Neuner Joan M, Kamaraju Sailaja, Charlson John A, Wozniak Erica M, Smith Elizabeth C, Biggers Alana, Smallwood Alicia J, Laud Purushottam W, Pezzin Liliana E
Center for Patient Care and Outcomes Research (JMN, SK, JC, EMW, ECS, AJS, PWL, LEP), Division of Hematology and Oncology, Department of Medicine (SK, JC), Division of Biostatistics, Department of the Institute for Health and Society (PWL), Division of General Internal Medicine, Department of Medicine (JMN, AB, LEP), Medical College of Wisconsin, Milwaukee, WI.
J Natl Cancer Inst. 2015 May 12;107(8). doi: 10.1093/jnci/djv130. Print 2015 Aug.
Aromatase inhibitors (AIs) substantially reduce breast cancer mortality in clinical trials, but high rates of nonadherence to these long-term oral therapies have reduced their impact outside of trials. We examined the association of generic AI availability with AI adherence among a large national breast cancer cohort.
Using a quasi-experimental prepost design, we examined the effect of generic AI introductions (7/2010 and 4/2011) on adherence among a national cohort of women with incident breast cancer in 2006 and 2007 who were enrolled in the Medicare D pharmaceutical coverage program. Medicare D claims were used to calculate AI adherence, defined as a medication possession ratio of 80% or more of eligible days, over 36 months. Multivariable logistic regression models estimated with generalized estimating equations were applied to longitudinal adherence data to control for possible confounders, including receipt of a Medicare D low-income subsidy, and to account for repeated measures. All statistical tests were two-sided.
Sixteen thousand four hundred sixty-two Medicare D enrollees were eligible. Adherence declined throughout the study. However, among women without a subsidy, the median quarterly out-of-pocket cost of anastrozole fell from $183 in the fourth quarter of 2009 to $15 in 2011, and declines in adherence were attenuated with generic AI introductions. Regression-adjusted adherence probabilities were estimated to be 5.4% higher after generic anastrozole was introduced in 2010 and 11% higher after generic letrozole/exemestane was introduced in 2011. Subsidy recipients had higher adherence rates throughout the study.
The introduction of generic medications attenuated the decline in adherence to AIs over three years of treatment among breast cancer survivors not receiving low-income subsidies for Medicare D coverage.
芳香化酶抑制剂(AIs)在临床试验中可大幅降低乳腺癌死亡率,但这些长期口服疗法的高不依从率降低了其在试验之外的效果。我们在一个大型全国性乳腺癌队列中研究了通用型AI的可及性与AI依从性之间的关联。
采用准实验性前后设计,我们研究了通用型AI引入(2010年7月和2011年4月)对2006年和2007年纳入医疗保险D部分药物覆盖计划的全国性新发乳腺癌女性队列中依从性的影响。医疗保险D部分的报销申请用于计算AI依从性,定义为在36个月内符合条件天数的药物持有率达到80%或更高。使用广义估计方程估计的多变量逻辑回归模型应用于纵向依从性数据,以控制可能的混杂因素,包括接受医疗保险D部分低收入补贴,并考虑重复测量。所有统计检验均为双侧检验。
16462名医疗保险D部分参保者符合条件。在整个研究过程中依从性下降。然而,在没有补贴的女性中,阿那曲唑的季度自付费用中位数从2009年第四季度的183美元降至2011年的15美元,随着通用型AI的引入,依从性下降得到缓解。经回归调整后的依从概率估计在2010年引入通用型阿那曲唑后提高了5.4%,在2011年引入通用型来曲唑/依西美坦后提高了11%。补贴接受者在整个研究过程中的依从率更高。
对于未获得医疗保险D部分覆盖低收入补贴的乳腺癌幸存者,通用型药物的引入减缓了三年治疗期间AI依从性的下降。