With the shadow of rebasing hanging over the end-stage renal disease payment bundle in 2013, dialysis providers are hunkering down on preparing for the worst. That includes shedding more and more units of the once-profitable anemia drug Epogen––and bringing hemoglobins down with it.
The latest data from the Dialysis Outcomes Practice Pattern Study and its Dialysis Practice Monitor––based on a sampling from 140 dialysis clinics and 5,000 dialysis patients across the country––show a continual drop in the use of Epogen – both in terms of the quantity of the dose and the number of doses––while hemoglobins continue to creep downward.
DOPPS and its Practice Monitor, managed by Arbor Research Collaborative for Health, presented their latest data during a web conference on May 2. Analysis by DOPPS researchers during the conference indicated that since the introduction of the new ESRD bundled payment system for dialysis in January 2011, there has been a substantial decrease in hemoglobin levels and epoetin dose, as well as an increase in intravenous iron use and serum ferritin and in parathyroid hormone levels. “These metrics changed most notably in 2011 (especially after the June 2011 label revision for erythropoiesis-stimulating agents…and generally have stabilized by mid to late 2012,” the researchers said.
Also notable was the fact that Epogen use and hemoglobin levels in the United States are now lower than other countries. “We have not observed similar changes (lower Epogen dose, hemoglobins) recently in other DOPPS countries, providing additional evidence that U.S. payment changes and the ESA label revision have driven trends in U.S. dialysis practice. For the first time in over a decade that the DOPPS has followed international trends, average Hb levels in our study are lower in the United States than in Europe, Canada, and Australia/New Zealand. Median prescribed epoetin doses are now generally similar to those other countries, while serum ferritin levels are now substantially higher in the United States.”
Other trends from the Dialysis Practice Monitor included:
- Dialysis adequacy and dialysis session length: Among those on hemodialysis for more than a year, the percentage of patients with a urea reduction ratio (URR) >65% increased from 91% to 97%, and the percentage of patients with single pool Kt/V >1.2 increased from 93% to 97%.
- The percentage of all hemodialysis patients with a short dialysis session length (<210 min/session) declined from 34% to 29%. “This likely contributed to the higher URR and Kt/V values, and it contrasts with a longer-term trend toward shorter dialysis treatment time in the United States during the last decade,” the DOPPS researchers said.
- Mean Hb among all patients declined from 11.5 g/dL in August 2010 to 10.9 g/dL in March 2012, with the largest decline seen since the June 2011 ESA label revision. Mean Hb levels have been stable since March 2012. Among patients treated with an ESA, the percentage with Hb >12 g/dL declined substantially, from 26% to 9%, while the percentage with Hgb <10 g/dL increased from 9% to 20%. In our most recent data, 4-5% of patients had Hgb <9 g/dL.
- Among patients receiving IV epoetin, mean prescribed dose decreased by 35% to 13,300 units/week, with the greatest decline after the June 2011 ESA label revision and a modest decline thereafter. High doses showed the greatest decline: >50,000 units/week declined from 11% to 3% of prescriptions. The average administered IV epoetin dose decreased by 44% to 11,100 units/week.
- IV iron use during a month increased from 55% to 68% of patients, while median serum ferritin levels (indicative of iron stores) increased from 561 to 794 ng/ml, and median transferrin saturation (TSAT) increased from 28% to 29%. In December 2012, 16% of patients had serum ferritin >1200 ng/mL. The increase in IV iron use occurred principally in 2011 and appears to have stabilized in 2012.
- Serum parathyroid levels increased 28% from August 2010 to April 2011, and have been generally stable since. In December 2012, the prevalence of very high PTH values (defined here as PTH >600 pg/mL) was 24% among black hemodialysis patients and 14% among non-black hemodialysis patients. While there has been no clear change in overall use of MBD medications, a DOPSS survey of U.S. medical directors indicates a shift to higher upper target PTH levels. Median serum calcium levels have now risen slightly (by 0.1 mg/dL), while serum phosphorus has remained relatively constant.