1Duke Clinical Research Institute, Durham, North Carolina.
2University of Maryland School of Pharmacy, Baltimore.
J Manag Care Spec Pharm. 2019 Aug;25(8):913-921. doi: 10.18553/jmcp.2019.25.8.913.
There is a paucity of studies validating budget impact models. The lack of such studies may contribute to the underuse of budget impact models by payers in formulary decision making.
To assess the face validity, internal verification, and predictive validity of a previously published model that assessed the budgetary impact of antidiabetic formulary changes.
4 experts with diverse backgrounds were selected and asked questions regarding the face validity of the structure/conceptual model, input data, and results from the budget impact model. To assess internal verification, structured "walk-throughs," unit tests, extreme condition tests, traces, replication tests, and double programming techniques were used. The predictive validity of the model was evaluated by comparing the predicted and realized budget using mean absolute scaled error. "Realized" budgetary impact of the formulary changes was calculated by taking the difference between realized budget in the year after the formulary changes and the budget had there been no formulary changes (i.e., the counterfactual). The counterfactual budget was modeled using the best fit autoregressive integrated moving average model.
When assessing the face validity of the model, the 4 experts brought up issues such as how to incorporate other health insurance, recent policy changes, cost inflation, and potential impacts on insulin use. The 6 internal verification techniques caught mistakes in equations, missing data, and misclassified data. The realized budget was found to be lower than the predicted budget, with 13% error and an absolute scaled error of 2.60. After removing the model assumption that past utilization trends would continue, the model's predictive accuracy improved (the absolute scaled error dropped below 1 to 0.48). The "realized" budgetary impact was found to be greater than the predicted budgetary impact, largely because of lower-than-expected utilization.
The budget impact model overpredicted utilization in the year after the formulary changes. Discoveries through the validation process improved the accuracy and transparency of the model.
This project was supported by grant number F32HS024857 from the Agency for Healthcare Research and Quality (AHRQ). The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ. AHRQ had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or design to submit the manuscript for publication. The findings discussed in this manuscript represent the views of the authors and do not necessarily reflect the views of the Department of Defense, the Defense Health Agency, nor the Departments of the Army, Navy, and Air Force. Hung reports a grant from the AHRQ, during the conduct of the study, and personal fees from CVS Health and BlueCross BlueShield Association, outside the submitted work. Mullins reports grants and personal fees from Bayer and Pfizer and personal fees from Boehringer Ingelheim, Janssen/J&J, Regeneron, and Sanofi-Aventis, outside the submitted work. Mullins, Slejko, and Shaya are employed by the University of Maryland School of Pharmacy. Haines and Lugo have nothing to disclose. Part of this content was previously presented as a poster at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; Denver, CO, and as poster and oral presentations at the 2017 AMCP Nexus Meeting; October 16-19, 2017; Dallas, TX. Part of this content was published as Hung's PhD dissertation.
验证预算影响模型的研究很少。这种研究的缺乏可能导致支付方在制定目录决策时较少使用预算影响模型。
评估先前发表的评估糖尿病处方集变更预算影响的模型的表面有效性、内部验证和预测有效性。
选择了 4 名具有不同背景的专家,就结构/概念模型、输入数据和预算影响模型的结果的表面有效性提出问题。为了评估内部验证,使用了结构化“走查”、单元测试、极端条件测试、跟踪、复制测试和双重编程技术。通过比较使用平均绝对比例误差的预测和实际预算来评估模型的预测有效性。通过计算实际预算与没有处方集变更(即反事实)时的预算之间的差异来计算处方集变更的“实际”预算影响。使用最佳拟合自回归综合移动平均模型对反事实预算进行建模。
在评估模型的表面有效性时,4 名专家提出了如何纳入其他健康保险、最近的政策变化、成本通胀以及对胰岛素使用的潜在影响等问题。6 种内部验证技术发现了方程式、缺失数据和分类错误。实际预算低于预测预算,误差为 13%,绝对比例误差为 2.60。在消除模型假设过去的使用趋势将继续的情况下,模型的预测准确性得到了提高(绝对比例误差降至 1 以下至 0.48)。“实际”预算影响大于预测预算影响,主要是由于利用率低于预期。
在处方集变更后的那一年,预算影响模型高估了利用率。验证过程中的发现提高了模型的准确性和透明度。
这项研究得到了美国卫生与公众服务部医疗保健研究与质量局(AHRQ)F32HS024857 号拨款的支持。内容仅由作者负责,不一定代表 AHRQ 的官方观点。AHRQ 没有参与研究的设计和进行;数据的收集、管理、分析和解释;稿件的准备、审查或批准;或设计提交稿件供出版。本文讨论的研究结果代表了作者的观点,不一定反映国防部、国防卫生署以及陆军、海军和空军部门的观点。洪在研究期间报告了来自 AHRQ 的拨款,并从 CVS Health 和 BlueCross BlueShield Association 获得个人酬金,这与提交的工作无关。马林斯报告了拜耳和辉瑞的赠款和个人酬金,以及百时美施贵宝、Regeneron 和赛诺菲-安万特的个人酬金,这些都与提交的工作无关。马林斯、斯莱科和沙亚受雇于马里兰大学药学院。海恩斯和卢戈没有什么可透露的。本文的部分内容之前曾作为海报在 2017 年 AMCP 管理式医疗和专科药房年会(2017 年 3 月 27-30 日;丹佛,CO)上展示,并在 2017 年 AMCP Nexus 会议(2017 年 10 月 16-19 日;达拉斯,TX)上以海报和口头报告的形式展示。本文的部分内容已发表为洪的博士论文。