title: How Do Payers Respond to Regulatory Actions? The Case of Bevacizumab.
abstract: OBJECTIVE
  In February 2008, the US Food and Drug Administration (FDA) granted accelerated approval for bevacizumab for metastatic breast cancer. After public hearings in July 2010, and June 2011, the FDA revoked this approved indication in November 2011, on the basis of additional evidence regarding its risk/benefit profile. The Centers for Medicare and Medicaid Services, local Medicare contractors, and commercial payers varied in their stated intentions to cover bevacizumab after FDA's regulatory actions. We examined payer-specific trends in bevacizumab use after the FDA's regulatory actions.
  
  
  METHODS
  We used outpatient medical claims compiled by IMS Health to evaluate trends in bevacizumab use for breast cancer for Medicare-insured and commercially insured patients (N = 102,906) using segmented regression. Given that Medicare coverage policies may vary across regional contractors, we estimated trends in bevacizumab use across 10 local coverage areas. In a sensitivity analysis, we estimated trends in bevacizumab use for breast cancer compared with trends in use for lung cancer using difference-in-differences models.
  
  
  RESULTS
  Among chemotherapy infusions for breast cancer, bevacizumab use decreased from 31% in July 2010, to 4% in September 2012. Use decreased by 11% among commercially insured and 13% among Medicare-insured patients after July 2010 (interaction P = .68) and continued to decline by 9% per month (interaction P = .61). We observed no contractor-level variation in bevacizumab use among Medicare beneficiaries. During the same period, bevacizumab use for lung cancer was stable.
  
  
  CONCLUSIONS
  Although insurers varied in public statements regarding coverage intentions, bevacizumab use declined similarly among all payers, suggesting that provider decision making, rather than payer-specific coverage policies, drove reductions.
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD Dusetzina@unc.edu.
authors.forename: Stacie B
authors.initials: SB
authors.lastname: Dusetzina
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: Shellie
authors.initials: S
authors.lastname: Ellis
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Freedman
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: Rena M
authors.initials: RM
authors.lastname: Conti
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: Aaron N
authors.initials: AN
authors.lastname: Winn
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: James D
authors.initials: JD
authors.lastname: Chambers
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: G Caleb
authors.initials: GC
authors.lastname: Alexander
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: Haiden A
authors.initials: HA
authors.lastname: Huskamp
authors.affiliation: UNC Eshelman School of Pharmacy; University of North Carolina at Chapel Hill, Gillings School of Global Public Health; UNC Lineberger Comprehensive Cancer Center; Cecil G. Sheps Center for Health Services Research, Chapel Hill, NC; University of Kansas School of Medicine, Kansas City, KS; Dana-Farber Cancer Institute; Tufts Medical Center Institute for Clinical Research and Health Policy Studies; Harvard Medical School; Brigham and Women's Hospital, Boston, MA; University of Chicago, Chicago, IL; Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY; and Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins Medicine, Baltimore, MD.
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Keating
mesh_terms: D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003284:Contract Services; D017277:Drug Approval; D005260:Female; D006801:Humans; D019458:Insurance Coverage / Q000639:trends; D007348:Insurance, Health / Q000639:trends; D007349:Insurance, Health, Reimbursement; D008175:Lung Neoplasms / Q000188:drug therapy*; D006278:Medicare / Q000331:legislation & jurisprudence / Q000639:trends; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010818:Practice Patterns, Physicians' / Q000639:trends; D014481:United States
chemical_list: D020533:Angiogenesis Inhibitors; D000068258:Bevacizumab