The impact of emerging safety and effectiveness evidence on the use of physician-administered drugs: the case of bevacizumab for breast cancer.
The impact of emerging safety and effectiveness evidence on the use of physician-administered drugs: the case of bevacizumab for breast cancer.
复制标题
DOI：
10.1097/mlr.0b013e318290216f
复制
发表时间：
2013-07
期刊：
影响因子：
3
通讯作者：
Keating NL
中科院分区：
文献类型：
--
作者：
Conti RM;Dusetzina SB;Herbert AC;Berndt ER;Huskamp HA;Keating NL
在医生管理的药物上的支出很高，并且经常使用未经美国食品和药物管理局（FDA）批准的药物。虽然这些药物可能是未来合理使用政策的目标，但关于医生如何应对新出现的安全性和有效性证据，我们知之甚少。我们分析了贝伐单抗（Avastin™）在乳腺癌中的应用变化，以应对其上市（2008年2月），两次FDA会议审查数据表明其风险超过其益处（2010年7月，2011年6月），以及FDA撤回批准（2011年11月）。使用基于人群的肿瘤学家处方审核数据（IntrinsiQ Intelligose）来衡量2008年1月至2012年4月接受贝伐单抗治疗的乳腺癌患者的月数。使用负二项回归估计每次监管行动后贝伐珠单抗患者的数量，与第一次FDA会议前的患者进行比较，调整癌症分期、治疗线、患者年龄和门诊附属机构。在FDA批准后，贝伐单抗用于乳腺癌的使用显著增加。在采取所有监管措施后，与首次会议前相比，使用量下降了65%（95%CI=64%-65%）。最大的下降是在第一次会议后的六个月内（37%，95%CI=28%-47%）。下降的速度没有不同的病人或癌症的特点，不同的办公室隶属关系最小。在FDA会议和监管行动之后，贝伐单抗用于乳腺癌的使用急剧下降，在此期间，指南建议或保险范围没有变化。医生似乎对新出现的关于医生给药的安全性和有效性的证据作出反应。
Spending on physician-administered drugs is high and uses not approved by the U.S. Food and Drug Administration (FDA) are frequent. While these drugs may be targets of future policy efforts to rationalize use, little is known regarding how physicians respond to emerging safety and effectiveness evidence. We analyzed changes in bevacizumab (Avastin™) use for breast cancer in response to its market launch (Feb-2008), two FDA meetings reviewing data suggesting that its risks exceed its benefits (July-2010, June-2011), and the FDA’s withdrawal of approval (Nov-2011). Data from a population-based audit of oncologists’ prescribing (IntrinsiQ Intellidose) were used to measure the monthly number of breast cancer patients treated with bevacizumab January, 2008-April,2012. The number of bevacizumab patients following each regulatory action was estimated using negative binomial regression, compared with patients before the first FDA meeting, adjusting for cancer stage, treatment line, patient age and outpatient office affiliation. Bevacizumab use for breast cancer increased significantly after FDA approval. Following all regulatory actions, there was a 65% decline (95%CI=64%-65%) in use compared with the period before the first meeting. The largest decline was in the six-month period following the first meeting (37%, 95%CI=28%-47%). The rate of decline did not differ by patient or cancer characteristics and differed minimally by office affiliation. Bevacizumab use for breast cancer declined dramatically after FDA meetings and regulatory actions, a period without changes in guideline recommendations or insurance coverage. Physicians appear responsive to emerging evidence concerning physician-administered drug safety and effectiveness.