Journal of managed care & specialty pharmacy最新文献

{"title":"Estimating the economic impact of blister-packaging on medication adherence and health care costs for a Medicare Advantage health plan.","authors":"Eric P Borrelli, Peter Saad, Nathan Barnes, Doina Dumitru, Julia D Lucaci","doi":"10.18553/jmcp.2024.24179","DOIUrl":"10.18553/jmcp.2024.24179","url":null,"abstract":"<p><strong>Background: </strong>Medication nonadherence is a persistent challenge in the United States, leading to increased health care resource utilization (HCRU) and health care costs and worsened health outcomes. Medicare Star Ratings is a program developed by the Centers for Medicare and Medicaid Services (CMS) to evaluate Medicare health plan quality and performance. Three of the Medicare Part D Star Ratings quality measures assess medication adherence, showing the importance CMS places on improving medication adherence in older adults. Although a variety of medication adherence-enhancing interventions are available to help promote adherence among patients, one intervention that has shown success historically is blister-packaging.</p><p><strong>Objective: </strong>To model the potential impact of blister-packaging chronic medications on HCRU and health care costs in the Medicare population.</p><p><strong>Methods: </strong>An economic model was developed to assess the potential impact of blister-packaging the 3 Medicare Star Ratings adherence measure medication classes: renin-angiotensin system antagonists (RASAs), statins, and noninsulin antidiabetics. The model perspective was that of a hypothetical Medicare Advantage health plan with a plan size of 100,000 members. A 12-month time horizon was used in the model. The dichotomous adherence threshold in the model was set at 80% or greater of the proportion of days covered (PDC). Literature-based references were used to inform both the impact of blister-packaging on the number of patients who become adherent as well as the impact of medication adherence on HCRU and health care costs for each of the medication classes. One-way sensitivity analyses and several scenario analyses were conducted to assess model uncertainty.</p><p><strong>Results: </strong>Owing to increased adherence from the blister-packaging intervention, the hypothetical health plan in the analysis saw 776 additional members adherent to RASAs, 1,651 additional members adherent to statins, and 414 additional members adherent to oral antidiabetics. Although medication expenditure increased for all 3 medication classes (RASAs: $274,963; statins: $730,083; oral antidiabetics: $100,529), medical costs decreased across all classes (RASAs: -$4,098,848; statins: -$5,549,699; oral antidiabetics: -$917,968). Total net health care costs decreased by $3,823,885 for RASAs (-$3.19 per member per month [PMPM]), $4,819,616 for statins (-$4.02 PMPM), and $817,438 for oral antidiabetics (-$0.68 PMPM). The entire Medicare Advantage population scenario analysis saw reductions in total health care costs of $1,081,394,737 for RASAs, $1,362,987,376 for statins, and $231,171,496 for oral antidiabetics.</p><p><strong>Conclusions: </strong>Dispensing chronic medications with blister-packaging for Medicare Advantage health plan patients was modeled to reduce HCRU and health care costs. Future studies are needed to assess whether the impact of blister-pack","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"1442-1454"},"PeriodicalIF":2.3,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11607205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289237","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":"Drugs anticipated to be selected for the Medicare Drug Price Negotiation Program in 2025.","authors":"Emma M Cousin, Sean D Sullivan, Ryan N Hansen, Nico Gabriel, Ayuri S Kirihennedige, Inmaculada Hernandez","doi":"10.18553/jmcp.2024.24167","DOIUrl":"10.18553/jmcp.2024.24167","url":null,"abstract":"<p><strong>Background: </strong>The Centers for Medicare and Medicaid Services (CMS) recently announced the Maximum Fair Price for the first 10 Medicare Part D drugs selected for price negotiation. By February 2025, CMS should announce the list of Part D drugs to be negotiated with implementation of the negotiated prices in 2027.</p><p><strong>Objective: </strong>To identify up to 15 Medicare Part D single-source drugs anticipated to be selected by CMS for price negotiation in 2025.</p><p><strong>Methods: </strong>We followed selection criteria identified in the Inflation Reduction Act and CMS guidance to identify drugs. We projected 2023 Part D gross spending using 2020-2022 data reported by CMS and linear prediction models. We ranked products according to the projected spending figure and identified those not eligible for selection because of (1) number of years since approval, (2) availability of a biosimilar or generic version, (3) approval for a single orphan indication, (4) whole human blood or plasma-derived, or (5) eligibility for the small biotech exception.</p><p><strong>Results: </strong>We identified 13 products likely subject to Medicare drug price negotiation, including 4 anticancer therapies, 3 noninsulin antidiabetic products, 2 inhalers, 1 antifibrotic therapy, 1 gastrointestinal agent, 1 enzyme replacement therapy, and 1 product indicated for dyskinesia. These 13 products each had projected annual gross Part D spending more than $1 billion. We identified 7 additional products with uncertainty to complete the list of 15, including an insulin, an antiviral, an antibiotic, an immunologic agent, an antidiabetic, and 2 cancer drugs. These products had projected gross Part D spending between $877 million and $1.399 billion. Twenty-two products with comparable levels of spending were deemed ineligible for selection because of availability of a generic or biosimilar version (10 products), insufficient years since approval (8 products), eligibility for the small biotech exception (3 products), and expected market discontinuation (1 product).</p><p><strong>Conclusions: </strong>Our identification of products anticipated to be selected for negotiation in 2025 (with implementation of negotiated prices in 2027) will help inform manufacturers, payers, patients, and policymakers of the products that will likely see a decrease in Medicare drug prices as result of negotiation. We identified 22 products with levels of spending that are comparable with those anticipated to be selected for negotiation but are not eligible, primarily because of generic or biosimilar availability or insufficient time on market.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"1203-1210"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142289236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AMCP Partnership Forum: Patient input and payer decision-making.","authors":"","doi":"10.18553/jmcp.2024.30.11.1329","DOIUrl":"10.18553/jmcp.2024.30.11.1329","url":null,"abstract":"<p><p>There has been growing consensus for the health care community to become more patient centered by considering patient needs, preferences, and values in decision-making. To advance partnership between payers and patient representatives to gather patient input and incorporate their perspective on the broad range of managed care pharmacy decisions, the AMCP held a multistakeholder Partnership Forum on December 6 and 7, 2023, in Alexandria, Virginia. Forum participants were asked to (1) identify opportunities for patient representatives to engage with payers and other managed care pharmacy decision-makers, (2) recognize challenges and propose potential solutions to establish patient engagement programs between payers and patient representatives, and (3) review and provide input on draft frameworks created by the 2023-24 AMCP Patient Voice Advisory Group. Key themes that emerged from the participant discussion included to assemble and draw upon successful examples and best practices, recognize different levels of engagement, build trust and relationships proactively, create defined access points and open dialogue channels, incorporate the patient perspective as an element of coverage decision-making, leverage existing patient data and reports, crystallize a key message furthering common goals, and facilitate ongoing education and learning.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1329-1336"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545860","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":"Stakeholder insights on cost, quality, and incorporating patient voice in managed care decisions on neovascular (wet) age-related macular degeneration: Findings from the AMCP Market Insights program.","authors":"Bridget Flavin, Andrew Schimel, Zachary Contreras, Michael H Shannon, Justin Bioc","doi":"10.18553/jmcp.2024.30.11-a.s1","DOIUrl":"10.18553/jmcp.2024.30.11-a.s1","url":null,"abstract":"<p><p>Wet age-related macular degeneration (AMD) is an acquired degeneration of the retina that can lead to central vision impairment. It is primarily treated with intravitreal injections of vascular endothelial growth factor inhibitors. Although vascular endothelial growth factor inhibitors can effectively prevent progression of vision loss in many patients, they require ongoing regular administration and are therefore associated with considerable treatment burden. To gain insights into the impact of wet AMD and its treatment, AMCP convened an expert panel of managed care stakeholders in April 2024 through its Market Insights program. Key issues related to wet AMD identified by participants included cost and affordability, provider-related considerations, biosimilar adoption, measuring and improving quality, and incorporating the patient voice. Suggested payer best practices related to these issues in wet AMD also emerged from the discussion.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11-a Suppl","pages":"S1-S9"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529448/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545880","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 across stages of amyotrophic lateral sclerosis in the United States.","authors":"Katie Stenson, Sheena Chew, Shaobin Dong, Kim Heithoff, Min-Jung Wang, Jeffrey Rosenfeld","doi":"10.18553/jmcp.2024.30.11.1239","DOIUrl":"10.18553/jmcp.2024.30.11.1239","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;People living with ALS (plwALS) experience motor control loss, speech/swallowing difficulties, respiratory insufficiency, and early death. Advancing disease stage is typically associated with a greater burden on the health care system, and delays in diagnosis can result in substantial health care resource utilization (HCRU).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To estimate HCRU and cost burden of plwALS across disease stages from a US payer perspective we assessed HCRU and costs in early-, mid-, and late-stage ALS.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using insurance claims data from the IBM MarketScan Databases between January 2013 and December 2019, we identified plwALS as having at least 2 claims at least 27 days apart with an ALS &lt;i&gt;International Classification of Diseases, Ninth&lt;/i&gt; or &lt;i&gt;Tenth Revision&lt;/i&gt; diagnosis code (335.20/G12.21) or at least 1 ALS diagnosis code and prescription filled for riluzole/edaravone. Eligible plwALS were aged at least 18 years and had at least 12 months of enrollment data before and at least 6 months after the index date (date diagnosis criteria met). plwALS were grouped into disease stages using an ALS severity-based staging algorithm developed using ALS symptom and staging survey data from 142 neurologists reporting on 880 plwALS. The starting date of each severity stage was defined as the first date of an ALS symptom within the early-, mid-, and late-stage categories, respectively. The ending date for a severity stage was defined as the day before the first date of an ALS symptom from a more severe category. plwALS could transition to more severe stages, with reverse transition of severity excluded. Mixed regression modeling was used to assess differences in HCRU and costs per person-year between severity stages, adjusted for age and sex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;2,273 plwALS were included in the total ALS study sample, with 1,215 early-stage, 1,511 midstage, and 1,186 late-stage plwALS. 90% of early-stage plwALS had ALS symptoms before diagnosis, and 27% of late-stage plwALS had a late-stage symptom before diagnosis. In the evaluation period, later-stage ALS groups had more overall hospital admissions (early = 0.15, middle = 0.23, and late = 0.74; &lt;i&gt;P&lt;/i&gt; &lt; 0.01), outpatient visits/service (early = 26.81, middle = 32.78, and late = 48.54; &lt;i&gt;P&lt;/i&gt; &lt; 0.01), emergency department visits (early = 0.46, middle = 0.69, and late = 1.03; &lt;i&gt;P&lt;/i&gt; &lt; 0.01), and total prescription count (early = 9.23, middle = 11.37, and late = 12.72; &lt;i&gt;P&lt;/i&gt; &lt; 0.01) over 12 months. Annualized costs increased as ALS progressed (early = $31,411, middle = $51,481, and late = $121,903; &lt;i&gt;P&lt;/i&gt; &lt; 0.01), which was primarily driven by higher frequency of and cost per hospital admission.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;HCRU and costs increased with ALS progression, with diagnosis frequently occurring even after experiencing late-stage symptoms. These findings highlight the potential value of delaying ","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1239-1247"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545863","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":"Budget impact analysis of including biosimilar adalimumab on formulary: A United States payer perspective.","authors":"Stephen Chaplin, Joris van Stiphout, Anna Chen, Edward Li","doi":"10.18553/jmcp.2024.24036","DOIUrl":"10.18553/jmcp.2024.24036","url":null,"abstract":"<p><strong>Background: </strong>The biosimilar market is growing rapidly, as evidenced by 41 approvals and 37 launches to date. As adalimumab biosimilars launch in the United States, competition among biosimilar and reference adalimumab will likely increase across multiple reference indications, including rheumatology, dermatology, and gastrointestinal diseases, which may lead to decreased payer costs.</p><p><strong>Objective: </strong>To evaluate the costs of adding biosimilar adalimumab to a US commercial plan by exploring various utilization and price differential scenarios.</p><p><strong>Methods: </strong>A 3-year budget impact model for a US commercial plan of 1 million people was developed to assess switching from reference adalimumab or any self-injectable reference tumor necrosis factor (TNF) inhibitor to biosimilar adalimumab. Pharmacy and medical costs were analyzed through high- and low-conversion scenarios from reference adalimumab and the TNF inhibitor class. Price reductions of 5% to 60% relative to reference adalimumab based on previous biosimilar launches were also explored. Short-term medical costs were evaluated as additional simple and complex office visits, with scenarios of half of switch patients having 1 visit up to all switch patients having 10 visits.</p><p><strong>Results: </strong>In a target population of 1,863 patients, switching from reference adalimumab to biosimilar adalimumab had cumulative cost savings of $5,756,073 with slow conversion (10%-20% over 3 years) and $28,780,365 with fast conversion (50%-100% over 3 years). Similar results were seen when switching from any other self-injectable reference TNF inhibitor. Cost savings more than $1 million were seen with a 10% conversion from reference adalimumab and a 15% price reduction from reference adalimumab. Additional office visit scenarios had a negligible impact on budget, with no changes in per-member-per-month costs until all switch patients had 10 additional complex visits, in which per-member-per-month costs increased by $0.02.</p><p><strong>Conclusions: </strong>In a hypothetical plan of 1 million lives, use of biosimilar adalimumab in commercial plans can lead to significant cost savings for payers because of increased competition. Greater and faster biosimilar conversion rates from reference adalimumab and other reference TNF inhibitors resulted in decreased costs. Additionally, even with short-term medical expenditures, cost savings were still realized when switching to biosimilar adalimumab.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"1226-1238"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141766249","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":"Patient-reported disability progression outcomes among patients with multiple sclerosis: Results of an outcomes-based agreement.","authors":"Elizabeth C S Swart, Samuel K Peasah, Jacqueline Alderson, RaeAnn Maxwell, Chronis Manolis, Chester B Good","doi":"10.18553/jmcp.2024.30.11.1211","DOIUrl":"10.18553/jmcp.2024.30.11.1211","url":null,"abstract":"<p><strong>Background: </strong>Outcomes-based agreements (OBAs) are agreements between payers and manufacturers in which payment for medications is tied to patient outcomes. These contracts aim to measure the value of prescription medications on predefined clinical indicators in real-world patient populations. OBAs are gaining traction in the United States as the health care industry shifts from volume-based to value-based care. Multiple sclerosis (MS) is an appealing therapeutic area for OBAs because of its prevalence, high cost of medications, and multiple effective therapeutic options.</p><p><strong>Objective: </strong>To describe findings from an OBA that was prospectively conducted in a large regional health system for patients with MS taking interferon β-1a or dimethyl fumarate.</p><p><strong>Methods: </strong>In this prospective real-world analysis, commercial or health insurance exchange members were included based on the parameters of the OBA. Disability progression was assessed using a patient-reported outcome, patient-determined disease steps (PDDS). In the OBA, members aged 18 years or older with an MS diagnosis were included in the contract. A baseline score was collected for eligible members, with follow-up scores occurring between a 90-day and 180-day postbaseline score. If a follow-up score was greater than the baseline score, a subsequent PDDS score was collected between 90-days and 120-days to determine if the PDDS score remained elevated, indicating that the member had disability progression.</p><p><strong>Results: </strong>During the contract period, 410 patients were eligible for PDDS collection, with 241 and 169 patients in the dimethyl fumarate and interferon β-1a cohorts, respectively. There were 162 patients who were lost to follow-up, and 64 patients who were ineligible per contract parameters. Of the remaining 184 eligible patients (107 on dimethyl fumarate and 77 on interferon β-1a), 21 (11%) patients had confirmed disability progression (6 on dimethyl fumarate [5.6%] and 15 on interferon β-1a [19.5%]).</p><p><strong>Conclusions: </strong>Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1211-1216"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522456/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545875","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 ensifentrine for the treatment of chronic obstructive pulmonary disease.","authors":"Abigail C Wright, Grace A Lin, Melanie D Whittington, Avery McKenna, Finn Raymond, David M Rind, Foluso Agboola","doi":"10.18553/jmcp.2024.30.11.1338","DOIUrl":"10.18553/jmcp.2024.30.11.1338","url":null,"abstract":"","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1338-1342"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545878","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":"Comorbid depression and anxiety and their association with health care resource utilization among individuals with type 1 diabetes in the United States.","authors":"Yueh-Yi Chiang, Susan dosReis, Charmaine Rochester-Eyeguokan, Eberechukwu Onukwugha","doi":"10.18553/jmcp.2024.30.11.1288","DOIUrl":"10.18553/jmcp.2024.30.11.1288","url":null,"abstract":"<p><strong>Background: </strong>Type 1 diabetes mellitus (T1DM) is a prevalent chronic endocrine disorder and accounts for 5%-10% of all diabetes cases worldwide. T1DM can have a substantial impact on health care utilization. Although it is well known that individuals with diabetes are at a greater risk of mental health disorders, specific evidence addressing the health care burden of comorbid depression/anxiety in people affected by T1DM is lacking.</p><p><strong>Objective: </strong>To assess health care resource utilization (HCRU) among adults with T1DM and comorbid depression or anxiety.</p><p><strong>Methods: </strong>We identified individuals aged 18 to 64 with a T1DM diagnosis from January 1, 2017, to December 31, 2021, using a 25% random sample of the IQVIA PharMetrics Plus for Academics database. The index date was the date of the first medical claim with a T1DM diagnosis. Eligibility required continuous medical and prescription coverage for 12 months before (baseline) and after (follow-up) the index date. Comorbid depression/anxiety and baseline characteristics were assessed during the baseline period. The following 2 mutually exclusive groups were created: individuals with T1DM and comorbid depression/anxiety, and those with only T1DM. To balance baseline demographic and clinical characteristics between the groups, we implemented 1:1 propensity-score matching. We assessed all-cause, diabetes-related, and major adverse cardiovascular event-related HCRU during the follow-up period. Logistic (binary) and negative binomial (count) regression models examined the association between comorbid depression/anxiety and HCRU across types of health care settings.</p><p><strong>Results: </strong>Out of 6,491 eligible individuals with T1DM, 1,168 (18%) had either depression or anxiety. In the matched cohort of 2,314 individuals, those with T1DM and comorbid depression/anxiety had significantly higher odds of all-cause emergency department visits (odds ratio = 1.67; 95% CI = 1.39-2.00) and higher rates of physician office visits (incidence rate ratio = 1.37; 95% CI = 1.27-1.47) and other outpatient encounters (incidence rate ratio = 1.23; 95% CI = 1.13-1.34) than those with only T1DM. Findings were similar for diabetes-related and major adverse cardiovascular event-related HCRU.</p><p><strong>Conclusions: </strong>Comorbid depression/anxiety among individuals with T1DM results in significantly higher HCRU than T1DM alone. The findings underscore the importance of effective management of comorbid depression/anxiety in the T1DM population.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1288-1297"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545861","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":"Dose escalation of biologics in biologic-naive patients with Crohn's disease: Outcomes from the ODESSA-CD study.","authors":"Noa Krugliak Cleveland, Sabyasachi Ghosh, Niranjan Kathe, Kandavadivu Umashankar, Kirti Mirchandani, Arunima Hait, Riyanka Paul, Ninfa Candela, Tao Fan, David T Rubin","doi":"10.18553/jmcp.2024.30.11.1276","DOIUrl":"10.18553/jmcp.2024.30.11.1276","url":null,"abstract":"<p><strong>Background: </strong>Dose escalation of biologics may restore response in patients with Crohn's disease (CD) who experience inadequate response or loss of response, but the rates of dose escalation and subsequent adverse clinical outcomes have not been well characterized.</p><p><strong>Objective: </strong>To evaluate the rate of dose escalation of biologics and associated adverse clinical outcomes and economic outcomes in biologic-naive patients with CD.</p><p><strong>Methods: </strong>ODESSA-CD (real wOrld Dose EScalation and outcomeS with biologics in IBD pAtients with Crohn's Disease) was a retrospective cohort study conducted using claims data from IBM MarketScan databases. Adults with CD with at least 1 claim for an index drug (adalimumab, infliximab, ustekinumab, or vedolizumab) between January 1, 2017, and December 31, 2018, and no claims for biologics in the 6 months prior (ie, biologic naive) were included. Follow-up ended on June 30, 2020. Cox proportional hazards models and logistic regression models were used to compare the rate of dose escalation and the likelihood of adverse clinical outcomes and costs after dose escalation, respectively.</p><p><strong>Results: </strong>Of the 2,664 eligible patients, most (71.4%) were younger than 50 years and 50.5% were male. The rate of dose escalation was higher with the anti-tumor necrosis factor α (TNFα) treatments adalimumab (hazard ratio [HR] = 1.703; <i>P</i> < 0.0001) and infliximab (HR = 1.690; <i>P</i> < 0.0001) compared with vedolizumab, but there was no significant difference between ustekinumab and vedolizumab (HR = 0.842; <i>P</i> = 0.730). After dose escalation, the likelihood of infection, sepsis, and inflammatory bowel disease-related hospitalization did not differ among biologics (anti-TNFα vs vedolizumab: odds ratio [OR] = 1.141, <i>P</i> = 0.599; ustekinumab vs vedolizumab: OR = 0.891; <i>P</i> = 0.836); however, corticosteroid use was more likely with anti-TNFα treatment than with vedolizumab (OR = 1.740, <i>P</i> = 0.002). Among patients whose dose was escalated, index drug costs were likely to be higher with anti-TNFα treatment and ustekinumab than with vedolizumab (anti-TNFα vs vedolizumab: ratio of expected cost = 1.429, <i>P</i> = 0.002; ustekinumab vs vedolizumab: ratio of expected cost = 3.115, <i>P</i> < 0.0001).</p><p><strong>Conclusions: </strong>Patients who were biologic naive and received ustekinumab or vedolizumab were less likely to undergo dose escalation than those who received anti-TNFα treatment. Adverse clinical outcomes after dose escalation were similar among these biologics but with different costs. These analyses may inform providers and payers of the clinical and economic implications of dose escalation.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1276-1287"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545862","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}