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How Do Payers Respond to Regulatory Actions? The Case of Bevacizumab. J Oncol Pract 2015 Jul;11(4):313-8



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PURPOSE: 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.

CONCLUSION: 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.

Author List

Dusetzina SB, Ellis S, Freedman RA, Conti RM, Winn AN, Chambers JD, Alexander GC, Huskamp HA, Keating NL


Aaron Winn PhD Assistant Professor in the School of Pharmacy Administration department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Angiogenesis Inhibitors
Breast Neoplasms
Contract Services
Drug Approval
Insurance Coverage
Insurance, Health
Insurance, Health, Reimbursement
Lung Neoplasms
Middle Aged
Neoplasm Metastasis
Practice Patterns, Physicians'
United States
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a