Biosimiliar ESAs Patient Share Remains Minimal in CKD Non-Dialysis

February 7, 2013 - Exton, Penn. – BioTrends Research Group, one of the world’s leading research and advisory firms for specialized biopharmaceutical issues, finds the following key results, according to a recent BioTrends’ study, ChartTrends: Renal Anaemia in Chronic Kidney Disease - Non-Dialysis (CKD-ND) and Dialysis, of 962 EU5 dialysis patient charts and 928 EU5 CKD-ND patient charts:

• Erythropoiesis-stimulating agents (ESAs) treatment prevalence in both haemodialysis (HD) and peritoneal dialysis (PD) patient populations has declined from two years ago and the decline of 9 percent in HD reached statistical significance
• Surveyed nephrologists significantly over-estimate the haemoglobin level at which they initiate ESAs in dialysis; this finding is pronounced in every EU5 country with the exception of Italy
• ESA treatment prevalence in the Stage 4 CKD-ND patient population is up 12 percent from two years ago, according to 382 Stage 4 CKD-ND patient charts
• Nephrologists significantly underestimate their use of ESAs in Stage 4 (predominately in France and Italy) and directionally in Stage 5 non-dialysis (significantly in Italy)
• Aranesp (Amgen), Eprex/Erypo (Janssen-Cilag), NeoRecormon (Roche) and Mircera (Roche) and collectively ESA biosimilars are leading the dialysis market. In particular, ESA biosimilars in the dialysis population have reached mid-teen double-digit patient share, but use is much less in the CKD-ND patient population
• HD IV iron treatment prevalence has remained flat from two years ago, but nephrologists over-estimate the use of IV iron in PD and under-estimate the use of oral iron in PD
• In CKD-ND, Venofer (Vifor Pharmaceuticals), Ferinject (Vifor Pharmaceuticals) and Ferrlecit (Sanofi) lead this space. Rienso, which recently launched in EU5 from Takeda Pharmaceuticals (developed by AMAG Pharmaceuticals), has captured minimal share at this point

“ESA cardiovascular warnings and cost containment pressures may be the reason for these declining ESA treatment prevalences found in the dialysis patient charts,” said Rob Dubman, BioTrends’ Director of Nephrology.

ChartTrends: Renal Anaemia in Chronic Kidney Disease - Non-Dialysis (CKD-ND) and Dialysis is a syndicated report series, in which 210 nephrologists provided patient chart data on 962 dialysis patients in the EU5 and 191 nephrologists provided patient chart data on 928 CKD-ND patients in the EU5 in the most recent wave of research to uncover the actual management related to renal anaemia. Through an in-depth review of patient charts, details such as product dosing and titration, switching, concomitant medications and a host of laboratory and patient demographic variables help define patient types and identify therapy triggers.

The study also evaluated referral patterns, co-morbidities, blood transfusions, hospitalizations and a host of other patient demographics and laboratory data. BioTrends is publishing ChartTrends: Renal Anemia in dialysis and CKD-ND reports later this year in the US. Additional ChartTrends Dialysis reports have been published in China and Latin America (Brazil, Argentina and Mexico).