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Blood, Vol. 92 No. 11 (December 1), 1998:
pp. 4047-4052
The Costs and Cost-Effectiveness of Unrelated Donor Bone Marrow
Transplantation for Chronic Phase Chronic Myelogenous Leukemia
By
Stephanie J. Lee,
Claudio Anasetti,
Karen M. Kuntz,
Jonathan Patten,
Joseph H. Antin, and
Jane C. Weeks
From the Department of Adult Oncology, Dana-Farber Cancer Institute
and the Department of Medicine, Brigham and Women's Hospital, Harvard
Medical School, Boston, MA; the Department of Health Policy and
Management, Harvard School of Public Health, Boston, MA; and Fred
Hutchinson Cancer Research Center, Seattle, WA.
 |
ABSTRACT |
Unrelated donor transplantation prolongs survival in some patients
with chronic myelogenous leukemia (CML) in chronic phase. However,
there are growing concerns about the intensive resources required for
this procedure given health care budget constraints. To address this
issue, we conducted a study of the costs and cost-effectiveness of
unrelated donor transplantation for chronic phase CML. The costs of
transplantation were derived from 157 patients from the Brigham and
Women's Hospital (BWH) and the Fred Hutchinson Cancer Research Center
(FHCRC). Estimates of the effectiveness of transplantation were taken
from our previous work using data from the International Bone Marrow
Transplant Registry and the National Marrow Donor Program.
The median cost of the first 6 months of care including donor
identification, marrow collection, patient hospitalization for
transplantation and all outpatient medications and readmissions through
6 months postmarrow infusion was $178,500 (range, $85,000 to $462,400)
and the mean was $196,200. Mean costs for patients surviving beyond 6 months posttransplant were significantly lower than for patients dying
within that period ($189,700 v $211,000, respectively,
P = .03). Posttransplant follow-up costs were high for
months 6 to 18, then decreased. The incremental cost-effectiveness of
transplantation within 1 year of diagnosis versus  -interferon therapy without transplant in the base case of a 35-year-old patient was $51,800/quality-adjusted life year (QALY) gained. Sensitivity analysis showed that most ratios were between $50,000 to $100,000/QALY or within the intermediate zone of acceptable cost-effectiveness ratios.
© 1998 by The American Society of Hematology.
| |
INTRODUCTION |
APPROXIMATELY 4,300 people are
diagnosed with chronic myelogenous leukemia (CML) annually in the
United States.1 Allogeneic stem cell
transplantation is the only proven curative therapy, but patient age,
comorbid disease, and inability to identify a donor limit this option
to a minority of patients. It has been estimated that 35% of patients
with CML under the age of 55 years will undergo allogeneic
transplantation in the United States.2 Despite the
relatively small number of individuals undergoing transplantation for
this indication, the high morbidity of the procedure and the fact that
only a subset of transplanted patients survives long-term have led many
to question whether the benefits of transplantation justify the costs.
When unrelated donors are required, the donor identification process
raises costs, while higher morbidity and mortality3,4 lower
benefits relative to related-donor transplantation.
Calculation of cost-effectiveness ratios using standardized methods
facilitates judgments about whether the benefits of a medical
intervention are sufficient to justify the costs. The common measure of
dollars per quality-adjusted life year (QALY) gained used in
cost-effectiveness ratios allows comparisons among diverse medical
interventions including those that improve quality of life and those
that extend length of life, and very high-cost, life-saving procedures
applied to few individuals and low-cost, modest benefit ones applied to
large populations. Rough guidelines for acceptable cost-effectiveness
ratios have been suggested based on current budgetary constraints and
demonstrated societal spending choices. In general, interventions
available at less than $50,000 per QALY have been considered
cost-effective.5 A cost-effectiveness ratio of greater than
$100,000 per QALY is not considered cost-effective relative to other
interventions. Cost-effectiveness ratios between $50,000 to $100,000
per QALY are intermediate.
This study was undertaken to evaluate the costs and cost-effectiveness
of non-T-cell depleted unrelated donor transplantation for chronic
phase CML. The analysis considers all phases of transplantation: donor
identification, donor and patient evaluation, stem cell harvest,
hospitalization for transplant, posttransplant outpatient care and
medications, and readmissions to the hospital. Primary cost data were
obtained from a large cohort of patients transplanted at two major
medical centers. Based on our previous study of the effectiveness of
unrelated donor transplantation for chronic phase CML,6 we
were able to calculate a cost-effectiveness ratio for this procedure
and examine sensitivity to a variety of assumptions.
| |
MATERIALS AND METHODS |
Cost data sources Transplantation.
Sequential cohorts of patients with chronic phase CML undergoing
transplantation from fully matched or one antigen mismatched unrelated
donors at two institutions provided the primary cost data. Class I A
and B antigens were typed serologically, while class II DRB1 allele
typing used either serologic or molecular techniques. The first group
of 49 patients was transplanted at the Brigham and Women's Hospital
(BWH), Boston, MA between June 1991 and December 1996. The second
cohort of 108 patients was transplanted between January 1992 and April
1996 at the Fred Hutchinson Cancer Research Center (FHCRC), Seattle,
WA. Patients received cyclophosphamide and total body irradiation (12 to 14 Gy) with or without high dose cytarabine.7-9
Graft-versus-host disease (GVHD) prophylaxis consisted of cyclosporine
and methotrexate with or without steroids. Some patients were treated
on research protocols, which may have increased costs. However, we were
not able to separate protocol costs from other clinically indicated studies and procedures, or adjust costs for clinical effects resulting from these protocols.
All medical costs were obtained from the accounting systems at the BWH
and FHCRC. Costs incurred before October 1992 at the BWH were
calculated based on the charges adjusted by the institutional aggregate
ratio of costs to charges (RCC). After October 1992, charges were
converted to costs using departmental RCC adjustments. The
institutional RCC was used for all FHCRC data because departmental figures were not available. Professional fees were not available at
either institution and are not included in this analysis. All costs
were adjusted to 1996 dollars using the medical care component of the
consumer price index.
Costs were divided into peritransplant (within 1 month before
hospitalization for transplantation until 6 months postmarrow infusion)
and posttransplant (divided into 6-month intervals, including both
inpatient and outpatient care). Costs of donor identification, all
necessary pretransplant testing for patient and donor, and marrow
collection costs were included in the peritransplant period regardless
of when they occurred. Two patients in the Fred Hutchinson cohort
underwent second stem cell infusion during their initial transplant
hospitalization. All costs for these procedures were included. Two
additional Fred Hutchinson patients underwent second transplantation
more than 6 months after their initial transplant. These second
transplants were considered to be part of the initial Fred Hutchinson
hospitalization costs after adjustment for year of transplant to assure
inclusion in the analysis (because only Brigham and Women's patients
were used to calculate posttransplant follow-up costs). No Brigham and
Women's Hospital patient received additional stem cell infusions or
adoptive immunotherapy, underwent second transplant, or relapsed.
Because 90% of patients transplanted at FHCRC live outside the local
Seattle area and were returned to the care of their local physicians
after 100 days, cost data available from this site underestimate true
peritransplant costs. Using BWH data, we examined the contribution of
costs occurring between 3 to 6 months to total peritransplant costs and
found that they represented only 3.8% of the total. Thus, no
adjustments were made for loss of information between 100 days and 6 months for the Fred Hutchinson patients. Costs during the
peritransplant period ( 1 to 6 months) did not differ between the
institutions and were pooled.
Because most Fred Hutchinson patients left the Seattle area after 100 days, long-term cost data were not available. Thus, only patients from
the BWH were used to determine posttransplant care costs because
detailed information was available. All inpatient and outpatient
activity through September 1, 1997 was captured from the hospital
accounting system and converted to costs using departmental RCCs. In
addition, the charts of all BWH patients were reviewed to assure
inclusion of hospitalizations outside of the area, outpatient
medication usage, and other procedures not captured in the
institutional accounting system. When patients were hospitalized at
outside institutions and bills were not available, length of stay was
multiplied by the approximate daily inpatient cost for other patients
readmitted to the BWH ($1,500/d). Outpatient medication costs were
calculated using the average wholesale price published in the 1997 Red
Book. When available, prices quoted for the Health Care Financing
Agency or generic brands were used.10 A pharmacy dispensing
fee of $2.50/mo was added for each medication. The cost of outpatient
dialysis was not available from patient bills and was therefore
assigned the inpatient procedure dialysis cost of $500/d.
Costs were calculated for 6-month intervals based on the number of
individuals alive at the start of each interval; the median costs for
the intervals were relatively stable. A highly aberrant cost (a single
hospital admission 3 years posttransplant costing $100,000) was
included in the base case evaluation and its influence tested in
sensitivity analysis.
Cost data sourcesNontransplant management of CML.
The costs of CML care without transplantation were divided into two
categories: outpatient medical therapy for chronic phase CML and
inpatient induction therapy for blast crisis. We estimated that
patients would require maintenance doses of either 5 million units/m2 (assuming a body surface area of 1.8 m2) of -interferon three times per week ($14,470/year)
or 1,000 mg of hydroxyurea a day ($932/yr) to maintain control of
counts. Only 50% of patients beginning -interferon were assumed to
continue this medication after 6 months, while the rest returned to
hydroxyurea treatment.11,12 Medication costs were estimated
from doses in the literature and the average wholesale prices as listed
in the Red Book.10 Patients were estimated to have one
moderate-complexity visit every other month ($78) in conjunction with
phlebotomy ($2.75) and a complete blood count ($5.40). No other
medication or medical care costs were assumed during the outpatient
phase.
Inpatient costs for induction chemotherapy were collected from the BWH
accounting system for eight patients treated for 10 episodes of CML in
blast crisis with a variety of chemotherapy regimens between June 1992 and June 1997. Costs were calculated from charges using methods
identical to those used for transplant costs. In the absence of
published estimates, we assumed that 100% of untransplanted patients
would eventually enter blast crisis unless they died of a cause
unrelated to their CML, and 50% of patients entering blast crisis
would undergo one induction chemotherapy cycle in an attempt to reenter
chronic phase. No other terminal care costs were included.
Perspective of the cost analysis.
A modified societal perspective was adopted for the cost analysis.
Although societal costs should also include nonmedical items such as
transportation to the hospital and caregiver time, given the
retrospective nature of the analysis, no attempt was made to enumerate
and include these costs. In addition, medical services provided within
the home could not be captured due to lack of documentation in the
hospital accounting system or the medical record.
Whereas the charges appearing on hospital bills reflect market
influences and payments often vary with contract negotiations, costs
are estimates of the actual resources used to provide the service. All
monetary figures presented in this report refer to costs, which are
usually lower than charges.
The Markov model.
A Markov model is an analytic framework, which tracks the clinical
events occurring in a hypothetical cohort of patients under various
scenarios.13 The analyst sets the key parameters of the
model based on clinical information and reasonable assumptions. The
model can then be used to test the effect of changes in assumptions on
the final outcome of the cohort.
The costs were incorporated into our decision analysis Markov model,
which calculates discounted, quality-adjusted life expectancies of
newly diagnosed CML patients based on their age, time from diagnosis to
transplant, and whether they choose transplant or nontransplant
therapy.1 The base case was considered to be a 35-year-old
patient. We compared transplantation within the first year after
diagnosis with -interferon or hydroxyurea therapy. The outcomes of
-interferon and hydroxyurea treatment were represented by results of
a meta-analysis of seven randomized trials analyzed on an
intention-to-treat basis.14 Survival beyond 5 years was modeled using the annual death rates for later years as presented in
the paper. A discount rate of 3% per year was used for both costs and
life years, and utilities of 0.979 for life without chronic GVHD, and
0.90 for life with chronic GVHD, respectively, were assumed. These
utilities were derived from physicians using the standard gamble
methodology as previously described.6 For the purposes of
this analysis, we assumed a utility of 1.0 for either -interferon or
hydroxyurea therapy and tested this assumption in sensitivity analyses.
We calculated an incremental cost-effectiveness ratio, which is the
difference in costs divided by the difference in effectiveness between
a given therapy and the next best option. This is an appropriate value
to use when deciding between mutually exclusive therapies. Note that
this value is different than simply the costs of a program divided by
its benefits.15
Sensitivity analysis.
Sensitivity analyses were performed on key variables including cost
estimates, patient age, discount rate, utilities, handling of
aberrantly high posttransplant hospitalizations, and long-term medical
costs more than 5 years posttransplant. Ranges for testing were
identified from the medical literature and the recommendations of the
Panel on Cost-Effectiveness in Health and Medicine.15
Statistical methods.
Costs were compared using the Wilcoxon Rank Sum test. Multiple linear
regression was used to assess the association between peritransplant
costs and patient age, patient gender, whether a patient was
mismatched, site, length of stay during the transplant hospitalization
and whether a patient died during the transplant hospitalization or
after hospital discharge, but before 6 months. A stepwise forward
selection process was used to determine variables significant at
P < .05.
| |
RESULTS |
Patient characteristics.
The characteristics of patients from the FHCRC and the BWH are shown in
Table 1 and are similar to those of the
registry cohort used to calculate effectiveness. Three-year overall
survival was similar for the combined FHCRC/BWH cohort transplanted at different intervals from diagnosis (59%) and used in the cost analysis, and registry patients transplanted within 1 year of diagnosis
(58%) used to calculate effectiveness. The overall survival for the 45 FHCRC/BWH patients who were 50 years old or less and transplanted from
fully matched unrelated donors within 1 year of diagnosis was 77% at 3 years (median follow-up, 3.16 years).
Costs of Unrelated Donor (URD) transplantation for CML.
Median costs through 6 months posttransplant were not significantly
different between the two institutions and were pooled (FHCRC $173,300;
range, $85,000 to $462,400 v BWH $193,200; range, $99,100 to
$331,300, P = .27). Room and board accounted for 30% to 39%
of costs, while pharmacy represented 21% to 24% of costs. The
majority of other costs were attributable to donor identification and
marrow procurement, diagnostic studies, and blood bank. Mean peritransplant costs (including donor identification and harvest) were
$196,200 for the combined cohort (median $178,500; range, $85,000 to
$462,400). In multivariate modeling, the most significant predictors of
costs within the first 6 months were initial hospital length of stay
(partial r2 = .33, P = .0001) and
death (partial r2 = .04, P = .0025).
Factors identifiable before transplantation (site, patient age, patient
gender, degree of matching, time from diagnosis to transplant) were not
found to be significantly predictive at P < .05. Conclusions
were unchanged if the logarithm of costs was modeled. Patients who
survived to hospital discharge, but died before 6 months, were the most
costly because of the high costs of rehospitalization.
Posttransplant care costs remained high during months 6 to 18 posttransplant, then decreased and plateaued except for a single hospitalization 3 years after transplantation, which cost $100,000 (Table 2). The effect of alternative
approaches to handling this aberrant value was tested in sensitivity
analysis. For the base case, an average of costs over the period of 18 to 54 months was calculated and the mean value of $6,900/6 mo was
incorporated into the model during this time period. Beyond 54 months,
cost data were not available and $5,900/6 mo (the average cost through 54 months excluding the outlier) was entered into the model for all
surviving patients.
Patients dying within 6 months of transplantation (n = 48) were
significantly more costly in the first 6 months than those surviving
(n = 109) beyond 6 months ($211,000 v $189,700, respectively, P = .03). Thus, we entered separate costs into the model for
patients who did and did not survive beyond 6 months. Although it has
been noted in the literature that patients use more resources just before their deaths of other diseases, the small number of deaths beyond the 6-month period did not allow us to evaluate this or incorporate differential costs into the model.16
Cost-effectiveness analysis.
The base case was defined as a 35-year-old patient transplanted within
1 year of diagnosis. This scenario was compared with one in which the
same patient elected -interferon or hydroxyurea therapy. Discounted
lifetime costs of transplantation were calculated to be $333,600, while
the cost of interferon therapy was $61,800 and hydroxyurea therapy,
$31,400. The model calculated that a 35-year-old patient transplanted
within 1 year of diagnosis would attain 9.95 discounted,
quality-adjusted life years (QALYs), while a patient treated with
interferon would have 4.70 QALYs and with hydroxyurea, 4.50 QALYs.
Therefore, the incremental cost-effectiveness ratio of early bone
marrow transplantation (BMT) versus interferon is $51,800/QALY. When
early BMT is compared with hydroxyurea therapy, the incremental
cost-effectiveness ratio is $55,500/QALY.
Sensitivity analysis.
In sensitivity analysis, which looks at the effects of different
modeling assumptions, the cost-effectiveness ratios for early BMT
versus -interferon ranged from $32,600/QALY to $126,800/QALY, although most fell within the range of $50,000 to $100,000/QALY (Table
3). Variables such as patient age that
influenced the effectiveness of transplantation had the greatest
influence on the cost-effectiveness ratio. Age at transplant of 25 years rather than 35 lowered the cost-effectiveness ratio to
$43,200/QALY, while the ratio for a 45-year-old patient was high at
$126,800/QALY. Using the -interferon arm of the Guilhot et al
study17 instead of the meta-analysis results14
in the model increased the cost-effectiveness ratio to $86,100/QALY.
When we used the survival curve of the 45 patients in the FHCRC/BWH
cost cohort who were 50 years old or less at the time of transplant,
received marrow from 6 of 6 matched donors and were transplanted less
than 1 year from the time of diagnosis (3-year overall survival 77%,
median follow-up, 3.16 years), the cost-effectiveness ratio was
$42,200/QALY.
If we assume that the quality of life of patients treated with
interferon is the same as patients with chronic GVHD (0.9), the
incremental cost-effectiveness ratio would be $49,500/QALY.
| |
DISCUSSION |
Our results highlight that unrelated donor transplantation for CML is
expensive in absolute costs, but because it prolongs life substantially
for some patients, the ratio of costs to effectiveness is in the range
of other well-accepted medical interventions. Compared with
-interferon therapy, we estimate that unrelated donor
transplantation costs $271,800 more, but results in an average of 5.25 more quality-adjusted life years for a 35-year-old patient. Thus the
incremental cost-effectiveness ratio is $51,800/QALY. Sensitivity
analysis showed that this estimate is fairly robust; when model
parameter estimates were varied through clinically realistic ranges,
the cost-effectiveness ratio generally remained between $50,000/QALY
and $100,000/QALY.
Previous studies have shown that the short-term cost of allogeneic
transplantation from related donors ranges from $100,000 to
$200,000.18-25 We found the costs of care in the first 6 months after unrelated donor transplantation to be $196,200, higher
than most estimates for related donor transplantation, but not
dramatically so. This likely reflects the fact that while patients
undergoing unrelated donor transplantation have higher morbidity and
thus costs, many of the initial expenses are expected to be the same, including costs of inpatient hospitalization and treatment of acute
posttransplant complications.
The cost-effectiveness ratio of unrelated donor transplantation for CML
may be compared with that of other medical
interventions.26,27 While our base case ratio of
$51,800/QALY is higher than other procedures such as cervical cancer
screening in an elderly population,28 it is in the same
range as other commonly performed procedures such as renal
dialysis29 and more favorable than some pharmaceuticals such as the newer antihypertensive agents.30 Therefore, our results do not support the concern that the costs of unrelated donor
transplantation for CML are not justified by the benefits.
We chose to model a 35-year-old patient as our base case because this
represents the median age at transplant. We also focused on unrelated
donor transplantation because we expected the costs to be higher and
the effectiveness lower than related donor transplantation; if
unrelated donor transplantation is cost-effective, then one would
expect the cost-effectiveness ratio for related donor transplantation to be even more favorable. Although we are not aware of any reports of
the cost-effectiveness of related donor transplantation for CML,
published ratios for acute myelogenous leukemia range from $15,300 to
$29,000 per life year saved (adjusted to 1996 dollars).19,22
Several limitations to this study must be noted. First, the efficacy
results were derived from modeling, as no randomized trials of
transplant versus nontransplant therapy have been performed. More
recent changes in transplantation practice, such as better HLA matching
or approaches to GVHD, are not reflected in this cohort. Second, the
cost data were retrospective and accrued over a number of years at only
two institutions. They do not include the costs of establishing the
unrelated donor registry or donor searches for patients unable to
locate a donor. Inclusion of professional fees, which are likely higher
in the transplant arm than the nontransplant arm, would be expected to
raise the net cost of the transplantation strategy. Third, although we
had follow-up cost data until 5 years posttransplant, we do not know if
those cured of their malignancy by transplantation will have more late
medical complications and costs than the average population. Fourth, we
note that both nontransplant17 and transplant9
therapy are improving and that cost-effectiveness ratios will need to
be continually reevaluated in light of changes in costs and
effectiveness.
On the other hand, many assumptions in this analysis favor
nontransplant therapy. For example, we assumed that only 50% of patients entering blast crisis would undergo induction therapy. We also
excluded several costs, which would be expected to improve the
cost-effectiveness ratio of transplantation, such as cytogenetic studies and palliative care for patients electing nontransplant therapy. Therefore, the cost-effectiveness ratio of transplantation may
well be an overestimate.
Thus, unrelated donor transplantation is costly, but the high degree of
effectiveness in appropriate populations results in a
cost-effectiveness ratio comparable to that of other accepted medical
interventions used in the prevention, screening or treatment of both
malignant and nonmalignant disease. Furthermore, if transplant costs
can be lowered while health outcomes improve, the cost-effectiveness ratio of unrelated donor transplantation will become more favorable than shown in this analysis.
| |
ACKNOWLEDGMENT |
We thank Dr Fred Appelbaum for review of the manuscript and helpful
comments. Victoria Doroshenko was helpful in providing cost data. The
International Bone Marrow Transplant Registry and the National Marrow
Donor Program provided the data used to calculate the effectiveness of
unrelated donor transplantation.
| |
FOOTNOTES |
Submitted March 26, 1998;
accepted July 23, 1998.
Supported in part by a Health Services Research Fellowship from the
Agency for Health Care Policy and Research and National Institutes of
Health Grant No. CA75267-01.
The publication costs of this
article were defrayed in part by
page charge payment. This article
must therefore be hereby marked
"advertisement"
in accordance with 18 U.S.C. section
1734 solely to indicate this fact.
Address reprint requests to Stephanie Lee, MD, MPH, Center for Outcomes
and Policy Research, Dana-Farber Cancer Institute, 454 Brookline Ave,
Boston, MA 02115.
| |
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Abstract
Introduction