Sydor Anne M, Bergin Emily, Kay Jonathan, Stone Erik, Popovian Robert
1. Division of Patient-Focused Economic and Policy Research Global Healthy Living Foundation, Upper Nyack, New York, USA.
Division of Patient-Focused Economic and Policy Research Global Healthy Living Foundation, Upper Nyack, New York, USA.
J Health Econ Outcomes Res. 2024 Mar 25;11(1):86-93. doi: 10.36469/001c.94544. eCollection 2024.
Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the 2 largest US formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion. The number of people likely to have adverse events due to the exclusion could be as high as 1 million for atrial fibrillation/venous thromboembolism, 900 000 for migraine prevention, and 500 000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924 000 for atrial fibrillation/venous thromboembolism, 646 000 for migraine, and 138 000 for psoriasis. Substitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced medication substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.
药物处方集最初旨在促进使用具有成本效益的仿制药，现在则旨在为协商采购价格的药房福利管理公司实现财务收益最大化。在第二大公开可用的药房福利管理处方集中，55%的强制替代并非针对相同活性成分和/或制剂的仿制药或生物类似药版本，可能对患者没有医学或经济益处。我们模拟了排除用于心房颤动/静脉血栓栓塞、偏头痛预防和银屑病的新型药物的影响，这些都需要用不同的活性成分进行替代。利用人口数据、美国两大处方集的市场份额以及2021年的处方数据，我们计算了有多少人可能受到此类排除的影响。利用已发表文献的数据，我们计算了这些人中可能有多少人会因处方集排除而停止治疗和/或出现不良事件。因排除而可能出现不良事件的人数，心房颤动/静脉血栓栓塞可能高达100万，偏头痛预防可能高达90万，银屑病可能高达50万。因病情而可能停止治疗的人数，心房颤动/静脉血栓栓塞高达92.4万，偏头痛高达64.6万，银屑病高达13.8万。在目前使用的处方集中，用不等效治疗进行替代很常见，并且对数以十万计的患者会产生重大影响。强制药物替代会导致发病率和死亡率的高昂增加，应该成为任何处方集排除成本效益分析的一部分。
