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followed by general hospital visits (43.3%)
and nursing home visits (7.4%). The major
cost driver for 2000-2 was dialysis center
visits ($US95 million), followed by general
hospital visits ($US92 million), and

prescription medication ($US11 million). The cost analysis revealed that ESRD patients with hyperphosphatemia within Florida

Medicaid imposed an economic burden
(including facility, medical, and prescription claims) of $US228 million for the years
2000-2. Conclusions: This is the first study to report the economic impact of ESRD with hyperphosphatemia. Given the high
economic burden of this population, efforts should be undertaken to enhance
preventative measures for

hyperphosphatemia as well as the treatment and recovery of these patients.


Nolan CR.

Strategies for improving long-term survival in patients with ESRD.

Journal of the American Society of Nephrology. Vol. 16(11 SUPPL.

2)(pp S120-S127), 2005.

In 2003, more than 320,000 people in the
United States were receiving dialysis for
ESRD, with predicted increases to 650,000
by 2010 and 2 million by 2030. Mortality

from cardiovascular disease (CVD) in


patients with ESRD is 10 to 30 times higher
than in the general population. The exact
mechanism of accelerated CVD in patients
with kidney disease is unknown. Treatment
costs for ESRD are in excess of $14 billion
annually (6.4% of Medicare budget).
Strategies to improve long-term outcomes
include aggressive risk factor modification,
minimization of dialysis complications, and
kidney transplantation. Because

abnormalities of mineral metabolism


contribute to mortality risk, phosphate binder therapy is fundamental. More expensive non-calcium-containing phosphate binders such as sevelamer have been

recommended to reduce cardiovascular calcification. However, the lack of outcome data and the $2 to $3 billion annual cost make it difficult to justify widespread

utilization of newer binders as first-line
therapy. Conversely, kidney transplantation






is known to improve survival in ESRD.


Progression of atherosclerosis and CVD in
patients with renal failure is largely due to
loss of renal function per se, and provision
of a functioning kidney through renal
transplantation halts the progression of CVD
and dramatically reduces mortality. Despite
this fact, many patients lose Medicare
funding for immunosuppressive therapy 3 yr
posttransplantation. To achieve the goal of
prevention of cardiovascular mortality in
patients with ESRD, it clearly would be more
prudent, efficacious, and cost-effective to
use Medicare prescription drug dollars to
provide full coverage for life-long

immunosuppressive drug therapy after renal transplantation.


Huybrechts KF, Caro JJ, Wilson DA, et al.
Health and economic consequences

of sevelamer use for

hyperphosphatemia in patients on hemodialysis. Value in Health. Vol. 8(5) (pp 549-561), 2005.

A model of the predicted long-term


consequences of sevelamer compared with
calcium-based binders (acetate and
carbonate) was developed. Methods: Long-
term cardiovascular implications of 1 year of
treatment with phosphate binders in patients
on hemodialysis are estimated based on the
patient's demographics, comorbidities, and
physiologic and renal parameters. The initial
calcification score and expected changes
over 1 year are derived using regression
equations developed from the Treat-to-Goal
study and translated to cardiovascular
disease risk based on equations developed
from a long-term cohort study. In this article,
the implications of cardiovascular disease
for life expectancy and medical costs are
accounted for from a US payer perspective.
Results: The cardioprotective effect of
sevelamer over 1 year is estimated to result
in a 12% reduction in cardiovascular events
compared with calcium acetate. In a
population of 100 patients, the savings of
$205,600 accrued due to avoiding nine
cardiovascular events with sevelamer,
largely offset the increased binder costs,
leading to a favorable cost-effectiveness
ratio of about $2200 per (discounted) life-
year gained. Conclusions: Although both
binders provide equivalent phosphate
binding capacity, the results indicate that the
advantage of 1 year of treatment with
sevelamer in attenuating the progression of calcification has important clinical and

economic consequences, suggesting that this provides good value for money.


Collins AJ, St Peter WL, Dalleska FW, et al.
Hospitalization risks between

Renagel phosphate binder treated and non-Renagel treated patients. Clinical Nephrology. Vol. 54(4)(pp 334-341), 2000.

We evaluated 152 sevelamer hydrochloride treated Medicare patients on hemodialysis in a case-controlled study matching 152

randomly selected non-sevelamer


hydrochloride treated Medicare patients
from the same dialysis facilities and time
period. The main outcomes evaluated were
the risk of all-cause hospitalization and per-
member per-month (PMPM) Medicare
expenditures in the follow-up period.
Patients and methods: Medicare patients
were identified from a total of 195 patients
who were included in a long-term safety and
efficacy clinical trial evaluating sevelamer
hydrochloride [Chertow et al. 1999a]. The
average serum calcium-phosphate product
as well as lipid profiles improved in the
sevelamer hydrochloride treated group
during the trial. Sevelamer treated patients
were matched with randomly selected
Medicare patients for age, gender, race,
diabetic status, and geographic location.
Comorbid conditions were characterized and
sequential Cox regression models were
applied with the outcome being risk of first
hospitalization in a 17- month follow-up
period. Results: Across all four models, the
relative risk of hospitalization was 46% to
54% less in the sevelamer hydrochloride
treated group, as compared to the case
control group (significant at the p-value 0.03
level). Overall, Medicare expenditures for
the control patients per-member per-month
were US-$4,745, compared to US-$3,368 in
the sevelamer hydrochloride treated
patients. Conclusion: Sevelamer

hydrochloride treated patients had a 50%


lower likelihood of hospitalization in the
follow-up period after adjustments for the

differences in the population. Potential bias may exist between groups because of

differences in baseline characteristics that
could not be adjusted for within the study
design. We feel that to further advance this




area, a randomized clinical trial should be performed.

Brophy DF, Wallace JF, Kennedy DT, et al.
Cost-effectiveness of sevelamer

versus calcium carbonate plus

atorvastatin to reduce LDL in

patients with chronic renal

insufficiency with dyslipidemia and hyperphosphatemia.

Pharmacotherapy. Vol. 20(8 I)(pp 950-957), 2000.

We conducted a cost-effectiveness analysis
to compare costs and clinical outcomes of
sevelamer versus calcium carbonate plus
atorvastatin for treatment of dyslipidemia in
patients with chronic renal insufficiency. The
model was from the third-party payer

perspective. Efficacy and adverse event

rates for each regimen were obtained from
published clinical trials. Drug costs were
based on average wholesale prices;
monitoring costs were based on Medicare
reimbursement rates. Our model suggests
that the combination of calcium carbonate
plus atorvastatin is substantially more cost-
effective than sevelamer in reducing low-
density lipoprotein (LDL) in these patients.
One-way sensitivity analyses were
performed to assess if 25% and 50% price
reductions in sevelamer affected overall
cost-effectiveness results. A 50% sevelamer
price reduction was less expensive than
combination therapy but remained less cost-
effective. A two-way sensitivity analysis on
the probability that a patient achieves the
goal of a 35% LDL reduction resulted in
calcium carbonate plus atorvastatin
remaining more cost-effective. Further cost-
effectiveness studies are necessary to
corroborate our data.




Acknowledgments

Author: Dr Gordon Mallarkey Project Officer, NSW Therapeutic Advisory Group Inc Reviewers: NSW Therapeutic Advisory Group Inc.
This work is copyright of the NSW Therapeutic Advisory Group Inc and NSW Health Department. Apart from any use as
permitted under the Copyright Act 1968, no part of this information may be reproduced by any process without written
permission.

Whilst the information contained in this document has been presented with all due care, and the information is considered


to be true and correct at the date of publication, changes in circumstances after publication may impact on the accuracy of
the information.

This document is a selected collation of published material and should not be relied on as professional advice other than in this context. The information provided should not be regarded as a substitute for detailed expert advice in individual cases. NSW Therapeutic Advisory Group Inc will accept no responsibility for any loss, claim or damage suffered or


caused by any person acting or refraining from action as a result of any material in this document.


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