Journal of managed care & specialty pharmacy最新文献

{"title":"Budget impact analysis of revumenib for the treatment of relapsed or refractory acute leukemias with a <i>KMT2A</i> translocation in the United States.","authors":"Ivo Abraham, Pam Martin, Shailja Vaghela, Tim Klein, Eric Chow, Marie Rush, Robert Morlock, Huan Huang","doi":"10.18553/jmcp.2025.25027","DOIUrl":"10.18553/jmcp.2025.25027","url":null,"abstract":"<p><strong>Background: </strong>Acute leukemias (ALs), including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL), are heterogeneous diseases characterized by different phenotypic, genetic, and molecular alterations that can guide treatment decisions. ALs harboring lysine methyltransferase 2A gene translocation (<i>KMT2t</i>), previously known as mixed-lineage leukemia, are associated with high rates of relapsed or refractory (R/R) disease. Revumenib, a first-in-class oral menin inhibitor, has shown improved clinical outcomes in patients with R/R <i>KMT2At</i> ALs.</p><p><strong>Objective: </strong>To estimate, using a budget impact model (BIM), the financial impact of introducing revumenib for the treatment of adult patients with R/R <i>KMT2At</i> ALs on the formulary of a hypothetical US 1-million-member commercial health plan.</p><p><strong>Methods: </strong>The BIM compared scenarios with or without revumenib and the resulting impact on commercial US third-party payers over a 3-year time horizon. Although no other therapies specifically targeted for R/R <i>KMT2At</i> ALs were approved during BIM development, 11 additional pharmacotherapies for R/R ALs (5 for AML and 6 for ALL, not including revumenib) were included as treatment options in the model. Clinical data included adverse event (AE) rates, duration of treatment, time to subsequent treatment, and survival outcomes. Cost inputs (USD 2024) included in the model comprised drug acquisition and administration, grade 3 or greater AEs, treatment-related supportive care and monitoring, subsequent treatment, and end-of-life costs. The differential cost per member per month (PMPM) was estimated. One-way sensitivity analyses varying the costs of drug acquisition and toxicity by ±20% and scenario analyses varying uptake of revumenib and epidemiology inputs, as well as excluding costs related to supportive care and posttreatment discontinuation, were performed.</p><p><strong>Results: </strong>An estimated 1.7 adult patients (AML, 1.1; ALL, 0.6) were treatment eligible annually. Estimated 3-year total plan costs without and with revumenib were $2,146,564 and $2,126,919, respectively, for savings of -$19,646. Including revumenib was estimated to yield a differential PMPM cost of -$0.0005 over 3 years. The total number of grade 3 or greater AEs was lower over 3 years (10.82 vs 10.99, respectively) in the plan with revumenib vs without. Sensitivity and scenario analyses validated the robustness of the model.</p><p><strong>Conclusions: </strong>The BIM demonstrated that including revumenib in a formulary for adult patients with R/R <i>KMT2At</i> ALs was approximately cost neutral, offering patients access to a targeted treatment with potential for improved clinical outcomes.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"680-693"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12205252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144208645","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":"Advancing the conversation: 30 years of scholarship in managed care pharmacy.","authors":"Laura E Happe","doi":"10.18553/jmcp.2025.31.7.617","DOIUrl":"10.18553/jmcp.2025.31.7.617","url":null,"abstract":"<p><p>This article commemorates the 30th anniversary of the <i>Journal of Managed Care & Specialty Pharmacy</i> (<i>JMCP</i>), reflecting on its evolution to a central voice in managed care pharmacy. Launched in 1995, <i>JMCP</i> has chronicled the profession's growth while shaping the national conversation around value, access, and outcomes. The journal's early content addressed educational gaps and shared practical insights from the field, developing over time to feature rigorous health economics and outcomes research studies. <i>JMCP</i> and its authors played a pivotal role in elevating real-world evidence, as well as guiding stakeholders through transformative policy shifts like Medicare Part D and the Inflation Reduction Act. Over the years, <i>JMCP</i> has delved into complex topics such as management of high-cost drugs, value assessment, equity, and access. Acknowledging its most influential contributors and publications, this article illustrates how <i>JMCP</i> has remained a dynamic forum for scholarly dialogue. With an enduring legacy of connecting researchers, practitioners, and policymakers, <i>JMCP</i> remains poised to guide managed care pharmacy through future challenges in pursuit of improved patient health through evidence-based decision-making.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 7","pages":"617-626"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12205191/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505966","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":"Health care resource utilization and costs in Medicare Advantage beneficiaries using glucagon-like peptide-1 receptor agonists vs sodium-glucose cotransporter-2 inhibitors.","authors":"Insiya B Poonawalla, Petir Abdal, Mary Hayes, Isha John, Monica Diaz, Suzanne Dixon, Andy Bowe","doi":"10.18553/jmcp.2025.31.7.627","DOIUrl":"10.18553/jmcp.2025.31.7.627","url":null,"abstract":"<p><strong>Background: </strong>Glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended as first-line therapy for glycemic management for adults with type 2 diabetes and specific comorbidities. It is unknown whether there are meaningful differences in how GLP-1 RA vs SGLT2i therapy may affect health care resource utilization and medical costs.</p><p><strong>Objective: </strong>To compare health care resource utilization and costs in adults with type 2 diabetes newly initiating GLP-1 RA vs SGLT2i therapy.</p><p><strong>Methods: </strong>We used the Humana Healthcare Research database and a retrospective cohort study design to identify patients with type 2 diabetes, enrolled in a Medicare Advantage Prescription Drug plan from January 1, 2018, to June 30, 2022. Eligible patients had at least 2 pharmacy claims for a GLP-1 RA or SGLT2i drug and had at least 12 months of continuous enrollment prior to and after the first prescription claim. Propensity score matching adjusted for population differences between GLP-1 RA and SGLT2i groups. Subgroup analyses included patients with baseline atherosclerotic cardiovascular disease and obesity. Main outcomes included inpatient stays, emergency department visits, and all-cause health care costs in the 12-month follow-up period.</p><p><strong>Results: </strong>The 1:1 matched cohort consisted of 22,167 individuals each treated with SGLT2i or GLP-1 RA, had a mean age of 68.2 years, and was 52.2% female, 73.4% White, and 18.6% Black. There were no significant differences in all-cause or diabetes-related inpatient stays or emergency department visits between GLP-1 RA and SGLT2i users for overall and subgroup analyses. Compared with SGLT2i patients, those on GLP-1 RA had 3.1% (95% CI = 0.9%-5.3%) higher medical costs in the overall cohort but 2.9% (95% CI = -5.5% to -0.2%) lower medical costs in the obesity subgroup. Pharmacy costs for patients on GLP-1 RA were 6% to 9% higher for overall and subgroup analyses, resulting in 4% to 6% higher total health care costs for GLP-1 RA users relative to SGLT2i users.</p><p><strong>Conclusions: </strong>There were no significant differences in health care resource utilization in the overall cohort between patients taking GLP-1 RA vs those taking SGLT2i, and pharmacy and total health care costs were higher in the GLP-1 RA group. In the obesity subgroup, GLP-1 RA initiators had lower medical costs.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 7","pages":"627-640"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505977","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":"The financial value of improving patient access to COVID-19 antiviral therapy in Medicare Part D: A simulation study.","authors":"Andrew S Aguilar, Tyler Engel, Wesley Furnback, Gabriela Dieguez, David J Campbell, Benjamin Diner, Sean D Sullivan, William Dorling","doi":"10.18553/jmcp.2025.24348","DOIUrl":"10.18553/jmcp.2025.24348","url":null,"abstract":"<p><strong>Background: </strong>Nirmatrelvir-ritonavir is an approved treatment for mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Age is the leading risk factor for severe COVID-19, making treatment access particularly important for the Medicare population. Part D plans must include COVID-19 antivirals on formularies. However, unlike Medicare Advantage prescription drug (MAPD) plans, which assume risk for both medical and pharmacy costs, standalone prescription drug plans (PDPs) have a financial disincentive to cover them in the preferred tier. As reimbursement transitions to Part D plans in 2025, it is important for plans to understand the budget impact of providing treatment access at different formulary tiers.</p><p><strong>Objective: </strong>To examine challenges to preferred tier access to nirmatrelvir-ritonavir in Part D and their impact on COVID-19 treatment abandonment and hospitalization rates.</p><p><strong>Methods: </strong>Using a combination of actuarial and budget impact models, we estimated the potential impact of Part D formulary tier placements of nirmatrelvir-ritonavir on plan budgets, therapy abandonment, and hospitalizations using real-world prescription data from Milliman's Prescription Drug Consolidated Database. Potential impacts were summarized separately for PDP, MAPD, and the Medicare fee-for-service program in 2025.</p><p><strong>Results: </strong>Specialty tier placement of nirmatrelvir-ritonavir resulted in savings to the Medicare program of $2.14 billion compared with $2.22 billion for preferred tier placement. Compared with placement in the specialty tier, nirmatrelvir-ritonavir positioned at the preferred brand tier saves the Medicare program an additional $80.7 million by reducing patient abandonment by 62% and COVID-19-related hospitalization costs by $2.14 billion after accounting for the increase in net Part D plan liabilities. These savings consist of (1) a net cost reduction, after accounting for medical cost offsets, of $65.1 million for MAPD plans, (2) an increase in net Part D liability of $710.9 million for PDPs, and (3) cost savings to Medicare fee-for-service from reduced COVID-19-related hospitalizations of $726.5 million.</p><p><strong>Conclusions: </strong>Coverage of nirmatrelvir-ritonavir, on any tier, is cost-saving for the Medicare program overall. Preferred coverage with lower patient cost-sharing results in additional savings and improved patient outcomes from lower hospitalizations and mortality rates. Individual Medicare plans should consider the overall clinical and cost impacts of nirmatrelvir-ritonavir on the health system when determining formulary tier placement. Better alignment of incentives for PDPs is needed to address the financial barriers to expanding access for therapies that can improve clinical outcomes and produce savings to the Medicare program.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"651-661"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969842","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":"The effectiveness and value of suzetrigine for moderate to severe acute pain: A summary from the Institute for Clinical and Economic Review's Midwest Comparative Effectiveness Public Advisory Council.","authors":"Dmitriy Nikitin, David M Rind, Brett McQueen, Finn Raymond, Sol Sanchez, Michael J DiStefano, Antal Zemplenyi, Woojung Lee, Daniel Ollendorf","doi":"10.18553/jmcp.2025.31.7.729","DOIUrl":"10.18553/jmcp.2025.31.7.729","url":null,"abstract":"","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 7","pages":"729-734"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505979","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":"Mind over migraine: Disease burden, innovative therapies, and managed care trends in treating migraine disease.","authors":"Bridget Flavin","doi":"10.18553/jmcp.2025.31.7-a.s1","DOIUrl":"10.18553/jmcp.2025.31.7-a.s1","url":null,"abstract":"<p><p>Migraine is a genetically influenced complex neurological disease characterized by attacks of moderate to severe headaches and a variety of concomitant symptoms. Migraine disease can significantly impact individuals' daily activities and quality of life. It is a major cause of disability and loss of productivity, which can be exacerbated by migraine-related stigma. Recent advances in migraine treatment and ongoing research may offer additional options for patients; however, treatment barriers still exist, resulting in underdiagnosis and undertreatment of migraine disease, especially in some minority and vulnerable groups. Primary care and emergency department providers are often the first point of contact for patients with migraine disease, so there is opportunity for them to assist in addressing these barriers, particularly with strategies to make care more patient-centered. Managed care organizations can also play a role in overcoming these barriers and supporting equitable access.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 7-a Suppl","pages":"S1-S13"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505980","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":"Cost-effectiveness analysis model for sotagliflozin compared with insulin monotherapy for patients with type 1 diabetes and chronic kidney disease.","authors":"Jaehong Kim, Shanshan Wang, Moises Marin, Slaven Sikirica, Mariam Anderson, Jason Shafrin","doi":"10.18553/jmcp.2025.31.7.641","DOIUrl":"10.18553/jmcp.2025.31.7.641","url":null,"abstract":"<p><strong>Background: </strong>Patients with type 1 diabetes (T1D) have a greater than 50% lifetime risk of developing comorbid chronic kidney disease (CKD). Glycemic control can reduce diabetes-related complications and slow CKD progression. Adding sotagliflozin to insulin therapy reduced A1c by 0.46% compared with insulin monotherapy in patients with T1D. However, the long-term economic value for patients with both T1D and CKD remains unknown.</p><p><strong>Objective: </strong>To evaluate the cost-effectiveness of sotagliflozin as an add-on to insulin in patients with T1D and CKD from a US payer perspective.</p><p><strong>Methods: </strong>A Markov model was generated for individuals diagnosed with both T1D and comorbid CKD stage 3 from a US payer's perspective. Clinical and economic outcomes were assessed over 30 years and included number of patients prevented from dialysis and transplantation, life-years, quality-adjusted life-year (QALY) gains, incremental costs, incremental cost-effectiveness ratio (ICER), and net monetary benefit. Dynamic pricing, through genericization, was incorporated to account for the economic impacts of market entry by generics.</p><p><strong>Results: </strong>Sotagliflozin add-on therapy improved survival, extending life expectancy by 1.27 years (13.08 with sotagliflozin vs 11.81 with insulin monotherapy). During the first 10 years after treatment initiation, dialysis and transplant utilization decreased by 3.06 (99.35 vs 102.41) and 1.73 (30.59 vs 32.32) per 1,000 patients, respectively. QALYs per patient increased by 0.63 (7.70 vs 7.07), largely driven by prolonged time in pre-end-stage renal disease health states (0.59; 6.75 vs 6.16). Total costs rose by $72,914 ($484,674 vs $411,760), primarily because of pharmacy costs increasing by $69,060 ($96,242 vs $27,364). The ICER was $115,677 per QALY and the model was most sensitive to pharmacy costs.</p><p><strong>Conclusions: </strong>Sotagliflozin is a cost-effective adjunct to insulin therapy for T1D and CKD patients, providing clinical benefits and falling below the $150,000/QALY willingness-to-pay threshold in 59% of probabilistic sensitivity analysis simulations.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 7","pages":"641-650"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505976","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":"Implementation of a nonstatin prior authorization checklist for patients with hypercholesterolemia: In 2 community health care systems.","authors":"Dana McCormick, Pam R Taub, Jeffrey Carter, Kathleen Moreo, Cherilyn L Heggen","doi":"10.18553/jmcp.2025.31.7.723","DOIUrl":"10.18553/jmcp.2025.31.7.723","url":null,"abstract":"<p><strong>Background: </strong>Health plans have acknowledged there is a significant unmet need to improve prior authorization (PA) processes to increase patient access to life saving nonstatin therapies. Outcomes from a series of regional working groups in the United States provided recommendations for developing standardized patient eligibility criteria and a checklist for streamlining the PA process.</p><p><strong>Objective: </strong>To (1) develop a standardized PA checklist to streamline collection of adequate PA documentation by prescribers, regardless of health insurance plan type, and (2) measure the impact of the PA checklist in clinical practice in a controlled observational study.</p><p><strong>Methods: </strong>A working group of thought leaders representing payers and providers was assembled by PRIME Education, in collaboration with the Academy of Managed Care Pharmacy, the American Society for Preventive Cardiology, and the Preventive Cardiovascular Nurses Association. The working group developed and finalized a PA checklist for PCSK9 inhibitors that was integrated into the electronic medical record for 2 large community health care systems with geographic representation of patients with cardiovascular disease: Random chart audits were conducted prior to (historical controls) and 6 months after (post-intervention) implementation of the checklist (n = 100 each set). Primary study endpoints were rates of approvals and time to approval/receipt of prescribed drug. Statistical analyses measured changes in PA documentation outcomes, including treatment history and authorization approvals/denials. Survey questions provided to health care provider teams before and after integration of the PA checklist measured changes in prescriber attitudes on effectiveness and efficiency of the PA checklist.</p><p><strong>Results: </strong>Following implementation of the PA checklist, a 19% absolute increase in initial PA approvals and a 2-day overall reduction in time-to-treatment with prescribed PCSK9 inhibitor therapy were observed. Documentation of side effects (54%; <i>P</i> < 0.0001), statin contraindications (31%; <i>P</i> < 0.0001), and prior lipid therapies failed (20%; <i>P</i> < 0.0001) also increased postimplementation. In surveys, prescribers reported greater efficiency and effectiveness of the PA process when using the standardized PA checklist.</p><p><strong>Conclusions: </strong>Time-to-treatment for nonstatin therapies for eligible patients with hypercholesterolemia was decreased in 2 community health systems following integration of a standardized PA checklist developed through a collaboration between patients and providers.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 7","pages":"723-728"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505978","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":"Associations between chronic active lesions and clinical outcomes in multiple sclerosis: A systematic literature review.","authors":"Francesca Bagnato, Margaret Mordin, Nupur Greene, Snehal Mahida, Janneke van Wingerden","doi":"10.18553/jmcp.2025.24294","DOIUrl":"10.18553/jmcp.2025.24294","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative disease. Emerging evidence suggests that chronic disease processes within the central nervous system are important drivers of the ongoing disability accumulation in people with MS (pwMS). Chronic lesion activity driven by smoldering neuroinflammation is considered one of the neuropathological hallmarks of disease progression in worsening disability. Our understanding of the role of chronic active lesions (CALs) in MS pathology has expanded with improvements in imaging technology. Three in vivo imaging biomarkers of CALs are available to detect CALs: paramagnetic rim lesions (PRLs), 18 kDa translocator protein (TSPO)-positron emission tomography rim-positive lesions, and the magnetic resonance imaging (MRI)-defined slowly expanding lesions (SELs).</p><p><strong>Objective: </strong>To evaluate associations between CALs and measures of worsening disability in pwMS.</p><p><strong>Methods: </strong>A systematic literature search was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using PubMed, Embase, and the Cochrane Library on April 21, 2023. The review included randomized controlled trials, retrospective studies, and prospective cross-sectional and longitudinal studies conducted during 2010-2023 reporting the outcomes of interest. Studies evaluating people with any MS phenotype were included if they reported any associative analysis between CALs and clinical outcomes.</p><p><strong>Results: </strong>A total of 30 of 149 unique studies identified in the literature met the inclusion criteria. Of these 30 publications, 18 were based on PRLs, 9 on MRI-defined SELs, 1 on PRLs and MRI-defined SELs simultaneously, and 2 on TSPO-positive lesions. PRLs were associated with disability worsening in 17 studies, as measured by clinical disability scales. MRI-defined SELs were associated with worsening disability in 10 studies.</p><p><strong>Conclusions: </strong>CALs are frequently associated with disease progression and disability accumulation. CALs may provide an indicator of disease severity and may assist with the assessment of treatment efficacy.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"694-721"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204335/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975312","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":"Cost per outcome of nivolumab + relatlimab vs BRAF + MEK inhibitor combinations for first-line treatment of <i>BRAF</i>-mutant advanced melanoma.","authors":"Kirollos S Hanna, Jennell Palaia, Divya Patel, Andriy Moshyk, Zheng-Yi Zhou, Fan Yang, Yiqiao Xin, Viviana Garcia-Horton","doi":"10.18553/jmcp.2025.25015","DOIUrl":"10.18553/jmcp.2025.25015","url":null,"abstract":"<p><strong>Background: </strong>The National Comprehensive Cancer Network guidelines list combination immunotherapy as the preferred first-line (1L) treatment for unresectable or metastatic melanoma over BRAF and MEK inhibitor (BRAFi/MEKi) therapy, regardless of <i>BRAF</i> mutation status. However, the economic impact of 1L treatment with nivolumab plus relatlimab (NIVO + RELA) vs BRAFi/MEKi therapies for <i>BRAF-</i>mutated advanced melanoma has not been assessed.</p><p><strong>Objective: </strong>To compare the health care costs, cost per progression-free life-year (PFLY), and cost per life-year (LY) of NIVO + RELA vs dabrafenib plus trametinib (DAB + TRAM), encorafenib plus binimetinib (ENCO + BINI), and vemurafenib plus cobimetinib (VEM + COBI) as 1L treatment for <i>BRAF</i>-mutated, unresectable or metastatic melanoma.</p><p><strong>Methods: </strong>A cost-per-outcome model compared the economic value of NIVO + RELA vs each BRAFi/MEKi therapy. Clinical inputs were derived from previous matching-adjusted indirect comparisons using individual patient data from the <i>BRAF</i>-mutant subgroup of RELATIVITY-047 and published data pooled from COMBI-d, COMBI-v, COLUMBUS, and coBRIM. LYs, PFLYs per investigator, and treatment duration were estimated using the restricted mean survival time. Health care costs (2024 US dollars), including drug acquisition and administration costs, disease management costs over the preprogression and postprogression periods, and adverse event management costs, were calculated over 5 years. Several scenario analyses were performed, including adding subsequent treatment costs.</p><p><strong>Results: </strong>Over 5 years, NIVO + RELA was associated with improved PFLYs and LYs compared with DAB + TRAM (mean PFLY: 1.94 vs 1.82 years, mean LY: 3.41 vs 2.77 years), ENCO + BINI (1.87 vs 1.78 years and 3.40 vs 2.91 years, respectively), and VEM + COBI (2.12 vs 1.80 years and 3.39 vs 2.63 years). The estimated total costs over 5 years were lower for NIVO + RELA vs DAB + TRAM ($300,479 vs $519,770), ENCO + BINI ($343,996 vs $572,556), and VEM + COBI ($296,361 vs $317,851). Main cost drivers were drug acquisition and administration costs. NIVO + RELA had lower costs per PFLY and per LY than DAB + TRAM ($155,107 vs $285,617 and $88,203 vs $187,699, respectively); ENCO + BINI ($183,628 vs $322,113 and $101,151 vs $196,924); and VEM + COBI ($139,688 vs $176,645 and $87,315 vs $121,086). The sensitivity analyses' results supported the base-case results.</p><p><strong>Conclusions: </strong>NIVO + RELA showed improved LYs and PFLYs at lower cost than all 3 BRAFi/MEKi comparators over 5 years. These results support the economic value of NIVO + RELA for patients with previously untreated, <i>BRAF</i>-mutated, unresectable or metastatic melanoma.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"671-679"},"PeriodicalIF":2.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12204334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110895","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}