FDA Adcomm decides no label changes for ESA use with respect to kidney patients on dialysis and can't decide on an optimal dose...What, no micromanagement of medicine? How refreshing.
Meanwhile as Scott Gottlieb points out, CMS is likely not to make any coverage decision because...it already has. Bundled payments for ESAs based on one size fits all hemocrit levels are due in 2010 for the Medicare renal program. We have been here before. Price per dose limits in the 90s led to increase in death among kidney patients.
http://www.boston.com/business/globe/articles/2007/09/12/panel_says_anemia_drug_doses_ok_as_is/
Meanwhile as Scott Gottlieb points out, CMS is likely not to make any coverage decision because...it already has. Bundled payments for ESAs based on one size fits all hemocrit levels are due in 2010 for the Medicare renal program. We have been here before. Price per dose limits in the 90s led to increase in death among kidney patients.
http://www.boston.com/business/globe/articles/2007/09/12/panel_says_anemia_drug_doses_ok_as_is/