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Current reviews of allergy and clinical immunology
(Supported by a grant from Astra Pharmaceuticals, Westborough, Mass)
Series editor: Harold S. Nelson, MD
Health economics of asthma and rhinitis.
II. Assessing the value of interventions
Sean D. Sullivan, PhD,a and Kevin B. Weiss, MDb Seattle, Wash, and Chicago, Ill
Health care providers and payers are being asked to weigh
data on the economic impact of new interventions along with
clinical evidence when making decisions about the care of
patients. The notion of incorporating formal health economic
assessments into clinical and resource decisions is a difficult
concept for many in the health care sector. However, it is the
reality in today’s environment. To effectively participate in
these ongoing discussions, clinicians and other decision makers
must be able to understand and critically assess the evidence
on economic impact of medical interventions. This second of 2
articles describes the elements of comparative economic evalu-
able to then take a position that only high-quality eco-
ations, reviewing the published literature on asthma and rhini-
nomic evidence should be used. The purpose of this 2-
tis in an attempt to critically appraise the studies from the per-
part review is to provide decision makers with the tools
spective of one who might use data for decision making.
to evaluate economic evidence for treatments for asthma
Unfortunately, the quality of the economic evidence in these
two disease states is not extensive. Until better economic analy-
ses are conducted and made available, the allocation of
The first part of this review characterized the econom-
resources for asthma and allergic rhinitis will continue to pri-
ic burden of asthma and rhinitis.3 This second portion of
marily rely on expert opinion rather than evidence-based liter-
the review focuses on the critical elements of compara-
ature. (J Allergy Clin Immunol 2001;107:203-10.)
tive economic analyses that are useful for decision mak-ers. Part II is specifically written for clinicians and deci-
Key words: Asthma, allergic rhinitis, economics, cost-effectiveness
sion makers who are not well versed in the purposes andmethods of cost-effectiveness analysis (CEA). It argues
Evidence-based medicine is concerned with the con-
that cost-effectiveness studies have much in common
scientious, explicit, and judicious use of the current best
with the clinical literature that most clinicians are com-
evidence in making decisions about the care of individual
fortable reading and critically appraising. Thus it will
patients.1 Increasingly, health care providers are being
highlight important similarities and differences between
asked to weigh economic evidence alongside clinical evi-
sound economic and sound clinical evaluations. Some of
dence when making decisions about the care of their
the more subtle aspects of CEA (eg, discounting of future
patients.2 This review takes the position that today’s
costs and benefits, comparative measures of benefit) are
health care environment makes some consideration of
not emphasized here. The interested reader can find
economics for determining resource use inevitable. If one
greatly expanded discussions of these issues, along with
accepts the notion that economic considerations are
the major themes discussed below, in several excellent
unavoidable in clinical decision making, it seems reason-
Before discussing the major issues that should be
addressed when evaluating economic evidence, thisreview first outlines the important similarities and differ-
From athe Departments of Pharmacy and Health Services, University of
ences between clinical evidence and economic evidence.
Washington School of Pharmacy, Seattle; and bCenter for Health ServicesResearch, Rush Primary Care Institute, Rush-Presbyterian-St Luke’s Med-
CEAs take a “population” viewpoint for decision mak-
ing. This viewpoint involves basing decisions on evi-
Supported in part by an educational grant from the Asthma and Allergy Foun-
dence gathered from studies of populations rather than
on evidence gathered on a case-by-case basis. So, for
Received for publication November 7, 2000; accepted for publication
example, the clinician who is deciding whether a partic-
Reprint requests: Kevin B. Weiss, MD, Director, Center for Health Services
ular controller treatment is appropriate for his or her asth-
Research, Rush Primary Care Institute, Rush-Presbyterian-St Luke’s Med-
ma patient would look to the literature reporting results
ical Center, 1653 W Congress Pkwy, Chicago, IL 60612.
from clinical trials rather than considering how this treat-
ment worked on his or her last patient (or even a col-
league’s patients). Similarly, CEA is designed to help
Sullivan and Weiss
health care providers and payers make informed resource
The results presented in CEA papers are derived from
allocation decisions based on evidence gathered from
a simple equation that integrates estimates of total costs
studies of populations, including the study types that are
and clinical outcomes. This simple equation has been
familiar to clinical readers (eg, randomized controlled
described as depicting an intervention’s value for money;
trials, case-control studies, cohort studies).
that is, the cost-effectiveness of a new intervention in a
Although clinical and economic impact studies have
defined population of patients represents the added total
much in common, there are important differences
costs required to achieve an incremental improvement in
between the two methodologies. First, the perspective is
outcome when compared with a currently accepted treat-
generally different. Clinical decisions are usually made
ment. If the added cost-to-clinical benefit ratio is accept-
from the perspective of what is best for the patient. Eco-
able to decision makers, it is said to have value. The cost-
nomic analyses are generally conducted from the broader
societal perspective, that is, including all costs and bene-
fits that are attributable to the intervention, even if they do
not necessarily involve the patient directly. Taking a soci-etal perspective is important in CEA because costs and
Here, 2 therapies are compared: A
(usually the new
benefits from medical treatments often “spill over” to oth-
technology) and B
(the established or usual therapy). The
ers beyond the person receiving treatment. For example,
incremental cost-effectiveness of A versus B is thus the
when a child is vaccinated against chicken pox, he or she
attributable benefit per incremental level of expenditure
benefits from the vaccine, but so do other children who
for the new technology. The most common result of a
would have been exposed to the virus if the child had not
cost-effectiveness evaluation for new medical interven-
been vaccinated and had contracted the disease. Some-
tions is one in which health benefits improve compared
times, taking the societal perspective leads to different
with standard care, but at an additional expense to the
conclusions than taking the perspective of the patient.
health care system. It is important to note that interven-
Second, although clinical effectiveness is necessary
tions that marginally increase costs and provide better
for a therapy to be cost-effective, a treatment can have
health outcomes for patients are necessarily useful and
clinical effectiveness and still not be cost-effective. Thus
worth paying for. In a health care system with a fixed
the clinical information provided from randomized trials
budget, these additional expenditures on new treatments
may not necessarily help with economic decisions. This
for asthma or allergic rhinitis must be weighed in relation
fact has not been lost on the proponents of evidence-
to alternative uses of these funds in other disease states.
based medicine, who note that practicing evidence-basedhealth care is at least as likely to increase medical care
ASSESSMENT OF VALUE IN THE CARE OF
PERSONS WITH ASTHMA AND RHINITIS
Third, economic analyses are conducted under a
framework in which the decision maker operates within
Following is a concise review of studies of both asth-
a limited resource environment. Decisions to spend more
ma and allergic rhinitis that highlight the utility of eco-
on one program will necessarily mean spending less on
nomic evaluations for clinical and resource decision
other programs. As a result, economic analyses almost
making. Only a few of these studies have met recom-
always involve a comparison between alternative thera-
mended standards for economic evaluation.9-11 The
pies to ascertain which therapy offers the best health
review emphasizes studies that conform to appropriate
value per dollar expended. Clinical evidence more com-
scientific rigor but also points out notable studies that fail
monly compares a new therapy with placebo care, even
to meet guidelines. Also identified are important or con-
when placebo care (ie, no care) is not the standard of
temporary interventions that lack even basic published
evidence of economic benefit. These areas would befruitful for research. The methodology used for the liter-
BASIC PRINCIPLES OF CEA
ature search was described in part I of this series.3
CEA can be defined as a set of related methods to assess
Economic evaluations in asthma
and quantify the costs and clinical consequences of med-
Asthma is principally diagnosed
ical care treatments to estimate the “economic value” of
and managed with objective measures of lung function.
the intervention in relation to alternative treatments. These
For persons already diagnosed, national guidelines rec-
methods were described briefly in the first part of this
ommend periodic monitoring of pulmonary function by
review.3 A CEA of competing medical treatments should
either spirometry or peak flow measurements.12 To date,
incorporate evidence on the clinical consequences (effica-
there have been no health economic evaluations to assess
cy and safety) and the costs and relative cost-effectiveness
this recommendation. There has been one report of the
of treatment alternatives.7,8 Guidelines for designing and
economic consequences of use of pulmonary function
reporting CEAs—including methods for incorporating
tests to screen for asthma.13 This study of an adult popu-
evidence on costs and effects—are now available and
lation in The Netherlands examined both asthma and
should be read by those who are interested in conducting
chronic obstructive pulmonary disease collectively, mak-
or critically appraising these types of studies.
ing it impossible to single out the value of diagnostic
Sullivan and Weiss 205
Summary of randomized health economic studies of pharmacotherapy for persistent asthma
of study measured
saved $9.43 foreach symptom-free day gained
Adapted from Sullivan SD, Weiss KB. Pharmacoeconomics of asthma treatments. In: Barnes PJ, et al, editors. Asthma: basic mechanisms and clinical manage-ment. 3rd ed. San Diego: Academic Press; 1998. p. 909.RCT
, Randomized controlled trial; BID
, twice daily; PEFR
, peak expiratory flow rate; ED
, emergency department.
*Study had a planned 3-year follow-up but only 39 patients reached a follow-up period of 22 months.
testing for asthma alone. There appear to be no health
or they were of too short a duration to assess outcome and
economic evaluations of the use of other types of diag-
economic impact on a chronic condition such as asth-
nostic tests such as x-ray films, serologic tests, or skin
ma.14,17-22 Table I provides an overview of selected stud-
ies that meet many of the economic-evaluation standards.
Pharmacotherapy represents the founda-
The National Guidelines for the
tion for clinical management of asthma. Not surprisingly,
Diagnosis and Management of Asthma12 recommend
there are a number of studies that present findings on the
inhaled corticosteroids (ICSs) in addition to as-needed
economic impact of drug treatments. Many of these stud-
bronchodilator therapy as treatment for persons with per-
ies did not meet 2 of the basic criteria for cost analysis.
sistent asthma. There is substantial evidence to support this
This was because they either failed to include all costs14-16
recommendation.23,24 However, addition of ICS medica-
Sullivan and Weiss
tions to an existing regimen of inhaled or oral bronchodila-
gest a favorable economic profile for adding ICSs to short-
tor therapy contributes significantly to the overall cost of
treating these patients. An important research question is
Data are beginning to appear that compare different
whether ICSs along with as-needed bronchodilators are
anti-inflammatory therapies, but as yet, these studies do
cost-effective compared with as-needed bronchodilators
not meet many of the criteria for a well-designed CEA.37
alone (BA) for treating persons with mild-to-moderate or
However, it is precisely these types of head-to-head stud-
moderate-to-severe asthma. Although several observational
ies that most decision makers want to see.
studies have attempted to examine this issue,25-30 this
One study examined the rel-
review focuses on randomized trials because of the strength
ative economic consequences of treating persons with
asthma with twice daily powder formoterol 12 µg as
One of these studies was a 16-week randomized trial of
compared with salmeterol 50 µg.38 However, the authors
budesonide, 400 µg/d and 800 µg/d, and placebo in 57
concluded that there were no statistically significant dif-
adults with mild asthma.33 Low-dose budesonide demon-
ferences in symptom-free days between the two treat-
strated better control of morning and nocturnal symp-
ment groups, and because of this, no incremental cost-
toms, improved peak flow measurements, and was judged
to be cost-beneficial compared with placebo. High-dose
Of current interest in the United States is the potential
budesonide did not improve lung function or symptom
economic impact of combination bronchodilator and cor-
scores relative to low-dose budesonide. In another study
ticosteroid products. Investigators examined the costs and
Connett et al34 examined the cost-effectiveness of inhaled
effects of use of the salmeterol/fluticasone propionate
budesonide compared with placebo in a 6-month random-
fixed-dose combination product (SFC) 50/250 µg twice
ized trial of 40 children aged 1 to 3 years with persistent
daily versus budesonide 800 µg twice daily.39 This study
asthma. The results indicated that budesonide produced a
involved 353 adult and adolescent participants (≥12
favorable clinical response, increasing symptom-free
years) who were symptomatic while receiving current
days when compared with placebo. The results also sug-
doses of ICSs. The patients were followed up for 24
gested that compared with placebo, budesonide increased
weeks. The results indicated that patients taking SFC had
overall effectiveness and reduced overall costs by about
significant improvements in several outcomes. The incre-
mental cost-effectiveness for SFC was $1.12 per symp-
Rutten-van Mölken et al35 reported on the cost-
tom-free day gained. This study suggests that this combi-
effectiveness of adding ICSs to an as-needed bron-
nation therapy may have a favorable economic profile for
chodilator regimen (ICS + BA) compared with as-needed
patients with asthma whose symptoms are otherwise
BA in a 12-month randomized trial of 116 children with
poorly controlled with moderate doses of inhaled steroids.
asthma aged 7 to 16 years. The investigators evaluated
Inhaled cromolyn sodium and nedocromil.
FEV1 as the primary outcome and frequency of symptom-
appear to be no randomized controlled economic evalua-
free days and school absences as secondary outcome
tions of inhaled cromolyn sodium or nedocromil. How-
measures. ICS + BA was estimated to cost about $4.75
ever, 2 published studies attempt to estimate the eco-
per symptom-free day gained relative to use of BA.
nomic value of these compounds. One study is based on
One of the most comprehensive trials to date investigat-
retrospective analysis of 53 patients categorized into 2
ed the costs and effects of adding inhaled anti-inflamma-
groups: those who received cromolyn sodium for at least
tory therapy to inhaled β2-agonist. This study was based
1 year and those who did not receive cromolyn sodium as
on 274 adult participants aged 18 to 60 years with moder-
part of their treatment regimen.40 Another, more recent
ately severe asthma or chronic obstructive pulmonary dis-
study of nedocromil sodium was conducted that used a
ease as defined by pulmonary function criteria.36 Each
retrospective pre-post design to examine this therapy for
patient was randomly assigned to either inhaled fixed-dose
553 adults with asthma.41 These 2 studies suffer from
terbutaline plus inhaled placebo, inhaled terbutaline plus
selection and other biases common to retrospective
800 µg of inhaled beclomethasone per day, or inhaled
analyses and therefore provide little information about
terbutaline plus inhaled ipratropium bromide 160 µg per
the health economic value of these compounds.
day. Patients were followed up for as much as 2.5 years.
One health economic study
The economic objective of this study was to determine the
of the use of zafirlukast for children and adults with
relative cost per unit of benefit for the 3 therapeutic arms.
mild-to-moderate asthma was reported; however, the
The clinical results indicated that addition of the ICS to
study did not report on the cost of the study drug, there-
fixed-dose terbutaline led to a significant improvement in
by making this an incomplete assessment of economic
pulmonary function and symptom-free days, whereas
impact.14 There are presently no other published studies
addition of inhaled ipratropium bromide to fixed-dose
that meet current standards to provide an understanding
terbutaline produced no significant clinical benefits over
placebo. The incremental cost-effectiveness for ICS was
There have been a few stud-
approximately $5 per symptom-free day gained. The
ies of various other pharmacotherapeutic strategies. One
incremental cost-effectiveness of ipratropium bromide
suggested that inhaled anticholinergics might be of ben-
was not evaluated because of the lack of clinical benefit
efit in treating children with asthma.42 There also appears
relative to placebo. The results from these studies do sug-
to be only 1 health economic evaluation of asthma phar-
Sullivan and Weiss 207
macotherapy conducted within a developing country.
issues: (1) acute care delivered in emergency depart-
This cost-minimization study, conducted in India, found
ments and hospitals, and (2) managed care disease-
the use of oral β-agonists provided no additional clinical
benefit and increased costs for persons using as-needed
Studies of asthma care in emergency departments and
A number of studies have examined ways in
Other literature has explored the cost consequences of
which emergency departments or hospitals might achieve
nebulizers versus metered-dose inhalers (MDIs) with or
optimal asthma care outcomes at lower costs. Several
without spacers in the acute care setting.44-49 Although
studies have characterized the use of short-stay observa-
most of these studies have design limitations, collectively
tion units in the emergency department.71-73 Collectively,
they suggest that there is no significant difference in clini-
these studies suggest that there are cost benefits to the
cal outcomes between nebulizers and MDIs.44,50 These
studies also suggest that MDIs offer modest cost savings.
Several other studies have examined the economics of
Although there are published studies of various other types
asthma clinical pathways designed to improve and
of medication-delivery devices,51-53 they do not meet
streamline hospital care.74-78 These studies, all nonran-
many of the standards for health economic evaluations.
domized and mostly retrospective in design, uniformly
Economic studies of asthma patient education, self-
focused on length of stay without clearly defining the
management programs, and specialty consultation.
costs associated with the intervention. While a majority
Several publications document the clinical and econom-
of these studies reported decreased length of stay, the
ic impact of patient-oriented asthma education programs.
actual cost benefit of the pathway intervention remains
These educational interventions vary from formal class-
unclear. For example, one well-designed trial resulted in
room-based medication compliance programs to asthma
self-management programs for adults and children/par-
Studies of disease-management programs.
ents. Overall, the economic evaluations of these pro-
management has become popular during the past
grams are quite favorable, especially when the programs
decade.79-81 Although there is currently no standard defi-
are aimed at high-risk patients or those with high-end
nition for this term, most program descriptions focus on
health care utilization (such as a prior hospitalization).54-65
population management and include some type of multi-
These studies nearly all take the form of cost-benefit
faceted team approach to improving the delivery of care.
analyses, with costs attributed to program costs and ben-
There are now a number of health economic studies eval-
efits related to changes in emergency department and
uating asthma-specific disease-management programs.82-90
hospital utilization. One particularly well-designed ran-
Each of these studies has notable design limitations, par-
domized controlled trial of an inner-city population was
ticularly in relation to sample selection, controls, and eco-
able to demonstrate cost savings from a program of five
nomic analyses. However, together they suggest that a
1-hour asthma education sessions targeted to children
comprehensive approach to asthma management—
who had been hospitalized during the previous year.64
beyond pharmacotherapy—may have some merit. Further
True cost-effectiveness studies in the field of asthma
research in the form of prospective randomized clinical
education and training for self-management are infre-
trials will help to better elucidate the economic value of
quent. Two separate cost-effectiveness studies of asthma
this approach to improving asthma outcomes.
self-management programs in Finland arrived at conflict-
Other miscellaneous asthma-related health economic
ing conclusions. One study resulted in a cost-effective-
There are a number of other health economic stud-
ness ratio of 118 Finish Marks per health day gained.66
ies related to asthma care that span the spectrum from exam-
Another similar study in Finland found no significant
ining the value of diagnosis and treatment of gastroe-
health economic value at either 1 or 3 years.67 Another
sophageal reflux for asthma91 to psychosomatic therapy92 to
study of asthma self-management in India met a number
use of pharmacists in guiding therapy93,94 and use of physi-
of the standards for economic evaluation but fell short of
cian audit with feedback.95 The methods used in these stud-
calculating a cost-effectiveness ratio.68 This study sug-
ies do not meet many of the established standards for health
gested that there were health improvements in terms of
economic studies, making the results difficult to interpret.
peak flow measurements and productive days lost, aswell as average marginal cost savings of 22%.
Economic evaluations in allergic rhinitis
There have also been studies examining the economic
The economic-evaluation literature in asthma is limit-
impact of referrals to specialists for persons with moder-
ed but growing and becoming increasingly relevant and
ate-to-severe asthma.69,70 Retrospective chart reviews
rigorous. This is not the case for the economic-evaluation
found significant reductions in sick office visits, emer-
literature in allergic rhinitis. The paucity of literature is
gency department visits, hospital days, and costs of care.
compounded by the lack of a standardized approach to
However, the results must be interpreted with caution in
undertaking CEA for this condition. Most notable is the
light of limitations imposed by the choice of study design
lack of standard outcome measure to use in the denomi-
nator of the cost-effectiveness equation.
Economic evaluation of innovations in health care
This review describes 4 studies of pharmacotherapy
The health economic literature exploring new
and 1 study of immunotherapy for treatment of allergic
strategies in asthma care delivery addresses 2 general
rhinitis. There are no existing reports on the economic
Sullivan and Weiss
impact of the myriad of avoidance strategies and medical
asthma. There also appears to be a favorable economic
and disease-management interventions in this disease.
benefit to targeted and sustained asthma education direct-
In a randomized controlled clinical trial of the use of
ed at self-management for selected subgroups of patients.
intranasal fluticasone propionate (200 µg once daily)
Disease-management programs may, with further study,
versus terfenadine tablets (60 µg twice daily) versus
provide a comprehensive intervention strategy that adds
placebo, the authors reported cost-efficacy ratios for flu-
value to current clinical care of persons with asthma.
ticasone to be more favorable than those of terfenadine or
Beyond these modest conclusions, there remain signifi-
placebo in reducing nasal symptoms.96 Unfortunately,
cant questions about the value of other treatments.
the study reported only drug costs and focused exclu-
A number of problems need to be addressed before
sively on adults with allergies to mountain cedar. The
studies of this type can be effectively used to determine
utility of these data are questionable.
optimal clinical strategies. First is the lack of standardized
Another retrospective analysis of budesonide aqueous
outcomes for use in health economic analysis of both asth-
nasal spray and intranasal fluticasone propionate for treat-
ma and rhinitis. For asthma, the symptom-free day is
ment of perennial allergic rhinitis reported budesonide to
beginning to emerge as a standard measure. Researchers in
be more cost-effective.97 However, the economic analysis
the field of rhinitis have not, as yet, benefited from nation-
was distilled into a simple cost comparison because of
al or international discussions aimed at standardizing out-
lack of statistically significant differences in clinical end-
come measures for this condition. Second, investigators
points. More troubling was the fact that the results of this
need to more carefully apply appropriate research designs,
6-week study were extrapolated to predict 12-month
with sufficient time horizons, relevant comparators, and
costs, which could be seen to adversely affect the face
accurate measures of resource use and cost, before these
data will be taken seriously by decision makers.
Another study explored the “willingness-to-pay”
Finally, clinicians should be a part of the process of
approach to valuing the benefits of 2 types of intranasal
critically evaluating economic evidence for new medical
budesonide compounds for treatment of seasonal allergic
interventions, in the same way they now evaluate clini-
rhinitis.98 The authors of this study found no difference
cal evidence. The task of becoming an effective evalua-
in willingness to pay for aqueous versus dry-powder
tor of CEAs is not as daunting as it may first seem
because these studies have more similarities than differ-
There appears to be only 1 study modeling the long-
ences with the clinical literature. The knowledgeable
term economic consequences of specific immunotherapy
clinician can play a role in ensuring that only high-qual-
in the treatment of allergic rhinitis.99 This model sug-
ity cost-effectiveness studies are used for decision mak-
gests that for a small subset of patients with 3 years of
ing in their organizations. In addition, enlarging the
continuous symptoms, there may be an economic advan-
audience of critical readers of CEAs will likely improve
tage to treatment with immunotherapy. Although this
the quality of studies that are published in the medical
study is interesting, the next step would be to challenge
literature. As economic evidence becomes more impor-
the results in the form of an experimental clinical trial.
tant in medical decision making, it is essential that clin-
One other comparative study of rhinitis attempted to
icians participate in the process of translating this evi-
examine the economic impact of a disease-treatment pro-
gram.100 However, this study did not clearly define the
Until better economic analyses are conducted and
actual disease-intervention program, thereby limiting
made available, the allocation of resources for asthma
and allergic rhinitis will continue to rely primarily onexpert opinion rather than evidence-based literature.
We thank Ms Robin Wagner for her editorial assistance and Ms
Josephine Diaz and Ms Monica Blumthal for their assistance with
The health economic literature for asthma and rhinitis
has evolved considerably during the past decade. CEA isnow recognized as a standardized methodology for
assisting decision makers in selecting and reimbursinghealth care interventions that maximize the health of
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Special Meeting Minutes May 23, 2011 Page Special Meeting Minutes A Special Meeting of the Board of Education of the Scotia-Glenvil e Central School District was held in the Library Media Center of the Middle School, in said district on May 23, 2011. President Carbone cal ed the meeting to order at 6:15 p.m. Present: Carbone, Conlon, Crapo, Normington, Smith, Yagielski, Superintendent Swartz,
ADDITION OF BEVACIZUMAB TO CAPECITABINE IMPROVES PROGRESSION-FREE SURVIVAL IN ELDERLY PATIENTS Key Points: • The addition of bevacizumab to capecitabine significantly prolonged progression-free survival in elderly patients with previously untreated metastatic colorectal cancer who were not considered candidates for oxaliplatin- or irinotecan-based chemotherapy. • No d