Erythropoeitin Stimulating Agents Take a Hit as New Reimbursement Structure is I

PRESS RELEASE
July 11, 2011, 3:57 p.m. EDT
Erythropoeitin Stimulating Agents Take a Hit as New Reimbursement Structure is Implemented in the US Dialysis Market and Future Changes Are Likely Still to Come

EXTON, Pa., Jul 11, 2011 (BUSINESS WIRE) -- The renal anemia market has been hit hard over the past few years due to new clinical data (e.g. CHOIR, CREATE, TREAT), bundling, and now, most recently, labeling changes to ESAs and new proposed Quality Incentive Program (QIP) measures. While the impact of these two most recent events is not yet known, the new reimbursement program for drugs administered during dialysis treatments ("Dialysis Bundle"), which went into effect in January of this year, is clearly having a negative impact on the use of erythropoietin stimulating agents (ESAs) in the dialysis setting. According to nephrologists surveyed in a BioTrends study fielded in June, the most recent changes in the management of renal anemia include tighter hemoglobin target levels resulting in lower ESA doses, increased use of iron and increased use of subcutaneous ESA administration. Nephrologists also report significantly lower hemoglobin levels at ESA initiation and hold compared to last year, indicating more conservative use of ESAs. Moreover, 21% of nephrologists report seeing an increase in blood transfusions in dialysis patients in the past six months compared to 13% of nephrologists who reported this in the preceding quarter. Although ESA use in chronic kidney disease non-dialysis (CKD-ND) has been stable, nephrologists report that if they were not limited by cost, reimbursement or formularies, their use of Amgen's Aranesp would increase significantly at the expense of Centocor Ortho Biotech's Procrit.

With more focus on iron as a potential strategy to lower overall ESA utilization, approximately one-third of nephrologists report a change in their intravenous (IV) iron protocol in the dialysis setting in the past three months. The most commonly reported protocol change is higher ferritin / transferrin saturation (TSAT) thresholds leading to more iron use. Despite an increased focus on iron and a reported increase in use, there have been no significant changes in the percent of hemodialysis patients on IV iron compared to the prior year, however the percent of peritoneal dialysis patients on IV iron has increased significantly. Other significant events in the IV iron market include the recent availability Sanofi's Ferrlecit as a branded generic, Nulecit, marketed by Watson. Currently, use of Nulecit is very low, but there are differences based on primary chain affiliation. And regardless of affiliation, the vast majority of nephrologists report moderate or high comfort using Nulecit and feel the product is moderately to highly interchangeable with Ferrlecit. Interestingly, if they were not limited by cost, reimbursement or formularies, nephrologists report they would significantly increase their use of AMAG's Feraheme in both the dialysis and CKD-ND setting with market leader, Venofer, being the most negatively impacted.

TreatmentTrends(R): US Nephrology is a syndicated quarterly report series, based on primary market research, that provides a comprehensive view of the current and expected future management of renal anemia and bone and mineral metabolism in patients with kidney disease. The Q2 2011 wave was fielded with approximately 200 nephrologists in early June 2011. A parallel report surveying over 250 nephrologists in Europe is also available.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com .

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SOURCE: BioTrends Research Group, LLC

BioTrends Research Group, LLC
Jennifer Robinson, 610-363-3872
jrobinson@bio-trends.com
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Decision Resources, Inc.
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Copyright Business Wire 2011

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