Journal of managed care & specialty pharmacy最新文献

{"title":"Capivasertib cost-effectiveness in treating advanced breast cancer: A US health care perspective.","authors":"Chijioke Okeke, Javeria Khalid, J Douglas Thornton, Moosa Tatar","doi":"10.18553/jmcp.2025.31.9.900","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.900","url":null,"abstract":"<p><strong>Background: </strong>Capivasertib has gained US Food and Drug Administration approval in combination with a hormonal-based regimen (eg, fulvestrant) for managing hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer, with results from the CapiTello-291 trial showing Capivasertib plus fulvestrant to have superior efficacy compared with fulvestrant alone.</p><p><strong>Objective: </strong>To examine the cost-effectiveness of capivasertib plus fulvestrant vs fulvestrant alone for treating HR+/HER2- advanced breast cancer in the United States from a payer's perspective.</p><p><strong>Methods: </strong>A Markov model of 708 participants with 3 health states (progression-free, progressive disease, death) from CapiTello-291 trial data was used to compare the costs and efficacy of the two treatment strategies on TreeAge Pro software. This model adopted a willingness-to-pay (WTP) threshold of $100,000 per quality-adjusted life-year (QALY) from a US health care perspective. A 10-year lifetime horizon with a monthly cycle length was used with a 3% discount on costs and utilities derived from previously published resources. To assess our model's uncertainty, multiple one-way sensitivity analyses and probabilistic sensitivity analyses using various distribution ranges of our model parameters were conducted.</p><p><strong>Results: </strong>In the base model, capivasertib plus fulvestrant treatment was expected to generate an incremental 0.62 QALYs at an incremental cost of $79,117.66, which resulted in an incremental cost-effectiveness ratios of $128,283.61/QALY. Our sensitivity analysis shows that at willingness-to-pay levels of $130,000/QALY and $500,100/QALY, the likelihood of capivasertib plus fulvestrant being cost-effective compared with fulvestrant monotherapy was 50% and 100%, respectively.</p><p><strong>Conclusions: </strong>The findings from this study suggest that adding capivasertib to fulvestrant treatment is not cost-effective when compared with fulvestrant alone, from the perspective of the US health care system. Considering the notable therapeutic impact that the inclusion of this medication in standard treatment plans can have, it is necessary to engage in more extensive talks and negotiations over the pricing of this newly approved medication.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"900-908"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AMCP Market Insights: Payer best practices for timely diagnosis and optimal management of idiopathic hypersomnia.","authors":"Bridget Flavin, Denise Wolff, Zachary Contreras, Ryan Haumschild, Diana Kimmel, Michael Kobernick, Farzana Rahman","doi":"10.18553/jmcp.2025.31.9-a.s1","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9-a.s1","url":null,"abstract":"<p><p>Idiopathic hypersomnia (IH) is a chronic, neurologic disorder with a primary symptom of excessive daytime sleepiness. There are challenges to timely, accurate diagnosis of IH and, therefore, to optimal management. To better understand these challenges and identify opportunities, AMCP Market Insights virtually convened an expert panel of managed care stakeholders in April 2024. Key insights from the discussion related to addressing diagnostic challenges in IH, making coverage decisions for medications used in IH, and implementing coverage criteria for medications used in IH. Suggested payer best practices in IH also emerged from the discussion.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9-a Suppl","pages":"S1-S9"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397975/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world costs, treatment patterns, and clinical outcomes associated with treatments for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer.","authors":"Rahul Mudumba, Xiaofan Liu, Ian Davis, John A Romley, Jorge J Nieva","doi":"10.18553/jmcp.2025.31.9.890","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.890","url":null,"abstract":"<p><strong>Background: </strong>Alectinib, brigatinib, and lorlatinib are all preferred first-line (1L) therapies for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in National Comprehensive Cancer Network (NCCN) guidelines. Although clinical trials have demonstrated their efficacy, real-world evidence on treatment patterns, costs, and outcomes may help differentiate these therapies and inform optimal 1L treatment selection in the absence of head-to-head comparisons.</p><p><strong>Objective: </strong>To evaluate real-world outcomes for patients with ALK+ NSCLC receiving 1L ALK tyrosine kinase inhibitors (TKIs), focusing on drug acquisition costs, health care utilization, and clinical outcomes.</p><p><strong>Methods: </strong>This retrospective observational cohort study used data from Optum's deidentified Clinformatics Data Mart Database (2016-2021). Patients were identified using <i>International Classification of Diseases, Tenth Revision</i> codes for lung cancer and ALK TKI pharmacy claims. Eligible patients were aged 18 years, with at least 6 months of continuous enrollment prior to the index date and at least 1 ALK TKI prescription fill. Health care resource utilization (proxied by claim counts) and associated costs (2024 US dollars) were measured per-patient-per-month (PPPM). Time to treatment discontinuation or death (TTD) and overall survival (OS) were assessed using the Kaplan-Meier method.</p><p><strong>Results: </strong>Among 696 patients, the 1L therapy distribution was crizotinib (n = 366), alectinib (n = 267), brigatinib (n = 22), ceritinib (n = 25), and lorlatinib (n = 16). Total PPPM costs were $28,216 (SD: $29,017). Average 30-day supply costs for ALK TKIs were $17,766 (SD: $2,797). Median OS was 25.5 months (95% CI: 21.1-32.5), and median TTD for 1L therapy was 8.0 months (95% CI: 6.4-9.6). Only 24.3% of patients transitioned to another ALK TKI in a second-line (2L) setting, highlighting high discontinuation rates. Alectinib and lorlatinib were the most common 2L therapies.</p><p><strong>Conclusions: </strong>This study highlights the economic burden and variable clinical outcomes among patients with advanced ALK+ NSCLC. These real-world estimates inform cost-effectiveness analyses and clinical decision-making regarding treatment sequencing, particularly given uncertainty surrounding multiple preferred 1L options in clinical guidelines.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"890-899"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Current landscape of US Food and Drug Administration use of expedited regulatory approvals for colorectal cancer care.","authors":"Danea M Horn, Mireille Jacobson, Kathryn A Phillips","doi":"10.18553/jmcp.2025.31.9.929","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.929","url":null,"abstract":"<p><strong>Background: </strong>US Food and Drug Administration (FDA) expedited regulatory pathways (ERPs) accelerate the availability of drugs and diagnostic tests for severe conditions and fill unmet medical needs. ERPs accelerate access to new therapeutics but also increase the uncertainty of the benefits of available treatments.</p><p><strong>Objective: </strong>To examine how ERPs have influenced the landscape of pharmaceutical treatments for colorectal cancer (CRC), one of the most common forms of cancer in the United States.</p><p><strong>Methods: </strong>This cross-sectional study used data from public FDA records on all CRC drug approvals before and after the passage of the FDA Safety and Innovation Act in 2012. Descriptive analyses were performed to characterize FDA approval trends by ERP. Primary outcomes included the number and timing of FDA-approved CRC drugs, the use of ERPs, outstanding postmarketing requirements, and the availability of molecular diagnostic tests associated with these treatments.</p><p><strong>Results: </strong>Of the 24 FDA-approved CRC drugs on the market, 75% were approved through at least 1 ERP. The use of ERPs for FDA approvals increased by 18 percentage points (from 63% to 81%) pre-to-post 2012 or 30% relative to baseline. The most common pathway was Accelerated Approval, which accounted for 72% of ERP-approved drugs. CRC treatments have become increasingly targeted using molecular diagnostics, with 25% of CRC drugs approved before 2012 having associated molecular diagnostics, increasing to 75% after 2012 and 100% after 2018.</p><p><strong>Conclusions: </strong>ERPs have expedited approvals for new and increasingly targeted CRC treatments. All CRC treatments approved through Accelerated Approval or Breakthrough Therapy Designation after 2018 still await confirmatory trial results. These findings highlight the complexity of available drugs and diagnostic tests and the challenges facing managed care pharmacists in formulary management, diagnostic test coordination, and the development of utilization criteria given limited long-term clinical evidence.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"929-936"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of a real-time prescription benefit on adherence and utilization of low-cost prescription alternatives for members new to diabetes treatment.","authors":"Elizabeth C S Swart, Jennifer L Nguyen, Samuel K Peasah, Douglas Mager, Urvashi Patel, Chester B Good","doi":"10.18553/jmcp.2025.31.9.862","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.862","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Chronic diseases such as diabetes are a major burden to the US health care system. High medication adherence helps improve diabetes outcomes and reduce cost. Cost of medications can contribute to nonadherence. Use of a formulary decision support system with e-prescribing may be associated with greater use of generic medications, leading to lower costs and better adherence. A real-time prescription benefit (RTPB) solution provides patient-specific drug pricing, benefit information, and therapeutic options to choose the most cost-effective and clinically appropriate treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To examine whether RTPB is associated with increased adherence measured by proportion of days covered, higher utilization of generics, and generic dispensing rate? Is RTPB associated with lower plan and patient out-of-pocket (OOP) per-user per-month costs?&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study used a retrospective, matched intervention-control analysis of commercial health plan members from a large pharmacy benefits manager. Members were eligible for inclusion if they initiated therapy between January and August 2021. Members were excluded if they were not continuously eligible for coverage over the study period. Members who initiated diabetes therapy with a prescriber using RTPB (intervention) were compared with those new to therapy with a prescriber not using RTPB (control). Index date for both samples was the first medication prescription in the index period. Members were matched on age and sex demographics. The evaluation period lasted 12 months after index date. Multivariable linear regression models were used to assess the impact of an RTPB program on adherence and proportion of prescriptions filled with a generic. A generalized linear model (gamma distribution, log link) estimated plan and OOP patient costs, whereas a generalized linear model model with the Poisson distribution was used to estimate the number of controlling for patient age, sex, social determinants of health score, and other patient- and plan-level covariates.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;1,302 matched pairs were included in the analysis. Findings show the proportion of days covered was 68.7% for control and 71.4% for RTPB members (&lt;i&gt;P&lt;/i&gt; &lt; 0.05). The average number of generic prescriptions for control and RTPB samples were 4.06 and 5.66, respectively (&lt;i&gt;P&lt;/i&gt; &lt; 0.05) and the generic dispensing rates were 44.9% and 60.1%, respectively (&lt;i&gt;P&lt;/i&gt; &lt; 0.05). The mean plan cost per member per month for diabetes medications, for the non-RTPB group, was 32.3% higher than the RTPB sample (a difference of $81.69, &lt;i&gt;P&lt;/i&gt; &lt; 0.0001) and the mean patient cost per month was 88.8% higher than the RTPB sample (a difference of $9.71, &lt;i&gt;P&lt;/i&gt; &lt; 0.0001).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Access to RTPB tools provides prescribers with formulary benefit and therapeutic options that allow them to provide the lowest-cost clinical treatment, thu","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"862-867"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Addressing complexity: The development and pilot testing of a user-friendly Medicare Part D patient decision aid tool.","authors":"Devika A Shenoy, Abigail VanLonkhuyzen, Bradley Q Fox, Sabrina M Morales, Sai H Rachakonda, Gina Upchurch, Anna Hung","doi":"10.18553/jmcp.2025.31.9.868","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.868","url":null,"abstract":"<p><strong>Background: </strong>Selecting a Medicare Part D prescription drug plan can be challenging because of limited health insurance literacy and complex plan features. Existing online tools, such as the Medicare Plan Finder (MPF), often lack personalization.</p><p><strong>Objective: </strong>To describe the conceptualization and development of a personalized Medicare Part D decision aid (DA) to supplement the MPF.</p><p><strong>Methods: </strong>A user-centered, iterative design process informed by the Ottawa Decision Support Framework and International Patient Decision Aid Standards was used to develop a DA that helps older adults with Part D plan selection. First, a literature review and 1-hour interviews with Medicare-eligible individuals informed the development of a prototype. These individuals formed a stakeholder advisory board (SAB). The first prototype was then alpha tested with 2 SAB focus groups. Using focus group feedback, the final prototype was developed. Beta testing participants, including Medicare-eligible individuals and Medicare counselors, were recruited and completed an online version of the DA, alongside pre-DA and post-DA questionnaires to examine DA effectiveness using a modified Health Insurance Literacy Measure, a modified System Usability Scale, and a user satisfaction survey.</p><p><strong>Results: </strong>Before the development of the prototype, SAB interviewees (n = 9) suggested that simplified explanations of insurance terminology and side-by-side comparisons of options would be important to the DA. Alpha testing (n = 7) feedback was used to modify the first prototype to improve usability and clarity. Among 25 beta testing participants, Health Insurance Literacy Measure scores increased from 19.76 (SD = 7.15) before using the aid to 24.13 (SD = 4.02) afterward (<i>P</i> = 0.0009). Approximately one-quarter of participants indicated that they would change to a new plan after the tool, whereas half affirmed that the DA validated their existing plan choice.</p><p><strong>Conclusions: </strong>This pilot study shows that a user-centered, interactive DA can improve health insurance literacy and support Medicare Part D plan decisions.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"868-878"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Costs of obesity, obesity-related complications, and weight loss in the United States: A systematic literature review.","authors":"Alison M Bjornson, Shelagh M Szabo, Bonnie M K Donato, Megan Gardner, Effie Kuti","doi":"10.18553/jmcp.2025.25051","DOIUrl":"10.18553/jmcp.2025.25051","url":null,"abstract":"<p><strong>Background: </strong>One hundred million American adults are living with obesity; 75% also have obesity-related complications. Related medical spending exceeds $261 billion dollars. A contemporary synthesis of evidence on the average, per person cost for people living with obesity (PwO) and the impact of obesity-related complications in the United States is lacking.</p><p><strong>Objective: </strong>To summarize estimates of direct medical costs among PwO by obesity severity and presence of obesity-related complications and to characterize the impact of weight loss on direct medical cost savings.</p><p><strong>Methods: </strong>A systematic literature review was implemented in MEDLINE/EMBASE on February 21, 2023, identifying observational studies and economic models published since 2012 reporting on direct medical costs among US PwO. Identified studies were screened; outcomes including all-cause and obesity-specific direct medical costs were extracted. Direct medical costs data were summarized overall, by obesity severity (class I, II, or III), and by the presence of obesity-related complications. Impact on cost savings with weight loss was also summarized. Where possible, comparisons with normal weight cohorts, obesity-related complications subgroups, and treated and untreated groups were explored.</p><p><strong>Results: </strong>From 9,725 records identified, 32 studies (6.0%) were deemed eligible, all reporting all-cause, direct medical cost estimates. For mean costs per person per year (PPPY) by obesity severity (n = 15 studies), findings relative to a normal weight cohort (n = 11 studies) indicated total costs among PwO ranged from 1.1-fold (class I) to 3.3-fold (class III) higher. For costs by the presence of obesity-related complications (n = 7 studies; relative to an \"obesity-only\" group) costs were up to 5-fold greater among PwO with both type 2 diabetes and hypertension. Substantial savings were associated with 5% weight loss over 1 year (n = 5 studies). When costs among PwO using obesity medications (OMs) were compared with those among eligible nonusers (n = 3 studies), in 1 study OM users incurred lower costs than nonusers after 2 years. When mean costs among adults undergoing weight loss surgery were compared with nonsurgery controls (n = 5 studies), there was no associated reduction in cumulative total costs across the study periods.</p><p><strong>Conclusions: </strong>Evidence from this review indicates that direct medical costs among PwO increase with increasing obesity severity and development of obesity-related complications. Although cost savings were observed with 5% weight loss, uncertainty surrounding cost savings accounting for the cost of more recently approved interventions remains. Furthermore, current evidence is lacking, and longitudinal studies considering a wider range and overlap of obesity-related complications are needed to help document and quantify the current direct cost burden of obesity.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"851-861"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Guideline adherence of xanthine oxidase inhibitor utilization to treat gout in primary care.","authors":"Liza W Claus, Madison E Auten, Joseph J Saseen, Sarah J Billups","doi":"10.18553/jmcp.2025.31.9.922","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.922","url":null,"abstract":"<p><strong>Background: </strong>Gouty arthritis affects 3.9% of American adults and can be effectively managed using urate-lowering therapy initiated at a low dose and titrated to achieve a serum urate of less than 6 mg/dL, the \"treat-to-target\" approach. This approach is often underused in primary care (PC) settings.</p><p><strong>Objective: </strong>To identify the proportion of patients newly prescribed a xanthine oxidase inhibitor (XOI) who have their dose titrated to achieve a serum urate (SU) of less than 6 mg/dL.</p><p><strong>Methods: </strong>This retrospective cohort analysis used prescription orders from administrative electronic health record (EHR) databases to identify adult patients with a diagnosis of gout who were newly prescribed an XOI inhibitor by a CU Medicine PC provider. The primary endpoint was the proportion of patients prescribed an XOI who had their dose up-titrated, achieved a target SU of less than 6 mg/dL, or experienced both of these within 6 months of their first XOI prescription date. Additionally, the number of incident gout flares within 12 months was compared between groups stratified by XOI up-titration performed and achievement of SU target, adjusting for confounders using logistic regression.</p><p><strong>Results: </strong>Of 1,600 patients evaluated, 851 met eligibility criteria. Of these, 704 (83%) were male, 649 (76%) were White, and the average age was 59 years. Within 6 months, 179 patients (21%) had their XOI dose up-titrated and 239 (28%) achieved an SU of less than 6 mg/dL; 66 patients (8%) had their XOI dose up-titrated and achieved an SU of less than 6 mg/dL within 6 months. 113 patients experienced gout flare, with SU less than 6 mg/dL associated with lower odds of flare (OR = 0.41, 0.23-0.71).</p><p><strong>Conclusions: </strong>Within a university-based PC population, the proportion of patients newly prescribed an XOI receiving up-titration or achieving SU less than 6 mg/dL within 6 months of medication initiation is low, suggesting that a treat-to-target approach is underused.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"922-927"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of empirical treatment failure on health care resource utilization and costs among female patients with uncomplicated urinary tract infections in a US-based Integrated Health Delivery Network.","authors":"Jeffrey J Ellis, Anushree Iyengar, Hari Bandi, Michiel J M Niesen, Ediz S Calay, Tyler E Wagner, Madison T Preib, Amy G Edgecomb, Meghan E Luck","doi":"10.18553/jmcp.2025.31.9.879","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.9.879","url":null,"abstract":"<p><strong>Background: </strong>Uncomplicated urinary tract infections (uUTIs) are one of the most common outpatient infections in the United States. Despite this, there are limited data on the impact of oral antibiotic treatment failure (TF) on health care resource utilization (HCRU) and costs for patients with empirically treated uUTIs.</p><p><strong>Objective: </strong>To describe all-cause total health care costs in female patients with uUTIs who fail (TF cohort) and who do not fail (no-TF cohort) initial, empirically prescribed, oral antibiotic treatment. Secondary objectives were to describe all-cause HCRU and UTI-related HCRU and costs in the TF cohort and no-TF cohort.</p><p><strong>Methods: </strong>This study used deidentified electronic health record (EHR) data for female patients aged 12 years and older collected from a US Integrated Delivery Network between January 2016 and January 2023. Eligibility criteria included a uUTI outpatient diagnosis, empirical antibiotic prescription within ±5 days of index uUTI diagnosis, and 12 months or more of EHR activity pre-index and post-index. TF was defined as at least 1 of the following within 28 days after the index date (date of first antibiotic treatment within 5 days of first uUTI diagnosis): second oral antibiotic prescription; intravenous antibiotic administration; or emergency department (ED) or inpatient stay with UTI listed as the primary diagnosis (index uUTI excluded). HCRU and costs 12 months post-index were captured by setting of care, with medical and pharmacy cost estimates based on the most recent available Centers for Medicare and Medicaid Services fee schedule reimbursement rates and prescription costs. Propensity score matching (1:1) was used to control for cohort imbalances.</p><p><strong>Results: </strong>Of 28,460 patients with a uUTI diagnosis, 4,330 (15.2%) experienced empirical antibiotic TF. Mean age of matched TF and no-TF patients (3,957 per cohort) was 53 years; 95% and 96%, respectively, were White. During the index uUTI episode, the TF cohort had higher mean total all-cause costs ($1,369 vs $482; <i>P</i> < 0.001) and UTI-related costs ($392 vs $78; <i>P</i> < 0.001) and a higher proportion of the TF cohort compared with the no-TF cohort had all-cause inpatient stays (3.1% vs 0.5%; <i>P</i> < 0.001) and ED visits (19.1% vs 7.6%; <i>P</i> < 0.001). All-cause and UTI-related total costs remained significantly higher in the TF cohort across time intervals during the 12-month post-index period, including the 181 to 365 days interval.</p><p><strong>Conclusions: </strong>Empirical antibiotic TF in female patients with uUTIs results in significantly increased HCRU and costs during the uUTI episode and beyond.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 9","pages":"879-889"},"PeriodicalIF":2.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144957259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world patient profile and step-up dosing process of early initiators of teclistamab for multiple myeloma in US hospitals: An analysis using the Premier Healthcare Database.","authors":"Carlyn Rose Tan, Eric Chinaeke, Nina Kim, Dee Lin, Laura Hester, Jessica Fowler, Dina Gifkins, Sian Walker, Alex Z Fu, Bingcao Wu","doi":"10.18553/jmcp.2025.31.8.772","DOIUrl":"10.18553/jmcp.2025.31.8.772","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Teclistamab is the first-in-class B cell maturation × cluster of differentiation 3 T cell bispecific antibody approved in the United States for relapsed or refractory multiple myeloma (MM). During the first year following US Food and Drug Administration approval, many institutions initiated teclistamab step-up dosing (SUD) in hospital settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To describe patient characteristics, length of hospital stay (LOS) during SUD, and real-world incidence and management of cytokine release syndrome (CRS) among patients with MM who initiated teclistamab in US hospital settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This retrospective observational study used the Premier Healthcare Database and included patients (≥18 years) with confirmed MM who received at least 1 teclistamab administration in a hospital setting between November 1, 2022, and September 21, 2023. We descriptively analyzed characteristics across all patients included as well as SUD patterns, LOS (defined as the time between admission to discharge), and CRS in those who completed SUD. CRS was identified using &lt;i&gt;International Classification of Diseases, Tenth Revision, Clinical Modification&lt;/i&gt; (ICD-10-CM) codes and a symptom- and treatment-based algorithm (the Keating algorithm).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 413 patients were included. The median age (range) of the patients was 69 (32-89) years, 47.5% of patients were aged at least 70 years, and 69.7% had Medicare insurance. Most patients were male (56.4%), White (63.4%), and non-Hispanic (86.0%); 24.2% were Black. Most patients were treated in urban hospitals (96.4%), with 86.7% in teaching hospitals and 90.8% in hospitals with at least 300 beds. At the index hospital encounter, 47.9% of patients presented with anemia, 40.0% with peripheral neuropathy, and 35.8% with renal impairment/failure. Among 302 patients who completed SUD as of the data cutoff, 91.4% completed SUD in a single inpatient admission with a mean LOS of 8.7 days, after omitting extreme outliers; most patients had a 2-day (36.1%) or 3-day (31.1%) interval between SUD doses. CRS, per ICD-10-CM codes, was observed in 31.8% of patients (24.2% grade 1, 4.6% grade 2, and 1.0% grade 3). Per the Keating algorithm, 28.5% of patients experienced CRS-related symptoms, including fever (15.2%) and hypotension (10.3%); most of the events were classified as mild. Most patients with a complete SUD period had documented dexamethasone (97.0%) and acetaminophen (93.7%), 78.5% received diphenhydramine, and 29.8% received tocilizumab at any time during the SUD period.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This large, national, real-world study of patients with MM treated with teclistamab confirmed that early initiators of teclistamab were older adults from diverse racial groups with substantial comorbidities. Despite these factors, most patients were able to safely complete SUD following label-described schedules with manag","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"772-781"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}