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美国制药行业营销支出与 PCSK9(前蛋白转化酶枯草溶菌素 9)抑制剂处方之间的关联。

Association Between Industry Marketing Payments and Prescriptions for PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibitors in the United States.

机构信息

Department of Epidemiology (K.I.) UCLA Fielding School of Public Health.

Department of Social Epidemiology, Graduate School of Medicine, Kyoto University, Kyoto, Japan (K.I.).

出版信息

Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007521. doi: 10.1161/CIRCOUTCOMES.120.007521. Epub 2021 May 10.

DOI:10.1161/CIRCOUTCOMES.120.007521
PMID:33966446
Abstract

BACKGROUND

Marketing payments from the pharmaceutical industry to physicians have come under scrutiny due to their potential to influence clinical decision-making. Two proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) were approved by the US Food and Drug Administration in 2015 for reducing low-density lipoprotein cholesterol in high-risk patients, but their initial uptake was limited due to their high-cost and stringent prior authorization requirements. We sought to investigate the association between industry marketing and early adoption of PCSK9i among US physicians.

METHODS

We used nationwide databases of primary care physicians, cardiologists, and endocrinologists treating Medicare beneficiaries to examine the association between PCSK9i-related marketing payments in 2016 and the number of filled PCSK9i prescriptions in 2017, after adjusting for physician characteristics. In subgroup analyses, we stratified our analyses by physician specialty and prior experience with prescribing PCSK9i.

RESULTS

Among 209 840 physicians included in this analysis, 49 341 (24%) physicians received 292 941 PCSK9i-related marketing payments in 2016. The total value of these payments was $19 million, with a median payment of $61 per physician (interquartile range, $25-$132). Most payments (95%) were for meals, with a median of $14 per meal. The receipt of PCSK9i-related payments in 2016 was associated with increased PCSK9i prescription in 2017 (adjusted risk ratio, 3.18 [95% CI, 2.95-3.42]). This association was larger among primary care physicians (adjusted risk ratio, 6.67 [95% CI, 5.87-7.57]) than cardiologists (adjusted risk ratio, 2.00 [95% CI, 1.84-2.16]) and endocrinologists (adjusted risk ratio, 4.06 [95% CI, 2.95-5.59]). The association was observed across all types of payments.

CONCLUSIONS

At a time when few physicians had experience with prescribing PCSK9i under strict prior authorization requirements, industry marketing payments to physicians for PCSK9i, predominantly in the form of meals, were associated with increased PCSK9i prescription in the subsequent year.

摘要

背景

由于制药业向医生支付的营销费用可能影响临床决策,因此受到了审查。两种前蛋白转化酶枯草溶菌素/ kexin 9 型抑制剂(PCSK9i)于 2015 年获得美国食品和药物管理局批准,用于降低高危患者的低密度脂蛋白胆固醇,但由于其高成本和严格的事先授权要求,最初的采用受到限制。我们试图研究制药业营销与美国医生早期采用 PCSK9i 之间的关系。

方法

我们使用治疗医疗保险受益人的初级保健医生、心脏病专家和内分泌科医生的全国性数据库,研究了 2016 年与 PCSK9i 相关的营销支出与 2017 年 PCSK9i 处方数量之间的关系,同时调整了医生特征。在亚组分析中,我们根据医生的专业和先前使用 PCSK9i 开处方的经验对分析进行了分层。

结果

在这项分析中,包括 209840 名医生,49341 名(24%)医生在 2016 年收到了 292941 笔与 PCSK9i 相关的营销支出。这些支出总额为 1900 万美元,每位医生的中位数支出为 61 美元(四分位距,25-132 美元)。大多数支出(95%)是餐费,中位数为每顿饭 14 美元。2016 年收到与 PCSK9i 相关的款项与 2017 年 PCSK9i 处方增加有关(调整后的风险比,3.18[95%CI,2.95-3.42])。与心脏病专家(调整后的风险比,2.00[95%CI,1.84-2.16])和内分泌科医生(调整后的风险比,4.06[95%CI,2.95-5.59])相比,这种关联在初级保健医生中更大(调整后的风险比,6.67[95%CI,5.87-7.57])。这种关联在所有类型的支出中都存在。

结论

在很少有医生有经验根据严格的事先授权要求开 PCSK9i 处方的情况下,制药业向医生支付 PCSK9i 的营销费用,主要是以餐费的形式,与随后一年 PCSK9i 处方的增加有关。

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