University of Michigan, Ann Arbor.
University of Utah College of Pharmacy, Salt Lake City.
J Manag Care Spec Pharm. 2021 Aug;27(8):1086-1095. doi: 10.18553/jmcp.2021.20560. Epub 2021 Apr 12.
Patient support programs (PSPs) improve medication-taking behavior in the first 12 months of treatment for patients with immune-mediated diseases, but it is unknown if these benefits are sustained. As immune-mediated diseases continue to increase in prevalence and economic burden, understanding the potential value of PSPs in helping patients adhere to their long-term treatment plan and avoid costly hospital visits is crucial. Launched nationally in 2015, HUMIRA Complete (a PSP for adalimumab patients) provides an opportunity to study long-term effects of PSP participation, including the impact on medication-taking behavior and hospital visits. To evaluate the sustained relationship between PSP participation, long-term medication-taking behavior, and hospital visits. A longitudinal, retrospective matched-cohort study was conducted of patients initiating adalimumab between January 2015 and February 2016 with or without enrolling in the PSP, using patient-level data from the HUMIRA Complete PSP linked with Symphony Health claims. The sample included adult, commercially insured patients diagnosed with an indicated disease who were biologic-naive and had data available for ≥ 6 months before and ≥ 12 months after initiating adalimumab. Adherence (proportion of days covered) and hospital visits were assessed at 12, 24, and 36 months for patients with sufficient follow-up data. Multivariable generalized models estimated differences between cohorts, controlling for baseline characteristics and hospital visits. Duration of persistence and time to a hospital visit were compared using Kaplan-Meier analyses. Hazard ratios were estimated using multivariable Cox proportional hazards models. The matched cohort included 2,268 patients (1,134 per cohort), and patient attrition was similar across cohorts. The PSP cohort consistently demonstrated higher adalimumab adherence than the non-PSP cohort at 12 (64.8% vs. 50.1%, < 0.0001; 29% greater), 24 (49.4% vs. 38.4%; < 0.0001; 29% greater), and 36 (39.4% vs. 35.1%; = 0.02; 12% greater) months. PSP participation was associated with a 30% lower hazard of discontinuation ( < 0.0001), and median duration of persistence was 4.8 months longer for the PSP cohort (13.2 vs. 8.4 months; < 0.0001). The PSP cohort had lower rates of hospital visits at 12 (30% vs. 37%; < 0.001; 19% lower), 24 (44% vs. 53%; = 0.01; 17% lower), and 36 (55% vs. 65%; < 0.01; 16% lower) months, and PSP participation was associated with a 25% lower hazard of a hospital visit ( < 0.0001). Median time to a hospital visit was 10.8 months longer for the PSP cohort (32.7 vs. 21.9 months; < 0.0001). Findings were consistent across therapeutic areas: hazard of a hospital visit was 28%, 27%, and 37% lower for rheumatology, gastroenterology, and dermatology patients participating in the PSP (all < 0.05). Patients with immune-mediated diseases receiving adalimumab and utilizing this PSP had improved long-term medication-taking behavior and lower risk of hospital visits, demonstrating the potential of PSPs to improve patient outcomes and lower the burden to the health care system. Design, study conduct, and financial support for the study were provided by AbbVie Inc., which participated in the interpretation of data, review, and approval of the manuscript. Fendrick has received 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 equity in Zansors, Sempre Health, Wellth, and V-BID Health. Brixner has received consulting fees from AbbVie, Novartis, Xcenda, Elevar Therapeutics, Sanofi, UCB Pharma, and the Millcreek Outcomes Group. Rubin has received consulting fees from AbbVie, Abgenomics, Allergan Inc., Amgen, Celgene Corporation, Forward Pharma, Genentech/Roche, Janssen Pharmaceuticals, Merck & Co., Miraca Life Sciences, Mitsubishi Tanabe Pharma Development America, Napo Pharmaceuticals, Pfizer, Salix Pharmaceuticals Inc., Samsung Bioepis, Sandoz Pharmaceuticals, Shire, Takeda, and Target Pharmaceuticals; and research support from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, Takeda, and UCB Pharma. Mease has received grant/research support from AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; consulting fees from AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Genentech, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, and UCB; and has served on the speakers bureau for AbbVie, Amgen, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB. Liu has no financial conflict of interest. Davis is an employee of Medicus Economics, which received payment from AbbVie to participate in this research. Mittal is an employee and stockholder of AbbVie. This study used a cohort of patients previously described in Brixner D, Rubin DT, Mease P, et al. Patient support program increased medication adherence with lower total health care costs despite increased drug spending. 2019 Jul;25(7):770-79 (doi: 10.18553/jmcp.2019.18443). As such, the sample selection and select baseline characteristics and 12-month outcomes have been published previously; however, the hospital visit outcomes and the longer-term medication-taking behavior outcomes have not been previously published or presented.
患者支持计划(PSP)可改善免疫介导性疾病患者在治疗的头 12 个月内的服药行为,但尚不清楚这些益处是否可持续。随着免疫介导性疾病的患病率和经济负担不断增加,了解 PSP 帮助患者坚持长期治疗计划和避免昂贵的医院就诊的潜在价值至关重要。2015 年在全国推出的 HUMIRA Complete(阿达木单抗患者的 PSP)为研究 PSP 参与的长期影响提供了机会,包括对服药行为和医院就诊的影响。
评估 PSP 参与、长期服药行为和医院就诊之间的持续关系。采用患者层面的数据,对 2015 年 1 月至 2016 年 2 月期间接受阿达木单抗治疗的患者进行了一项全国性、回顾性、匹配队列研究,无论是否参加 PSP,均使用了 Humira Complete PSP 链接的 Symphony Health 索赔数据。该样本包括被诊断为有指征疾病的成年商业保险患者,这些患者在开始使用阿达木单抗前至少有 6 个月的数据,并且在开始使用阿达木单抗后至少有 12 个月的数据。对于有足够随访数据的患者,在 12、24 和 36 个月时评估了依从性(覆盖天数比例)和医院就诊情况。使用 Kaplan-Meier 分析比较了队列之间的差异,控制了基线特征和医院就诊情况。使用多变量 Cox 比例风险模型比较了持续时间和到医院就诊的时间。
匹配队列包括 2268 名患者(每组 1134 名),各队列的患者流失情况相似。PSP 队列在 12 个月(64.8% vs. 50.1%,<0.0001;29%更高)、24 个月(49.4% vs. 38.4%;<0.0001;29%更高)和 36 个月(39.4% vs. 35.1%;=0.02;12%更高)时的阿达木单抗依从性始终高于非 PSP 队列。PSP 参与与停药的风险降低 30%相关(<0.0001),PSP 队列的持续时间中位数长 4.8 个月(13.2 个月 vs. 8.4 个月;<0.0001)。PSP 队列在 12 个月(30% vs. 37%;<0.001;19%更低)、24 个月(44% vs. 53%;=0.01;17%更低)和 36 个月(55% vs. 65%;<0.01;16%更低)时的医院就诊率较低,PSP 参与与医院就诊的风险降低 25%相关(<0.0001)。PSP 队列的首次就诊时间中位数长 10.8 个月(32.7 个月 vs. 21.9 个月;<0.0001)。在治疗领域中均发现了相似的结果:参与 PSP 的风湿科、胃肠病科和皮肤科患者的就诊风险降低了 28%、27%和 37%(均<0.05)。
接受阿达木单抗治疗并使用该 PSP 的免疫介导性疾病患者改善了长期服药行为,降低了医院就诊的风险,表明 PSP 有可能改善患者的预后并降低医疗保健系统的负担。AbbVie Inc. 提供了研究的设计、研究的进行和研究的资金支持,该公司参与了数据的解释、审查和手稿的批准。芬德雷克拥有 Merck、AstraZeneca、Trizetto、Amgen、Lilly、AbbVie、Johnson & Johnson 和 Sanofi 的个人酬金;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署获得赠款;并在 Zansors、Sempre Health、Wellth 和 V-BID Health 中拥有股权。布里克斯纳从 AbbVie、Novartis、Xcenda、Elevar Therapeutics、Sanofi、UCB Pharma 和 Millcreek Outcomes Group 获得咨询费。鲁宾从 AbbVie、Abgenomics、Allergan Inc.、Amgen、Celgene Corporation、Forward Pharma、Genentech/Roche、Janssen Pharmaceuticals、Merck & Co.、Miraca Life Sciences、 Mitsubishi Tanabe Pharma Development America、Napo Pharmaceuticals、Pfizer、Salix Pharmaceuticals Inc.、Samsung Bioepis、Sandoz Pharmaceuticals、Shire、Takeda 和 Target Pharmaceuticals 获得咨询费;并从 AbbVie、Genentech/Roche、Janssen Pharmaceuticals、Prometheus Laboratories、Shire、Takeda 和 UCB Pharma 获得研究支持。米泽斯从 AbbVie、Amgen、BMS、Celgene、Janssen、Lilly、Merck、Novartis、Pfizer、SUN Pharma 和 UCB 获得研究资金/研究支持;从 AbbVie、Amgen、BMS、Boehringer Ingelheim、Celgene、Galapagos、Genentech、Gilead、GlaxoSmithKline、Janssen、Lilly、Novartis、Pfizer、SUN Pharma 和 UCB 获得咨询费;并在 AbbVie、Amgen、Celgene、Janssen、Lilly、Novartis、Pfizer 和 UCB 担任演讲者。刘没有财务利益冲突。戴维斯是 Medicus Economics 的员工,该公司从 AbbVie 获得报酬参与这项研究。米塔尔是 AbbVie 的员工和股东。这项研究使用了以前在 Brixner D、Rubin DT、Mease P 等人的研究中描述过的患者队列。患者支持计划增加了药物治疗的依从性,尽管药物支出增加,但总体医疗成本降低。2019 年 7 月;25(7):770-79(doi:10.18553/jmcp.2019.18443)。因此,样本选择和一些基线特征和 12 个月的结果以前已经发表过;然而,医院就诊结果和长期服药行为结果以前没有发表过或呈现过。