Department of Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, RI; Department of Physical Medicine and Rehabilitation, Rhode Island Hospital, Lifespan Physicians Group, Providence, RI.
Department of Neurosurgery, The Warren Alpert Medical School of Brown University, Providence, RI.
Pain Physician. 2021 Sep;24(6):489-494.
Chronic pain accounts for several hundred billion dollars in total treatment costs, and lost productivity annually. Selecting cost-effective pain treatments can reduce the financial burden on both individuals and society. Targeted drug delivery (TDD), whereby medications used to treat pain are delivered directly to the intrathecal space, remains an important treatment modality for chronic pain refractory to oral medication management. These medications can be administered alone (monotherapy), or in conjunction with other medications to give a synergistic affect (compounded therapy). While compounded therapy is often prescribed for pain refractory to both oral management and intrathecal monotherapy, compounded administration has not been approved by the United States Food and Drug Administration (FDA), and is thought to be more expensive. In this study, we hypothesized that TDD delivering monotherapy vs compounded therapy would differ significantly in cost.
In 2015, a pharmacy-led initiative resulted in an institution-wide policy requiring that all TDD patients, being treated with compounded therapy, be transitioned to FDA-approved intrathecal monotherapy. The intent of this new policy was to eliminate use of non-FDA approved, "off-label" medications. During this transition, our practice used the opportunity to retrospectively analyze and compare the costs of monotherapy vs compounded therapy.
Billing, drug dosing, and pain data were collected from 01/2015 to 01/2019, and reviewed retrospectively for patients originally on compounded intrathecal medication therapy, and compared before and after transition to monotherapy.
A multidisciplinary hospital-based spine center within an academic tertiary care facility.
Electronic medical records from the institutional TDD program were retrospectively reviewed to identify all patients on compounded drug therapy before the transition period (2015-2016). Patients were excluded from the study if they chose to switch their care to another practice rather than transitioning from compounded therapy to monotherapy. Cost per medications refill, cost per year, and reported pain scale before and after the transition were computed, and differences were compared using unpaired t tests. Refill costs of individual drugs were also compared.
Of 46 patients originally on compounded therapy, 26 patients met inclusion criteria. The most common pre-transition drugs administered as compounded therapy were bupivacaine (n = 17), morphine (n = 15), and clonidine (n = 14), while hydromorphone (n = 10), baclofen (n = 5), and fentanyl (n = 1) were less common. There was a 51.3% decrease in cost per refill (P = 0.135) and a 50.0% decrease in cost per year (P = 0.283) after transition. Morphine and clonidine were both significantly more expensive than hydromorphone and bupivacaine (P < 0.05). After removing cases in which hydromorphone was the baseline opiate, there was a 64.8% decrease in cost per refill (P = 0.041) and a 66.8% decrease in cost per year (P = 0.190). There was no significant difference in the average reported pain scale across the transition (P = 0.323), suggesting stable pain management efficacy.
This retrospective study is limited by its small cohort size and lack of a control group.
Based on single-institutional billing data, transition from compounded therapy to monotherapy TDD resulted in cost savings, dependent on the specific combination of drugs initially used for therapy. A larger multi-institutional study is indicated.
慢性疼痛导致的总治疗费用高达数百亿美元，每年还会导致生产力损失。选择具有成本效益的疼痛治疗方法可以减轻个人和社会的经济负担。靶向药物输送（TDD）是一种将用于治疗疼痛的药物直接输送到鞘内空间的重要治疗方式，仍然是治疗对口服药物管理有抗药性的慢性疼痛的重要治疗方式。这些药物可以单独使用（单药治疗），也可以与其他药物联合使用以产生协同作用（复合治疗）。虽然复合治疗通常用于治疗对口服管理和鞘内单药治疗都有抗药性的疼痛，但复合给药尚未获得美国食品和药物管理局（FDA）的批准，并且被认为更昂贵。在这项研究中，我们假设 TDD 输送的单药治疗与复合治疗在成本上会有显著差异。
2015 年，一项由药房主导的计划导致机构内出台了一项政策，要求所有接受复合治疗的 TDD 患者都要转为经 FDA 批准的鞘内单药治疗。这项新政策的目的是消除使用未经 FDA 批准的“标签外”药物。在这一过渡期间，我们的实践利用这个机会回顾性分析和比较单药治疗与复合治疗的成本。
从 2015 年 1 月至 2019 年 1 月收集了计费、药物剂量和疼痛数据，并对最初接受复合鞘内药物治疗的患者进行回顾性回顾，并比较了治疗前和治疗后转为单药治疗的情况。
一家学术型三级医疗机构的多学科脊柱中心内的一个机构 TDD 项目。
回顾性审查机构 TDD 计划的电子病历，以确定在过渡期间（2015-2016 年）接受复合药物治疗的所有患者。如果患者选择将护理转至另一家实践，而不是从复合治疗转为单药治疗，则将其排除在研究之外。计算了每个药物补充的成本、每年的成本以及治疗前后的报告疼痛量表，并使用未配对 t 检验比较差异。还比较了个别药物的补充成本。
在最初接受复合治疗的 46 名患者中，有 26 名患者符合纳入标准。最常见的用于复合治疗的术前药物是布比卡因（n = 17）、吗啡（n = 15）和可乐定（n = 14），而氢吗啡酮（n = 10）、巴氯芬（n = 5）和芬太尼（n = 1）则较少见。在治疗后，补充治疗的成本降低了 51.3%（P = 0.135），每年的成本降低了 50.0%（P = 0.283）。吗啡和可乐定的成本均显著高于氢吗啡酮和布比卡因（P < 0.05）。在去除氢吗啡酮作为基线阿片类药物的病例后，补充治疗的成本降低了 64.8%（P = 0.041），每年的成本降低了 66.8%（P = 0.190）。在治疗过程中，报告的平均疼痛量表没有显著差异（P = 0.323），表明疼痛管理的疗效稳定。
这项回顾性研究的局限性在于其样本量小，缺乏对照组。
根据单机构计费数据，从复合治疗转为鞘内单药 TDD 治疗可节省成本，具体取决于最初用于治疗的药物组合。需要进行更大的多机构研究。
