University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, Birmingham, AL, USA.
Pharmacoepidemiol Drug Saf. 2013 Nov;22(11):1214-21. doi: 10.1002/pds.3475. Epub 2013 Sep 9.
After U.S. licensure, parenterally administered medications are identified using non-specific drug codes. Accurately identifying these medications is critical to safety and effectiveness research. Methods to identify medications prior to assignment of specific drug codes have not been well described.
To describe a generalized approach using non-specific drug codes to identify parenteral therapies in Medicare claims and to assess the ability of that approach to identify tocilizumab (TCZ), a new biologic agent approved in 2010.
We used 2008-2010 Medicare data for a cohort of rheumatoid arthritis patients for algorithm development. Our algorithm classified non-specific drug codes based upon: 1) ICD9 codes; 2) unit values (i.e. dose); 3) codes for infusion/injection procedures; 4) expected versus observed total reimbursement amount and reimbursement per unit. We assessed algorithm performance by linking to an arthritis registry to examine external validity.
Of 472 803 claims with non-specific drug codes, 9762 claims satisfied the TCZ algorithm. 74.3% of 9762 claims were classified as TCZ by exact unit price or allowed amount, 4.4% by unique doses, 21.3% by diagnosis code and small deviation from unit price or allowed amount. The algorithm demonstrated good performance characteristics: sensitivity 94% (95% CI 80-99), specificity 100% (99-100) and PPV 97% (84-100).
Claims-based algorithms in Medicare or similar data systems can accurately identify newly approved biologics administered parenterally prior to the assignment of specific drug codes.
在美国获得许可后，通过非特异性药物代码来识别肠胃外给药的药物。准确识别这些药物对于安全性和有效性研究至关重要。但在此之前，尚未很好地描述用于在特定药物代码分配之前识别药物的方法。
描述一种使用非特异性药物代码在医疗保险索赔中识别肠胃外治疗的通用方法，并评估该方法识别托珠单抗（TCZ）的能力，TCZ 是一种 2010 年批准的新型生物制剂。
我们使用了 2008 年至 2010 年的医疗保险数据来开发类风湿关节炎患者队列的算法。我们的算法根据以下标准对非特异性药物代码进行分类：1）ICD9 代码；2）单位值（即剂量）；3）输注/注射程序代码；4）预期与实际总报销金额和单位报销金额。我们通过与关节炎登记处进行链接来评估算法的外部有效性，以评估算法性能。
在 472803 份具有非特异性药物代码的索赔中，有 9762 份索赔符合 TCZ 算法。在这 9762 个索赔中，74.3%通过确切的单价或允许的金额，4.4%通过独特的剂量，21.3%通过诊断代码和单价或允许的金额的小偏差被归类为 TCZ。该算法具有良好的性能特征：敏感性为 94%（95%CI80-99），特异性为 100%（99-100），PPV 为 97%（84-100）。
医疗保险或类似数据系统中的基于索赔的算法可以在特定药物代码分配之前准确识别新批准的肠胃外给药的生物制剂。
