ASCO/ASH, ACCC, EMEA and now the FDA all say the following with respect to ESA dosing
"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.
http://www.fda.gov/cder/drug/infopage/RHE/default.htm
"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.
http://www.fda.gov/cder/drug/infopage/RHE/default.htm