molony_EU.qxp 8/2/08 11:16 Page 24
Phosphorus Control
Figure 2: Results of the Renagel In New Dialysis Study
other accepted interventions in patients with chronic diseases with
significant morbidities and mortalities.
11
1.00
p=0.016
On the CE plane, an intervention can result in:
0.75
• improved outcomes at lower overall cost;
74% survival • improved outcomes at increased cost (the most commonly
observed occurrence);
0.50
• diminished outcomes at significant cost savings (a circumstance
that might be justified/ethical if such cost savings allow for the
al distribution function
46% survival
saved resource to be used to benefit the patient or society); and
Surviv
0.25
• diminished outcomes at increased cost.
Absolute risk reduction
28% or 0.28, NNT=4
For the first time, the potential impact of the use of sevelamer as a PO
4
0.00
0612182430364248546066
binder – instead of calcium-based PO
4
binders – has been established
Months
by recently published observational studies and the results of two RCTs
Sevelamer Calcium with long-term outcomes. A CE analysis based on reported
improvements in survival, as well as some potential improvements in
This study was an attempt to estimate the number needed to treat (NNT) from an observed
increased mortality in patients randomised to calcium versus sevelamer. The survival curves
morbidity, demonstrated a favourable CE of sevelamer versus calcium-
are from Block et al.
3
The per cent survival, the absolute risk reduction (ARR) and the NNT
based PO
have been estimated from the survival curves and were not included as part of the analysis
4
binders.
10
If future studies confirm the reduction in
by Block et al. An estimate of survival difference from the extremes of the survival curves hospitalisations and improvements in quality of life indicated by the
provides the most optimistic estimate of survival differences that the data allow. There is a
DCOR data as reported by St Peter, and furthermore show that the
roughly 30% absolute difference in survival at 60 months, which gives an ARR of 28% or an
NNT of approximately 4%. At 36 months, the ARR in mortality with use of sevelaver appears survival benefit demonstrated in RIND and DCOR in the over-65
to be closer to 15% for an estimated NNT of seven patients.
population extends to the younger prevalent dialysis patients, the CE
of sevelamer may be significantly greater than reported by Manns and,
Recent CE analyses have begun to take into account these most recent more recently, by Taylor et al.
findings. Manns et al. used data abstracted from the American Society
of Nephrology (ASN) presentations of DCOR (prior to their Thus, currently available published data demonstrate improved
publication). They argued that there are no survival benefits outcomes with sevelamer as a PO
4
binder in both incident and elderly
attributable to sevelamer for patients under 65 years of age, no
significant improvements in hospitalisation rates and no difference in
health-related quality of life for all patients.
9
On the basis of these
Currently available published data
assumptions, they have recently reported a cost per QALY of
CA$157,000, achieved through use of sevelamer compared with
demonstrate improved outcomes with
CaCO
3
. Assuming no benefit, their cost-minimalisation approach
sevelamer as a phosphate (PO
4
)
yielded an estimate of an incremental cost of CA$17,000 per patient
treated with sevelamer.
binder in both incident and elderly
haemodialysis patients, resulting in a
Taylor et al. conducted a CE analysis using somewhat different
greater cost-effectiveness of
assumptions with significantly different results. The results of this
analysis were first reported at the ASN 2007.
10
Using a conservative sevelamer versus calcium PO
4
binders.
survival estimate for incident dialysis patients derived from the RIND
study for 18 months only
3
and a range of estimates of hospitalisation
rates estimated from Collins,
8
they have determined for incident haemodialysis patients, resulting in a greater CE of sevelamer versus
patients an incremental cost per life-year of roughly £14,800 and per calcium PO
4
binders. This CE will be increased further in magnitude by
QALY of roughly £25,900 when sevelamer is compared with CaCO
3
. any concurrent further improvements in quality of life and reduced
These estimates for life-years and QALYs gained are consistent with cost and hospitalidations. ■
1. Black WC, The cost-effectiveness plane: a graphic 5. Borzecki AM, Lee A, Wang SW, et al., Survival in end stage 8. Collins AJ, St Peter WL, Dalleska FW, et al., Hospitalization
representation of cost-effectivenes, Med Dec Making, renal disease: Calcium carbonate vs sevelamer, J Clin Pharm risks between Renagel phosphate binder treated and non-
1990;10:212–15. Ther, 2007; in press. Renagel treated patients, Health Policy, 2000;54(4):334–41.
2. Smeeth L, Haines A, Ebrahim S, Numbers needed to treat 6. St Peter W, Liu DJ, Fan Q, Weinhandl E, DCOR Study: 9. Manns B, Klarenbach S, Lee H, et al., Economic evaluation of
derived from meta-analyses; sometimes informative, usually Assessing impact of sevelamer vs calcium binders on sevelamer in patients with end-stage renal disease, Nephrol
misleading, BMJ, 1999;318:1548–51. hospitalization & morbidity in hemodialysis patients using Dial Transplant, 2007;22:2867–78.
3. Block GA, Raggi P, Bellasi A, et al., Mortality effect of CMS data, presentation to the American Society of 10. Taylor MJ, Elgazzar HA, Chaplin S, An international economic
coronary calcification and phosphate binder choice in incident Nephrology, 2006. evaluation of sevelamer hydrochloride versus calcium-based
hemodialysis patients, Kidney Internl, 2007;71:438–41. 7. St Peter W, Liu DJ, Fan Q, Weinhandl E, DCOR Study: phosphate binders in patients new to dialysis, American
4. Suki WN, Zabaneh R, Cangiano JL, et al., Effects of Assessing economic impact of sevelamer vs calcium binders Society of Nephrology, San Francisco, November 2, 2007.
sevelamer and calcium-based phosphate binders on mortality on hospitalization & morbidity in hemodialysis patients using 11. Drummond MF, Sculpher MJ, Torrance GW, et al., Methods
in hemodialysis patients, Kidney Internl, CMS data, presentation to the American Society of for the economic evaluation of health care programmes,
2007;72(9):1130–37. Nephrology, 2006. Oxford University Press, 2005.
24 EUROPEAN RENAL DISEASE 2007
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