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Affymax, Inc. (AFFY) Message Board

  • ezgi.ulusoy ezgi.ulusoy Feb 7, 2014 10:19 AM Flag

    Hemoglobin Levels in dialysis patients continue to fall...

    Hemoglobin levels in dialysis patients continue to fall

    Published on Friday, 17 January 2014 6:22 AM CST by Michael Fraase filed under ESRD
    The latest numbers from the Dialysis Outcomes and Practice Patterns Study’s (DOPPS) Practice Monitor — including data through August 2013 — indicates that hemoglobin levels in dialysis patients continue to fall.

    Between early 2012 and August 2013, mean hemoglobin levels in hemodialysis patients have declined substantially:

    Those patients treated with an erythropoiesis-stimulating agent (ESA) — like Amgen’s Epogen — with a hemoglobin level greater than 12 g/dL declined from 26 percent to 8 percent. Generally, this is good news and is most likely directly related to the US Food and Drug Administration’s (FDA) black-box warning for Epogen in 2007 and the US Centers for Medicare & Medicaid Services (CMS) institution of the “dialysis payment bundle” where it pays dialysis providers a flat fee for each dialysis treatment instead of allowing separate reimbursement for Epogen.
    For the three-year period of August 2010-August 2013, mean prescribed ESA dosages decreased by 38 percent.
    For the three-year period of August 2010-August 2013, average administered ESA dosages decreased by 40 percent because of frequent dose withholding.
    The last two metrics are not good news and probably reflect an underutilization of ESAs as evidenced by a marked increase in the use of blood transfusions when a dialysis patient’s hemoglobin drops too low.

    The DOPPS data is gathered from a sample of 3,200-4,000 dialysis patients in 100-120 US facilities. The study began in January 2011, with the introduction of the dialysis payment bundle.

    Last year, CMS proposed restoring the “floor” to hemoglobin measurement in its 2016 end-stage renal disease (ESRD) quality incentive program (QIP) after eliminating the requirement that dialysis providers report low levels of hemoglobin in patients.

    Sentiment: Hold

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      As I’ve written, repeatedly, I can report within two-tenths of a g/dL accuracy what my hemoglobin level is based on my level of fatigue. Anything under 11.5 g/dL and I can barely hold my head up and have to take a rest laying down after a shower. For the last three months, my hemoglobin has been hovering around 10.5 g/dL. I’ve talked with my nephrologist, as well as the charge nurse and facility administrator (and anyone else who would listen) at my dialysis facility about this and I get a lot of hand-wringing and little else. Why? Because Epogen is now a cost-center rather than a profit-center for the corporate dialysis providers. The “floor” hemoglobin measurement reporting requirement must be restored — sooner rather than later — and the reporting requirement trigger should be at 10.5 g/dL not 10.0 g/dL.

 
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