Association Between FDA Safety Warnings, CMS Coverage Restrictions and Adherence to Guidelines for ESA Use in Patients with Myelodysplastic Syndromes
Hendrick F, Davidoff A, Zeidan A, Gore S, Baer M. Association Between FDA Safety Warnings, CMS Coverage Restrictions and Adherence to Guidelines for ESA Use in Patients with Myelodysplastic Syndromes. Blood 2012, 120: 971. DOI: 10.1182/blood.v120.21.971.971.Peer-Reviewed Original ResearchErythropoiesis stimulating agentsCMS national coverage determinationsFDA safety warningsESA useNational Coverage DeterminationMyelodysplastic syndromeESA initiationSerum EPO levelsMDS patientsUse of ESAsEPO levelsChronic renal failureOff-label indicationsProportion of patientsChemotherapy-related anemiaSpecific clinical parametersOff-label useTreatment of anemiaEnd of studySerum erythropoietin levelsLikelihood of responseLogistic regression modelsThromboembolic eventsTransfusion useAdverse events