EMBARGO until Wednesday November 14, 2007
Kidney International's embargo policy is that publicity on papers stays under embargo until the online publication date of the paper. This paper is an Advance Online Publication release published every Wednesday; in this case, November 14, 2007.
Dear Colleague:
We are pleased to announce that: Kidney International (KI), the official journal of the International Society of Nephrology, will publish our paper: Cotter D, Thamer M, Zhang Y, Kaufman J, Hernan MA The Effect of Epoetin Dose on Hematocrit, Kidney Int. as an ADVANCE ONLINE PUBLICATION, November 14, 2007 - next Wednesday.
Study Summary:
Nearly all dialysis patients receive epoetin therapy to treat anemia. Using the United States Renal Data System we monitored 14,001 patients aged 65 and older who started dialysis and epoetin treatment in 2003-2004. We estimated the dose-response relationship for the average epoetin dose and hematocrit during a three-month initiation and subsequent three-month maintenance phase using a marginal structural model to adjust for measured time-dependent confounding by indication. During the initiation phase, an S-shaped dose-response relationship for average monthly epoetin dose and hematocrit response was found. Average hematocrit levels rose as the epoetin dose was increased from 9,000 to approximately 22,500 units/week. At higher doses, the effect of increasing epoetin was minimal with average hematocrit levels plateauing at 38.5% but this was less evident in the maintenance phase (months 4 to 6). Among patients who reached this phase, doses required to maintain the hematocrit were lower than those required to achieve similar hematocrits in the initiation phase. The dose-response curve found in our study suggests that published recommendations for starting doses (2,300-4,600 U given thrice weekly) are appropriate and can maintain the hematocrit in the desired target range of 33-36%.
the epoetin dose - hematocrit response curve can be found at: here
Policy Implications:
Application of our findings could be useful in setting regulatory and reimbursement policies. For example, the model can be used to calculate the epoetin adjustment to the ESRD composite rate, should epoetin be "bundled" into this fixed payment scheme as has been recently discussed by Congress and CMS. Based on our analysis of 2004 Medicare claims data, if dialysis providers were to target a maximum hematocrit of 35% to 36%, an upper bound currently under consideration by FDA, the ESRD composite rate adjustment for epoetin should be priced between $22.65 and $37.38 per treatment (using a rate of $8.75 per 1,000 epoetin units). According to these projections, annual Medicare epoetin payments (~ $2 billion) would be reduced by 40% to 60%.
Thank you for honoring the EMBARGO, any questions please contact:
Dennis J. Cotter
President
Medical Technology and Practice Patterns Institute, Inc.
4733 Bethesda Ave., Suite 510
Bethesda, MD 20814
(301) 652-4005
fax: (301) 652-8335
dcott@mtppi.org
ACKNOWLEDGEMENT
Dr. Kaufman serves as a consultant and has received past grant support from Amgen and F. Hoffmann-La Roche. There were no conflicts of interest for any of the other authors. The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as the official policy or interpretation of the U.S. Government. Finally, as the principal investigator, and independent of any commercial funders, I had full access to the data in the study and I take responsibility for the integrity of the data and the accuracy of the data analysis. Research was supported in part by NIH grants R01-DK066011-01A2 and R01-HL080644
MTPPI is a 501(c)3 non-profit institute (www.mtppi.org) established in 1986. Our research interests are in conducting assessments of the effectiveness of chronic disease treatments and factors that influence practice patterns and clinical outcomes.