1 University of Utah College of Pharmacy, Salt Lake City.
2 University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois.
J Manag Care Spec Pharm. 2019 Jul;25(7):770-779. doi: 10.18553/jmcp.2019.18443. Epub 2019 May 11.
The U.S. health care system is currently evolving from a volume-based care to a value-based care approach, which is in part supported by the introduction of patient support programs (PSP). For patients treated with adalimumab (ADA), the addition of a dedicated, trained nurse to the PSP (HUMIRA Complete, rolled out nationally in 2015) provides further emphasis on value-based care.
To determine the effectiveness of the HUMIRA Complete PSP, including the Nurse Ambassador component, in a real-world setting for patients receiving ADA across a broad range of approved indications (rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, uveitis, and hidradenitis suppurativa).
A longitudinal retrospective study was conducted using patient-level data from the HUMIRA Complete PSP data linked to the real-world, patient-level Symphony Health Solutions administrative claims database. Commercially insured patients were included who were aged ≥ 18 years with ≥ 2 diagnoses of an indicated disease who were biologically naive before initiating ADA or who had no claims for synthetic-targeted immune modulator therapy before their earliest ADA claim in the database between January 2015 and February 2017. The first claim had to have occurred in 2015 or later, and continuous medical and drug data coverage were required for ≥ 6 months before and ≥ 12 months after the first ADA claim and index date. PSP patients (with at least an initial and follow-up dedicated nurse call) were matched 1:1 to non-PSP patients based on pharmacy type, indication, and propensity score, estimated with covariates for age, sex, year of first ADA use, and baseline comorbidities. Adherence to ADA was compared using proportion of days covered along with discontinuation of ADA, defined as a gap in treatment greater than the previous days supply with no additional ADA claim, total costs, medical costs, and drug costs (2017 U.S. dollars) over 12 months. Baseline demographic and clinical characteristics were summarized descriptively. Differences between cohorts were assessed using t-tests for adherence and costs and log-rank tests for discontinuation.
2,268 patients (1,134 per group) were included. Baseline characteristics were similar between cohorts after matching. Participation in the PSP was associated with 29.3% higher ADA adherence (64.8% vs. 50.1%; < 0.0001) and 22.0% lower ADA discontinuation rate (51.4% vs. 65.9%; < 0.0001). Disease-related medical costs and all-cause medical costs were significantly lower by 35% ($10,162 vs. $15,511; = 0.005) and 29.2% ($25,074 vs. $35,419; = 0.0004), respectively, for PSP versus non-PSP patients. Total costs were also lower by 9% ($62,421 vs. $68,706; = 0.056), and drug costs were 12.2% higher ($37,347 vs. $33,287; = 0.0016).
This retrospective study demonstrates that participation in the PSP augments value-based care by improving outcomes for patients with chronic diseases by helping them not only manage a complex treatment regimen but also lower annual health care costs.
Design, study conduct, and financial support for this study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the manuscript; all authors contributed to the development of the publication and maintained control over the final content. Brixner reports consulting fees from AbbVie, AstraZeneca, Becton Dickinson, Millcreek Outcomes Group, Sanofi, and UCB Pharma. Rubin reports consulting fees from AbbVie, Abgenomics, Allergan, Forward Pharma, Genentech/Roche, Janssen Pharmaceuticals, Merck & Co., Napo Pharmaceuticals, Pfizer, Shire, Takeda, and Target Pharmaceuticals and research support from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda. Mease reports grant/research support from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; consulting fees from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; and served on the speakers bureaus for AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, and UCB. Mittal and Ganguli are employees and stockholders of AbbVie. Liu has no financial conflict of interest. Davis is an employee of Medicus Economics, which reports payment from AbbVie to participate in this research. Fendrick reports personal fees from Merck, AstraZeneca, Trizetto, Amgen, Lilly, AbbVie, Johnson & Johnson, and Sanofi; grants from the National Pharmaceutical Council, PhRMA, the Gary and Mary West Health Foundation, the states of New York and Michigan, the Laura and John Arnold Foundation, the Robert Wood Johnson Foundation, and the Agency for Healthcare Research and Quality; and has equity in Zansors, Sempre Health, Wellth, and V-BID Health. Data from this study were presented in part at the Academy of Managed Care & Specialty Pharmacy Annual Meeting; April 25, 2018; Boston, MA.
美国医疗保健系统正从基于数量的医疗服务向基于价值的医疗服务转变,这在一定程度上得到了患者支持计划(PSP)的支持。对于接受阿达木单抗(ADA)治疗的患者,PSP 中增加了专门的、经过培训的护士(HUMIRA Complete,2015 年在全国范围内推出),进一步强调了基于价值的医疗服务。
在广泛批准的适应症(类风湿关节炎、克罗恩病、溃疡性结肠炎、银屑病、银屑病关节炎、强直性脊柱炎、葡萄膜炎和化脓性汗腺炎)范围内,评估 ADA 治疗患者的 HUMIRA Complete PSP 及其护士大使组成部分的有效性。
使用从 HUMIRA Complete PSP 数据链接到 Symphony Health Solutions 真实世界、患者层面的行政索赔数据库的患者水平数据进行了一项纵向回顾性研究。纳入了年龄≥18 岁、至少有 2 种所指示疾病的诊断且在开始 ADA 治疗之前为生物初治或在数据库中最早 ADA 索赔之前没有合成靶向免疫调节剂治疗索赔的商业保险患者。首次索赔必须发生在 2015 年或之后,并且在首次 ADA 索赔和索引日期之前和之后≥6 个月需要有≥12 个月的连续医疗和药物数据覆盖。根据药房类型、适应症和倾向评分(使用年龄、性别、首次使用 ADA 的年份和基线合并症的协变量进行估计),对 PSP 患者(至少有初始和随访专用护士电话)与非 PSP 患者进行 1:1 匹配。使用覆盖天数来比较 ADA 的依从性,并定义为治疗中断,即前一天的供应量有差距,且没有额外的 ADA 索赔,12 个月内的总费用、医疗费用和药物费用(2017 年美元)。使用描述性统计方法总结了基线人口统计学和临床特征。使用 t 检验评估依从性和成本差异,使用对数秩检验评估停药差异。
纳入了 2268 名患者(每组 1134 名)。匹配后,队列之间的基线特征相似。参与 PSP 与 ADA 依从性提高 29.3%(64.8% vs. 50.1%; < 0.0001)和 ADA 停药率降低 22.0%(51.4% vs. 65.9%; < 0.0001)相关。与非 PSP 患者相比,PSP 患者的疾病相关医疗费用和所有原因医疗费用分别显著降低 35%($10162 与$15511; = 0.005)和 29.2%($25074 与$35419; = 0.0004)。总费用也降低了 9%($62421 与$68706; = 0.056),药物费用也增加了 12.2%($37347 与$33287; = 0.0016)。
这项回顾性研究表明,参与 PSP 通过帮助患者不仅管理复杂的治疗方案,而且降低年度医疗保健成本,从而改善慢性病患者的基于价值的医疗服务。
这项研究的设计、实施和财务支持由 AbbVie 提供。AbbVie 参与了数据的解释、审查和手稿的批准;所有作者都为出版物的发展做出了贡献,并保持了对最终内容的控制。Brixner 报告称,他有 AbbVie、AstraZeneca、Becton Dickinson、Millcreek Outcomes Group、Sanofi 和 UCB Pharma 的咨询费。Rubin 报告称,他有 AbbVie、Abgenomics、Allergan、Forward Pharma、Genentech/Roche、Janssen Pharmaceuticals、Merck & Co.、Napo Pharmaceuticals、Pfizer、Shire、Takeda 和 Target Pharmaceuticals 的咨询费和研究支持,以及来自 AbbVie、Genentech/Roche、Janssen Pharmaceuticals、Prometheus Laboratories、Shire 和 Takeda 的研究支持。Mease 报告称,他有 AbbVie、Amgen、BMS、Celgene、Genentech、Janssen、Lilly、Merck、Novartis、Pfizer、SUN Pharma 和 UCB 的赠款/研究支持;AbbVie、Amgen、BMS、Celgene、Genentech、Janssen、Lilly、Merck、Novartis、Pfizer、Roche 和 UCB 的咨询费;并在 AbbVie、Amgen、BMS、Celgene、Genentech、Janssen、Lilly、Merck、Novartis、Pfizer、Roche 和 UCB 的演讲者名单上。Mittal 和 Ganguli 是 AbbVie 的员工和股东。Liu 没有财务冲突利益。Davis 是 Medicus Economics 的员工,该公司因参与这项研究而获得 AbbVie 的报酬。Fendrick 从 Merck、AstraZeneca、Trizetto、Amgen、Lilly、AbbVie、Johnson & Johnson 和 Sanofi 获得个人酬金;从国家制药理事会、PhRMA、加里和玛丽·韦斯特健康基金会、纽约州和密歇根州、劳拉和约翰·阿诺德基金会、罗伯特·伍德·约翰逊基金会和医疗保健研究和质量局获得赠款;并在 Zansors、Sempre Health、Wellth 和 V-BID Health 拥有股权。这项研究的数据部分在管理医疗保健和专科药房协会年度会议上展示;2018 年 4 月 25 日;波士顿,MA。