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
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