Roche Pharmaceuticals

Once Monthly C.E.R.A. Could Save About 50% of the Time Health Professionals Spend on Anaemia Management in Dialysis Centres Each Year

Basel, Switzerland (ots/PRNewswire) - - New Study Reveals Potential for Improved use of Resources Whilst Maintaining High Quality Anaemia Management A new study has found that converting dialysis patients from more frequently administered erythropoiesis-stimulating agents (ESAs) to once-monthly C.E.R.A., a continuous erythropoietin receptor activator, could cut nearly in half the annual time spent on anaemia management in a dialysis centre. A 'Time and Motion' study in dialysis centres in Germany and the UK that modelled use of once-monthly administration of C.E.R.A. for the management of anaemia, showed that, for a centre of 100 patients, an average of 37 - 43 working days a year of healthcare professionals' time could be saved if they treated their patients with C.E.R.A.. In Germany, the study showed that the time devoted to ESA-related tasks would reduce from 79 to 36 working days per year (a 54% reduction) and in the UK, from 95 days to 58 (a reduction of nearly 40%). The results of the study were presented today at the 44th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Barcelona. (i) The study was undertaken to quantify health professionals' time and associated costs related to the management of anaemia following current routine practices. It also modelled the potential for improved efficiency and cost-savings with the use of a novel treatment effective at maintaining haemoglobin levels when administered just once monthly. C.E.R.A. is not marketed yet, but has recently received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing authorisation be granted in the EU. "What is exciting about this study is that it shows the potential - and substantial - savings that could be achieved in a single centre seeing on average 100 dialysis patients per year," said Dr. Ulrich Saueressig, Internist at Gemeinschaftspraxis, Wuppertal, Germany; and lead author who presented the data. "In effect, by reducing time consuming administrative and routine tasks, we are giving healthcare professionals considerably more time to use their skills and knowledge to benefit patients directly." About the study This study was conducted in 12 dialysis centres in Germany and the UK (similar data was also collected in the United States and presented earlier this year). Activities associated with anaemia management were identified through interviews with dialysis centre staff: the activities were then grouped into observed tasks (preparation, distribution, administration of ESAs) and non-observed tasks (which are related to anaemia management but intertwined with other activities such physician visits, laboratory assessment, review of blood results). The observed tasks were timed by trained research nurses using a stop watch while time estimates for non-observed tasks were obtained through interviews. A total of 461 time and motion observations were collected. Activity-based costing methods were used to translate healthcare personnel time associated with anaemia management and supplies, into monetary units. Personnel time was assigned a cost on the basis of time spent on specific tasks multiplied by the national average salaries for the healthcare member performing each task (e.g., nurse, technician, physician). Costs relating to ESA drug acquisition were not included in the analysis. Data from the time and cost assessments for ESA treatment were used to estimate the total time and cost offsets that might be achieved with 100 per cent use of once-monthly C.E.R.A. at an average centre in each country treating 100 patients. Key results Time and budget related to anaemia management with current ESAs: - The average total number of working days per year (one working day equals 8 hours) devoted to ESA-related activities was 79 in German centres and 95 in UK centres based on a 100 patients per centre. - The average annual total costs associated with current ESA administration per centre was EUR17,031 in Germany and GBP18,739 in the UK. - The weighted average number of ESA administrations per patient per month was 8 among the participating centres in Germany and 7 in the UK. Savings if once-monthly C.E.R.A. had been used in 100% of patients: - The estimated average total number of days per year devoted to ESA-related activities would decrease by 43 days in German dialysis centres and by 37 days in a UK dialysis centre if 100 per cent of patients were switched to C.E.R.A., the modelling showed. - As a consequence, the average estimated cost savings because of the reduction in task frequency would be EUR9,798 in German centres and GBP6,615 in the UK, based on 100 patients. - Based on interview responses, activities associated with ESA treatment which would be expected to decrease in frequency following conversion to once-monthly C.E.R.A. included ESA preparation, injection and record-keeping (both countries) and physician visits (Germany only). About C.E.R.A. C.E.R.A., is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin. C.E.R.A. is the only drug to have compared itself in its registration program to three ESAs: epoetin alfa, beta and darbepoetin alfa. In May, C.E.R.A. received an approvable letter from the US FDA and a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending a marketing authorisation be granted in the EU. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. Information about the Roche Group is available on the Internet at www.roche.com. Additional information about renal anaemia is available on the Internet at www.AnaemiaWorld.com. References (i) Ulrich Saueressig, et al. Staff time and costs for anaemia management with erythropoietic stimulating agents in patients on haemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007 ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: For further information please contact: Sheila Gies, Roche, Mobile:+1-973-687-0188. Diane Lorton: Galliard Healthcare, Mobile: +44-(0)7717-531-823

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