Journal of managed care & specialty pharmacy最新文献

{"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":"https://doi.org/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":"1-10"},"PeriodicalIF":2.3,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between statin discontinuation after proprotein convertase subtilisin/kexin type 9 inhibitor initiation and subsequent atherosclerotic cardiovascular disease events.","authors":"Samuel K Peasah, Tiffany Lee, Duy Do, Yan Huang, Angela Inneh, Urvashi Patel, Aryan N Aiyer, Chester B Good","doi":"10.18553/jmcp.2025.31.4.377","DOIUrl":"10.18553/jmcp.2025.31.4.377","url":null,"abstract":"<p><strong>Background: </strong>Clinical guidelines recommend the use of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) in patients with atherosclerotic cardiovascular disease (ASCVD) and nonoptimal low-density lipoprotein.</p><p><strong>Objective: </strong>To evaluate the association between discontinuation of statin use after PCSK9i initiation and subsequent ASCVD events.</p><p><strong>Methods: </strong>This pre-post retrospective comparative study used national administrative data of adult statin medication users (age ≥18 years) with an index PCSK9i claim (January 1, 2019, to April 30, 2021), prior ASCVD diagnosis, and a 2-year follow-up period. Proportions and probability of ASCVD events post-index (PCSK9i) vs pre-index (PCSK9i) for patients who discontinued statins (discontinued cohort) and those who continued statins (continued cohort) were compared. Propensity score weighting was used to balance patient baseline characteristics. Multivariate Poisson regression and time-to-event Cox regression models were used to assess the association between statin discontinuation and ASCVD events.</p><p><strong>Results: </strong>There were 294 and 46 patients in the continued and discontinued cohorts, respectively. Unweighted results showed that patients in the continued cohort were more likely to receive high-intensity statins (32% vs 22%; <i>P</i> = 0.4) and have a Charlson Comorbidity Index score of 3 or more (62% vs 54%; <i>P</i>  =  0.5) at baseline. Baseline statin adherence was lower in the discontinued cohort (6.7% vs 59%; <i>P</i> < 0.001) but 30% each in the propensity 1:1 matched cohort. The 2 cohorts (after matching) had similar ASCVD event prevalence (discontinued cohort: 24% vs continued cohort: 26%) in the baseline and the same lower prevalence (6.5% each; <i>P</i> > 0.9) in the 24-month follow-up period. The odds of any ASCVD event post-index was comparable between the 2 cohorts (reference: continued cohort; odds ratio = 1.88; 95% CI = 0.28-14.6; <i>P</i> = 0.51). There were no statistically significant differences between the 2 groups in the Cox regression (<i>P</i> = 0.47).</p><p><strong>Conclusions: </strong>Post-ASCVD event rates were significantly lower in both cohorts, but discontinuation of statins was not associated with unfavorable ASCVD outcomes.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"377-385"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730305","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":"Economic impact of sotagliflozin among patients with heart failure and type 2 diabetes: Budget impact analysis from the US payer perspective.","authors":"Jason Shafrin, Shanshan Wang, Jaehong Kim, Slaven Sikirica","doi":"10.18553/jmcp.2025.31.4.386","DOIUrl":"10.18553/jmcp.2025.31.4.386","url":null,"abstract":"<p><strong>Background: </strong>Heart failure (HF) is a leading cause of mortality in the United States, often complicated by comorbidities like diabetes mellitus. These patients face high hospitalization risks, impacting clinical outcomes and health care resources. The Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) trial showed that sotagliflozin, a sodium-glucose cotransporter inhibitor, reduced rehospitalizations in patients with HF and diabetes mellitus. Although clinically beneficial, the economic impact of sotagliflozin from a payer perspective remains unclear, warranting further pharmacoeconomic analysis to guide managed care decisions.</p><p><strong>Objective: </strong>To quantify the budget impact of sotagliflozin for US payers over a 5-year time horizon.</p><p><strong>Methods: </strong>A payer-perspective budget impact model was developed to assess the financial impact of incorporating sotagliflozin for the treatment of patients recently hospitalized for HF with comorbid type 2 diabetes (T2D) over 5 years to US payer health plans. The study used a population reflecting the SOLOIST-WHF clinical trial, with economic parameters adjusted by payer mix (all payer, commercial, Medicare, and Medicaid). Health care resource utilization included hospitalization, emergency department (ED) visit, and adverse events' care. Economic outcomes examined the medical and pharmacy budget impact for payers at the per-user, per member per month (PMPM), and total plan costs levels.</p><p><strong>Results: </strong>For a hypothetical 1-million-member all-payer plan, 1,516 patients hospitalized for HF with comorbid T2D would be eligible for sotagliflozin. For all-payer plans, annual per-user costs increased by $4,996 because of higher pharmacy costs ($8,260) but were partially offset by lower medical costs (-$2,608) because of reduced rehospitalization and ED visits from sotagliflozin. PMPM total budget impact of sotagliflozin would be $0.08 PMPM in year 1 and $0.38 in year 5, corresponding with total plan cost of $75,736 in year 1 and $378,681 by year 5. Commercial payer PMPM costs were lower ($0.02 in year 1; $0.11 in year 5), and higher for Medicare ($0.23 PMPM in year 1, increasing to 1.13 PMPM in year 5). Breakeven rebate rates ranged between 31.5% and 79.4%.</p><p><strong>Conclusions: </strong>Although sotagliflozin increases pharmacy costs for recently hospitalized HF patients with T2D, approximately 21%-68% of pharmacy costs were offset from reduced rehospitalization and ED visits.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"386-395"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730308","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 direct costs incurred over 12 months by patients with migraine initiating self-injectable calcitonin gene-related peptide monoclonal antibodies: A US real-world study.","authors":"Oralee J Varnado, Brenna Brady, Anthony Zagar, Yvonne Robles, Alan Ó Céilleachair, Margaret Hoyt","doi":"10.18553/jmcp.2025.31.4.351","DOIUrl":"10.18553/jmcp.2025.31.4.351","url":null,"abstract":"<p><strong>Background: </strong>Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are approved for migraine prevention. Limited information is available comparing the health care resource utilization (HCRU) and direct costs associated with initiating different CGRP mAbs.</p><p><strong>Objective: </strong>To compare all-cause and migraine-related HCRU and direct costs in US patients with migraine initiating the self-injectable CGRP mAbs, galcanezumab, fremanezumab, or erenumab.</p><p><strong>Methods: </strong>This retrospective cohort study used data from Merative Marketscan Commercial and Medicare Databases. Adults with at least 1 claim (first claim=index) for the above CGRP mAbs between May 2018 and September 2020 (index period), with continuous enrollment for 12 months pre-index (baseline [BL]) and post-index (follow-up [FU]) were included. Patients with a claim for index drug during BL were excluded. Mean HCRU and mean total costs (inpatient, outpatient, and outpatient pharmacy costs) were evaluated over 12 months post-index. Propensity score matching was used to balance the galcanezumab vs fremanezumab (2:1) and galcanezumab vs erenumab (1:1) cohorts. <i>P</i> values of <0.05 were considered statistically significant.</p><p><strong>Results: </strong>After matching, patient demographics and clinical characteristics were similar between galcanezumab vs fremanezumab (n=2,674 sets) and galcanezumab vs erenumab (n=3,503 sets) cohorts. Relative to BL, numerically lower all-cause and migraine-related HCRU (inpatient and outpatient visits) were observed in all cohorts over the 12-month post-index period, whereas outpatient pharmacy HCRU was numerically higher. All-cause and migraine-related total costs (mean) were higher over the FU period in all cohorts (all <i>P</i> < 0.001). Mean all-cause and migraine-related cost increases were numerically similar for galcanezumab vs fremanezumab ($503 vs $518 [<i>P</i>=0.825] and $467 vs $468 [<i>P</i>=0.990]), and for galcanezumab vs erenumab ($504 vs $499 [<i>P</i>=0.934] and $462 vs $443 [<i>P</i>=0.375]). Outpatient pharmacy costs contributed greatly to migraine-related costs, whereas all-cause costs were greatly driven by outpatient costs.</p><p><strong>Conclusions: </strong>HCRU and direct cost differences observed at 12 months following initiation of self-injectable CGRP mAbs for migraine prevention were numerically similar across cohorts for patients treated with galcanezumab, fremanezumab, and erenumab. More work should be done to learn if these drugs perform differently with respect to other important factors not examined here.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"351-365"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730355","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":"Determining health care cost drivers in older Hodgkin lymphoma survivors using interpretable machine learning methods.","authors":"Zasim Azhar Siddiqui, Yves Paul Mbous, Sabina Nduaguba, Traci LeMasters, Virginia G Scott, Jay S Patel, Usha Sambamoorthi","doi":"10.18553/jmcp.2025.31.4.406","DOIUrl":"10.18553/jmcp.2025.31.4.406","url":null,"abstract":"<p><strong>Background: </strong>The cost of health care for patients with Hodgkin lymphoma (HL) is projected to rise, making it essential to understand expenditure drivers across different demographics, including the older adult population. Although older HL patients constitute a significant number of HL patients, the literature on health care expenditures in older HL patients is lacking. Predictive capabilities of machine learning (ML) methods enhance our ability to leverage a data-driven approach, which helps identify key predictors of expenditures and strategically plan future expenditures.</p><p><strong>Objective: </strong>To determine the leading predictors of health care expenditures among older HL survivors across prediagnosis, treatment, and posttreatment phases of care.</p><p><strong>Methods: </strong>The study uses a retrospective research design to identify the incident cases of HL diagnosed between 2009 and 2017 using Surveillance, Epidemiology, and End Results-Medicare data. Three phases of cancer care (prediagnosis, treatment, and posttreatment) were indexed around the diagnosis date, with each phase divided into 12 months of baseline and 12 months of follow-up. ML methods, including XGBoost, Random Forest, and Cross-Validated linear regressions, were used to identify the best regression model for predicting Medicare and out-of-pocket (OOP) health care expenditures. Interpretable ML SHapley Additive exPlanations method was used to identify the leading predictors of Medicare and OOP health care expenditures in each phase.</p><p><strong>Results: </strong>The study analyzed 1,242 patients in the prediagnosis phase, 902 in the treatment phase, and 873 in the posttreatment phase. XGBoost regression outperformed Random Forest and Cross-Validated linear regression models with overall performance in predicting Medicare expenditures, with R-squared (root mean square error) values of 0.42 (1.39), 0.43 (0.56), and 0.46 (0.90) across the 3 phases of care, respectively. Interpretable ML methods highlighted baseline expenditures, number of prescription medications, and cardiac dysrhythmia as the leading predictors for Medicare and OOP expenditures in the prediagnosis phase. Chemotherapy and immunotherapy and surgical treatment and immunotherapy were the leading predictors of expenditures in the treatment and posttreatment phases, respectively.</p><p><strong>Conclusions: </strong>As ML applications increase in predicting health care expenditure, researchers should consider implementing models in different phases of care to identify the changes in the predictors. Leading predictors of health care expenditures can be targeted for informed policy development to address financial hardship in HL survivors.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"406-420"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730306","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":"Group-based trajectory modeling to identify longitudinal patterns and predictors of adherence among older adults on concomitant triple therapy (oral antidiabetic, renin-angiotensin-system antagonists, statins).","authors":"Sai S Cheruvu, Bilqees Fatima, Susan Abughosh","doi":"10.18553/jmcp.2025.31.4.396","DOIUrl":"10.18553/jmcp.2025.31.4.396","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Diabetes, hypertension, and hyperlipidemia frequently co-occur in older adults, significantly increasing their risk for cardiovascular disease, a leading cause of mortality in the United States. Managing these conditions often requires concomitant triple therapy, which includes antihypertensives, oral antidiabetics, and statins. Although medication adherence is critical for reducing cardiovascular risk, adherence to complex regimens is often suboptimal in older populations, further complicating disease management. Medicare's STAR metrics assess adherence to these medications as a measure of care quality. Traditional methods, like the proportion of days covered (PDC), provide single adherence estimates, but fail to capture the dynamic nature of adherence over time. Group-based trajectory modeling (GBTM) offers a more comprehensive approach, graphically depicting patterns of adherence behavior. This study seeks to understand longitudinal patterns and predictors of adherence of concurrent triple therapy among elderly patients under Managed Care using GBTM.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate adherence patterns to concurrent triple therapy (antidiabetic, antihypertensive, and lipid-lowering medications) among older patients using GBTM and identify predictors associated with each adherence trajectory.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Patients on concurrent triple therapy were identified using a Texas Medicare Advantage dataset from July 2016 to December 2016. Patients included had an overlap of 30 days of triple therapy, a second prescription of each component of triple therapy within the identification period, and a 12-month follow-up after the triple therapy. Monthly adherence was measured using PDC during follow-up. Patients were defined as adherent if they had at least 80% (24 out of the 30 days) covered for all 3 medications. The monthly PDC was incorporated into a logistic GBTM to provide distinct patterns of adherence. Two to five adherence groups were estimated using the second-order polynomial function of time. Predictors of adherence were identified using multinomial logistic regression, guided by the Anderson Behavioral Model.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 7,847 patients included, the following 4 distinct adherence trajectories were identified: adherent (42.5%), gaps in adherence (28.9%), gradual decline (13.4%), and rapid decline (15.3%). Female patients had higher odds of being in the gaps in adherence or rapid decline groups compared with males. Low-income subsidy recipients were less likely to experience rapid decline. Prior hospitalizations increased the likelihood of rapid decline in adherence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study identified heterogeneous adherence patterns among older adults on triple therapy for cardiovascular disease risk factors. Targeted interventions tailored to specific adherence trajectories are needed to improve medication adherence and health outcom","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"396-405"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730349","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 time is now: Addressing health inequities in the workforce.","authors":"Bruce W Sherman, Brian Sils, Kimberly Westrich","doi":"10.18553/jmcp.2025.31.4.421","DOIUrl":"10.18553/jmcp.2025.31.4.421","url":null,"abstract":"<p><p>As a major provider of health insurance for working-age Americans, employers can play a significant role in improving the health equity of their employees and family members. In this commentary, we describe how different stakeholders, including employers, their employees, clinicians, and health systems and health plans, each contribute to the observed inequities. Other systems-level factors, including racism, implicit bias, medical mistrust, health literacy limitations, and health care access and affordability concerns have been also shown to contribute to inequitable outcomes. Opportunities exist for employers to improve health equity among their benefits-enrolled employees and family members using data-driven approaches to ensure that benefits are more equitable in scope, access, and affordability. As an illustrative example of employer strategic considerations, we describe opportunities to identify and address inequities in prescription medication use. Additionally, employers can, and perhaps should, advocate for transparency in community-based health system and health plan reporting regarding health inequities and progress toward more equitable health care utilization and outcomes. Employers can also advocate for the delivery of more patient-centered, systems-based solutions, such as enhanced primary care and/or worksite clinics, and give consideration to establishing health equity performance-based incentives in their health care contracting. Further research in the employer setting can help to expand the adoption of a best-practices approach to achieving more equitable health outcomes.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"421-427"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730271","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":"Frequency of first generic drugs approved through \"skinny labeling,\" 2021 to 2023.","authors":"Therese J Ziaks, Chukwubuikem M Akanegbu, Alexander C Egilman, Aaron S Kesselheim","doi":"10.18553/jmcp.2025.31.4.343","DOIUrl":"10.18553/jmcp.2025.31.4.343","url":null,"abstract":"<p><strong>Background: </strong>Brand-name drug manufacturers receive a market exclusivity period following US Food and Drug Administration (FDA) approval, which can be extended through obtaining additional patents such as method-of-use patents. The skinny labeling pathway, in which the FDA approves generic prescriptions that carve out patent-protected indications from their labeling, has helped promote competition and timely market entry of low-cost generic prescriptions for many decades.</p><p><strong>Objective: </strong>To determine how the use of the skinny labeling pathway by generic prescription drug manufacturers has changed in recent years.</p><p><strong>Methods: </strong>Based on FDA-curated lists, we assessed the proportion of FDA-approved first generic prescriptions using the skinny labeling pathway from 2021 to 2023. We also examined whether the use of the pathway changed after a 2021 federal court decision (<i>GlaxoSmithKline v. Teva</i>) increased the risk of legal liability for generic manufacturers marketing skinny label generic prescriptions.</p><p><strong>Results: </strong>From 2021 to 2023, 42.9% of 21 susceptible brand-name drugs required a skinny labeled generic prescription, including 5 (56%) in 2021, 3 (43%) in 2022, and 1 (20%) in 2023.</p><p><strong>Conclusions: </strong>Previous literature found 43% of brand-name drugs experienced skinny labeling generic prescription competition in a 2015-2019 sample, which is consistent with the rate of skinny labeled generic prescription entry early in our sample. Then, the proportion of first generic prescriptions approved with a skinny label decreased annually from 2021 to 2023. Applying this 2021 <i>GlaxoSmithKline v. Teva</i> methodology in subsequent years can help determine whether the judicial decision has had a sustained chilling effect on generic prescription manufacturers' use of skinny labeling, resulting in delayed generic prescription competition as a result of fewer generic prescriptions entering the market.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"343-350"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730310","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":"Limited utility of price transparency data for drugs.","authors":"Yuvraj Pathak, Elvira Makk Frid, Nico Gabriel, Shangbin Tang, Inmaculada Hernandez","doi":"10.18553/jmcp.2025.31.4.338","DOIUrl":"10.18553/jmcp.2025.31.4.338","url":null,"abstract":"<p><p>Since 2021, hospitals have been required to report the prices of common, shoppable services, including drugs, as per the Hospital Price Transparency Rule. In this paper, we used Hospital Price Transparency data aggregated by Turquoise Health to investigate the usability of price transparency data to evaluate variation in reimbursement for provider-administered drugs. We extracted records for 30 procedure codes corresponding to provider-administered drugs reported by at least 1,000 National Provider Identifiers (NPIs) and evaluated variability in rates reported for each procedure code. Among 3,321,502 records extracted, 65% had missing NPI, reimbursement rate, or National Drug Code (NDC) information. The remaining 35% of entries reporting NDC information did not necessarily report negotiated rates in the quantity of the NDC. Instead, they contained a combination of prices expressed in at least 3 different quantities: the quantity in which the procedure code is expressed, the unit of the NDC, and the total quantity of drugs administered to the patient. Until providers follow standardized requirements for the reporting of the data, the Hospital Price Transparency data should be used with caution, as the inability to correctly identify the unit in which prices are expressed can lead to incorrect inferences about drug prices.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4","pages":"338-342"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11953851/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730360","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":"Transforming retinal disease management through diabetes care.","authors":"Catherine M Lockhart, Mark R Barakat, Jeffrey D Dunn, Terry Richardson, Tori Bratcher, Estay Greene, Michael Kobernick, Doron Schneider, Jeremy Wigginton","doi":"10.18553/jmcp.2025.31.4-a.s1","DOIUrl":"10.18553/jmcp.2025.31.4-a.s1","url":null,"abstract":"<p><p>In September 2024, AMCP and Impact Education, LLC, held a virtual Market Insights summit with chief medical and pharmacy officers and other senior health care executives to discuss the management of retinal diseases in patients with diabetes. The summit aimed to explore the impact of current policies on treatment access and costs, identify best practices for anti-vascular endothelial growth factor (anti-VEGF) coverage, and address barriers related to social determinants of health (SDOH). Anti-VEGF therapy, although effective for conditions such as diabetic macular edema and age-related macular degeneration, may require monthly injections that impose a significant burden on patients and caregivers, affecting adherence and outcomes. Key topics included examining the impact of current policies on treatment access and total cost of care, exploring opportunities for management of patients at increased risk for blindness, outlining the benefits of durable treatment approaches, addressing strategies to overcome access barriers related to SDOH, and identifying best practices in coverage policies for anti-VEGF agents. Strategies for addressing barriers to care were explored, including the potential use of gold carding, contingent on establishing clearer definitions of good care in retinal disease management, understanding prescribing variation, gaining standardized of definitions or guidelines for good\" care, and practical strategies for using extended dosing to support adherence and access. Health care executives reached agreement on the central role of ophthalmologists in preventing blindness in patients with diabetes and retinal diseases and the importance of timely access to appropriate treatments.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"31 4-a Suppl","pages":"S1-S11"},"PeriodicalIF":2.3,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143730281","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}