Carlyn Rose Tan, Eric Chinaeke, Nina Kim, Dee Lin, Laura Hester, Jessica Fowler, Dina Gifkins, Sian Walker, Alex Z Fu, Bingcao Wu
{"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":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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 <i>International Classification of Diseases, Tenth Revision, Clinical Modification</i> (ICD-10-CM) codes and a symptom- and treatment-based algorithm (the Keating algorithm).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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}
Wesley Nuffer, Angela Thompson, Kelly Stenhoff, Mistie Bjork
{"title":"Caring for communities: A 4-year pharmacy partnership focused on diabetes and cardiovascular health.","authors":"Wesley Nuffer, Angela Thompson, Kelly Stenhoff, Mistie Bjork","doi":"10.18553/jmcp.2025.31.8.828","DOIUrl":"10.18553/jmcp.2025.31.8.828","url":null,"abstract":"<p><p>Current community pharmacy practice faces several substantial pressures affecting the business model. Transitioning to a more patient-centered focus and providing additional direct patient care services that will eventually be billed for and reimbursed by third-party payers is a strategy for evolving this practice. This manuscript describes the impact of a 4-year funded project involving a network of independent pharmacies partnering with an academic pharmacy school to implement direct patient care services in diabetes and cardiovascular disease. Eleven independent pharmacies participated in the practice transformation project, receiving direct support from pharmacy faculty to build an infrastructure and begin offering formalized programs for diabetes and cardiovascular disease management. Each pharmacy selected which services they would implement and build across the 4 years. An emphasis was placed on establishing bi-directional communication with medical provider offices and identifying high-risk patients with these disease states to set up monthly meetings to optimize their health. All pharmacies successfully established 1 or more services in the areas of diabetes and/or cardiovascular disease and reported regular communication with local providers to summarize services and discuss specific patient concerns. All pharmacies implemented a blood pressure monitoring service at their location and 9 (82%) successfully provided a self-monitoring blood pressure program. Five pharmacies received accreditation to offer diabetes self-management education services, and 2 pharmacies received recognition to provide the National Diabetes Prevention Program. Seven pharmacies established appointment-based monthly counseling with high-risk patients. Implementation of these services is an important initial step in prioritizing direct patient care in the community pharmacy setting.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"828-834"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698804","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":"Will the emerging private-label market access channel help or hinder biosimilar market access?","authors":"Stanton R Mehr","doi":"10.18553/jmcp.2025.31.8.824","DOIUrl":"10.18553/jmcp.2025.31.8.824","url":null,"abstract":"<p><p>Until April 2024, adalimumab biosimilar uptake remained stagnant at 2% to 3%; the 3 largest pharmacy benefit managers (PBMs), which control 80% of prescriptions dispensed in the United States, maintained the reference product on formulary. That month, a major PBM changed its adalimumab formulary coverage policy, preferring 2 private-label biosimilars and 1 branded biosimilar, while excluding the reference product. The private-label biosimilar approach has since been adopted by the other 2 major PBMs, offering promise for biosimilar uptake, but seemingly only under the terms of the private-label arrangements. These arrangements may pose additional transparency issues for payers and plan sponsors, as well as barriers to biosimilar competition. The concerns raised by the emergence of the private-label channel apply not only to the adalimumab category but to ustekinumab and future biosimilars covered under the pharmacy benefit. Stakeholders concerned with biosimilar sustainability should monitor this situation as it continues to unfold for its effects on competition, conflicts of interest, and future biosimilar development.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"824-827"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288720/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698825","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}
Terry Richardson, Susan Wescott, Ruchi Gupta, Ryan Haumschild, Michael Kobernick, Joseph Albright, Mike Abdo, Justin Bioc
{"title":"AMCP Market Insights: Payer best practices in food allergy management.","authors":"Terry Richardson, Susan Wescott, Ruchi Gupta, Ryan Haumschild, Michael Kobernick, Joseph Albright, Mike Abdo, Justin Bioc","doi":"10.18553/jmcp.2025.31.8-b.s1","DOIUrl":"10.18553/jmcp.2025.31.8-b.s1","url":null,"abstract":"<p><p>The use of biologics in food allergy management is an emerging area; therefore, guidance is required for payers to ensure appropriate access. AMCP Market Insights undertook a multiphase program to refine proposed actions from a previous program into a set of payer best practices in food allergy management and to gain insights on gaps in knowledge regarding food allergy mechanisms and management. The program included a national survey of managed care professionals, individual expert interviews, and a moderated expert roundtable. Best practices identified were to increase awareness of food allergy mechanisms, mitigate accidental exposure impact, support behavioral health needs, ensure access to emergency medications, consider social determinants of health and equity, and assess cost-effectiveness. Best practices specific to omalizumab, which is currently the only biologic approved by the US Food and Drug Administration, were to establish appropriate initial coverage criteria and develop appropriate ongoing coverage criteria.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8-b Suppl","pages":"S1-S12"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12249918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144612176","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}
John G Rizk, Danya M Qato, Clifton O Bingham, Susan dosReis
{"title":"Group-based trajectory modeling to assess adherence to chronic urate-lowering therapies among commercially insured US adults with gout.","authors":"John G Rizk, Danya M Qato, Clifton O Bingham, Susan dosReis","doi":"10.18553/jmcp.2025.31.8.795","DOIUrl":"10.18553/jmcp.2025.31.8.795","url":null,"abstract":"<p><strong>Background: </strong>The benefits of urate-lowering therapies (ULTs) for the long-term management of gout are well established. However, suboptimal adherence remains a significant challenge, resulting in increased gout flares and higher health care utilization. The proportion of days covered (PDC) is commonly used to assess adherence but provides only a single value that fails to distinguish among individuals with differing and dynamic adherence patterns over time. Understanding fluctuations in adherence and their associated characteristics can inform interventions aimed at improving adherence.</p><p><strong>Objective: </strong>To identify distinct trajectories of ULT adherence in a commercially insured population and determine the sociodemographic and clinical factors associated with each trajectory.</p><p><strong>Methods: </strong>This retrospective cohort study used a 25% random sample from the IQVIA PharMetrics Plus database and included a commercially insured population who had a first index ULT prescription between 2017 and 2020, had at least 1 inpatient or 2 outpatient visits on different dates for gout in the year prior to the index ULT, and maintained continuous medical and prescription coverage for 1 year before and after the index ULT. A group-based trajectory model identified distinct adherence patterns and a multinomial logistic regression identified factors that were associated with adherence trajectory group membership.</p><p><strong>Results: </strong>A total of 9,404 beneficiaries in the analytic sample were categorized into 4 ULT adherence trajectory groups: early decline (PDC = 0 by month 6, 14.97%), high-then-low (PDC = 0 by month 10, 7.95%), intermediate (PDC 0.4-0.6, 16.57%), and continuously high (PDC ≥ 0.8, 60.51%). In general, groups showing intermediate or declining adherence were more likely to be younger than 46 years, be female, reside outside the Eastern United States, have conditions such as peripheral vascular disease or dementia, and be prescribed medications for gout flares in the baseline period compared with the continuously high adherence group. These adherence groups were also less likely to have documented cardiometabolic comorbidities or other arthritic conditions relative to the continuously high adherence group.</p><p><strong>Conclusions: </strong>Nearly 40% of beneficiaries were nonadherent to ULTs during the 1-year follow-up period. Adherence trajectory groups have unique characteristics that could help to target interventions and improve patient care.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"795-807"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288726/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698805","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}
Joseph F Merola, Sarah Welby, Helena Roque, Jie Song, Olga Pilipczuk, Chao Lu, Jessica A Walsh
{"title":"Real-world use of biologic and targeted synthetic disease-modifying antirheumatic drugs in US patients with psoriatic arthritis: Persistence, patient characteristics associated with discontinuation, and dosing patterns.","authors":"Joseph F Merola, Sarah Welby, Helena Roque, Jie Song, Olga Pilipczuk, Chao Lu, Jessica A Walsh","doi":"10.18553/jmcp.2025.31.8.808","DOIUrl":"10.18553/jmcp.2025.31.8.808","url":null,"abstract":"<p><strong>Background: </strong>Psoriatic arthritis (PsA) is a chronic, immune-mediated inflammatory arthropathy presenting with multiple manifestations, including peripheral arthritis, enthesitis, and skin psoriasis (PSO). Immunosuppressive/immunomodulatory therapies, including biologic/targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD), are common effective treatments for PsA; however, discontinuation is reported and contributing factors remain unclear.</p><p><strong>Objective: </strong>To describe the probability of persistence and time to discontinuation (including switch) of b/tsDMARD therapy in both b/tsDMARD-naive and -experienced patients with PsA within 12 months following initiation of a new b/tsDMARD. Secondary objectives included (1) describing the factors associated with b/tsDMARD persistence or nonpersistence and (2) assessing maintenance dose changes among patients with PsA initiating the anti-IL17A agents secukinumab (SEC) or ixekizumab (IXE). SEC and IXE were of particular focus owing to the variability in their dosage recommendation guidelines at the time of this study.</p><p><strong>Methods: </strong>This observational cohort study used Merative MarketScan data and included patients initiating a new prescription of b/tsDMARD treatment for PsA, with a diagnosis of PsA between January 1, 2017, and June 30, 2021. The primary outcome was persistence, defined as days of b/tsDMARD therapy use from index date to 12 months of continuous index treatment, or first occurrence of b/tsDMARD discontinuation/switch. Associations between patient characteristics and outcomes were explored using Cox regressions, with descriptive dose analyses exploring proportions of patients with specific starting/maintenance b/tsDMARD doses.</p><p><strong>Results: </strong>7,037 adult patients with PsA were included: 26.7% with PsA only and 73.3% with PsA+PSO at baseline. The 12-month probability for persistence of b/tsDMARD treatment was 51.2% (95% CI, 49.5%-52.9%), with an 8.3-month mean length of persistence. Treatment persistence probability at 12 months was 52.7% (50.8%-57.7%) for patients with PsA+PSO and 47.0% (43.7%-50.3%) for patients with PsA only. Treatment persistence probability at 12 months was 51.4% (49.6%-53.2%) for the b/tsDMARD-naive subgroup and 49.8% (45.5%-54.1%) for the b/tsDMARD-experienced group. Female sex and a baseline codiagnosis of fatigue were associated with an increased probability of nonpersistence, whereas codiagnosis of PSO was associated with decreased probability of nonpersistence. In the dosing analysis, of the patients initiating SEC therapy included in the analysis, 60.4% were prescribed a starting maintenance dose of 300 mg every 4 weeks (Q4W) and 34.1% were prescribed a starting maintenance dose of 150 mg Q4W. Of patients initiating IXE therapy included in the analysis, 84.4% were prescribed an 80-mg Q4W starting maintenance dose and 10.4% were prescribed a 160-mg Q4W starting maintenance dose.</p><p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"808-821"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288723/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698822","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}
Belen Herce-Hagiwara, Avery McKenna, Anil N Makam, Marina Richardson, Woojung Lee, Marie Phillips, David M Rind, Foluso Agboola
{"title":"The effectiveness and value of sonpiretigene isteparvovec for the treatment of advanced retinitis pigmentosa.","authors":"Belen Herce-Hagiwara, Avery McKenna, Anil N Makam, Marina Richardson, Woojung Lee, Marie Phillips, David M Rind, Foluso Agboola","doi":"10.18553/jmcp.2025.31.8.835","DOIUrl":"10.18553/jmcp.2025.31.8.835","url":null,"abstract":"","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"835-840"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698823","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":"Identifying and characterizing commercially insured patients with HFpEF with high vs low health care resource utilization.","authors":"Jacob Earl, Laura A Hart, Ryan N Hansen","doi":"10.18553/jmcp.2025.31.8.741","DOIUrl":"10.18553/jmcp.2025.31.8.741","url":null,"abstract":"<p><strong>Background: </strong>Heart failure with preserved ejection fraction (HFpEF) represents half of all HF diagnoses and is a growing public health concern. Despite therapeutic advancements, HFpEF contributes to substantial health care resource utilization (HCRU) and costs. Characterizing these measures and identifying potential associations in HFpEF is needed.</p><p><strong>Objective: </strong>To characterize the HCRU and costs among the bottom 10th and top 90th percentiles of total health care cost, examine associations of belonging to the 90th percentile, and analyze trends over time.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study using the Merative MarketScan database to examine commercially insured adults diagnosed with HFpEF from 2014 to 2021. HCRU and costs were estimated using a Cox proportional hazards model and Kaplan-Meier sample average techniques, bootstrapping was applied to generate credible intervals. Predictors of high HCRU were identified using a multivariable logistic regression model.</p><p><strong>Results: </strong>We had 24,071 eligible participants. The HCRU among the 90th percentile possessed an annual incremental average of 13 emergency department/urgent care visits, 3 inpatient admissions, and 30 days in the hospital. Total health care costs of the 90th percentile were $378,880 higher on average than the 10th percentile. Both cohorts experienced the highest HCRU and costs the first month after diagnosis. Credible intervals of total costs from bootstrapping overlapped from 2014 to 2021. Baseline characteristics associated with the 90th percentile included female sex (odds ratio [OR] = 1.13; 95% CI = 1.1-1.2), a Charlson comorbidity index (CCI) score of 2 (OR = 3.28; 95% CI = 3.0-3.6), and a CCI score greater than 2 (OR = 18.81; 95% CI = 16.9-20.9). Comorbidities associated with the 90th percentile included atrial fibrillation (OR = 3.51; 95% CI = 2.8-4.4), loop diuretics (OR = 2.18; 95% CI = 2.0-2.4), angiotensin receptor-neprilysin inhibitor (OR = 1.89; 95% CI = 1.1-3.2), and sodium-glucose cotransporter-2 inhibitors (OR = 4.48; 95% CI = 3.0-6.7). Comorbidities associated with the 10th percentile included diabetes (OR = 0.53; 95% CI = 0.4-0.7), hypertension (OR = 0.71; 95% CI = 0.6-0.8), and chronic kidney disease (OR = 0.63; 95% CI = 0.4-0.9). Interactions indicating multiple comorbidities were significant.</p><p><strong>Conclusions: </strong>Significant differences in HCRU exist between high- and low-cost patients with HFpEF. However, both groups experienced their highest utilization the first month after diagnosis. Total costs remained consistent from 2014 to 2022. Strategies to reduce the risk of HFpEF onset are essential for lowering health care expenditures. Future research is needed to examine the impact of access to newer therapies.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"741-751"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698806","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}
Chelsea P Renfro, Jessica Fann, Josh DeClercq, Rachael D Baggett, Patrick Nichols, Miranda Kozlicki, Leena Choi, Autumn D Zuckerman
{"title":"Ustekinumab infusion to subcutaneous transition: Coordinating care and identifying potential gaps.","authors":"Chelsea P Renfro, Jessica Fann, Josh DeClercq, Rachael D Baggett, Patrick Nichols, Miranda Kozlicki, Leena Choi, Autumn D Zuckerman","doi":"10.18553/jmcp.2025.31.8.764","DOIUrl":"10.18553/jmcp.2025.31.8.764","url":null,"abstract":"<p><strong>Background: </strong>Ustekinumab, approved for the treatment of moderate to severe Crohn disease (CD) and ulcerative colitis (UC), requires a clinic-administered intravenous (IV) induction infusion (loading dose) followed by transition to self-administered, subcutaneous (SC) injection for maintenance every 8 weeks. Many patients need subsequent dose escalations to obtain or maintain effectiveness. As an increasing number of CD and UC therapies require a similar dosing and escalation strategy, research evaluating care coordination requirements and clinical outcomes for patients prescribed ustekinumab can help guide best practices.</p><p><strong>Objective: </strong>To describe the care coordination process and response to therapy from decision to treat with ustekinumab through the first 12 months of initiating SC injection and evaluate differences in SC shipment timing between patients filling at a health-system specialty pharmacy (HSSP) compared with a non-HSSP.</p><p><strong>Methods: </strong>A single-center, retrospective cohort study was conducted. Patients prescribed ustekinumab for CD or UC between November 1, 2021, and March 31, 2022, were included. Patients were excluded if they never received an infusion or SC dose, received the SC dose at an infusion center, or became lost to follow-up. Outcomes included time between clinical events (decision to treat to IV infusion, prior authorization [PA] submission, PA approval, and SC shipment), the occurrence of SC shipments between 4 and 8 weeks after infusion (most appropriate time frame to prevent waste), and the occurrence of a dose escalation within the first 12 months of therapy. The occurrence of SC shipments within the 4- to 8-week window were analyzed using a multiple logistic regression with the following covariates: age, insurance type, and filling pharmacy type.</p><p><strong>Results: </strong>In the 70 included patients, the median age was 36 (IQR, 28-44) years. Most patients had commercial insurance (79%), and approximately half filled SC doses external to the HSSP (53%). Median time between events was as follows: decision to treat to PA submission: 3 days (IQR, 1-8); decision to treat to PA approval: 6 days (IQR, 3-14); decision to treat to infusion date: 20 days (IQR, 13-25); and PA approval to medication shipment: 49 days (IQR, 34-73). In the 70 SC doses shipped, 64% (n = 45) occurred within the 4- to 8-week window. Prescriptions filled with the HSSP had 2.5 times higher odds of being shipped in the appropriate window compared with non-HSSP prescriptions (95% CI, 0.8-7.8; <i>P</i> = 0.126). Thirty-nine patients (56%) had dose escalations.</p><p><strong>Conclusions: </strong>Ustekinumab initiation and escalation within the first year can be a complex process requiring a high level of care coordination to ensure patients receive timely therapy while reducing potential waste.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"764-771"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698824","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}
Feride H Frech, Gang Li, Timothy R Juday, Yingjie Ding, Soeren Mattke, Ara S Khachaturian, Aaron S Rosenberg, Colette Ndiba-Markey, Andrew Rava, Richard Batrla, Susan De Santi, Harald Hampel
{"title":"Real-world health care costs and resource utilization associated with mild cognitive impairment in the United States: A retrospective cohort study of commercial and Medicare data.","authors":"Feride H Frech, Gang Li, Timothy R Juday, Yingjie Ding, Soeren Mattke, Ara S Khachaturian, Aaron S Rosenberg, Colette Ndiba-Markey, Andrew Rava, Richard Batrla, Susan De Santi, Harald Hampel","doi":"10.18553/jmcp.2025.31.8.782","DOIUrl":"10.18553/jmcp.2025.31.8.782","url":null,"abstract":"<p><strong>Background: </strong>Mild cognitive impairment (MCI) is a transitional stage before Alzheimer disease and related dementias (ADRD). The link between AD and increased health care resource utilization (HCRU) and costs is well established but not the economic burden of MCI.</p><p><strong>Objective: </strong>To estimate the incremental economic burden of individuals with MCI in the United States.</p><p><strong>Methods: </strong>This was a retrospective cohort study that derived data from the MarketScan Commercial and Medicare Supplemental Databases. The observation period was from January 1, 2014, through December 31, 2019. Included individuals were (1) aged at least 50 years, (2) had at least 2 years of pre-index (ie, date of their first MCI diagnosis) continuous health plan enrollment, and (3) had at least 1 year of post-index continuous health plan enrollment. Individuals were excluded if they had (1) at least 1 claim with a diagnosis of Parkinson disease at any time during the study period, (2) at least 1 claim with a diagnosis of ADRD at any time before the index date, or (3) at least 1 pharmacy claim for an ADRD medication (donepezil, memantine, memantine/donepezil, galantamine, or rivastigmine) at any time before the index date. Outcomes included all-cause HCRU and health care costs for incident MCI individuals (MCI cohort) and matched individuals without MCI or dementia (control cohort) during the 12-month follow-up period. Controls were matched at a 3:1 ratio by age, sex, region, and index year.</p><p><strong>Results: </strong>In total, 5,185 individuals met the criteria for the MCI cohort and 15,555 for the control cohort. Mean age at baseline was 67 years and 57.7% were female in both cohorts. The MCI cohort had a higher comorbidity burden compared with the control cohort (1.5 vs 1.0 and 2.6 vs 1.8, respectively; <i>P</i> < 0.0001) All comorbidities assessed at baseline were more prevalent in the MCI cohort than in the control. Adjusted all-cause HCRU for all points of service and adjusted all-cause mean costs in total ($32,318 vs $13,894; mean ratio [MR] = 2.33, 95% CI = 2.23-2.43), for emergency department ($4,460 vs $3,849; MR = 1.16, 95% CI = 1.08-1.25), outpatient ($16,054 vs $7,265; MR = 2.21, 95% CI = 2.12-2.30), and pharmacy ($5,503 vs $2,933; MR = 1.88, 95% CI = 1.78-1.97) (all <i>P</i> < 0.0001) were significantly higher for the MCI cohort.</p><p><strong>Conclusions: </strong>The economic burden of MCI was more than double that for similar individuals without MCI or dementia. Timely diagnosis and intervention are key to delaying progression to AD and reducing associated costs.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 8","pages":"782-794"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12288724/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698808","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}