of copay cards and copay adjustment programs (CAPs; insurers' accumulator and maximizer policies), which redirect the copay card utilization benefits intended for patients' OOP expenses.</p><p><strong>Methods: </strong>Patients with chronic conditions were recruited through Janssen's Patient Engagement Research Council program. They completed a survey and attended a live virtual session to provide feedback on copay cards.</p><p><strong>Results: </strong>Among 33 participants (median age, 49 years [range, 24-78]), the most frequent conditions were cardiovascular-metabolic disease and inflammatory bowel disease. Patients associated copay cards with lessening financial burden, improving general and mental health, and enabling medication adherence. An impact on medication adherence was identified by 10 (63%) White and nine (100%) Black respondents. Some patients were unaware of CAPs despite having encountered them; they recommended greater copay card education and transparency about CAPs.</p><p><strong>Conclusion: </strong>Patients relied on copay cards to help afford their prescribed medication OOP expenses and maintain medication adherence. Use of CAPs may increase patient OOP expenses. Patients would benefit from awareness programs and industry - healthcare provider partnerships that facilitate and ensure access to copay cards.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"11 1","pages":"2254586"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/71/29/ZJMA_11_2254586.PMC10486291.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10570326","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}
引用次数: 0
Machine-learning prediction for hospital length of stay using a French medico-administrative database. 使用法国医疗管理数据库对住院时间进行机器学习预测。
Journal of market access & health policy Pub Date : 2022-11-26 eCollection Date: 2023-01-01 DOI: 10.1080/20016689.2022.2149318
Franck Jaotombo, Vanessa Pauly, Guillaume Fond, Veronica Orleans, Pascal Auquier, Badih Ghattas, Laurent Boyer
{"title":"Machine-learning prediction for hospital length of stay using a French medico-administrative database.","authors":"Franck Jaotombo,&nbsp;Vanessa Pauly,&nbsp;Guillaume Fond,&nbsp;Veronica Orleans,&nbsp;Pascal Auquier,&nbsp;Badih Ghattas,&nbsp;Laurent Boyer","doi":"10.1080/20016689.2022.2149318","DOIUrl":"https://doi.org/10.1080/20016689.2022.2149318","url":null,"abstract":"<p><strong>Introduction: </strong>Prolonged Hospital Length of Stay (PLOS) is an indicator of deteriorated efficiency in Quality of Care. One goal of public health management is to reduce PLOS by identifying its most relevant predictors. The objective of this study is to explore Machine Learning (ML) models that best predict PLOS.</p><p><strong>Methods: </strong>Our dataset was collected from the French Medico-Administrative database (PMSI) as a retrospective cohort study of all discharges in the year 2015 from a large university hospital in France (APHM). The study outcomes were LOS transformed into a binary variable (long vs. short LOS) according to the 90<sup>th</sup> percentile (14 days). Logistic regression (LR), classification and regression trees (CART), random forest (RF), gradient boosting (GB) and neural networks (NN) were applied to the collected data. The predictive performance of the models was evaluated using the area under the ROC curve (AUC).</p><p><strong>Results: </strong>Our analysis included 73,182 hospitalizations, of which 7,341 (10.0%) led to PLOS. The GB classifier was the most performant model with the highest AUC (0.810), superior to all the other models (all p-values <0.0001). The performance of the RF, GB and NN models (AUC ranged from 0.808 to 0.810) was superior to that of the LR model (AUC = 0.795); all p-values <0.0001. In contrast, LR was superior to CART (AUC = 0.786), p < 0.0001. The variable most predictive of the PLOS was the destination of the patient after hospitalization to other institutions. The typical clinical profile of these patients (17.5% of the sample) was the elderly patient, admitted in emergency, for a trauma, a neurological or a cardiovascular pathology, more often institutionalized, with more comorbidities notably mental health problems, dementia and hemiplegia.</p><p><strong>Discussion: </strong>The integration of ML, particularly the GB algorithm, may be useful for health-care professionals and bed managers to better identify patients at risk of PLOS. These findings underscore the need to strengthen hospitals through targeted allocation to meet the needs of an aging population.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2149318"},"PeriodicalIF":0.0,"publicationDate":"2022-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/49/3d/ZJMA_11_2149318.PMC9707380.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40548582","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}
引用次数: 1
Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars. 国际协调理事会(ICH)生物仿制药批准指南提案。
Journal of market access & health policy Pub Date : 2022-11-17 eCollection Date: 2023-01-01 DOI: 10.1080/20016689.2022.2147286
Sarfaraz K Niazi, Waleed Mohammed Al-Shaqha, Zafar Mirza
{"title":"Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars.","authors":"Sarfaraz K Niazi,&nbsp;Waleed Mohammed Al-Shaqha,&nbsp;Zafar Mirza","doi":"10.1080/20016689.2022.2147286","DOIUrl":"https://doi.org/10.1080/20016689.2022.2147286","url":null,"abstract":"<p><strong>Objectives: </strong>Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an independent, non-profit association under Swiss law, will significantly enhance the affordability of biological drugs.</p><p><strong>Methods: </strong>Regulatory guidelines from the Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and World Health Organization (WHO) were analyzed for historical changes and elements critical to the safety and efficacy of biosimilars.</p><p><strong>Results: </strong>Analysis of all EMA and FDA filings show that none of the animal testing and clinical efficacy testing failed because animals do not have the required receptors to initiate pharmacologic responses, and efficacy studies cannot be statistically powered to conclude any results. New analytical technologies will enable good biosimilarity determination, avoiding both tests.</p><p><strong>Conclusion: </strong>Scientifically based ICH guidelines that remove redundant studies will reduce development costs, improve safety, and allow global drug distribution based on single compliance. These guidelines are particularly necessary for emerging countries lacking the expertise and resources to evaluate biosimilar filings.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2147286"},"PeriodicalIF":0.0,"publicationDate":"2022-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/61/1b/ZJMA_11_2147286.PMC9677983.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40483713","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}
引用次数: 1
Impact of the COVID-19 pandemic on the conduct of clinical trials: a quantitative analysis. COVID-19大流行对临床试验开展的影响:定量分析
Journal of market access & health policy Pub Date : 2022-08-09 eCollection Date: 2022-01-01 DOI: 10.1080/20016689.2022.2106627
Wojciech Margas, Piotr Wojciechowski, Mondher Toumi
{"title":"Impact of the COVID-19 pandemic on the conduct of clinical trials: a quantitative analysis.","authors":"Wojciech Margas,&nbsp;Piotr Wojciechowski,&nbsp;Mondher Toumi","doi":"10.1080/20016689.2022.2106627","DOIUrl":"https://doi.org/10.1080/20016689.2022.2106627","url":null,"abstract":"<p><strong>Background: </strong>Globally, healthcare has shouldered much of the socioeconomic brunt of the COVID-19 pandemic leading to numerous clinical trials suspended or discontinued.</p><p><strong>Objective: </strong>To estimate the COVID-19 impact on the number of clinical trials worldwide.</p><p><strong>Methods: </strong>Data deposited by 219 countries in the ClinicalTrials.gov database (2007-2020) were interrogated using targeted queries. A time series model was fitted to the data for studies ongoing, initiated, or ended between 2007 Quarter (Q) 1 and 2019 Q4 to predict the expected trials number in 2020 in the COVID-19 absence. The predicted values were compared with the actual 2020 data to quantify the pandemic impact.</p><p><strong>Results: </strong>The ongoing registered trials number grew from 2007 Q1 (33,739) to 2019 Q4 (80,319). By contrast, there were markedly fewer ongoing trials in all four quarters of 2020 compared with forecasted values (1.6%-2.8% decrease). When excluding COVID-19-related studies, this disparity grew further (3.4%-5.8% decrease), to a peak of almost 5,000 fewer ongoing trials than estimated for 2020 Q2. The initiated non-COVID-19 trials number was higher than predicted in 2020 Q4 (9.9%).</p><p><strong>Conclusions: </strong>This pandemic has impacted clinical trials. Provided that current trends persist, clinical trial activities may soon recover to at least pre-COVID-19 levels.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2106627"},"PeriodicalIF":0.0,"publicationDate":"2022-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5e/80/ZJMA_10_2106627.PMC9367669.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40629559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Systematic literature review on the implicit factors influencing the HTA deliberative process in Europe. 关于影响欧洲 HTA 审议过程的隐含因素的系统文献综述。
Journal of market access & health policy Pub Date : 2022-06-28 eCollection Date: 2022-01-01 DOI: 10.1080/20016689.2022.2094047
Clara Monleón, Hans-Martin Späth, Carlos Crespo, Claude Dussart, Mondher Toumi
{"title":"Systematic literature review on the implicit factors influencing the HTA deliberative process in Europe.","authors":"Clara Monleón, Hans-Martin Späth, Carlos Crespo, Claude Dussart, Mondher Toumi","doi":"10.1080/20016689.2022.2094047","DOIUrl":"10.1080/20016689.2022.2094047","url":null,"abstract":"<p><strong>Objectives: </strong>Deliberative processes in Health Technologies Assessment (HTA) result in recommendations that determine the reimbursement of medicines, diagnostics or devices. These processes are governed by explicit criteria, but are also influenced by implicit factors. The objective of this work was to identify the implicit factors influencing HTA deliberative processes in five European countries (France, Germany, Italy, Spain and the UK).</p><p><strong>Methods: </strong>A systematic review of literature published between 2009 and 2019 was conducted. The search was performed in Pubmed, The Cochrane Database of Systematic Reviews, Google Scholar and Center for Reviews and Dissemination. The ISPOR database was searched manually.</p><p><strong>Results: </strong>Out of 100 eligible publications, eight articles were selected for data extraction and analysis. The implicit factors in the HTA deliberative process most frequently mentioned in the identified literature are value judgments, biases, preferences and subjectivity. Five out of the eight articles highlight the need to further improve the transparency of the process, and three provide recommendations on how to address the influence of implicit factors on the HTA deliberative process through a framework.</p><p><strong>Conclusion: </strong>Even in countries with a long HTA history, evidence on implicit factors is scarce. Some methods have been recommended for addressing these factors. Further research is required to characterize the implicit factors in the HTA deliberative process at a country level and explore potential ways to mitigate the influence of these factors on the HTA deliberative process.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":"2094047"},"PeriodicalIF":0.0,"publicationDate":"2022-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ef/ee/ZJMA_10_2094047.PMC9267410.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40488927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Public health impact of COVID-19 in French ambulatory patients with at least one risk factor for severe disease COVID-19对至少有一种严重疾病危险因素的法国门诊患者的公共卫生影响
Journal of market access & health policy Pub Date : 2022-06-10 DOI: 10.1080/20016689.2022.2082646
A. Millier, R. Supiot, K. Benyounes, V. Machuron, K. Le lay, M. Sivignon, C. Leboucher, C. Blein, F. Raffi
{"title":"Public health impact of COVID-19 in French ambulatory patients with at least one risk factor for severe disease","authors":"A. Millier, R. Supiot, K. Benyounes, V. Machuron, K. Le lay, M. Sivignon, C. Leboucher, C. Blein, F. Raffi","doi":"10.1080/20016689.2022.2082646","DOIUrl":"https://doi.org/10.1080/20016689.2022.2082646","url":null,"abstract":"ABSTRACT Background Quantification of COVID-19 burden may be useful to support the future allocation of resources. Objective To evaluate the public health impact of COVID-19 in French ambulatory patients with at least one risk factor for severe disease. Study design A Markov model was used to estimate life years, costs, number of hospitalisations, number of deaths and long/prolonged COVID forms over a time horizon of 2 years. The hospitalisation probabilities were derived from an early access cohort, and the hospitalisation stay characteristics were derived from the French national hospital discharge database. Several scenario analyses were conducted. Results The number of hospitalisations reached 256 per 1,000 patients over the acute phase (first month of simulation), and 382 per 1,000 patients over 2 years. The number of deaths was 37 per 1,000 patients, and the number of long/prolonged COVID forms reached 407 per 1,000 patients. These translated into a reduction of 0.7 days of life per patient in the first month, with an associated cost of €1,578, and a reduction of 27 days of life over the time horizon, with an associated cost of €4,280. The highest burden was observed for patients over 80 years old, and those not vaccinated. The scenarios with a less severe situation or new treatments available showed a non-negligible burden reduction. Conclusion This study allowed us to quantify the considerable burden related to COVID-19 in infected patients, with at least one risk factor for severe form. Strategies with the ability to substantially reduce this burden in France are urgently required.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48514010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost comparison of adverse event management among breast and ovarian cancer patients treated with poly (ADP-ribose) polymerase inhibitors: analysis based on phase 3 clinical trials 多(ADP-核糖)聚合酶抑制剂治疗癌症患者不良事件管理的成本比较:基于3期临床试验的分析
Journal of market access & health policy Pub Date : 2022-06-08 DOI: 10.1080/20016689.2022.2078474
L. Fan, Yuanyuan Zhang, Peter Maguire, D. Muston, M. Monberg, J. R. Earla, A. Mihai, P. Gulati
{"title":"Cost comparison of adverse event management among breast and ovarian cancer patients treated with poly (ADP-ribose) polymerase inhibitors: analysis based on phase 3 clinical trials","authors":"L. Fan, Yuanyuan Zhang, Peter Maguire, D. Muston, M. Monberg, J. R. Earla, A. Mihai, P. Gulati","doi":"10.1080/20016689.2022.2078474","DOIUrl":"https://doi.org/10.1080/20016689.2022.2078474","url":null,"abstract":"ABSTRACT Background The economic impact of adverse events (AEs) for poly (ADP-ribose) polymerase inhibitors (PARPis) in ovarian or breast cancer has not been widely evaluated. Objective Compare PARPi-related AE management costs from a US payer perspective. Methods The frequency of treatment-related grade 3–4 AEs was obtained from published clinical trials of PARPis for the treatment of advanced ovarian cancer (AOC), platinum-sensitive recurrent ovarian cancer (PSROC), and metastatic breast cancer (MBC). AE management costs per patient (2020 USD) per treatment course were calculated by multiplying the AE unit costs by the frequency of AEs for each arm of each trial. Sensitivity analyses were conducted according to the lower and upper limits of the 95% confidence interval for AE rates and unit costs, respectively. Scenarios were also performed to explore the uncertainty of outcomes. Results Total AE management costs in AOC were: $3,904, olaparib; $5,595, olaparib plus bevacizumab; and $12,215, niraparib. In PSROC, total costs were: $3,894, olaparib; $6,001, rucaparib; and $11,492, niraparib, and in MBC: $3,574, olaparib; and $9,489, talazoparib. Hematological toxicities were the key drivers of AE management costs for PARPis. Conclusions The main AEs among PARPis were hematological. Olaparib was associated with lower AE costs compared to other PARPis.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46438093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
An integrated valuation model for payer and investor 付款人和投资者的综合估值模型
Journal of market access & health policy Pub Date : 2022-05-29 DOI: 10.1080/20016689.2022.2080631
M. Nuijten, S. Capri
{"title":"An integrated valuation model for payer and investor","authors":"M. Nuijten, S. Capri","doi":"10.1080/20016689.2022.2080631","DOIUrl":"https://doi.org/10.1080/20016689.2022.2080631","url":null,"abstract":"ABSTRACT Background In order to optimize positioning and associated drug price for both payer and investor, it is for a company essential to forecast the potential market access attractiveness for the new drug for different indications at the early onset of the clinical development program. This analysis must include the constraints from the perspective of the payer, but also the biotech companies, who require a minimum drug price to satisfy their investors. This paper aims to provide an Integrated Valuation Model for payer and investor, bridging concepts from health economics and economic valuation reflecting the perspectives of the payer and the investor for a drug in early clinical development phase. The concept is illustrated for a new hypothetical drug (Product X) in advanced breast cancer in 1-line, 2-line, and 3-line position. Methods The Integrated Valuation Model includes the outcomes of the budget impact model, pricing matrix model, and cost-effectiveness model reflecting the payer’s perspective. These models are interacted and linked with a discounted cash flow model in order to reflect also the economic value from the investor’s perspective. Results The maximum price in 1-line position is €269.7 for the payer and the minimum price is €14.7 for the investor, which are unit prices per administration corresponding with treatment regimens for the comparative treatments. In 2-line position, the maximum price is €274.1 for the payer and the minimum price for the investor increases to €184.5 for the investor because of the smaller market size in 2-line position, which leads to a smaller pricing corridor to satisfy both payer and investor. Consequently, Product X has market access attractiveness for both payer and investor in 1-line and 2-line position. However, the minimum price €942.7 in 3-line position for the investor is higher than the maximum price €283.3 for the payer, which means there is no market potential. Conclusion The practical strategic application of the Integrated Valuation Model is optimization of positioning and price of Product X. Hence, it can be a transparent tool in early-stage development of a compound based on upfront assessment of market access attractiveness for the payer and the investor.","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42746475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Barriers in precision medicine implementation among Advanced Nonsquamous Cell Lung Cancer-patients: A Real-World Evidence Scenario. 在晚期非鳞状细胞肺癌患者中实施精准医疗的障碍:一个真实世界的证据场景。
Journal of market access & health policy Pub Date : 2022-05-24 eCollection Date: 2022-01-01 DOI: 10.1080/20016689.2022.2077905
Flavia A Duarte, Carlos Gil Ferreira, Rodrigo Dienstmann, Bruno L Ferrari, Matheus Costa E Silva, Pedro Nazareth A Junior, Paulo Guilherme de O Salles, Paulo Henrique C Diniz
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