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Technology Evaluation Center
Special Report: Cost-Effectiveness
of Left-Ventricular Assist Devices
as Destination Therapy for
End-Stage Heart Failure
*
Assessment
Program
Volume 19, No. 2
April 2004
Executive Summary
Left-ventricular assist devices (LVADs) augment the impaired cardiac pumping ability in patients
experiencing end-stage heart failure. The scarcity of donor hearts makes heart transplantation
possible for only 2,200 patients per year. Patients with end-stage heart failure who are ineligible for
cardiac transplantation are currently managed with angiotensin-converting enzyme (ACE) inhibitors,
diuretics, digoxin, beta blockers, and inotropic agents. These patients may be excluded from heart
transplantation because of advanced age (e.g., over 65 years), or other major comorbidities such as
insulin-dependent diabetes mellitus or chronic renal failure. LVADs are intended to prolong survival
and improve functional status in comparison with medical management. A randomized trial on
the use LVADs as permanent implants, or as destination therapy, showed they can increase median
survival by 7.4 months, while potentially raising the cost of end-of-life care considerably. The present
cost-effectiveness analysis addresses use of LVAD destination therapy, compared with optimal medical
management, among patients who are not heart transplant candidates. This analysis takes a societal perspective; however, some elements of this perspective, such as use of indirect costs, were not
strictly followed.
The baseline cost-effectiveness analysis, using parameter estimates from published sources, showed
that use of LVADs leads to an increase in cost of $802,700 to gain one QALY, compared with optimal
medical management. Within the range of values used in this analysis, the incremental cost-effectiveness ratio (ICER) was fairly stable amid changes in these variables: utility for New York Heart
Association (NYHA) category III/IV; utility discount rate; cost of outpatient care; and cost discount
rate, cost of rehospitalization, and probability of rehospitalization for LVAD; and probability of rehospitalization for optimal medical management. Results were more sensitive to variations in utility for
NYHA category I/II and the cost of LVAD implantation. ICERs of $500,000/QALY or less depended
on improbable assumptions of very low costs for LVAD implantation, usually in combination with
extreme values on other variables. Although utilities from a general population would be preferred,
the estimates used here from LVAD recipients suffice, given the wide range of values surrounding
them in the sensitivity analysis. Indirect costs, such as lost wages and costs borne by caretakers,
are not included, but as return to work is unlikely for either LVAD or optimal medical management
patients, excluding indirect costs would not affect the strategies’ relative standings in the analysis.
The short time horizon should limit the impact of excluding indirect costs.
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* Please note: This Special Report is a cost-effectiveness analysis of left-ventricular assist devices as destination therapy, and
complements the 2002 clinical TEC Assessment (Volume 17, Number 19) on the same topic. Special Reports do not attempt to address
the question as to whether the TEC criteria are met.
NOTICE OF PURPOSE: TEC Assessments are scientific opinions, provided solely for informational purposes. TEC Assessments
should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the
TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any
particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated.
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1
Technology Evaluation Center
Contents
Objective
3
Discussion
24
Background
3
Conclusions
26
Methods
4
References
28
Appendix
29
Estimates of Outcomes and Costs
12
Cost-effectiveness Analysis Results
18
Published in cooperation with Kaiser Foundation Health Plan and
Southern California Permanente Medical Group.
TEC Staff Contributors
Author—David Samson; TEC Executive Director—Naomi Aronson, Ph.D.; Managing Scientific Editor—Kathleen M. Ziegler,
Pharm.D.; Research/Editorial Staff—Claudia J. Bonnell, B.S.N., M.L.S.; Maxine A. Gere, M.S.; Acknowledgements—Staff would
like to thank Alan Garber, M.D., Ph.D., and Gillian Sanders, Ph.D., for their contributions to the research and development of
this Special Report.
Blue Cross and Blue Shield Association Medical Advisory Panel
Allan M. Korn, M.D., F.A.C.P.—Chairman, Senior Vice President, Clinical Affairs/Medical Director, Blue Cross and Blue
Shield Association; David M. Eddy, M.D., Ph.D.—Scientific Advisor, Senior Advisor for Health Policy and Management, Kaiser
Permanente, Southern California. ■ Panel Members Peter C. Albertsen, M.D., Professor, Chief of Urology, and Residency Program
Director, University of Connecticut Health Center; Edgar Black, M.D., Vice President, Chief Medical Officer, BlueCross BlueShield
of the Rochester Area; Helen Darling, M.A., President, Washington Business Group on Health; Josef E. Fischer, M.D., F.A.C.S.,
Mallinckrodt Professor of Surgery, Harvard Medical School and Chair, Department of Surgery, Beth Israel Deaconess Medical
Center—American College of Surgeons Appointee; Alan M. Garber, M.D., Ph.D., Professor of Medicine, Economics, and Health Research and
Policy, Stanford University; Steven N. Goodman, M.D., M.H.S., Ph.D., Associate Professor, Johns Hopkins School of Medicine, Department of
Oncology, Division of Biostatistics (joint appointments in Epidemiology, Biostatistics, and Pediatrics)—American Academy of Pediatrics
Appointee; Michael A.W. Hattwick, M.D., Woodburn Internal Medicine Associates, Ltd. American College of Physicians Appointee;
I. Craig Henderson, M.D., Adjunct Professor of Medicine, University of California, San Francisco; Bernard Lo, M.D., Professor of
Medicine and Director, Program in Medical Ethics, University of California, San Francisco; Barbara J. McNeil, M.D., Ph.D., Ridley
Watts Professor and Head of Health Care Policy, Harvard Medical School, Professor of Radiology, Brigham and Women’s Hospital;
Brent O’Connell, M.D., M.H.S.A., Vice President and Medical Director, Pennsylvania Blue Shield/Highmark, Inc.; Stephen G. Pauker,
M.D., M.A.C.P., F.A.C.C., Sara Murray Jordan Professor of Medicine, Tufts University School of Medicine; and Vice-Chairman for Clinical
Affairs and Associate Physician-in-Chief, Department of Medicine, New England Medical Center; William R. Phillips, M.D., M.P.H., Clinical
Professor of Family Medicine, University of Washington—American Academy of Family Physicians’ Appointee; Earl P. Steinberg, M.D.,
M.P.P., President, Resolution Health, Inc.; Paul J. Wallace, M.D., Executive Director, Care Management Institute, Kaiser Permanente;
A. Eugene Washington, M.D., M.Sc., Executive Vice Chancellor, University of California, San Francisco; Jed Weissberg, M.D.,
Associate Executive Director for Quality and Performance Improvement, The Permanente Federation.
CONFIDENTIAL: This document contains proprietary information that is intended solely for Blue Cross and Blue Shield Plans
and other subscribers to the TEC Program. The contents of this document are not to be provided in any manner to any other
parties without the express written consent of the Blue Cross and Blue Shield Association.
2
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Objective
Left-ventricular assist devices (LVADs) augment
the impaired cardiac pumping ability in
patients experiencing end-stage heart failure.
The scarcity of donor hearts makes heart
transplantation possible for only 2,200 patients
per year. Patients with end-stage heart failure
who are ineligible for cardiac transplantation
are currently managed with angiotensin-converting enzyme (ACE) inhibitors, diuretics,
digoxin, beta blockers, and inotropic agents.
These patients may be excluded from heart
transplantation because of advanced age (e.g.,
over 65 years), or other major comorbidities
such as insulin-dependent diabetes mellitus
or chronic renal failure. LVADs are intended
to prolong survival and improve functional
status in comparison with medical management. A randomized trial on the use LVADs as
permanent implants, or as destination therapy,
showed they can increase median survival by
7.4 months, while potentially raising the cost of
end-of-life care considerably. The present costeffectiveness analysis addresses use of LVAD
destination therapy, compared with optimal
medical management, among patients who are
not heart transplant candidates. This analysis
takes a societal perspective; however, some elements of this perspective, such as use of indirect costs, were not strictly followed.
Background
Heart Failure
Chronic heart failure is a common disease
responsible for high mortality and morbidity.
Heart failure represents a complex clinical
syndrome caused by many different etiologies
whose clinical manifestations reflect a fundamental abnormality—a decrease in the myocardial contractile state such that cardiac output
is insufficient for the metabolic requirements
of the tissues and organs. The prevalence of
heart failure is estimated at 4 to 5 million cases,
with an incidence rate of 400,000 cases per
year (Eichorn 2001). The mortality rate is estimated to be as much as 700,000 cases per year.
(Zeltsman and Acker 2002).
Medical management is the mainstay of
supportive care for patients with chronic
heart failure. While medical therapies (e.g.,
angiotensin-converting enzyme (ACE) inhibitors and beta blockers) have improved survival
and quality of life outcomes for patients with
mild-to-moderate heart failure (Greenberg
2000; Cohn 2000a), irreversible end-stage
cardiac disease unresponsive to medical
therapy continues to occur at an approximate
rate of 60,000 patients per year (Oz et al. 1995).
Inotropic agents and the intra-aortic balloon
pump are the last options for medical management of patients with severe heart failure.
Cardiac transplantation is widely accepted as
the most effective therapy for the treatment of
end-stage cardiac failure, for which survival
rates for patients transplanted within the past
five years are 85.6% and 79.5% after 1 and
5 years, respectively (Miniati and Robbins
2002). In contrast, patients with New York
Heart Association (NYHA) class IV heart failure
not receiving transplantation have achieved
20–30% survival rates (Oz et al. 1995).
Despite documented success with long-term
survival and improved quality of life, use
of transplantation is limited to about 2,200
patients per year (United Network for Organ
Sharing 2001). The limited supply of donor
hearts prevents heart transplantation from
being a treatment option for many patients
with end-stage heart failure. Patients who have
very poor baseline function, advanced age and
comorbidities, such as insulin-dependent diabetes mellitus, are less likely to survive the transplantation procedure and would be expected to
have poorer long-term survival. Such patients
are excluded from transplant eligibility.
Ventricular Assist Devices
Left-ventricular assist devices (LVADs) are
intended to augment native left-ventricular
function in several settings. One setting is to
allow short-term recovery in patients with
postcardiotomy shock. A second is to serve
as a bridge to heart transplantation, helping
patients survive long enough on the waiting
list to reach a transplant date. The third setting
is the focus of this report, comprising a
permanent alternative to transplantation,
or destination therapy, among patients who
are not transplant candidates.
Different LVAD designs may be distinguished
by whether they are powered electrically or
pneumatically and whether a pulsatile pump
is used or a rotor mechanism, allowing for
continuous blood flow. The model for which
its manufacturer submitted a supplemental
premarket approval application (PMA)
to the U.S. Food and Drug Administration
(FDA) for destination therapy is the Thoratec
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3
Technology Evaluation Center
Heartmate ® VE (vented electric) Left
Ventricular Assist System (LVAS). The device
consists of a fully implantable pump served by
a percutaneous driveline, which provides for
power and venting. The patient can achieve a
high degree of mobility with a wearable battery
pack and system controller. An apical anastomosis links the left ventricle with the pump
via an inflow cannula. An outflow cannula is
anastomosed to the aorta.
FDA Status. A pneumatically powered
predecessor to the Heartmate® VE LVAS was
originally approved by the FDA in September
1994 as a bridge to transplantation for cardiac
transplant candidates. The electrically powered
VE version was approved in September 1998 for
the same indication. Thoratec submitted a
supplemental premarket approval application for use as destination therapy in patients
with end-stage left ventricular failure who are
ineligible for cardiac transplantation. The FDA
approved this application on November 6, 2002.
Methods
Time Horizon and Perspective
This cost-effectiveness analysis encompasses
the entire remainder of a patient’s lifetime,
to a maximum of 3 years. The 3-year limit is
based on randomized trial survival data suggesting that all trial patients were likely to be
dead by that time. This analysis takes a societal
perspective; however, some elements of this
perspective, such as use of indirect costs, were
not strictly followed. For example, utilities were
estimated from a study of LVAD recipients,
whereas a societal perspective would prefer
utilities obtained from a general population. A
wide range of utility values will be used in sensitivity analysis to assess whether utilities have
an important impact on the results of the analysis. As stated, indirect costs, such as lost wages
and costs borne by caretakers, are not included.
Given the complicated overall condition of these
patients, it is unlikely that patients receiving
either LVADs or optimal medical management
would return to work, so excluding indirect
costs would not greatly affect the strategies’
relative standings in the analysis. The short
time horizon should limit the impact of excluding indirect costs, as well.
Patient Population and Setting
The REMATCH trial determines the specific
patient population, strategies, and outcomes
4
of interest to this analysis (Rose et al. 2001;
1999). Patients were selected for the REMATCH
trial primarily for belonging to NYHA Class IV
for at least 90 days, despite use of ACE inhibitors, diuretics and digoxin. Patients also had a
left-ventricular ejection fraction of 25% or less
and a peak oxygen concentration of 12 mL/kg
or less, or continued need for intravenous (IV)
inotropic therapy for symptomatic hypotension, decreasing renal function, or worsening
pulmonary congestion. Patients were allowed
to continue on beta-blockers if given for at least
60 of the 90 days before randomization. Cardiac
transplantation contraindications included: age
older than 65 years; insulin-dependent diabetes
mellitus with end-organ damage; chronic renal
failure, and other major physical or mental
comorbidities. This analysis focuses on patients
similar to those selected for the REMATCH
trial. Results will apply to institutions similar
to those that participated in the REMATCH
trial, which included 20 experienced cardiac
transplantation centers.
Strategies
The REMATCH trial used the Heartmate® VE
LVAS. The device was implanted in either
a preperitoneal pocket or intraperitoneally.
Rose et al. (1999) described optimal medical
management as follows:
“Patients randomized to the optimal medical
management only treatment group will be
treated with digoxin, diuretics and an angiotensin-converting enzyme inhibitor. If angiotensin-converting enzyme inhibitors cannot be
tolerated because of allergy or hypotension,
then angiotensin II antagonists should be considered. Patients can receive treatment with a
β-blocker at the investigator’s discretion. The
goals of therapy are twofold: to ensure that
systemic perfusion maintains organ function
sufficiently to meet the resting metabolic needs
necessary for survival and to reduce ventricular filling pressures sufficiently to achieve
and maintain relief from symptomatic resting
congestion. Stabilization in some patients may
require short-term intravenous pharmacologic
support or mechanical fluid removal, which
can subsequently be discontinued in favor of
other therapies.”
Surgeons were required to follow a committee’s
management guidelines. Optimal medical
management guidelines were also developed
by a committee and gave specific recommendations on use of ACE inhibitors. Discontinuation
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
of IV inotropic agents was encouraged for
medically managed patients.
Decision Model/Markov Model
Quality-adjusted life years (QALYs) will be
the effectiveness metric used in this analysis. Figures 1 and 2 show the decision model
and Markov model that were used. The same
Markov model will be used for both treatment
modalities, but transition probabilities will be
estimated separately. Each includes “alive”
and “dead” as health states. Table 1 shows the
transition probability matrix. Time-dependent
transition probabilities were used for Markov
cohort simulations. Both Data 4.0 and Excel
software were used to construct the models.
Two quality-of-life categories were taken into
account in the model, based on whether the
patient belonged in New York Heart Association
Functional Classes I/II or Classes III/IV*. It was
assumed that the utilities for NYHA categories did not differ between LVAD and optimal
medical management patients.
*New York Heart Association Functional
Classification System for Heart Failure
Class I
No limitation on physical
activity (symptoms with greater
than ordinary activity)
Class II
Slight limitation on physical activity
(symptoms with ordinary activity)
Class III
Marked limitation on physical
activity (symptoms with less
than ordinary activity)
Class IV
Inability to carry on physical
activity (symptoms at rest)
Calculation of QALYs in the Model
Cycle-specific contributions to QALYs in
these Markov models are shown in Table 2
(row #4). Utilities will be estimated for the
2 quality of life categories: NYHA I/II and
NYHA III/IV. QALYs in each cycle were the
product of the cycle-specific survival probability
and a weighted average derived from a sum
of the products of the probability of being in
a quality-of-life category and each category’s
utility (Table 2, row #6). The probability of
belonging to the 2 quality-of-life categories
varies over time. Monthly estimates of these
probabilities could be used to let NYHA class
status contribute to quality-of-life measurement
in a dynamic way without creating separate
Markov states for the 2 NYHA categories.
Utility values for each NYHA category will be
discounted at a rate of 3%.
Cost Categories
Three main categories of costs were included:
implantation costs, rehospitalization costs, and
outpatient costs. Implantation costs apply only
to LVAD recipients, while rehospitalization
costs and outpatients costs apply to both strategies. Costs were estimated from a REMATCH
costing study (Oz et al. 2003) and on a study
of long-term LVAD use in bridge-to-transplant
patients at Columbia University (Moskowitz et
al. 2001; Gelijns et al. 1997). These studies used
the ratio of cost to charges method of estimating hospital costs, market prices for drugs and
devices, and payments for physician services.
Subcategories for hospitalization (implantation)
included: LVAD, professional payment, length
of stay, special care days, regular floor, operating room, diagnostics, laboratory, blood
products, drugs, miscellaneous costs, and
rehabilitation. Outpatient costs included professional payments, laboratory tests, and drugs.
It was assumed that monthly rehospitalization
and outpatient costs were the same for
patients receiving LVADs and optimal medical
management.
The following costs were not considered in this
analysis: any amounts that may have increased
the monthly rehospitalization due to device
malfunction, removal or reimplantation; any
added costs associated with specific types of
adverse events that were more common among
LVAD recipients in the REMATCH trial; and
indirect costs. Evidence on adverse events was
presented in the 2002 TEC Assessment of LVADs
as destination therapy (Volume 17, Number 19).
Calculation of Costs in the Model
Costs in each cycle of the Markov model were
the product of the cycle-specific survival probability and a weighted average derived from a
sum of the products of the probability of being
rehospitalized or not and the cost of rehospitalization or outpatient care (Table 2, row #11). The
probability of being in the hospital was derived
from data on the mean percentage of life spent
in the hospital. It was assumed that this percentage was constant over time and could be applied
as a fixed weight within each cycle. Costs were
valued in 2002 $US and were discounted at a 3%
rate. When costs had to be revalued, the Gross
Domestic Product Deflator was used (2004).
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Technology Evaluation Center
Figure 1. Decision Model
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Figure 2. State-cycle Diagram of the Markov Model
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Table 1. Transition Probability Matrix (P) for Markov Model
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No.
Characteristic
Baseline Value
1
Survival, cyclespecific probabilities,
extrapolation past last
follow-up
REMATCH Kaplan-Meier
curves, see Table 3,
Figure 3; maximum
follow-up of 27 months
for LVAD, 26 months
for OMM.
Sensitivity Analysis
Range of Values
not applicable
Comment
Source
Cycle-specific survival probabilities were estimated
from graph of Kaplan-Meier curves. Method
for obtaining cycle-specific survival transition
probabilities for Markov cohort simulations is
described in Figure 4.
Data update from February
2002 CDRH FDA (2002)
All patients in both groups were assumed to be
dead by 36 months. Extrapolation past last follow-up
performed by interpolating between last observed
survival probability and 0% at 36 months. When
cycle-specific survival probability dropped below
0.005, a value of 0 was substituted.
2
Survival, relation between
LVAD and OMM
Hazard ratio cited
in 2001: 0.52.
Hazard ratio 95% CI:
0.34, 0.78.
An exponential survival curve was fit to OMM data,
with a hazard rate of 0.128. Survival was assumed to
be 0 when the cycle-specific survival probability fell
below 0.005.
At the lower limit of the 95% CI, the hazard ratio is
0.78; the survival probability fell to 0 after 42 months
for OMM and after 53 months for LVAD. At the upper
limit of the 95% CI, the hazard ratio is 0.34, and the
survival probability fell to 0 after 121 months.
Rose et al. (2001)
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
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Table 2. Underlying Assumptions for Cost-effectiveness Analysis
7
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Sensitivity Analysis
Range of Values
No.
Characteristic
Baseline Value
Comment
Source
3
Extrapolation of survival
past point of last followup.
Linear interpolation from
survival probability at 26
months to assumed 0%
survival at 36 months.
Three other methods
of extrapolation were
explored: stop and
drop; exponential; and
Gompertz/exponential.
The first method, stop and drop, assumes that all
patients surviving to 26 months die immediately
thereafter. The second method used exponential
survival models for both LVAD and OMM. The OMM
model used the same hazard rate as mentioned
above for the analysis on the hazard ratio confidence
interval. The LVAD model was fit on the Kaplan-Meier
curve before 23 months, where the hazard appears
fairly constant (0.062). The third method used a
Gompertz model to extrapolate for LVAD and an
exponential model for OMM. The LVAD Kaplan-Meier
curve shows an increasing hazard between 23 and
26 months, so a Gompertz model was fit for this
interval and further.
4
Probability of being in
NYHA classes I/II or III/IV
REMATCH data on
NYHA class membership
at 0, 1, 3, 6, 9, 12, 18
and 24 months.
not applicable
Cycle-specific probabilities are based on available
data or interpolations between successive
reported probabilities. For extrapolations beyond
24 months, it is assumed that 24 month probabilities
stayed constant.
Thoratec, Inc. (2002)
5
Utility of NYHA classes
NYHA I/II: 0.81
NYHA III/IV: 0.55
NYHA I/II: 0.50–1.00
NYHA III/IV: 0.30–0.80
Standard gamble utilities were elicited from
29 bridge-to-transplant patients before LVAD
implantation and during LVAD support. The mean
utility for pre-implantation was assigned to NYHA
III/IV and the mean for LVAD support was assigned
to NYHA I/II. It was assumed that the utilities for
NYHA categories did not differ between LVAD and
OMM patients.
Moskowitz et al. (1997)
Technology Evaluation Center
8
Table 2. Underlying Assumptions for Cost-effectiveness Analysis (cont’d)
Sensitivity Analysis
Range of Values
No.
Characteristic
Baseline Value
6
Cycle-specific
contribution to QALYs
Utility within each
cycle was calculated
as a weighted average
(see right).
not applicable
$277,000
(2002 $US)
$125,000–425,000
7
LVAD implantation cost
Comment
Source
QALYt =
St [(PI/II * UI/II) + (PIII/IV * UIII/IV)]t / 12
Where t is the monthly cycle, St is the survival
probability, PI/II and PIII/IV are the probabilities of being
in the two NYHA categories and UI/II and UIII/IV are
the utilities associated with NYHA categories. This
method allows NYHA class to contribute to quality of
life measurement in a dynamic way without creating
separate Markov states for the two NYHA categories.
The average cost of the implantation, excluding
professional fees, in 52 destination LVAD patients
was reported by Oz et al. as $210,187 (±193,295). Oz
did not specify the year by which costs were valued,
but because data collection ended in June, 2002, this
analysis assumes valuation in 2002 $US.
Professional fees were estimated from Moskowitz
study of 12 bridge-to-transplant patients. Fees for
mean 17.5-day hospital stay were prorated to a
43.5-day stay, then adjusted for inflation factor from
1995 $US to 2002 $US:
(43.5 / 17.5) * $23,935 * 1.123 = $66,814
Oz et al. (2003);
Moskowitz et al. (2001);
Gelijns et al. (1997)
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
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Table 2. Underlying Assumptions for Cost-effectiveness Analysis (cont’d)
9
Table 2. Underlying Assumptions for Cost-effectiveness Analysis (cont’d)
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
Characteristic
Baseline Value
Sensitivity Analysis
Range of Values
8
Monthly
rehospitalization cost
$39,896
$10,000–70,000
Comment
Source
The average annual readmission cost, reported by
Oz et al. was $105,326. The probability of being
rehospitalized was 0.22. (see below). The annual
readmission cost was prorated to a full year of
hospitalization, then divided by 12 to yield a monthly
rehospitalization cost:
Oz et al. (2003);
Moskowitz et al. (2001);
Gelijns et al. (1997)
[(1 / 0.22) * $105,326] / 12 = $39,896
This amount excludes professional fees. It includes
the cost of LVAD replacements.
It was assumed that inpatient costs were the same
for both groups of patients.
9
Monthly outpatient cost
$1,719
$250–3,250
In a study of bridge-to-transplant patients, the
average weekly outpatient cost was $352, yielding
a full month cost of $1,531 (1995 $US). This amount
was revalued in 2002 $US. It was assumed that
outpatient costs were the same for both groups
of patients.
Moskowitz et al. (2001);
Gelijns et al. (1997)
10
Probability of
rehospitalization
LVAD: 0.22
OMM: 0.15
LVAD:
0.10–0.35
OMM:
0.05–0.30
There were a total of 18,406 LVAD support days,
of which 3,896 days (22%) were spent in the hospital.
Data were lacking on whether the probability
of rehospitalization changed over time, so it
was assumed that the proportion of days spent
in the hospital could be applied to each cycle
as a constant weight. The probability of being
an outpatient was calculated as one minus the
probability of rehospitalization.
Oz et al. 2003;
CDRH FDA (2002)
CDRH FDA data for OMM patients state that there
were a total of 10,085 days alive, of which 1,756
(15%) were spent in the hospital
Technology Evaluation Center
10
No.
No.
Characteristic
Baseline Value
11
Cycle-specific
contribution to costs
Cost within each cycle
was calculated as a
weighted average
(see right).
12
Cost correction for cycle 1
and cycle 2, LVAD
$11,673
13
Discount rate for
costs, utilities
3%
Sensitivity Analysis
Range of Values
Comment
not applicable
Ct = St [(Prehosp * Crehosp) + (Poutpt * Coutpt)]
Where Ct is the total cycle-specific cost, Prehosp is the
probability of rehospitalization, Crehosp is the cost of
rehospitalization, Poutpt is the probability of being an
outpatient, and Coutpt is the cost of outpatient care.
Implantation cost is entered as an initial cost for
LVAD, at cycle 0. Since the average hospital stay
for implantation is 43.5 days (1.429 months), cycle
specific costs for rehospitalization and outpatient
care for all of cycle 1 and 0.429 of cycle 2 should
be excluded This total is subtracted from the initial
cost of LVAD implantation, then added back in cycles
1 and 2.
1–5%
Source
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
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Table 2. Underlying Assumptions for Cost-effectiveness Analysis (cont’d)
11
Technology Evaluation Center
Sensitivity Analyses
One-way sensitivity analyses were conducted
for the following variables:
■
■
■
■
■
■
■
■
■
Uncertainty about the relative
survival of LVAD and optimal medical
management (OMM) groups
Methods for extrapolating survival
past the point of last follow-up
Utilities for NYHA categories I/II and III/IV
Utility discount rate
Cost of LVAD implantation
Cost of rehospitalization
Cost of outpatient care
Probability of rehospitalization
for LVAD and OMM
Cost discount rate
Two-way sensitivity analyses were performed
for pairwise combinations of these variables:
■
■
■
■
■
Utilities for NYHA categories I/II and III/IV
Cost of LVAD implantation
Cost of rehospitalization
Cost of outpatient care
Probability of rehospitalization
for LVAD and OMM
An additional analysis was performed that
set several variables at values that would
be highly favorable to LVAD, described as the
“best case” scenario.
Estimates of Outcomes and Costs
Survival
Staff from the Center for Devices and
Radiological Health at the Food and Drug
Administration (CDRH FDA, 2002) made a
presentation to the Circulatory System Devices
Advisory Committee in March 2002. The presentation included an update of survival data
through February 2002. These data were used
rather than earlier published data (Rose et al.
2001). Kaplan-Meier curves were overlaid with
grids to derive survival probabilities at monthly
marks (Table 3). Follow-up ended at 26 months
for both groups; the survival probability was 1%
for OMM patients and 10% for LVAD patients.
The published REMATCH report cited a hazard
ratio of 0.52, with a 95% confidence interval
between 0.34 and 0.78. To assess the impact
on the analysis of uncertainty around relative
survival, an exponential survival model with a
hazard rate of 0.128 was fit to the OMM Kaplan-
12
Meier curve and the hazard ratios for the confidence interval limits were applied to produce
LVAD exponential survival models.
Extrapolation of survival past the point of
last follow-up was performed according to 4
methods: stop and drop; linear interpolation
to 36 months; exponential survival models for
both LVAD and OMM; and a Gompertz LVAD
survival model along with an exponential OMM
survival model. The stop and drop method
assumed that all remaining patients in both
groups expired immediately after 26 months.
Linear interpolation was based on the assumption that all patients in both groups would be
deceased at 36 months, with the additional stop
rule of substituting 0% survival when the survival probability fell below 0.005. The method
using exponential survival models applied a
hazard rate of 0.128 for OMM, and a rate of
0.062 for LVAD. The OMM model used the same
hazard rate as mentioned above for the analysis on the hazard ratio confidence interval.
The LVAD model was fit on the Kaplan-Meier
curve before 23 months, where the hazard
appears fairly constant. The third method
used a Gompertz model to extrapolate for
LVAD and an exponential model for OMM. The
LVAD Kaplan-Meier curve shows an increasing hazard between 23 and 26 months, so a
Gompertz model was fit for this interval and
further. A stop rule was applied for all methods
in which survival probabilities below 0.005
were considered as 0.
Table 4 shows values for median and mean
survival that can be derived from the KaplanMeier curves. Extrapolation of survival curves
was performed by linear interpolation to 36
months. Mean survival reflects area under the
curve, or life expectancy.
For the Markov model, transition
probabilities were derived by the method
described in Figure 3.
NYHA Functional Class Categories
The proportions of LVAD and OMM patients
in NYHA categories were obtained from a
presentation made by representatives of LVAD
manufacturer, Thoratec, to the FDA Circulatory
Systems Devices Advisory Committee meeting
in March 2002 (Thoratec, Inc. 2002). Table 5
shows the probabilities for the proportions in
NYHA I/II or III/IV. Cycle-specific probabilities
between given values were imputed using linear
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Table 3. Cycle-specific Survival Probabilities (Extrapolations in Italics)
Month
Probability of Survival, LVAD
Probability of Survival, OMM
0
1.000
1.000
1
0.810
0.800
2
0.810
0.690
3
0.720
0.640
4
0.710
0.540
5
0.640
0.490
6
0.590
0.460
7
0.590
0.460
8
0.590
0.390
9
0.540
0.340
10
0.540
0.290
11
0.520
0.280
12
0.510
0.280
13
0.510
0.240
14
0.500
0.210
15
0.440
0.180
16
0.410
0.160
17
0.410
0.160
18
0.360
0.110
19
0.360
0.080
20
0.360
0.080
21
0.360
0.080
22
0.330
0.080
23
0.310
0.080
24
0.240
0.080
25
0.160
0.020
26
0.100
0.010
27
0.090
0.009
28
0.080
0.008
29
0.070
0.007
30
0.060
0.006
31
0.050
0.005
32
0.040
0.000
33
0.030
0.000
34
0.020
0.000
35
0.010
0.000
36
0.000
0.000
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13
Technology Evaluation Center
Table 4. Median and Mean Survival
Median Survival
Mean Survival
LVAD
OMM
days
405
180
months
13.30
5.90
years
1.11
0.49
days
392
221
months
12.87
7.26
years
1.07
0.61
Difference
7.40
5.61
Figure 3. Derivation of Transition Probabilities for Markov Cohort Simulations
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Table 5. New York Heart Association Function Class
LVAD
OMM
Month Post-Enrollment
% NYHA I/II
% NYHA III/IV
% NYHA I/II
% NYHA III/IV
0
0
100
0
100
1
54
46
0
100
3
68
32
3
97
6
80
20
9
91
9
82
18
0
100
12
71
29
0
100
18
44
56
0
100
24
71
29
33
67
14
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
interpolation. It was assumed that the probabilities for the last given follow-up point, 24
months, stayed constant for all remaining cycles.
and a lower mean score on SF-36 physical
functioning subscale (17 vs. 26, p=0.0747).
Survival did not differ between subgroups.
Utilities
A study by Moskowitz et al. (1997) assessed
quality of life for 29 bridge-to-transplant LVAD
recipients at Columbia University. Standard
gamble utilities were elicited before implantation and during LVAD support. The mean utility
value (standard deviation [SD]) for the preimplantation period was 0.548 (0.276). The utility
associated with preimplantation in this group
should be analogous to being in NYHA category
III/IV, so the cost-effectiveness analysis used
a value of 0.55 for this category. During LVAD
support, the mean utility was 0.809 (SD=0.136).
It was assumed that LVAD support in this group
is representative of being in NYHA category I/II.
The cost-effectiveness analysis used 0.81 for
this category.
To determine hospitalization costs, the
REMATCH data set was combined with CMS
data and line item bills from clinical centers.
Institution-specific cost reports were used
to calculate ratio-of-cost-to-charges for each
major resource category. There were 17 in-hospital deaths and 35 hospital survivors. Hospital
survivors had mean hospitalization costs of
$159,271 ± 106,423; hospital nonsurvivors had
mean costs of $315,015 ± 278,713. The average
cost of the implantation, excluding professional fees, was $210,187 (± 193,295). Oz et al.
(2003) excluded professional fees and did not
mention whether costs valued in a constant
$year. Since data collection ended in 2002, it
was assumed that costs were expressed as 2002
$US. Professional fees were estimated from the
study by Moskowitz et al. (2001) of 12 bridgeto-transplant patients (Table 7). Fees for mean
17.5-day hospital stay were prorated to a 43.5day stay, then adjusted for inflation factor from
1995 $US to 2002 $US:
Rehospitalization
Data on the probability of rehospitalization
were obtained from a paper by Oz et al. (2003)
and a Center for Devices and Radiologic Health
(CDRH) presentation at the FDA Circulatory
Systems Devices Advisory Committee meeting
in March 2002. According to Oz et al. (2003),
LVAD patients spent a total of 18,406 days on
LVAD support, of which 3,896 days (22%) were
spent in the hospital. CDRH data for OMM
patients showed a total of 10,085 days alive, of
which 1,756 (15%) were spent in the hospital.
No data are available on whether the probability
of rehospitalization changed over time, so it
was assumed that the proportion of days spent
in the hospital could be applied to each cycle
as a constant weight. The probability of being
an outpatient was calculated as one minus the
probability of rehospitalization.
Costs
Oz et al. (2003) reported on the costs associated
with LVAD in the REMATCH trial (Table 6).
Of the 68 LVAD recipients in the REMATCH
trial, 52 comprised the costing subgroup.
Patients were excluded for not being in CMS
database or participating hospitals were unable
to provide cost data. There were no significant
differences between the costing subgroup and
the excluded subgroup on baseline characteristics. However, the LVAD costing subgroup had
a nonsignificantly lower percentage of patients
using ACE inhibitors (56% vs. 81%, p=0.083)
Oz et al. (2003) reported that the average
annual readmission cost was $105,326. Based
on a probability of being rehospitalized of 0.22,
the annual readmission cost was prorated to
a full year of hospitalization, then divided by
12 to yield a monthly rehospitalization cost of
$39,896. This amount includes the cost of LVAD
replacements but excludes professional fees.
It was assumed that inpatient costs were the
same for both groups of patients.
Outpatient costs were estimated from studies
by Moskowitz et al. (2001) and Gelijns et al.
(1997), which analyzed costs associated with
long-term LVAD implantation in bridge-totransplant patients (Table 7). All cost estimates
were given in 1995 $US. The average cost of
the implantation was reported as $141,287. The
17.5-day average length of stay associated with
implantation was derived from a simulation.
Clinical discharge criteria were applied to the
sample, which had longer actual stays because
the FDA required long hospitalization periods
for these patients. The average weekly outpatient cost was $352, yielding a full month cost of
$1,531. When valued in 2002 $US, the monthly
outpatient cost is $1,719.
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15
Technology Evaluation Center
Table 6. Oz et al. (2003) Report on Costs of Destination LVADs
Patients
LVAD costing subgroup: 52 of 68 LVAD recipients from REMATCH trial.
LVAD noncosting subgroup: 16 patients excluded for not being in CMS database,
participating hospitals unable to provide cost data.
No significant difference between subgroups on baseline characteristics. The LVAD
costing subgroup had a nonsignificantly lower percentage of patients using ACE
inhibitors (56% vs. 81%, p=0.083) and a lower mean score on SF-36 physical functioning
subscale (17 vs. 26, p=0.0747).
Survival did not differ between subgroups.
Costs
Clinical data set closed 6/20/02. Survival and costs truncated at 22 months of follow-up.
To determine hospitalization costs, REMATCH data set combined with CMS data
and line item bills from clinical centers. Institution-specific cost reports were used to
calculate ratio-of-cost-to-charges for each major resource category.
Analysis excluded professional fees. Report did not mention whether costs valued
in constant $year.
Initial hospitalization, average length of stay 43.5 days, with 17 in-hospital deaths,
35 hospital survivors. Hospital survivors had mean hospitalization costs of
$159,271 ± 106,423; hospital nonsurvivors had mean costs of $315,015 ± 278,713.
Resource Category
LVAD
ICU days
Regular floor
Operating room
Diagnostics
Laboratory
Blood products
Drugs
Medical Supplies
Therapy
Renal
Other
Total, initial hospitalization
Average Cost
$62,308 ± 11,651
$50,262 ± 82,076
$18,807 ± 45,286
$10,983 ± 9,913
$3,833 ± 3,222
$10,426 ± 14,161
$6,773 ± 10,731
$15,685 ± 20,219
$12,376 ± 21,536
$13,784 ± 35,534
$1,674 ± 5,988
$79 ± 161
$210,187 ± 193,295
% of Total Cost
29.64%
23.91%
8.95%
8.95%
1.82%
1.52%
3.22%
7.46%
5.89%
6.56%
0.80%
0.04%
100%
Initial hospitalization cost predicted by: perioperative bleeding, pump housing infection,
and sepsis.
Total LVAD support days
In hospital (%)
Out of hospital (%)
18,406
3,896 (22%)
15,510 (78%)
16 patients had 17 LVAD replacements.
152 readmissions involved 34 patients and 1,634 hospital days. Mean readmission
cost: $30,627 ± 61,569. Mean annual readmission cost per patient: $105,326.
Mean annual cost for initial hospitalization and readmission: $309,273.
Outpatient costs not mentioned.
16
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Table 7. Moskowitz et al. (2001) Report on Costs of Long-Term LVAD Implantation in Bridge Patients.
Patients
12 individuals implanted with LVAD at Columbia University during 1994 and 1995. FDA
prohibited discharge in 1994 and dictated minimum stay in 1995. To simulate discharge
dates guided by clinical concerns, predefined discharge criteria applied to patient records
–
–
–
–
–
–
Recovery from surgery with adequate general health status
Absence of fever or evidence of systemic or driveline infections
Normal liver function test results (transaminases, bilirubin)
White blood cell count (<11,000/mm3)
Serum creatinine (<2 mg/dL)
Echocardiographic evidence indicating that the patient’s native heart has sufficient
contractility to open the aortic valve and maintain an arterial pressure with the LVAD
operating at its lowest rate
– Ability of patients/caretakers to change batteries, maintain device, and perform ADLs.
By end of study period, 2 patients died, 8 had heart transplantation,
and 2 remained on LVAD.
Mean duration of LVAD support, 177 days (13–481 days)
Mean length of stay, implantation, 17.5 days (± 5.32 days)
Costs
Initial Hospitalization, average length of stay 17.5 days (± 5.32 days), costs generally
estimated by ratio of charges to costs method in 1995 $US.
Resource Category
LVAD
Professional payment
Length of stay
Special care days
Regular floor
Operating room
Diagnostics
Laboratory
Blood products
Drugs
Miscellaneous
Rehabilitation
Total, initial hospitalization
Average Cost
$67,085
$23,935 ± 10,897
$14,765 ± 10,874
$7,071 ± 7,376
$10,818 ± 1,725
$3,900 ± 3,574
$3,407 ± 1,767
$2,873 ± 2,562
$3,257 ± 3,229
$3,235 ± 1,695
$670 ± 423
$141,287 ± 18,513
Total LVAD support days
In hospital (%)
Out of hospital (%)
2,012
746 (37%)
1,266 (63%)
% of Total Cost
48%
17%
10%
5%
8%
3%
2%
2%
2%
2%
0%
100%
Outpatient and Rehospitalization
124 hospital days, total cost $215,093 ($1,735 per day, $52,802 per month)
The average outpatient cost was $352 per week ($1,531 per month)
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17
Technology Evaluation Center
Cost-effectiveness Analysis Results
Total Costs for One Year
Table 8 shows the costs of 1 year on 3 interventions: LVAD as a bridge to transplantation; LVAD
as destination therapy; and OMM. Discounting
was not used in calculating these costs.
Baseline Analysis
Using the values for all parameters listed in
Table 2, the LVAD Markov model produced a
total of 0.755 QALYs at a total cost of $391,900.
The OMM Markov model yielded 0.332 QALYs
at a cost of $53,025. The incremental costeffectiveness ratio (ICER) was $802,700 per
QALY (Figure 4).
Sensitivity Analyses
Uncertainty Around Relative Survival. Table
9 shows that the lower limit on the hazard ratio
for LVAD relative to OMM produces an ICER
of $1,350,700/QALY. The survival probability
fell to 0 after 41 months in the OMM group
and after 53 months for the LVAD group. At the
upper limit of the confidence interval, the ICER
is $447,600/QALY. In this case, survival in the
LVAD group dropped to 0 after 121 months.
Extrapolation of Survival. Of the 4 methods
used to extrapolate survival past the point
of last follow-up, the exponential method
produces an ICER most favorable to LVAD
($641,600/QALY). This is also the least plausible of the 4 because both the original survival
data (Rose et al. 2001) and the update (CDRH
FDA 2002) show an increasing hazard for the
LVAD group between 23 and 26 months. The
exponential survival model for LVAD allows
the hazard to stay constant based on a fit with
the earlier segment of the survival curve. The
curve remains elevated past the period of
accelerated hazard at 23–26 months and falls
to a survival probability of 0 after 86 months.
At last follow-up (26 months), the survival
probability was 10% in the LVAD group and
1% in the OMM group; thus an extrapolation
with an extended tail on the survival curve
seems quite unlikely.
The Gompertz/exponential method used a
Gompertz model for the LVAD group to fit
the portion of the curve with an accelerating
hazard. This method produced an ICER that
was least favorable to LVAD ($846,900/QALY).
The stop and drop method differs slightly from
Gompertz/exponential, probably due to the
18
low survival probabilities in both groups at last
follow-up. The 3 methods besides exponential
achieve similar findings and the method using
linear interpolation to 36 months is the most
favorable, yielding an ICER of $802,700/QALY.
This method was used for the baseline analysis
and all sensitivity analyses.
Utilities for NYHA Categories I/II and III/IV.
Figure 5 shows how ICER values are affected
by varying the utility for NYHA category I/II
from 0.50 to 1.00. Across this range, ICERs
vary from $1,588,900/QALY to $615,900/QALY.
In Figure 6, the utility for NYHA category
III/IV ranges from 0.30 to 0.80. The resulting ICERs are between $708,400/QALY and
$926,000/QALY.
Utility Discount Rate. The discount rate for
utilities was allowed to vary from 1% to 5%
(Figure 7). ICERs did not vary substantially,
taking values between $784,500/QALY and
$821,100/QALY.
Cost of LVAD Implantation. The cost of the
initial hospital stay for LVAD implantation
was valued between $125,000 and $425,000
(Figure 8). The ICER varied from $442,600/
QALY to $1,153,200/QALY.
Cost of Rehospitalization. The cost for 1
month of being readmitted to the hospital
varied between $20,000 and $70,000 (Figure 9).
The low estimate for rehospitalization cost led
to an ICER of $701,400/QALY, while the higher
estimate produced an ICER of $904,700/QALY.
Cost of Outpatient Care. This cost category
had little impact on the ICER, across
values of $250 per month to $3,250 per
month (Figure 10). ICERs were between
$792,900/QALY and $812,900/QALY.
Probability of Rehospitalization for LVAD
and OMM. Figure 11 shows how ICERs are
affected by varying the probability of rehospitalization for LVAD between 0.10 and 0.35.
The lowest probability yields an ICER of
$679,400/QALY, while the highest has an ICER
of $936,200/QALY. It is important to note that
while the probability of rehospitalization for
LVAD was allowed to vary, the probability for
OMM stayed constant at 0.15. Thus, when the
LVAD probability of rehospitalization was 0.10,
it was lower than the value for OMM. A lower
relative probability of rehospitalization for
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Table 8. Total One Year Costs for Bridge LVAD, Destination LVAD and Optimal Medical Management
Intervention
1995 $US
2002 $US
Bridge LVAD
222,460
249,823
Destination LVAD
450,035
505,373
OMM
178,693
Figure 4. Baseline Cost-effectiveness Analysis
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Cost
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OMM
LVAD
$53,025
$391,906
$338,881
Incr Cost
Eff
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0.332 QALYs
0.755 QALYs
Incr Eff
0.422 QALYs
ICER
$802,674/QALY
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Table 9. Sensitivity Analysis on 95% Confidence Interval Around Hazard Ratio
Cost
LVAD
Cost
OMM
Cost
Difference
QALYs
LVAD
QALYs
OMM
QALYs
Difference
ICER
Lower limit,
95% CI
$357,812
$53,160
$304,652
0.560
0.334
0.226
$1,350,746
Baseline
$391,906
$53,025
$338,882
0.755
0.332
0.422
$802,674
Upper limit,
95% CI
$477,413
$53,160
$424,253
1.282
0.334
0.948
$447,645
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19
Technology Evaluation Center
Table 10. Sensitivity Analysis on Method of Survival Extrapolation
Extrapolation
Method
Cost
LVAD
Cost
OMM
Cost
Difference
QALYs
LVAD
QALYs
OMM
QALYs
Difference
ICER
(per QALY)
Gompertz/
exponential
$389,361
$54,650
$334,711
0.739
0.344
0.395
$846,888
Stop and drop
$387,678
$52,782
$334,896
0.729
0.331
0.398
$840,738
Linear
interpolation
$391,906
$53,025
$338,882
0.755
0.332
0.422
$802,674
Exponential
$417,516
$54,650
$362,866
0.910
0.344
0.566
$641,592
Figure 5. Sensitivity Analysis on Utility NYHA I/II
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Utility NYHA I/II
ICER
0.50
$1,588,874
0.60
$1,207,387
0.70
$973,622
0.80
$815,693
0.90
$701,849
1.00
$615,890
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20
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Figure 6. Sensitivity Analysis on Utility NYHA III/IV
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Utility NYHA III/IV
ICER
0.30
$708,363
0.40
$743,296
0.50
$781,854
0.60
$824,632
0.70
$872,361
0.80
$925,955
Utility Discount Rate
ICER
0.01
$784,499
0.02
$793,554
0.03
$802,674
0.04
$811,856
0.05
$821,103
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Figure 7. Sensitivity Analysis on Utility Discount Rate
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21
Technology Evaluation Center
Figure 8. Sensitivity Analysis on Cost of Implantation
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Cost of Implantation
ICER
$125,000
$442,644
$200,000
$620,289
$275,000
$797,934
$350,000
$975,579
$425,000
$1,153,224
Cost of
Rehospitalization
ICER
$10,000
$701,399
$20,000
$735,275
$30,000
$769,150
$40,000
$803,026
$50,000
$836,901
$60,000
$870,777
$70,000
$904,652
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Figure 9. Sensitivity Analysis on Cost of Rehospitalization per Month
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22
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Figure 10. Sensitivity Analysis on Cost of Outpatient Care Post-implant per Month
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Cost of
Outpatient Care
ICER
$250
$792,915
$1,000
$797,897
$1,750
$802,879
$2,500
$807,862
$3,250
$812,844
Probability of
Rehospitalization
LVAD
ICER
0.10
$679,442
0.15
$730,789
0.20
$782,135
0.25
$833,481
0.30
$884,828
0.35
$936,174
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Figure 11. Sensitivity Analysis on Probability of Rehospitalization LVAD
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©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
23
Technology Evaluation Center
LVAD seems very unlikely given evidence from
the REMATCH trial of a significantly higher rate
of serious adverse events for LVAD.
In Figure 12, the probability of rehospitalization for OMM ranged from 0.05 to 0.30, assuming a constant probability of 0.22 for LVAD.
At the upper end of the range, the probability
of rehospitalization for OMM is higher than
that for LVAD, which as noted above, is very
unlikely. ICERs varied from $867,000/QALY to
$706,100/QALY.
the LVAD unit alone is approximately $65,000.
It is unlikely that all other initial costs associated with implantation would commonly be
covered by an amount as low as $60,000.
Best Case Scenario. An analysis was performed
in which variables were set at values that
would be quite favorable to LVAD (Table 11).
An ICER of $214,700 is obtained. Such values
would be highly unlikely to occur both alone
and in combination.
Discussion
Cost Discount Rate. When the cost discount
rate was varied from 1% to 5%, ICERs were
between $806,700/QALY and $798,800/QALY.
Two-Way Sensitivity Analyses. Appendix
Tables A1–A21 present 2-way sensitivity analyses for selected variables. When paired with
other variables, the cost of LVAD implantation appears to have the greatest influence on
the results. Tables A2, A7, A12, A13, and A14
comprise all tables in which the cost of LVAD
implantation is paired with another variable.
These are the only analyses in which ICERs
below $500,000/QALY are observed. Such
results depend on estimates of LVAD costs at
the low extremes (e.g., $125,000). The cost of
Limitations of this Analysis
Simplicity of the Markov Models. Although
2 health states were included in the Markov
models, these are analogous to 3-state models
given that QALY calculations allowed surviving
patients to make transitions between 2 NYHA
categories, in addition to a death state. It would
be interesting to construct a model that has
separate states for being rehospitalized versus
being at home. LVAD patients spend 22% of
their days in the hospital compared with 15%
for OMM patients. LVAD patients also had a
significantly higher rate of serious adverse
events (Rose et al. 2001). The device was
Figure 12. Sensitivity Analysis on Probability of Rehospitalization OMM
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Probability of
Rehospitalization
OMM
ICER
0.05
$867,072
0.10
$834,873
0.15
$802,674
0.20
$770,474
0.25
$738,275
0.30
$706,076
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24
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Figure 13. Baseline Cost-effectiveness Analysis
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Cost Discount Rate
ICER
0.01
$806,703
0.02
$804,672
0.03
$802,674
0.04
$800,706
0.05
$798,770
����
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Table 11. Values of Best Case Scenario
Variable
Value
Utility for NYHA I/II
1.00
Utility for NYHA III/IV
0.30
Cost of LVAD Implantation
$125,000
Cost of rehospitalization (per mo)
$10,000
Cost of outpatient care (per mo)
$250
Probability of rehospitalization, LVAD
0.10
Probability of rehospitalization, OMM
0.10
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
25
Technology Evaluation Center
replaced 17 times in 16 patients and the
probability of device failure was 35% at 2
years (Oz et al. 2003; Rose et al. 2001). A more
complex model might be better able to show
the impact on quality of life of rehospitalization
due to adverse events and device malfunction.
The models used here were based on NYHA
class data that likely included a mix of
inpatients and outpatients, but a more detailed
approach might better reflect patients’ experiences. Unfortunately, data were unavailable
from the REMATCH trial to permit constructing
more complex models.
Utilities for NYHA Categories I/II and III/IV.
Uncertainty exists about which utility values
should be used for being in NYHA categories
I/II or III/IV. This analysis used published
mean standard gamble utilities derived from
29 bridge-to-transplant patients (Moskowitz
et al. 1997). The preimplantation mean utility
was assigned to NYHA category III/IV, while the
mean utility for LVAD support was assigned to
NYHA category I/II. The Moskowitz paper does
not provide data on NYHA class for patients
in this study before or after implantation.
However, previous studies of bridge-to-transplant patients have shown that patients were
generally in NYHA class III or IV before implantation and in class I or II after transplantation
(Frazier et al. 1995; 1994). Also, utilities for
bridge-to-transplant patients may differ from
destination patients, even within the same
NYHA categories. Furthermore, the mean utilities from Moskowitz may be biased because
they were not taken from a healthy population,
consistent with a societal perspective. Because
the sensitivity analyses used wide ranges for
utility values, and ICERs did not vary substantially, these concerns are not critical.
Cost Estimates and Assumptions. The
REMATCH destination therapy costing study by
Oz et al. (2003) provided estimates for LVAD
implantation costs and rehospitalization costs.
Earlier costing studies on bridge-to-transplant
LVAD patients gave information on outpatient
costs and professional fees for LVAD implantation (Moskowitz et al. 2001; Gelijns et al. 1997).
The REMATCH estimate on LVAD implantation
excluded professional fees, but this analysis
used bridge-to-transplant professional fee
data to augment the overall estimate. The
REMATCH estimate on rehospitalization also
excluded professional fees and no useful data
are available for estimating them. So the rehospitalization estimate of approximately $40,000
26
per month for LVAD may be too low. The sensitivity analysis on the cost of rehospitalization
ranged up to $70,000 per month, and at that
extreme, the ICER increased by about $100,000
relative to the baseline analysis result.
This cost-effectiveness analysis used monthly
rehospitalization costs and outpatient costs
based only on LVAD patients and assumed that
these costs were the same for LVAD and OMM.
No estimates of these costs for OMM patients
are available from the REMATCH trial. The
highly selected nature of REMATCH trial participants makes it prohibitively difficult to estimate OMM costs from some other source. It is
likely that both cost categories would be higher
for LVAD; in fact, the rehospitalization costs
from REMATCH include some individuals who
had device replacement, so the present analysis
may be conservative.
Outpatient costs were estimated from LVAD
bridge patients and it was assumed that costs
for outpatient care were the same for LVAD and
OMM patients. Outpatient costs for LVAD destination are probably not lower than those for
LVAD bridge patients, so estimates used here
may be conservative. It is unclear whether outpatient costs are similar between LVAD destination patients and OMM patients. However, the
sensitivity analysis on outpatient costs showed
it to have little impact on ICERs, so this issue
does not appear critical.
Probability of Rehospitalization for LVAD
and OMM. The only data available on rehospitalization described the proportion of days alive
spent in the hospital. These proportions were
applied as constant weights within each cycle
of the Markov models for LVAD and OMM.
Evidence was lacking on whether the probability of rehospitalization changed over time, so
the simplest assumption was to hold it constant.
Conclusions
The baseline cost-effectiveness analysis, using
parameter estimates from published sources,
showed that use of LVADs leads to an increase
in cost of $802,700 to gain 1 QALY, compared
with optimal medical management. Within
the range of values used in this analysis, the
ICER was fairly stable amid changes in these
variables: utility for NYHA category III/IV;
utility discount rate; cost of outpatient care;
and cost discount rate, cost of rehospitalization,
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
probability of rehospitalization for LVAD; and
probability of rehospitalization for OMM.
Results were more sensitive to variations in
utility for NYHA category I/II and the cost of
LVAD implantation. ICERs of $500,000/QALY
or less depended on improbable assumptions
of very low costs for LVAD implantation,
usually in combination with extreme values
on other variables. This analysis takes a
societal perspective; however, some elements
of this perspective, such as use of indirect costs,
were not strictly followed. Although utilities
from a general population would be preferred,
the estimates used here from LVAD recipients
suffice given the wide range of values surrounding them in the sensitivity analysis. As
stated, indirect costs, such as lost wages and
costs borne by caretakers, are not included, but
as return to work is unlikely for either LVAD or
OMM patients, excluding indirect costs would
not affect the strategies’ relative standings in
the analysis. The short time horizon should
limit the impact of excluding indirect costs.
NOTICE OF PURPOSE: TEC Assessments are scientific opinions, provided solely for informational purposes. TEC Assessments
should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the
TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any
particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated.
CONFIDENTIAL: This document contains proprietary information that is intended solely for Blue Cross and Blue Shield Plans
and other subscribers to the TEC Program. The contents of this document are not to be provided in any manner to any other
parties without the express written consent of the Blue Cross and Blue Shield Association.
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
27
Technology Evaluation Center
References
Center for Devices and Radiologic Health, Food and
Drug Administration. (2002). Presentation to Food and
Drug Administration Circulatory System Devices Advisory
Panel, March 4, 2002.
Cohn JN. (2000a). The management of heart failure. In:
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Cohn JN. (2000b). Pathophysiology and clinical
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(eds.), Cardiovascular Medicine, Churchill Livingstone,
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Eichhorn EJ. (2001). Prognosis determination in heart
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mortality and rehabilitation of transplant candidates
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end-stage heart failure. N Engl J Med, 345(20):1435-43.
Rose EA, Moskowitz AJ, Packer M et al. (1999).
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28
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Appendix
Table A1. Sensitivity Analysis – Utility for NYHA Classes I/II by Utility for NYHA Classes III/IV.
ICERs (per QALY)
Utility NYHA I/II
Utility NYHA III/IV
0.50
0.60
0.70
0.80
0.90
1.00
0.30
$1,257,472
$1,005,931
$838,248
$718,483
$628,663
$558,804
0.40
$1,371,933
$1,077,870
$887,614
$754,447
$656,026
$580,320
0.50
$1,509,318
$1,160,890
$943,157
$794,204
$685,879
$603,557
0.60
$1,677,281
$1,257,766
$1,006,120
$838,381
$718,579
$628,736
0.70
$1,887,308
$1,372,283
$1,078,086
$887,760
$754,553
$656,106
0.80
$2,157,462
$1,509,742
$1,161,141
$943,323
$794,321
$685,967
Table A2. Sensitivity Analysis – Utility for NYHA Classes I/II by Cost of LVAD Implantation
ICERs (per QALY)
Utility NYHA I/II
0.50
0.60
0.70
0.80
0.90
1.00
$125,000
$876,204
$665,829
$536,916
$449,824
$387,043
$339,640
$200,000
$1,227,847
$933,044
$752,395
$630,350
$542,374
$475,947
$275,000
$1,579,491
$1,200,259
$967,874
$810,876
$697,704
$612,253
$350,000
$1,931,135
$1,467,474
$1,183,353
$991,403
$853,035
$748,560
$425,000
$2,282,779
$1,734,688
$1,398,832
$1,171,929
$1,008,365
$884,867
Cost Implant
Table A3. Sensitivity Analysis – Utility for NYHA Classes I/II by Cost of Rehospitalization
ICERs (per QALY)
Utility NYHA I/II
0.50
0.60
0.70
0.80
0.90
1.00
$10,000
$1,388,403
$1,055,050
$850,780
$712,776
$613,295
$538,183
$20,000
$1,455,459
$1,106,006
$891,870
$747,201
$642,916
$564,175
$30,000
$1,522,515
$1,156,962
$932,960
$781,626
$672,536
$590,168
$40,000
$1,589,570
$1,207,918
$974,050
$816,051
$702,156
$616,160
$50,000
$1,656,626
$1,258,874
$1,015,141
$850,476
$731,777
$642,153
$60,000
$1,723,682
$1,309,829
$1,056,231
$884,901
$761,397
$668,146
$70,000
$1,790,738
$1,360,785
$1,097,321
$919,326
$791,017
$694,138
Cost Rehosp
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29
Technology Evaluation Center
Table A4. Sensitivity Analysis – Utility for NYHA Classes I/II by Cost of Outpatient Care
ICERs (per QALY)
Utility NYHA I/II
0.50
0.60
0.70
0.80
0.90
1.00
$250
$1,569,556
$1,192,709
$961,786
$805,776
$693,315
$608,402
$750
$1,576,131
$1,197,705
$965,815
$809,151
$696,220
$610,951
$1,250
$1,582,706
$1,202,701
$969,844
$812,527
$699,124
$613,499
$1,750
$1,589,281
$1,207,698
$973,873
$815,902
$702,028
$616,048
$2,250
$1,595,856
$1,212,694
$977,902
$819,278
$704,933
$618,597
$2,750
$1,602,431
$1,217,690
$981,931
$822,653
$707,837
$621,145
$3,250
$1,609,006
$1,222,687
$985,960
$826,028
$710,742
$623,694
Cost Outpt Care
Table A5. Sensitivity Analysis – Utility for NYHA Classes I/II by Probability of Rehospitalization for LVAD
ICERs (per QALY)
Utility NYHA I/II
0.50
0.60
0.70
0.80
0.90
1.00
0.10
$1,344,939
$1,022,022
$824,146
$690,463
$594,096
$521,335
0.15
$1,446,578
$1,099,258
$886,428
$742,642
$638,993
$560,733
0.20
$1,548,217
$1,176,494
$948,710
$794,821
$683,890
$600,131
0.25
$1,649,856
$1,253,729
$1,010,992
$847,000
$728,786
$639,529
0.30
$1,751,495
$1,330,965
$1,073,274
$899,180
$773,683
$678,927
0.35
$1,853,134
$1,408,201
$1,135,556
$951,359
$818,580
$718,325
P Rehosp LVAD
Table A6. Sensitivity Analysis – Utility for NYHA Classes I/II by Probability of Rehospitalization for OMM
ICERs (per QALY)
0.50
0.60
0.70
0.80
0.90
1.00
0.05
$1,716,348
$1,304,257
$1,051,737
$881,136
$758,158
$665,303
0.10
$1,652,611
$1,255,822
$1,012,680
$848,414
$730,003
$640,596
0.15
$1,588,873
$1,207,388
$973,623
$815,693
$701,848
$615,890
0.20
$1,525,135
$1,158,954
$934,566
$782,971
$673,694
$591,184
0.25
$1,461,398
$1,110,519
$895,509
$750,250
$645,539
$566,477
0.30
$1,397,660
$1,062,085
$856,452
$717,528
$617,385
$541,771
P Rehosp OMM
30
Utility NYHA I/II
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Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Table A7. Sensitivity Analysis – Utility for NYHA Classes III/IV by Cost of LVAD Implantation
ICERs (per QALY)
Utility NYHA III/IV
0.30
0.40
0.50
0.60
0.70
0.80
$125,000
$390,636
$409,900
$431,163
$454,753
$481,075
$510,630
$200,000
$547,408
$574,403
$604,200
$637,257
$674,143
$715,559
$275,000
$704,181
$738,907
$777,237
$819,762
$867,211
$920,488
$350,000
$860,954
$903,410
$950,274
$1,002,266
$1,060,279
$1,125,417
$425,000
$1,017,726
$1,067,914
$1,123,311
$1,184,770
$1,253,347
$1,330,346
Cost Implant
Table A8. Sensitivity Analysis – Utility for NYHA Classes III/IV by Cost of Rehospitalization
ICERs (per QALY)
Utility NYHA III/IV
0.30
0.40
0.50
0.60
0.70
0.80
$10,000
$618,989
$649,513
$683,206
$720,586
$762,295
$809,127
$20,000
$648,884
$680,883
$716,203
$755,388
$799,112
$848,205
$30,000
$678,779
$712,252
$749,200
$790,191
$835,928
$887,283
$40,000
$708,675
$743,622
$782,197
$824,993
$872,745
$926,362
$50,000
$738,570
$774,992
$815,194
$859,795
$909,561
$965,440
$60,000
$768,465
$806,361
$848,191
$894,597
$946,378
$1,004,519
$70,000
$798,361
$837,731
$881,187
$929,399
$983,195
$1,043,597
Cost Rehosp
Table A9. Sensitivity Analysis – Utility for NYHA Classes III/IV by Cost of Outpatient Care
ICERs (per QALY)
Utility NYHA III/IV
0.30
0.40
0.50
0.60
0.70
0.80
$250
$699,751
$734,259
$772,348
$814,605
$861,756
$914,698
$1,000
$704,148
$738,873
$777,201
$819,724
$867,171
$920,445
$1,750
$708,545
$743,487
$782,054
$824,842
$872,586
$926,193
$2,500
$712,942
$748,100
$786,907
$829,961
$878,001
$931,941
$3,250
$717,339
$752,714
$791,761
$835,080
$883,416
$937,688
Cost Outpt Care
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31
Technology Evaluation Center
Table A10. Sensitivity Analysis – Utility for NYHA Classes III/IV by Probability of Rehospitalization for LVAD
ICERs (per QALY)
Utility NYHA III/IV
0.30
0.40
0.50
0.60
0.70
0.80
0.10
$599,611
$629,180
$661,819
$698,028
$738,432
$783,797
0.15
$644,925
$676,729
$711,833
$750,779
$794,236
$843,030
0.20
$690,238
$724,277
$761,848
$803,530
$850,040
$902,262
0.25
$735,552
$771,825
$811,862
$856,281
$905,844
$961,495
0.30
$780,865
$819,373
$861,877
$909,032
$961,649
$1,020,728
0.35
$826,179
$866,921
$911,892
$961,783
$1,017,453
$1,079,960
P Rehosp LVAD
Table A11. Sensitivity Analysis – Utility for NYHA Classes III/IV by Probability of Rehospitalization for OMM
ICERs (per QALY)
Utility NYHA III/IV
0.30
0.40
0.50
0.60
0.70
0.80
0.05
$765,196
$802,930
$844,582
$890,791
$942,351
$1,000,245
0.10
$736,780
$773,113
$813,218
$857,711
$907,357
$963,100
0.15
$708,364
$743,296
$781,854
$824,631
$872,362
$925,955
0.20
$679,948
$713,479
$750,490
$791,551
$837,367
$888,811
0.25
$651,532
$683,661
$719,126
$758,471
$802,372
$851,666
0.30
$623,116
$653,844
$687,762
$725,391
$767,378
$814,521
P Rehosp OMM
Table A12. Sensitivity Analysis – Cost of LVAD Implantation by Cost of Rehospitalization
ICERs (per QALY)
Cost Implant
Cost Rehosp
$125,000
$200,000
$275,000
$350,000
$425,000
$10,000
$341,370
$519,016
$696,661
$874,306
$1,051,951
$20,000
$375,246
$552,891
$730,536
$908,181
$1,085,827
$30,000
$409,122
$586,767
$764,412
$942,057
$1,119,702
$40,000
$442,997
$620,642
$798,287
$975,932
$1,153,578
$50,000
$476,873
$654,518
$832,163
$1,009,808
$1,187,453
$60,000
$510,748
$688,393
$866,038
$1,043,684
$1,221,329
$70,000
$544,624
$722,269
$899,914
$1,077,559
$1,255,204
32
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Table A13. Sensitivity Analysis – Cost of LVAD Implantation by Cost of Outpatient Care
ICERs (per QALY)
Cost Implant
$125,000
$200,000
$275,000
$350,000
$425,000
$250
$432,886
$610,531
$788,176
$965,821
$1,143,466
$1,000
$437,868
$615,513
$793,159
$970,804
$1,148,449
$1,750
$442,851
$620,496
$798,141
$975,786
$1,153,431
$2,500
$447,833
$625,478
$803,123
$980,769
$1,158,414
$3,250
$452,815
$630,461
$808,106
$985,751
$1,163,396
Cost Outpt Care
Table A14. Sensitivity Analysis – Cost of LVAD Implantation by Probability of Rehospitalization for LVAD
ICERs (per QALY)
Cost Implant
$125,000
$200,000
$275,000
$350,000
$425,000
0.10
$319,413
$497,058
$674,704
$852,349
$1,029,994
0.15
$370,760
$548,405
$726,050
$903,695
$1,081,340
0.20
$422,106
$599,751
$777,396
$955,042
$1,132,687
0.25
$473,453
$651,098
$828,743
$1,006,388
$1,184,033
0.30
$524,799
$702,444
$880,089
$1,057,735
$1,235,380
0.35
$576,146
$753,791
$931,436
$1,109,081
$1,286,726
P Rehosp LVAD
Table A15. Sensitivity Analysis – Cost of LVAD Implantation by Probability of Rehospitalization for OMM
ICERs (per QALY)
Cost Implant
$125,000
$200,000
$275,000
$350,000
$425,000
0.05
$507,043
$684,688
$862,334
$1,039,979
$1,217,624
0.10
$474,844
$652,489
$830,134
$1,007,779
$1,185,425
0.15
$442,645
$620,290
$797,935
$975,580
$1,153,225
0.20
$410,445
$588,091
$765,736
$943,381
$1,121,026
0.25
$378,246
$555,891
$733,537
$911,182
$1,088,827
0.30
$346,047
$523,692
$701,337
$878,982
$1,056,628
P Rehosp OMM
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
33
Technology Evaluation Center
Table A16. Sensitivity Analysis – Cost of Rehospitalization by Cost of Outpatient Care
ICERs (per QALY)
Cost Rehosp
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
$250
$691,641
$725,517
$759,393
$793,268
$827,144
$861,019
$894,895
$1,000
$696,624
$730,499
$764,375
$798,250
$832,126
$866,002
$899,877
$1,750
$701,606
$735,482
$769,357
$803,233
$837,108
$870,984
$904,859
$2,500
$706,589
$740,464
$774,340
$808,215
$842,091
$875,966
$909,842
$3,250
$711,571
$745,447
$779,322
$813,198
$847,073
$880,949
$914,824
Cost Outpt Care
Table A17. Sensitivity Analysis – Cost of Rehospitalization by Probability of Rehospitalization for LVAD
ICERs (per QALY)
Cost Rehosp
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
0.10
$674,670
$676,267
$677,863
$679,460
$681,056
$682,653
$684,249
0.15
$685,808
$700,854
$715,900
$730,946
$745,992
$761,038
$776,084
0.20
$696,945
$725,441
$753,937
$782,432
$810,928
$839,424
$867,920
0.25
$708,083
$750,028
$791,973
$833,919
$875,864
$917,809
$959,755
0.30
$719,220
$774,615
$830,010
$885,405
$940,800
$996,195
$1,051,590
0.35
$730,358
$799,202
$868,047
$936,891
$1,005,736
$1,074,580
$1,143,425
P Rehosp LVAD
Table A18. Sensitivity Analysis – Cost of Rehospitalization by Probability of Rehospitalization for OMM
ICERs (per QALY)
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
0.05
$715,369
$766,113
$816,857
$867,601
$918,345
$969,089
$1,019,833
0.10
$708,385
$750,694
$793,004
$835,314
$877,624
$919,933
$962,243
0.15
$701,400
$735,276
$769,151
$803,027
$836,902
$870,778
$904,654
0.20
$694,416
$719,857
$745,299
$770,740
$796,181
$821,623
$847,064
0.25
$687,432
$704,439
$721,446
$738,453
$755,460
$772,467
$789,474
0.30
$680,447
$689,020
$697,593
$706,166
$714,739
$723,312
$731,885
P Rehosp OMM
34
Cost Rehosp
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure
Table A19. Sensitivity Analysis – Cost of Outpatient Care by Probability of Rehospitalization for LVAD
ICERs (per QALY)
Cost Outpt Care
$250
$1,000
$1,750
$2,500
$3,250
0.10
$664,942
$672,346
$679,749
$687,152
$694,556
0.15
$718,265
$724,659
$731,054
$737,448
$743,843
0.20
$771,587
$776,973
$782,359
$787,745
$793,130
0.25
$824,909
$829,286
$833,663
$838,041
$842,418
0.30
$878,231
$881,600
$884,968
$888,337
$891,705
0.35
$931,553
$933,913
$936,273
$938,633
$940,992
P Rehosp LVAD
Table A20. Sensitivity Analysis – Cost of Outpatient Care by Probability of Rehospitalization for OMM
ICERs (per QALY)
Cost Outpt Care
$250
$1,000
$1,750
$2,500
$3,250
0.05
$859,792
$863,510
$867,227
$870,944
$874,661
0.10
$826,354
$830,704
$835,054
$839,403
$843,753
0.15
$792,916
$797,898
$802,881
$807,863
$812,845
0.20
$759,477
$765,092
$770,707
$776,322
$781,937
0.25
$726,039
$732,287
$738,534
$744,782
$751,029
0.30
$692,601
$699,481
$706,361
$713,241
$720,121
P Rehosp OMM
Table A21. Sensitivity Analysis – Probability of Rehospitalization for LVAD by Probability of Rehospitalization for OMM
ICERs (per QALY)
P Rehosp LVAD
0.10
0.15
0.20
0.25
0.30
0.35
0.05
$743,842
$795,188
$846,535
$897,881
$949,227
$1,000,574
0.10
$711,642
$762,989
$814,335
$865,682
$917,028
$968,375
0.15
$679,443
$730,790
$782,136
$833,482
$884,829
$936,175
0.20
$647,244
$698,590
$749,937
$801,283
$852,630
$903,976
0.25
$615,045
$666,391
$717,737
$769,084
$820,430
$871,777
0.30
$582,845
$634,192
$685,538
$736,885
$788,231
$839,578
P Rehosp OMM
©2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.
35
Technology Evaluation Center
Technology
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Blue Shield Association
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© 2004 Blue Cross and Blue Shield Association. Reproduction without prior authorization is prohibited.