The influence of the risk evaluation mitigation strategy on erythropoieses stiulating agent use in medicare patients with breast and lung cancers with chemotherapy induced anemia
Patient safety is a priority to multiple stakeholders including health care providers, pharmaceutical/biotechnology companies and regulators, such as the Food and Drug Administration (FDA). The FDA has the authority to mandate a pharmaceutical or biotechnology company to implement a risk evaluation mitigation strategy (REMS) to reduce safety events while allowing appropriate patients to benefit from drugs. The FDA used such authority with a class of drugs, the erythropoiesis stimulating agents EPOGEN® (epoetin alfa) and PROCRIT® (epoetin alfa) beginning in February of 2010. These agents were approved by the FDA in 1993 to decrease the need for red blood cell (RBC) transfusions in anemic patients with cancer treated with myelosuppressive chemotherapy. A third ESA, ARANESP® (darbepoetin alfa), was approved in 2002 with the same indication. A retrospective observational study was conducted utilizing the Medicare 5% sample data for fee for service enrollees in Parts A and B with separate analyses of specific historical equivalent observational periods pre- and post-REMS implementation (pre-REMS: 1Q2008 through 4Q2009 and post-REMS: 1Q2010 through 4Q2011). The aims were addressed separately for Medicare patients with breast and/or lung cancers and a comparison of the results was made between these two categories. First, the study demonstrated that the relative reduction in ESA use was largest among breast cancer patients, 33.1%; OR 0.30; 95% CI [0.23, 0.40], and was 30.2%; OR 0.28 in lung cancer patients, 95% CI [0.23, 0.34]. Second, the likelihood of receiving a transfusion in breast cancer patients post-REMS unadjusted (OR = 1.50, p = 0.0011) and adjusted for demographics and comorbidities (OR = 1.51, p = 0.0011) was statistically significant. No change in RBC transfusion use was observed between pre- and post-REMS. Finally, no association was observed between ESA use and stroke status in unadjusted and demographic adjusted and comorbidity adjusted models. Of the three aims, the fact that no significant change in stroke was observed post-REMS is the impetus for further exploration of a possible policy change for the ESAs.
Hollingsworth, Kristen, "The influence of the risk evaluation mitigation strategy on erythropoieses stiulating agent use in medicare patients with breast and lung cancers with chemotherapy induced anemia" (2014). ETD Collection for Thomas Jefferson University. AAI3669454.