Journal of managed care & specialty pharmacy最新文献

{"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":"https://doi.org/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":"1-9"},"PeriodicalIF":2.3,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","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":"https://doi.org/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":"1-28"},"PeriodicalIF":2.3,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The consequences of pharmaceutical tariffs in the United States.","authors":"Sean D Sullivan, Jens Grueger, Aidan P Sullivan, Scott D Ramsey","doi":"10.18553/jmcp.2025.25090","DOIUrl":"https://doi.org/10.18553/jmcp.2025.25090","url":null,"abstract":"<p><p>The Trump Administration has threatened to impose tariffs on imported branded, generic, and biosimilar pharmaceutical products. Although specific details regarding the exact rates and implementation timeline remain unclear, the administration has indicated that these tariffs will be substantial. Tariffs can create supply chain disruptions, increase costs, limit patient access to essential medications, and negatively impact research and innovation. Rather than punitive tariffs, industrial policy options and collaborative international treaties may better serve US economic and public health interests and lead to a more secure and consistent domestic supply of critical medicines.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"1-4"},"PeriodicalIF":2.3,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144008541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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":"https://doi.org/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":"1-11"},"PeriodicalIF":2.3,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pediatric-onset rare disease therapy pipeline yields hope for some and gaps for many: 10-year projection of approvals, treated patients, and list price revenues.","authors":"Colin M Young, Sharon E Phares, Annie Kennedy, Jamie Sullivan, Baillie McGowan, Mark R Trusheim","doi":"10.18553/jmcp.2025.31.5.491","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.5.491","url":null,"abstract":"<p><strong>Background: </strong>More than 10,000 rare diseases affect more than 30 million Americans, nearly 70% of which manifest in childhood. The drug development pipeline boasts hundreds of candidates for pediatric-onset rare disease, but little is known about the impact of potential approvals.</p><p><strong>Objective: </strong>To quantify US projected product approvals, patients treated, and product revenues for pediatric-onset rare disease treatments through 2033.</p><p><strong>Methods: </strong>Four-stage model consisting of a Markov Chain Monte Carlo simulation of US Food and Drug Administration approvals, calculation of eligible patients per clinical trial criteria, and projection of adoption and list price revenues, all using publicly available data.</p><p><strong>Results: </strong>By 2033 the pipeline will yield approximately 45 new product approvals, a 14% growth in annual treated patients, and an incremental $10.7B in list price drug revenues ($28.2B: 2023; $38.9B: 2033) prior to any health care cost offsets, caregiving impacts, long-term social benefits, or other benefits from treating the additional patients.</p><p><strong>Conclusions: </strong>The projected approvals over the next decade will undoubtedly be transformational for the patient communities impacted, many of whom have no currently approved treatments. However, the number of newly identified rare diseases is likely to outpace the rate of new therapies to treat them. Resources are needed to accelerate progress as 95% of pediatric-onset rare diseases are projected to still have no approved treatments in the next decade, and even for the 5% that have some options, more is needed.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 5","pages":"491-498"},"PeriodicalIF":2.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144017162","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 of targeted-release formulation of budesonide (Tarpeyo) in conjunction with optimized renin-angiotensin system inhibitor (RASi) therapy relative to optimized RASi therapy alone for adults with primary immunoglobulin A nephropathy in the United States.","authors":"Mohsen Yaghoubi, Heng Jiang, Roman Casciano, Christopher Ngai, Mit Patel","doi":"10.18553/jmcp.2025.31.5.499","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.5.499","url":null,"abstract":"<p><strong>Background: </strong>Immunoglobulin A nephropathy (IgAN) is a rare autoimmune disease that often leads to end-stage renal disease. The goal of treatment is to reduce disease progression so that patients are less likely to develop kidney failure in their natural lifetime. Recent clinical trial results show that Tarpeyo, a targeted-release formulation of budesonide designed to deliver the drug directly to gut-associated lymphoid tissue, reduces estimated glomerular filtration rate loss, potentially modifying the disease and thus prolonging the time to kidney failure.</p><p><strong>Objective: </strong>To assess the cost-effectiveness of Tarpeyo in conjunction with optimized renin-angiotensin system inhibitor (RASi) therapy relative to optimized RASi therapy alone in US adult patients with primary IgAN.</p><p><strong>Methods: </strong>A cost-utility approach is taken based on the full dataset from the phase 3 NefIgArd clinical trial. A semi-Markov model was developed with a lifetime horizon, encompassing both the US commercial payer and societal perspectives. The model architecture incorporated 9 health states, reflecting varying degrees of disease severity and mortality. Transition probabilities between health states were determined by a robust regression analysis of individual patient-level data obtained from the NefIgArd clinical trial and supplemented with data from literature. In the base-case analysis, treatment effect was assumed to be continuously maintained over the model time horizon (lifetime) and treatment was reapplied every 2 years. Treatment cost, adverse event management, dialysis, transplantation, mortality costs, and indirect costs were considered.</p><p><strong>Results: </strong>Tarpeyo + optimized RASi was found to be dominant compared with optimized RASi alone from the perspective of a US third-party commercial payer, ie, cost saving ($105 729) with concurrent quality-adjusted life-year (QALY) gains of 1.12. The base-case results show that Tarpeyo is dominant when retreatment occurs every 2 years, with the treatment benefit assumed to be maintained over the same period throughout the model. Sensitivity analyses confirmed the robustness of the base-case results, showing that Tarpeyo plus optimized RASi is cost saving if benefits are sustained for at least 3 years. The treatment demonstrated high probabilities of cost-effectiveness at willingness-to-pay thresholds of less than $100K and less than $150K per QALY.</p><p><strong>Conclusions: </strong>Clinical trials suggest that adding Tarpeyo to optimized RASi can help preserve kidney function by reducing estimated glomerular filtration rate loss in patients with IgAN. This addition was estimated to produce a greater QALY gain and reduced overall net costs from the payer and societal perspective in the United States.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 5","pages":"499-509"},"PeriodicalIF":2.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12041922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995933","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":"Tirzepatide vs semaglutide and liraglutide for weight loss in patients with overweight or obesity without diabetes: A short-term cost-effectiveness analysis in the United States.","authors":"Ligang Liu, Jiayu Cui, Marjorie V Neidecker, Milap C Nahata","doi":"10.18553/jmcp.2025.31.5.441","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.5.441","url":null,"abstract":"<p><strong>Background: </strong>Glucagon-like peptide-1 receptor agonists and their analogues have emerged as effective pharmacotherapies for obesity.</p><p><strong>Objective: </strong>To assess the short-term cost-effectiveness of subcutaneous tirzepatide, semaglutide, liraglutide, and oral semaglutide for managing obesity or overweight in patients without diabetes.</p><p><strong>Methods: </strong>A decision tree model was developed using a 68-week time window with consideration of serious adverse events and treatment discontinuation from a US payer's perspective. The study population were adults with obesity or overweight with at least 1 weight-related comorbidity but without diabetes. Clinical data were obtained from clinical trials. Model utilities, disutilities, and the costs of serious adverse events were sourced from published literature. Medication costs were assigned from Red Book. All costs were calculated in 2024 US dollars. The incremental cost-effectiveness ratio was calculated based on the cost per quality-adjusted life-year (QALY) gained. A willingness-to-pay threshold of $150,000 per QALY was used. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the effect of parameter uncertainty on the results.</p><p><strong>Results: </strong>In the base-case analysis, both subcutaneous tirzepatide and oral semaglutide were cost-effective vs subcutaneous liraglutide and subcutaneous semaglutide. Compared with oral semaglutide, subcutaneous tirzepatide was cost-effective, with an incremental cost-effectiveness ratio of $34,212 per QALY gained. Sensitivity analyses indicated the results were highly sensitive to medication costs and the effectiveness of medications. The probabilistic sensitivity analysis suggested that subcutaneous tirzepatide was most likely to remain cost-effective, with a 98% probability at a willingness to pay of $150,000 per QALY compared with other medications.</p><p><strong>Conclusions: </strong>Subcutaneous tirzepatide and oral semaglutide were cost-effective therapies compared with subcutaneous liraglutide and subcutaneous semaglutide for the short-term management of obesity in adults without diabetes. At or under a willingness-to-pay threshold of $150,000 per QALY, subcutaneous tirzepatide was most cost-effective, surpassing oral semaglutide. These findings provide valuable insights for health care decision-makers in selecting antiobesity medications.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 5","pages":"441-450"},"PeriodicalIF":2.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144028943","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 influence of medication adherence on Medicare Star Ratings: A decade-long analysis of health plan performance.","authors":"Eric P Borrelli, Peter Saad, Nathan Barnes, Julia D Lucaci","doi":"10.18553/jmcp.2025.31.5.512","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.5.512","url":null,"abstract":"<p><strong>Background: </strong>The Medicare Star Ratings Program, managed by the Centers for Medicare & Medicaid Services, assesses Medicare health plan performance. This program consists of quality measures that evaluate plan performance for both Medicare Part C and Part D, including 3 key medication adherence measures.</p><p><strong>Objective: </strong>To assess the potential relationship between performance on medication adherence measures and overall star rating performance for Medicare Advantage (MA) health plans.</p><p><strong>Methods: </strong>An analysis was conducted using annual Medicare Star Rating health plan performance data from 2015 to 2024 to assess the impact of performance on medication adherence measures on health plan overall star rating. Numerical percentages were calculated to assess the rates of a health plan achieving at least a 4-star overall rating if they achieved 4 or more stars, as well as a 5-star rating on each medication adherence measure or composite measure.</p><p><strong>Results: </strong>From 2015 to 2024, 4,213 health plan contracts received a star rating, of which 2,076 achieved at least a 4-star overall rating (49.3%). For plans achieving at least 4 stars on the medication adherence measures, 70%-74% of them also achieved at least a 4-star overall summary rating, depending on the specific measure. Among plans achieving 5 stars on any adherence measure, 85%-90% of them achieved at least a 4-star overall rating.</p><p><strong>Conclusions: </strong>Assessing a decade of the Medicare Star Rating performance data showed that MA health plans that performed well on the medication adherence measures also had a high rate of achieving a 4-star overall rating. Future research should explore the interplay between medication adherence measures and other Medicare Star Rating criteria.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 5","pages":"512-519"},"PeriodicalIF":2.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986145","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":"Assessing variation in US payer coverage of anti-vascular endothelial growth factor therapies for the treatment of age-related macular degeneration, diabetic retinopathy, and diabetic macular edema.","authors":"James D Chambers, Molly T Beinfeld, Terry Richardson, Michael Pangrace","doi":"10.18553/jmcp.2025.24340","DOIUrl":"10.18553/jmcp.2025.24340","url":null,"abstract":"<p><strong>Background: </strong>Timely anti-vascular endothelial growth factor (anti-VEGF) therapy is recommended to preserve vision in age-related macular degeneration (AMD), diabetic retinopathy (DR), and diabetic macular edema (DME). Coverage of anti-VEGF agents for the treatment of retinal diseases varies, resulting in administrative burdens for providers and treatment delays for patients.</p><p><strong>Objective: </strong>To examine how US commercial and Medicare Advantage (MA) health plans cover anti-VEGF therapies for the treatment of retinal diseases using information from the Tufts Medical Center Specialty Drug Evidence and Coverage Database.</p><p><strong>Methods: </strong>This descriptive study evaluated coverage of US Food and Drug Administration (FDA)-approved anti-VEGF drugs for AMD, DR, and DME current as of April 2024 using the Specialty Drug Evidence and Coverage Database from 18 of the largest US commercial health plans and MA offerings from a subset of 6 of these plans.</p><p><strong>Results: </strong>Substantial variation exists in commercial coverage across FDA-approved anti-VEGF therapies for AMD, DR, and DME. Descriptive assessment showed that approximately 65% of commercial coverage decisions and approximately 52% of MA decisions included restrictions beyond the FDA label. Coverage decisions for originator products were more likely to include restrictions compared with those for biosimilar products. Step therapy protocols were found in up to 75% of plans but were variable by drug, with most requiring a first-line trial of bevacizumab. Evidence cited to support coverage restrictions was likewise variable.</p><p><strong>Conclusions: </strong>Descriptive data show that US commercial and MA coverage and step therapy protocols vary substantially across health plans, which may potentially contribute to administrative burdens and treatment delays.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"451-460"},"PeriodicalIF":2.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039497/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772458","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":"Changes in blood pressure, medication adherence, and cardiovascular-related health care use associated with the 2018 angiotensin receptor blocker recalls and drug shortages among patients with hypertension.","authors":"Katherine Callaway Kim, Eric T Roberts, Julie M Donohue, Chester B Good, Lindsay M Sabik, Joshua W Devine, Mina Tadrous, Katie J Suda","doi":"10.18553/jmcp.2025.31.5.461","DOIUrl":"https://doi.org/10.18553/jmcp.2025.31.5.461","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;One of the largest-ever retail drug shortages began in 2018 when several angiotensin II receptor blockers (ARBs) for treating hypertension, heart failure, and chronic kidney disease-valsartan, losartan, and irbesartan-were recalled for carcinogenic impurities. The long-term consequences of the ARB shortages and whether certain groups experienced more adverse outcomes is unknown.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate changes in adherence and health outcomes after ARB recalls and to identify patients who experienced greater changes in access and adverse clinical outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using an integrated claims and electronic health record dataset and a difference-in-differences design, we evaluated changes in the proportion of days covered (PDC) for ARBs and similar drugs (angiotensin-converting enzyme inhibitors [ACE-Is]), uncontrolled blood pressure, major cardiovascular event (MACE)-related acute care visits, and all-cause ambulatory care visits in the 12 months before vs 18 months after recalls for valsartan, losartan, and irbesartan users vs patients taking similar, nonrecalled drugs (ACE-Is, nonrecalled ARBs). Triple-difference models characterized heterogeneous associations by pre-recall patient demographic (race, ethnicity, age), clinical (baseline indication, mental health conditions), and adherence variables.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Adjusting for pre-recall patient characteristics, we observed no significant changes in PDC for ARBs and ACE-Is (combined), uncontrolled blood pressure, or ambulatory care visits among 86,507 recalled ARB users vs 123,583 comparison drug users in the 18 months after the recalls. Following the recalls, medication switches increased on average by an additional 2.08 percentage points (p.p.) per quarter (95% CI = 2.01-2.15) for recalled ARB vs comparison drug users, a 195.9% relative increase. We observed the most switches in the 90-day period immediately after valsartan's recall (difference-in-difference: 9.48 p.p.; 95% CI = 9.36-9.59; relative change = 892%). Cumulatively, 55.2% of valsartan, 7.6% of losartan, and 18.9% of irbesartan users switched medications after 18 months. We observed an increase in the proportion of recalled ARB vs comparison patients who experienced medication gaps exceeding 30 days (1.13 p.p. per quarter on average; 95% CI = 0.97-1.30), which was most apparent after approximately 15 months (5 quarters). Although MACE-related acute care visits did not change in the quarter (90 days) immediately after valsartan's recall, we observed an increase of 1.40 additional visits per 1,000 recalled ARB vs comparison drug patients in each subsequent quarter, a 9.3% relative increase. Results were similar across most subgroups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The 2018 ARB recalls were associated with immediate changes in antihypertension medication use. Many patients transitioned to alternative medications. Although overall impacts","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 5","pages":"461-471"},"PeriodicalIF":2.3,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039498/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144064077","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}