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Health care resource utilization and costs across stages of amyotrophic lateral sclerosis in the United States. 美国各期肌萎缩性脊髓侧索硬化症的医疗资源利用率和成本。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1239
Katie Stenson, Sheena Chew, Shaobin Dong, Kim Heithoff, Min-Jung Wang, Jeffrey Rosenfeld
<p><strong>Background: </strong>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).</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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 <i>International Classification of Diseases, Ninth</i> or <i>Tenth Revision</i> 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.</p><p><strong>Results: </strong>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; <i>P</i> < 0.01), outpatient visits/service (early = 26.81, middle = 32.78, and late = 48.54; <i>P</i> < 0.01), emergency department visits (early = 0.46, middle = 0.69, and late = 1.03; <i>P</i> < 0.01), and total prescription count (early = 9.23, middle = 11.37, and late = 12.72; <i>P</i> < 0.01) over 12 months. Annualized costs increased as ALS progressed (early = $31,411, middle = $51,481, and late = $121,903; <i>P</i> < 0.01), which was primarily driven by higher frequency of and cost per hospital admission.</p><p><strong>Conclusions: </strong>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
背景:ALS 患者(plwALS)会出现运动控制能力丧失、言语/吞咽困难、呼吸功能不全和早期死亡。疾病阶段的延长通常会给医疗保健系统带来更大的负担,而诊断的延误会导致大量医疗保健资源的使用(HCRU):为了从美国支付方的角度估算各疾病阶段的 HCRU 和 plwALS 的成本负担,我们评估了 ALS 早期、中期和晚期的 HCRU 和成本:利用 IBM MarketScan 数据库中 2013 年 1 月至 2019 年 12 月期间的保险理赔数据,我们确定了 plwALS,即至少有 2 次理赔间隔 27 天以上,且具有 ALS 国际疾病分类第九版或第十版诊断代码(335.20/G12.21)或至少 1 个 ALS 诊断代码,并开具了利鲁唑/艾达拉酮处方。符合条件的 plwALS 年龄至少为 18 岁,在索引日期(符合诊断标准的日期)之前至少有 12 个月的注册数据,在索引日期之后至少有 6 个月的注册数据。采用基于 ALS 严重程度的分期算法对 plwALS 进行疾病分期,该算法是根据 142 位神经科医生对 880 名 plwALS 报告的 ALS 症状和分期调查数据开发的。每个严重程度分期的起始日期分别定义为早期、中期和晚期类别中出现 ALS 症状的首个日期。严重程度阶段的结束日期定义为更严重类别中出现 ALS 症状的首个日期的前一天。plwALS 可以过渡到更严重的阶段,但不包括严重程度的反向过渡。在对年龄和性别进行调整后,采用混合回归模型评估不同严重程度阶段的 HCRU 和每人年费用差异。结果:ALS 研究总样本中包括 2,273 例 plwALS,其中早期 1,215 例,中期 1,511 例,晚期 1,186 例。90%的早期患者在确诊前出现过 ALS 症状,27%的晚期患者在确诊前出现过晚期症状。在评估期间,晚期 ALS 组的总体入院率(早期 = 0.15,中期 = 0.23,晚期 = 0.74;P < 0.01)、门诊就诊/服务次数(早期 = 26.81,中期 = 32.78,晚期 = 48.54;P <0.01)、急诊就诊次数(早期 = 0.46,中期 = 0.69,晚期 = 1.03;P <0.01)和 12 个月的总处方数(早期 = 9.23,中期 = 11.37,晚期 = 12.72;P <0.01)。年化费用随着 ALS 的进展而增加(早期=31,411 美元,中期=51,481 美元,晚期=121,903 美元;P <0.01),这主要是由于入院频率和每次入院费用增加所致:结论:HCRU 和费用随着 ALS 的进展而增加,甚至在出现晚期症状后仍可确诊。这些研究结果凸显了通过在病程早期诊断并适当治疗plwALS,从而延缓病情恶化至更耗费资源的阶段的潜在价值。
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引用次数: 0
Budget impact analysis of including biosimilar adalimumab on formulary: A United States payer perspective. 将阿达木单抗生物仿制药纳入处方集的预算影响分析:美国付款人的观点。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 Epub Date: 2024-07-27 DOI: 10.18553/jmcp.2024.24036
Stephen Chaplin, Joris van Stiphout, Anna Chen, Edward Li

Background: 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.

Objective: To evaluate the costs of adding biosimilar adalimumab to a US commercial plan by exploring various utilization and price differential scenarios.

Methods: 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.

Results: 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.

Conclusions: 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.

背景:生物仿制药市场发展迅速,迄今已有41个品种获批,37个品种上市。随着阿达木单抗生物仿制药在美国上市,生物仿制药和阿达木单抗参比药之间在多个参比适应症(包括风湿病、皮肤病和胃肠道疾病)上的竞争可能会加剧,这可能会导致支付方成本下降:通过探讨各种使用和价格差异情况,评估在美国商业计划中增加生物类似药阿达木单抗的成本:方法: 为一个有 100 万人的美国商业计划开发了一个为期 3 年的预算影响模型,以评估从参考阿达木单抗或任何自注射参考肿瘤坏死因子 (TNF) 抑制剂转向生物类似药阿达木单抗的情况。通过参考阿达木单抗和TNF抑制剂类药物的高转换率和低转换率情景,对药费和医疗费用进行了分析。此外,还根据以往生物类似物的上市情况,探讨了相对于参考阿达木单抗5%至60%的降价幅度。短期医疗成本被评估为额外的简单和复杂就诊次数,从半数转换患者就诊1次到所有转换患者就诊10次:在1,863名患者的目标人群中,从参照阿达木单抗转为生物类似药阿达木单抗,慢速转换(3年内转换10%-20%)可累计节省成本5,756,073美元,快速转换(3年内转换50%-100%)可累计节省成本28,780,365美元。从任何其他自注射参考 TNF 抑制剂转换而来的结果与此类似。从参考阿达木单抗转换10%,以及从参考阿达木单抗降价15%,可节省超过100万美元的成本。额外的诊疗方案对预算的影响可以忽略不计,在所有转换患者额外接受 10 次复杂诊疗之前,每名成员每月的成本没有变化,在这种情况下,每名成员每月的成本增加了 0.02 美元:在一个拥有 100 万人的假定计划中,由于竞争加剧,在商业计划中使用阿达木单抗生物仿制药可为支付方节省大量成本。参照阿达木单抗和其他参照 TNF 抑制剂的生物仿制药转换率更高、更快,从而降低了成本。此外,即使有短期医疗支出,转用阿达木单抗生物仿制药后仍可节省成本。
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引用次数: 0
Patient-reported disability progression outcomes among patients with multiple sclerosis: Results of an outcomes-based agreement. 多发性硬化症患者报告的残疾进展结果:基于结果的协议结果。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1211
Elizabeth C S Swart, Samuel K Peasah, Jacqueline Alderson, RaeAnn Maxwell, Chronis Manolis, Chester B Good

Background: 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.

Objective: 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.

Methods: 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.

Results: 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%]).

Conclusions: Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA.

背景:以疗效为基础的协议(OBAs)是支付方与生产商之间达成的协议,其中药物支付与患者疗效挂钩。这些合同旨在衡量处方药在真实世界患者群体中预定义临床指标的价值。随着医疗保健行业从基于数量的医疗保健向基于价值的医疗保健转变,OBA 在美国越来越受到重视。多发性硬化症(MS)因其发病率高、用药成本高以及有多种有效的治疗方案而成为 OBAs 颇具吸引力的治疗领域:描述一个大型地区医疗系统对服用干扰素 β-1a 或富马酸二甲酯的多发性硬化症患者进行的前瞻性 OBA 的研究结果:在这项前瞻性真实世界分析中,商业保险或健康保险交易所的成员都根据OBA的参数被纳入其中。采用患者报告的结果--患者自定疾病步骤(PDDS)来评估残疾进展情况。在 OBA 中,年龄在 18 岁或 18 岁以上且确诊为多发性硬化症的会员均被纳入合同范围。对符合条件的会员进行基线评分,并在基线评分后的 90 天和 180 天之间进行随访评分。如果随访分数高于基线分数,则在 90 天和 120 天之间收集后续 PDDS 分数,以确定 PDDS 分数是否仍然升高,这表明会员的残疾程度有所加深:在合同期内,有 410 名患者符合收集 PDDS 分值的条件,其中富马酸二甲酯组和干扰素 β-1a 组分别有 241 名和 169 名患者。有 162 名患者失去随访,64 名患者根据合同参数不符合条件。在其余184名符合条件的患者中(107名服用富马酸二甲酯,77名服用β-1a干扰素),有21名(11%)患者的残疾状况得到了证实(6名服用富马酸二甲酯[5.6%],15名服用β-1a干扰素[19.5%]):我们的研究结果表明,患者报告的有意义的结果,如残疾进展,可以在创新的 OBA 中进行操作。
{"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}
引用次数: 0
The effectiveness and value of ensifentrine for the treatment of chronic obstructive pulmonary disease. 安塞芬净治疗慢性阻塞性肺病的效果和价值。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1338
Abigail C Wright, Grace A Lin, Melanie D Whittington, Avery McKenna, Finn Raymond, David M Rind, Foluso Agboola
{"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}
引用次数: 0
Comorbid depression and anxiety and their association with health care resource utilization among individuals with type 1 diabetes in the United States. 美国 1 型糖尿病患者合并抑郁症和焦虑症及其与医疗资源利用的关系。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1288
Yueh-Yi Chiang, Susan dosReis, Charmaine Rochester-Eyeguokan, Eberechukwu Onukwugha

Background: 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.

Objective: To assess health care resource utilization (HCRU) among adults with T1DM and comorbid depression or anxiety.

Methods: 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.

Results: 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.

Conclusions: 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.

背景:1 型糖尿病(T1DM)是一种常见的慢性内分泌疾病,占全球糖尿病病例总数的 5%-10%。1 型糖尿病会对医疗保健的使用产生重大影响。众所周知,糖尿病患者罹患精神疾病的风险更高,但目前还缺乏具体证据来说明 T1DM 患者合并抑郁/焦虑症所带来的医疗负担:目的:评估患有 T1DM 并合并抑郁或焦虑症的成人的医疗资源利用率(HCRU):我们使用 IQVIA PharMetrics Plus for Academics 数据库中 25% 的随机样本,对 2017 年 1 月 1 日至 2021 年 12 月 31 日期间确诊为 T1DM 的 18 至 64 岁患者进行了识别。索引日期为首次诊断为 T1DM 的医疗索赔日期。资格要求在指数日期之前(基线)和之后(随访)的 12 个月内连续投保医疗和处方保险。在基线期间对合并抑郁/焦虑和基线特征进行了评估。我们设立了以下两个互斥组:T1DM 和合并抑郁/焦虑症的患者,以及仅患有 T1DM 的患者。为了平衡各组之间的人口统计学和临床特征,我们采用了 1:1 的倾向分数匹配。我们评估了随访期间的全因、糖尿病相关和主要不良心血管事件相关 HCRU。逻辑(二元)和负二项(计数)回归模型检验了不同类型医疗机构中合并抑郁/焦虑与 HCRU 之间的关联:在 6,491 名符合条件的 T1DM 患者中,有 1,168 人(18%)患有抑郁症或焦虑症。在 2,314 人的匹配队列中,与仅患有 T1DM 的患者相比,患有 T1DM 并合并抑郁/焦虑症的患者到急诊科就诊的几率明显更高(几率比 = 1.67;95% CI = 1.39-2.00),医生诊室就诊率(发病率比 = 1.37;95% CI = 1.27-1.47)和其他门诊就诊率(发病率比 = 1.23;95% CI = 1.13-1.34)也更高。与糖尿病相关的HCRU和与重大不良心血管事件相关的HCRU的研究结果相似:结论:T1DM 患者合并抑郁/焦虑会导致 HCRU 明显高于单纯 T1DM 患者。结论:T1DM 患者合并抑郁/焦虑症会导致 HCRU 明显高于单纯 T1DM 患者,这些发现强调了有效管理 T1DM 患者合并抑郁/焦虑症的重要性。
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引用次数: 0
Dose escalation of biologics in biologic-naive patients with Crohn's disease: Outcomes from the ODESSA-CD study. 克罗恩病患者对生物制剂的剂量升级:ODESSA-CD 研究的结果。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1276
Noa Krugliak Cleveland, Sabyasachi Ghosh, Niranjan Kathe, Kandavadivu Umashankar, Kirti Mirchandani, Arunima Hait, Riyanka Paul, Ninfa Candela, Tao Fan, David T Rubin

Background: 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.

Objective: To evaluate the rate of dose escalation of biologics and associated adverse clinical outcomes and economic outcomes in biologic-naive patients with CD.

Methods: 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.

Results: 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; P < 0.0001) and infliximab (HR = 1.690; P < 0.0001) compared with vedolizumab, but there was no significant difference between ustekinumab and vedolizumab (HR = 0.842; P = 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, P = 0.599; ustekinumab vs vedolizumab: OR = 0.891; P = 0.836); however, corticosteroid use was more likely with anti-TNFα treatment than with vedolizumab (OR = 1.740, P = 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, P = 0.002; ustekinumab vs vedolizumab: ratio of expected cost = 3.115, P < 0.0001).

Conclusions: 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.

背景:克罗恩病(CD)患者如果反应不足或失去反应,生物制剂的剂量升级可能会恢复患者的反应,但剂量升级率和随后的不良临床结果尚未得到很好的描述:目的:评估对生物制剂无反应的克罗恩病患者使用生物制剂的剂量升级率及相关不良临床结果和经济结果:ODESSA-CD(克罗恩病 IBD 患者使用生物制剂的真实剂量升级和结果)是一项回顾性队列研究,使用的是 IBM MarketScan 数据库中的索赔数据。研究纳入了在 2017 年 1 月 1 日至 2018 年 12 月 31 日期间至少报销过一次指标药物(阿达木单抗、英夫利昔单抗、乌司替吉单抗或韦多珠单抗),且之前 6 个月未报销过生物制剂(即生物制剂天真者)的成人克罗恩病患者。随访于 2020 年 6 月 30 日结束。Cox比例危险模型和Logistic回归模型分别用于比较剂量升级率和剂量升级后出现不良临床结果和费用的可能性:在2664名符合条件的患者中,大多数(71.4%)年龄在50岁以下,50.5%为男性。抗肿瘤坏死因子α(TNFα)疗法阿达木单抗(危险比[HR] = 1.703; P < 0.0001)和英夫利昔单抗(HR = 1.690; P < 0.0001)与维妥珠单抗相比,剂量升级率更高,但乌司替尼单抗与维妥珠单抗之间没有显著差异(HR = 0.842; P = 0.730)。剂量升级后,感染、败血症和炎症性肠病相关住院的可能性在不同生物制剂之间没有差异(抗肿瘤坏死因子α vsvedolizumab:几率比[OR] = 1.141,P = 0.599;ustekinumab vs vedolizumab:几率比[OR] = 0.891;P = 0.730):OR=0.891;P=0.836);然而,使用皮质类固醇治疗抗肿瘤坏死因子α的几率要高于使用维多珠单抗(OR=1.740,P=0.002)。在剂量增加的患者中,抗肿瘤坏死因子α治疗和乌司替库单抗的指数药物成本可能高于维多珠单抗(抗肿瘤坏死因子α vs 维多珠单抗:预期成本比 = 1.429,P = 0.002;乌司替库单抗 vs 维多珠单抗:预期成本比 = 3.115,P < 0.0001):结论:与接受抗肿瘤坏死因子α治疗的患者相比,接受乌司替库单抗或韦多珠单抗治疗的生物制剂天真患者进行剂量升级的可能性较低。这些生物制剂在剂量升级后的不良临床结果相似,但费用不同。这些分析可让提供者和支付者了解剂量升级的临床和经济影响。
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引用次数: 0
Economic burden of recurrent hyperkalemia in patients with chronic kidney disease. 慢性肾病患者复发性高钾血症的经济负担。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 Epub Date: 2024-08-05 DOI: 10.18553/jmcp.2024.24114
George Bakris, Abiy Agiro, Alexandra Greatsinger, Fan Mu, Erin E Cook, Manasvi Sundar, Elaine Louden, Ellen Colman, Pooja Desai
<p><strong>Background: </strong>Hyperkalemia is a common complication of chronic kidney disease (CKD) and can become recurrent in half of cases. However, the incremental economic burden associated with recurrent hyperkalemia is unknown.</p><p><strong>Objective: </strong>To evaluate all-cause health care resource utilization (HRU) and medical costs in patients with stage 3/4 CKD with recurrent hyperkalemia vs normokalaemia and vs nonrecurrent hyperkalemia.</p><p><strong>Methods: </strong>Data were from Optum's de-identified Market Clarity Data (January 1, 2016, to August 1, 2022). This retrospective observational cohort study compared patients with stage 3/4 CKD with recurrent hyperkalemia (≥2 hyperkalemia events within 1 year [hyperkalemia event: hyperkalemia diagnosis or potassium [K+]>5 mmol/l]; index was the first hyperkalemia event) with an exact- and propensity score-matched cohort of patients with normokalemia (K+ ≥3.5 to ≤5 mmol/l; random K+ as index) and separately with a matched cohort of patients with nonrecurrent hyperkalemia (1 hyperkalemia event within 1 year; index was hyperkalemia event). Patient characteristics, medication use, HRU, and medical costs were compared between cohorts using standardized mean differences during the 12-month baseline period. All-cause HRU and medical costs during the 12-month follow-up were compared using Wilcoxon rank sum tests for continuous variables and McNemar tests for categorical variables. Substudies of recurrent hyperkalemia vs normokalemia were conducted for patients with Medicare coverage and renin-angiotensin-aldosterone system inhibitor (RAASi) use.</p><p><strong>Results: </strong>The recurrent hyperkalemia vs normokalemia sample comprised 4,549 matched pairs (Medicare substudy: 3,151; RAASi substudy: 3,535) and the recurrent hyperkalemia vs nonrecurrent hyperkalemia sample comprised 1,599 matched pairs. Baseline characteristics, HRU, and medical costs of the cohorts were similar after matching. During follow-up, patients with recurrent hyperkalemia had a mean of 11.2 more health care encounters (0.5 more inpatient admissions, 0.3 more emergency department visits, and 7.2 more outpatient visits) than patients with normokalemia. Patients with recurrent hyperkalemia also had double the total annual medical costs vs normokalemia ($34,163 vs $15,175; <i>P</i> < 0.001), mainly driven by inpatient costs ($21,250 vs $7,392), which accounted for 62.2% and 48.7% of total costs, respectively. Results were similar in the RAASi and Medicare substudies. Recurrent hyperkalemia was associated with a mean 4.3 more all-cause health care encounters and $14,057 higher medical costs (both <i>P</i> < 0.001) than nonrecurrent hyperkalemia.</p><p><strong>Conclusions: </strong>Recurrent hyperkalemia in patients with stage 3/4 CKD was associated with higher all-cause HRU and medical costs compared with normokalemia (including in patients with Medicare coverage and RAASi use) and nonrecurrent hyperkalemia. Research i
背景:高钾血症是慢性肾脏病(CKD)的常见并发症,半数病例可反复发作。然而,与复发性高钾血症相关的增量经济负担尚不清楚:目的:评估复发性高钾血症与正常高钾血症和非复发性高钾血症的 3/4 期 CKD 患者的全因医疗资源利用率(HRU)和医疗费用:数据来自 Optum 的去标识化 Market Clarity 数据(2016 年 1 月 1 日至 2022 年 8 月 1 日)。这项回顾性观察队列研究比较了复发性高钾血症(1年内≥2次高钾血症事件[高钾血症事件:诊断为高钾血症或血钾[K+]>5 mmol/l];指标为首次高钾血症事件)的3/4期CKD患者与精确和倾向评分匹配的正常血钾患者队列(K+≥3.5至≤5毫摩尔/升;随机K+为指数),并分别与非复发性高钾血症患者(1年内发生过1次高钾血症事件;指数为高钾血症事件)的匹配队列进行比较。使用 12 个月基线期间的标准化均值差异对不同队列的患者特征、用药情况、HRU 和医疗费用进行比较。连续变量采用 Wilcoxon 秩和检验,分类变量采用 McNemar 检验,比较随访 12 个月期间的全因 HRU 和医疗费用。对参加医疗保险和使用肾素-血管紧张素-醛固酮系统抑制剂(RAASi)的患者进行了复发性高钾血症与正常血钾的替代研究:复发性高钾血症与正常血钾样本包括 4,549 对配对(医疗保险子研究:3,151 对;RAASi 子研究:3,535 对),复发性高钾血症与非复发性高钾血症样本包括 1,599 对配对。配对后,两组患者的基线特征、HRU 和医疗费用相似。在随访期间,复发性高钾血症患者平均比正常血钾患者多接受了 11.2 次医疗护理(住院次数多 0.5 次,急诊就诊次数多 0.3 次,门诊就诊次数多 7.2 次)。复发性高钾血症患者的年度医疗总费用也是正常血钾患者的两倍(34,163 美元对 15,175 美元;P < 0.001),主要是住院费用(21,250 美元对 7,392 美元),分别占总费用的 62.2% 和 48.7%。RAASi 和医保子研究的结果相似。与非复发性高钾血症相比,复发性高钾血症导致的全因医疗就诊次数平均增加 4.3 次,医疗费用增加 14,057 美元(P 均<0.001):结论:与正常血钾(包括医保和使用 RAASi 的患者)和非复发性高钾血症相比,3/4 期慢性肾脏病患者复发性高钾血症与较高的全因 HRU 和医疗费用相关。需要进行研究以了解旨在预防高钾血症复发的长期治疗策略是否可以减轻这种经济负担。
{"title":"Economic burden of recurrent hyperkalemia in patients with chronic kidney disease.","authors":"George Bakris, Abiy Agiro, Alexandra Greatsinger, Fan Mu, Erin E Cook, Manasvi Sundar, Elaine Louden, Ellen Colman, Pooja Desai","doi":"10.18553/jmcp.2024.24114","DOIUrl":"10.18553/jmcp.2024.24114","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Hyperkalemia is a common complication of chronic kidney disease (CKD) and can become recurrent in half of cases. However, the incremental economic burden associated with recurrent hyperkalemia is unknown.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate all-cause health care resource utilization (HRU) and medical costs in patients with stage 3/4 CKD with recurrent hyperkalemia vs normokalaemia and vs nonrecurrent hyperkalemia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Data were from Optum's de-identified Market Clarity Data (January 1, 2016, to August 1, 2022). This retrospective observational cohort study compared patients with stage 3/4 CKD with recurrent hyperkalemia (≥2 hyperkalemia events within 1 year [hyperkalemia event: hyperkalemia diagnosis or potassium [K+]&gt;5 mmol/l]; index was the first hyperkalemia event) with an exact- and propensity score-matched cohort of patients with normokalemia (K+ ≥3.5 to ≤5 mmol/l; random K+ as index) and separately with a matched cohort of patients with nonrecurrent hyperkalemia (1 hyperkalemia event within 1 year; index was hyperkalemia event). Patient characteristics, medication use, HRU, and medical costs were compared between cohorts using standardized mean differences during the 12-month baseline period. All-cause HRU and medical costs during the 12-month follow-up were compared using Wilcoxon rank sum tests for continuous variables and McNemar tests for categorical variables. Substudies of recurrent hyperkalemia vs normokalemia were conducted for patients with Medicare coverage and renin-angiotensin-aldosterone system inhibitor (RAASi) use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The recurrent hyperkalemia vs normokalemia sample comprised 4,549 matched pairs (Medicare substudy: 3,151; RAASi substudy: 3,535) and the recurrent hyperkalemia vs nonrecurrent hyperkalemia sample comprised 1,599 matched pairs. Baseline characteristics, HRU, and medical costs of the cohorts were similar after matching. During follow-up, patients with recurrent hyperkalemia had a mean of 11.2 more health care encounters (0.5 more inpatient admissions, 0.3 more emergency department visits, and 7.2 more outpatient visits) than patients with normokalemia. Patients with recurrent hyperkalemia also had double the total annual medical costs vs normokalemia ($34,163 vs $15,175; &lt;i&gt;P&lt;/i&gt; &lt; 0.001), mainly driven by inpatient costs ($21,250 vs $7,392), which accounted for 62.2% and 48.7% of total costs, respectively. Results were similar in the RAASi and Medicare substudies. Recurrent hyperkalemia was associated with a mean 4.3 more all-cause health care encounters and $14,057 higher medical costs (both &lt;i&gt;P&lt;/i&gt; &lt; 0.001) than nonrecurrent hyperkalemia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Recurrent hyperkalemia in patients with stage 3/4 CKD was associated with higher all-cause HRU and medical costs compared with normokalemia (including in patients with Medicare coverage and RAASi use) and nonrecurrent hyperkalemia. Research i","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"1261-1275"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893572","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}
引用次数: 0
Impact of discontinuing disease-modifying therapies on health care utilization among midlife patients with multiple sclerosis in the United States. 美国中年多发性硬化症患者停用改变病情疗法对使用医疗服务的影响。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1248
Yiran Qian, Carolyn T Thorpe, Casey Tak, Stephanie Iyer, Amanda Seyerle, Joshua M Thorpe
<p><strong>Background: </strong>Multiple sclerosis (MS) is a lifelong progressive neurological disease treated primarily with disease-modifying therapies (DMTs). Disease activity tends to decline as patients age. Midlife represents a crossroads where the risks of DMT may outweigh the benefits, prompting providers to consider DMT discontinuation to reduce treatment burden. However, real-world evidence on the impact of DMT discontinuation among midlife patients is lacking.</p><p><strong>Objective: </strong>To evaluate the association between DMT discontinuation and health care utilization among midlife patients with MS.</p><p><strong>Methods: </strong>Midlife patients with MS who received an injectable or oral DMT between 2001 and 2018 were identified from the MarketScan commercial claims database. DMT discontinuation, defined as a treatment gap exceeding 90 days in days supply, was the independent variable. Patients who discontinued DMTs had their index date set as the last gap day, whereas index dates for those who continued DMTs were matched based on the time distribution of index dates of discontinuers. Inpatient hospitalizations (all-cause, MS-related, and non-MS-related), emergency department (ED) visits (all-cause, MS-related, and non-MS-related), and relapse-related hospitalizations and outpatient visits were independently evaluated during the 365-day follow-up. Patients were observed until the occurrence of an event (depending on the model), deviation from the treatment group, disenrollment, death, end of follow-up, or data unavailability. Stabilized inverse probability of treatment weighting (sIPTW) was employed to balance the 2 groups. The associations between DMT discontinuation and each utilization outcome were estimated using Cox proportional hazard regression models with sIPTW.</p><p><strong>Results: </strong>Of 149,721 midlife patients with MS, 22.8% discontinued DMTs and 77.2% continued DMTs. Patients who discontinued DMTs had a higher cumulative incidence for all utilization outcomes during the 365-day follow-up than those who continued DMTs. Cox regression showed that DMT discontinuation was associated with a 10.3% and 24.9% higher rate of all-cause and non-MS-related inpatient hospitalizations, respectively, with no significant association found for MS-related hospitalizations. Patients discontinuing DMTs exhibited higher utilization rates for ED visits, with an increase of 21.3% for all-cause, 23.0% for MS-related, and 20.9% for non-MS-related visits compared with those who continued DMTs. We also observed a 15.9% and 52.1% higher rate of relapse-related hospitalizations and outpatient visits associated with DMT discontinuation, respectively.</p><p><strong>Conclusions: </strong>This study revealed that DMT discontinuation was associated with higher health care services utilization among midlife patients with MS, especially relapse-related outpatient visits. DMT discontinuation during midlife may be premature, and DMTs may still
背景:多发性硬化症(MS)是一种终生进展性神经系统疾病,主要通过改变病情疗法(DMT)进行治疗。随着患者年龄的增长,疾病活动趋于减弱。中年时期是一个十字路口,DMT 的风险可能大于收益,这促使医疗机构考虑停用 DMT 以减轻治疗负担。然而,关于中年患者停用 DMT 的影响尚缺乏实际证据:目的:评估中年多发性硬化症患者停用 DMT 与使用医疗服务之间的关系:从 MarketScan 商业索赔数据库中识别出 2001 年至 2018 年间接受过注射或口服 DMT 的中年多发性硬化症患者。DMT停药是自变量,其定义为治疗间隙超过90天的天数供应。停用 DMT 的患者的指数日期设定为最后的间隙日,而继续使用 DMT 的患者的指数日期则根据停用者指数日期的时间分布进行匹配。在 365 天的随访期间,对住院(全因、多发性硬化症相关和非多发性硬化症相关)、急诊(ED)就诊(全因、多发性硬化症相关和非多发性硬化症相关)、复发相关住院和门诊进行了独立评估。对患者进行观察,直至发生事件(取决于模型)、偏离治疗组、退出治疗组、死亡、随访结束或无法获得数据。为平衡两组患者,采用了稳定反向治疗概率加权法(sIPTW)。使用带 sIPTW 的 Cox 比例危险回归模型估算了 DMT 停用与各利用结果之间的关系:在 149721 名中年多发性硬化症患者中,22.8% 的患者停用了 DMT,77.2% 的患者继续使用 DMT。与继续使用 DMT 的患者相比,停用 DMT 的患者在 365 天随访期间所有使用结果的累积发生率都更高。Cox 回归显示,停用 DMT 与全因住院率和非 MS 相关住院率分别高出 10.3% 和 24.9% 相关,而与 MS 相关的住院率则无显著关联。与继续使用 DMTs 的患者相比,停用 DMTs 的患者的急诊就诊率较高,全因就诊率增加了 21.3%,MS 相关就诊率增加了 23.0%,非 MS 相关就诊率增加了 20.9%。我们还观察到,与停用DMT相关的复发相关住院率和门诊就诊率分别增加了15.9%和52.1%:本研究显示,中年多发性硬化症患者停用 DMT 与较高的医疗服务使用率有关,尤其是与复发相关的门诊就诊率。中年时期停用DMT可能为时过早,可能仍需使用DMT来减少医疗服务的使用。
{"title":"Impact of discontinuing disease-modifying therapies on health care utilization among midlife patients with multiple sclerosis in the United States.","authors":"Yiran Qian, Carolyn T Thorpe, Casey Tak, Stephanie Iyer, Amanda Seyerle, Joshua M Thorpe","doi":"10.18553/jmcp.2024.30.11.1248","DOIUrl":"10.18553/jmcp.2024.30.11.1248","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Multiple sclerosis (MS) is a lifelong progressive neurological disease treated primarily with disease-modifying therapies (DMTs). Disease activity tends to decline as patients age. Midlife represents a crossroads where the risks of DMT may outweigh the benefits, prompting providers to consider DMT discontinuation to reduce treatment burden. However, real-world evidence on the impact of DMT discontinuation among midlife patients is lacking.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate the association between DMT discontinuation and health care utilization among midlife patients with MS.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Midlife patients with MS who received an injectable or oral DMT between 2001 and 2018 were identified from the MarketScan commercial claims database. DMT discontinuation, defined as a treatment gap exceeding 90 days in days supply, was the independent variable. Patients who discontinued DMTs had their index date set as the last gap day, whereas index dates for those who continued DMTs were matched based on the time distribution of index dates of discontinuers. Inpatient hospitalizations (all-cause, MS-related, and non-MS-related), emergency department (ED) visits (all-cause, MS-related, and non-MS-related), and relapse-related hospitalizations and outpatient visits were independently evaluated during the 365-day follow-up. Patients were observed until the occurrence of an event (depending on the model), deviation from the treatment group, disenrollment, death, end of follow-up, or data unavailability. Stabilized inverse probability of treatment weighting (sIPTW) was employed to balance the 2 groups. The associations between DMT discontinuation and each utilization outcome were estimated using Cox proportional hazard regression models with sIPTW.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of 149,721 midlife patients with MS, 22.8% discontinued DMTs and 77.2% continued DMTs. Patients who discontinued DMTs had a higher cumulative incidence for all utilization outcomes during the 365-day follow-up than those who continued DMTs. Cox regression showed that DMT discontinuation was associated with a 10.3% and 24.9% higher rate of all-cause and non-MS-related inpatient hospitalizations, respectively, with no significant association found for MS-related hospitalizations. Patients discontinuing DMTs exhibited higher utilization rates for ED visits, with an increase of 21.3% for all-cause, 23.0% for MS-related, and 20.9% for non-MS-related visits compared with those who continued DMTs. We also observed a 15.9% and 52.1% higher rate of relapse-related hospitalizations and outpatient visits associated with DMT discontinuation, respectively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study revealed that DMT discontinuation was associated with higher health care services utilization among midlife patients with MS, especially relapse-related outpatient visits. DMT discontinuation during midlife may be premature, and DMTs may still","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1248-1260"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545874","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}
引用次数: 0
Social determinants of health and newer glucose-lowering drugs adoption among US Medicare beneficiaries with type 2 diabetes. 美国 2 型糖尿病医疗保险受益人的健康社会决定因素与新型降糖药物的采用。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1298
Wei-Han Chen, Yujia Li, Aokun Chen, John M Allen, Yi Guo, Lori Bilello, Steven M Smith, Lanting Yang, Amie J Goodin, Jiang Bian, Jingchuan Guo

Background: Two classes of newer glucose-lowering drugs (GLDs), sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists, improve cardiovascular and renal outcomes among patients with type 2 diabetes (T2D). However, racial and ethnic minority groups carry higher cardiovascular risks but have lower access to newer GLDs. Contextual-level social determinants of health (SDOH) may be the underlying factor associated with newer GLD adoption.

Objective: To identify the association between contextual-level SDOH and real-world adoption of newer GLDs among Medicare beneficiaries and to examine the nonstationarity in the associations.

Methods: Data were from 15% random samples of January 2017 to December 2018 nationwide Medicare beneficiaries. We identified patients with T2D who did not use newer GLDs in the year before the index date-January 1, 2018-and followed the cohort for 1 year to record their status of initiating a newer GLD. We used a geographically weighted multivariable Poisson regression model to determine to what extent the SDOH-newer GLD initiation association (β coefficient) varied geographically.

Results: We identified 795,469 eligible Medicare beneficiaries with T2D during the study period from our dataset. Of the study cohort, mean age was 73.1 (SD = 10.5) years, 424,312 (53.3%) were female, 562,994 (70.8%) were non-Hispanic White, 96,891 (12.2%) were non-Hispanic Black, 84,744 (10.6%) were Hispanic, and 29,645 (3.7%) were Asian/Pacific Islander. Newer GLD initiation was negatively associated with the percentage of the population reporting non-Hispanic Black race, Hispanic ethnicity, and unemployment, as revealed by nonspatial regression analyses. The county-level median household income was also associated with higher newer GLD initiation. The spatial analysis presented distinct distributions of local parameter estimates for each contextual-level SDOH.

Conclusions: We identified key contextual-level SDOH associated with real-world adoption of newer GLDs and explored their geographic variation through spatially explicit, data-driven analytical approaches. Identifying areas of strong association between SDOH and newer GLD initiation is crucial for policymakers to allocate resources and develop interventions that address structural inequities.

背景:钠-葡萄糖共转运体-2抑制剂和胰高血糖素样肽-1受体激动剂这两类新型降糖药(GLDs)可改善2型糖尿病(T2D)患者的心血管和肾脏预后。然而,少数种族和少数族裔群体的心血管风险较高,但获得新型 GLDs 的机会较少。环境层面的健康社会决定因素(SDOH)可能是与采用新型 GLD 相关的潜在因素:确定医疗保险受益人中环境层面的 SDOH 与现实世界中采用较新 GLD 之间的关联,并研究关联中的非平稳性:数据来自 2017 年 1 月至 2018 年 12 月全国医疗保险受益人的 15% 随机样本。我们确定了在指数日期前一年(2018 年 1 月 1 日)未使用较新 GLD 的 T2D 患者,并对该队列进行了为期 1 年的随访,以记录他们开始使用较新 GLD 的情况。我们使用了一个地理加权多变量泊松回归模型来确定SDOH-较新GLD启动关联(β系数)的地理差异程度:我们从数据集中确定了 795,469 名在研究期间患有 T2D 的合格医疗保险受益人。在研究队列中,平均年龄为 73.1 岁(SD = 10.5),424,312 人(53.3%)为女性,562,994 人(70.8%)为非西班牙裔白人,96,891 人(12.2%)为非西班牙裔黑人,84,744 人(10.6%)为西班牙裔,29,645 人(3.7%)为亚洲/太平洋岛民。非空间回归分析表明,较新的 GLD 启动与非西班牙裔黑人、西班牙裔和失业人口比例呈负相关。县级家庭收入中位数也与较高的较新 GLD 启动率有关。空间分析表明,每种背景水平的 SDOH 的地方参数估计值都有不同的分布:我们确定了与现实世界中采用较新的 GLD 相关的关键背景级 SDOH,并通过空间明确、数据驱动的分析方法探讨了其地理差异。对于政策制定者来说,确定 SDOH 与采用较新 GLD 之间存在密切联系的地区对于分配资源和制定干预措施以解决结构性不平等问题至关重要。
{"title":"Social determinants of health and newer glucose-lowering drugs adoption among US Medicare beneficiaries with type 2 diabetes.","authors":"Wei-Han Chen, Yujia Li, Aokun Chen, John M Allen, Yi Guo, Lori Bilello, Steven M Smith, Lanting Yang, Amie J Goodin, Jiang Bian, Jingchuan Guo","doi":"10.18553/jmcp.2024.30.11.1298","DOIUrl":"10.18553/jmcp.2024.30.11.1298","url":null,"abstract":"<p><strong>Background: </strong>Two classes of newer glucose-lowering drugs (GLDs), sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists, improve cardiovascular and renal outcomes among patients with type 2 diabetes (T2D). However, racial and ethnic minority groups carry higher cardiovascular risks but have lower access to newer GLDs. Contextual-level social determinants of health (SDOH) may be the underlying factor associated with newer GLD adoption.</p><p><strong>Objective: </strong>To identify the association between contextual-level SDOH and real-world adoption of newer GLDs among Medicare beneficiaries and to examine the nonstationarity in the associations.</p><p><strong>Methods: </strong>Data were from 15% random samples of January 2017 to December 2018 nationwide Medicare beneficiaries. We identified patients with T2D who did not use newer GLDs in the year before the index date-January 1, 2018-and followed the cohort for 1 year to record their status of initiating a newer GLD. We used a geographically weighted multivariable Poisson regression model to determine to what extent the SDOH-newer GLD initiation association (β coefficient) varied geographically.</p><p><strong>Results: </strong>We identified 795,469 eligible Medicare beneficiaries with T2D during the study period from our dataset. Of the study cohort, mean age was 73.1 (SD = 10.5) years, 424,312 (53.3%) were female, 562,994 (70.8%) were non-Hispanic White, 96,891 (12.2%) were non-Hispanic Black, 84,744 (10.6%) were Hispanic, and 29,645 (3.7%) were Asian/Pacific Islander. Newer GLD initiation was negatively associated with the percentage of the population reporting non-Hispanic Black race, Hispanic ethnicity, and unemployment, as revealed by nonspatial regression analyses. The county-level median household income was also associated with higher newer GLD initiation. The spatial analysis presented distinct distributions of local parameter estimates for each contextual-level SDOH.</p><p><strong>Conclusions: </strong>We identified key contextual-level SDOH associated with real-world adoption of newer GLDs and explored their geographic variation through spatially explicit, data-driven analytical approaches. Identifying areas of strong association between SDOH and newer GLD initiation is crucial for policymakers to allocate resources and develop interventions that address structural inequities.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1298-1307"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545877","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}
引用次数: 0
A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs. 对患者使用替代性资助计划的经历和获得特药的情况进行描述性调查。
IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-11-01 DOI: 10.18553/jmcp.2024.30.11.1308
William B Wong, Irina Yermilov, Hannah Dalglish, Lori Bienvenu, Jonathan James, Sarah N Gibbs
<p><strong>Background: </strong>Alternative funding programs (AFPs) seek to reduce health plan sponsor costs, for example by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs) via an AFP vendor as a third-party.</p><p><strong>Objective: </strong>To describe patients' experiences and specialty medication access with AFPs.</p><p><strong>Methods: </strong>A survey method consisting of 26 optional single-choice and multiple-choice questions with branching logic divided across 5 sections (related to patient challenges with AFPs) was administered to patients recruited from an experienced AFP online patient panel and a patient advocacy group. The survey assessed patients' awareness of AFPs from their employers, experience with the patient assistance program application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of delay in access. All descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels; statistical analyses were carried out for the exploratory analyses.</p><p><strong>Results: </strong>The final sample included 227 patients. Most patients (61% [136/223]) first heard of the AFP as part of their health benefit when trying to obtain their medication. Of 198 patients, 88% reported being stressed because of the medication coverage denial and the uncertainty of obtaining their medication. More than half of patients (54% [115/213]) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for 68.2 days (approximately 2 months); 24% (51/215) reported the wait for the medication worsened their condition and 64% (138/215) reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. A significantly higher proportion of patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% [19/30] vs 81% [52/64]; <i>P</i> = 0.022), whereas more patients with lower incomes (<$50,000 vs >$50,000) reported not receiving any medication (12% [7/57] vs 5% [7/129]; <i>P</i> = 0.657), although these differences were not significant.</p><p><strong>Conclusions: </strong>Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being, and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their he
背景:替代性资助计划(AFP)旨在降低医疗计划赞助商的成本,例如,将特药排除在受益人的计划覆盖范围之外,并要求患者通过作为第三方的 AFP 供应商从替代性来源(通常是制造商的患者援助计划)获得药物:描述患者使用 AFP 的经历和特药获取情况:调查方法:从一个经验丰富的 AFP 在线患者小组和一个患者权益团体中招募患者,对他们进行调查,调查内容包括 26 道单选题和多选题,并在 5 个部分(与患者在使用 AFP 时遇到的挑战有关)设置了分支逻辑。该调查评估了患者从其雇主处了解 AFP 的情况、通过 AFP 供应商申请患者援助计划的经验、药物获取的及时性(如果获准)和/或延迟获取药物对健康的影响。所有描述性和探索性亚组分析均按疾病领域和报告的收入水平进行;探索性分析则进行统计分析:最终样本包括 227 名患者。大多数患者(61% [136/223])在试图获得药物治疗时,首次听说 AFP 是其健康福利的一部分。在 198 名患者中,88% 的患者表示由于药物覆盖范围被拒绝以及获得药物的不确定性而感到压力。一半以上的患者(54% [115/213])表示对 AFP 供应商的福利经理感到不舒服。平均而言,患者表示等待获得药物的时间长达 68.2 天(约 2 个月);24% 的患者(51/215)表示等待药物的时间使他们的病情恶化,64% 的患者(138/215)表示等待药物的时间使他们感到压力和/或焦虑。表示等待时间对其产生负面影响的患者考虑更换工作或离职的比例是表示等待时间对其没有影响的患者的 3-5 倍。在血友病和其他出血性疾病患者中,报告接受处方药物治疗的比例明显低于其他疾病患者(63% [19/30] vs 81% [52/64];P = 0.022),而收入较低(50,000 美元)的患者报告未接受任何药物治疗的比例更高(12% [7/57] vs 5% [7/129];P = 0.657),但这些差异并不显著:结论:大多数通过 AFP 获得专科药物的患者表示对这一过程感到不舒服,并经历了治疗延迟,这可能与疾病进展、精神状况恶化以及考虑更换工作有关。雇主在考虑将 AFP 纳入其医疗计划时,应注意其对员工健康、员工保留率以及员工与雇主关系的潜在下游影响。
{"title":"A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs.","authors":"William B Wong, Irina Yermilov, Hannah Dalglish, Lori Bienvenu, Jonathan James, Sarah N Gibbs","doi":"10.18553/jmcp.2024.30.11.1308","DOIUrl":"10.18553/jmcp.2024.30.11.1308","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Alternative funding programs (AFPs) seek to reduce health plan sponsor costs, for example by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs) via an AFP vendor as a third-party.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To describe patients' experiences and specialty medication access with AFPs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A survey method consisting of 26 optional single-choice and multiple-choice questions with branching logic divided across 5 sections (related to patient challenges with AFPs) was administered to patients recruited from an experienced AFP online patient panel and a patient advocacy group. The survey assessed patients' awareness of AFPs from their employers, experience with the patient assistance program application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of delay in access. All descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels; statistical analyses were carried out for the exploratory analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The final sample included 227 patients. Most patients (61% [136/223]) first heard of the AFP as part of their health benefit when trying to obtain their medication. Of 198 patients, 88% reported being stressed because of the medication coverage denial and the uncertainty of obtaining their medication. More than half of patients (54% [115/213]) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for 68.2 days (approximately 2 months); 24% (51/215) reported the wait for the medication worsened their condition and 64% (138/215) reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. A significantly higher proportion of patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% [19/30] vs 81% [52/64]; &lt;i&gt;P&lt;/i&gt; = 0.022), whereas more patients with lower incomes (&lt;$50,000 vs &gt;$50,000) reported not receiving any medication (12% [7/57] vs 5% [7/129]; &lt;i&gt;P&lt;/i&gt; = 0.657), although these differences were not significant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being, and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their he","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 11","pages":"1308-1316"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522444/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545859","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}
引用次数: 0
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Journal of managed care & specialty pharmacy
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