A health economic model of breakthrough pain

Article (PDF Available)inThe American Journal of Managed Care 14(5 Suppl 1):S129-40 · June 2008with117 Reads
Source: PubMed
Although the literature adequately addresses the biologic basis, epidemiology, and management of breakthrough pain (BTP), it does not yet describe the full impact of this troubling, widespread phenomenon. The risks of a scanty understanding of BTP impact are failure to take preventive measures, underdiagnosis, undertreatment, and inappropriate management. Studies to date of the impact of BTP have followed pharmacoeconomic approaches. Building on prior efforts, this paper develops a more comprehensive health economic model that encompasses the full spectrum of costs, outcomes, risks and benefits associated with BTP and its management. The authors provide a rubric within which stakeholders--including providers, institutional leaders, administrators, and policymakers--can systematically balance the myriad potential effects of different treatment scenarios to guide decision-making. The paper then extends this model to the population level, providing a template for health economic analysis of alternate strategies for managing BTP, and delineating steps for accomplishing the analysis.
© Managed Care &
Healthcare Communications, LLC
reakthrough pain (BTP) is an abrupt onset, transitory flare
of pain occurring in the context of managed, chronic, base-
line cancer pain.
BTP builds to a moderate or severe in-
tensity, usually peaking within 3 to 5 minutes after onset;
episodes last approximately 30 minutes. To distinguish it from inade-
quate background analgesia, BTP is usually defined as 4 or fewer epi-
sodes in a 24-hour period.
BTP prevalence estimates among cancer patients vary from 24% to
95%, depending on the definition of BTP and the setting from which
the study sample was drawn. A 63% prevalence of BTP has been
observed in patients admitted to hospice with nonmalignant terminal
This paper focuses on cancer-related BTP—the most frequent-
ly studied BTP scenario with the widest portfolio of US Food and Drug
Administration–approved or developing pharmacologic interventions.
Pharmacologic and Nonpharmacologic Management of BTP. A
solid body of literature establishes the importance of BTP, as well as
detailing strategies for its management; however, despite this available
information, undertreatment remains a common phenomenon. In a
study of guideline-based pain management versus standard care, Du
Pen et al demonstrated that a substantial reason for undertreatment
of cancer pain in general is underdosing of rescue medication for BTP.
Strategies for managing cancer-related BTP include nonopioid med-
ications (eg, nonsteroidal anti-inflammatory drugs, acetaminophen),
short-acting opioids (eg, codeine, hydrocodone, morphine, oxycodone,
hydromorphone, fentanyl), and nonpharmacologic strategies (eg, ice,
heat, guided imagery). Oral short-acting opioid formulations are most
effective for preemptive management of BTP in patients who suffer
predictable mo
derate-to-severe episo
des and who do not respond to
nonopioid or nonpharmacologic strategies. Rapid-onset transmucos-
al lipophilic opioids are recommended for patients with unpredictable
moderate-to-severe incident or idiopathic BTP.
Other strategies,
such as radiotherapy, neurosurgical procedures, acupuncture,
thecal and epidural infusions, neurolytic blocks, and yoga, can factor
importantly into the management of cancer pain in general, and im-
provement in BTP is a corollary outcome in these clinical scenarios.
A Health Economic Model
of Breakthrough Pain
Amy P. Abernethy, MD; Jane L. Wheeler; and Barry V. Fortner, PhD
Although the literature adequately
addresses the biologic basis, epidemiol-
ogy, and management of breakthrough
pain (BTP), it does not yet describe the
full impact of this troubling, widespread
phenomenon. The risks of a scanty
understanding of BTP impact are failure
to take preventive measures, under-
diagnosis, undertreatment, and inap-
propriate management. Studies to date
of the impact of BTP have followed
pharmacoeconomic approaches.
Building on prior efforts, this paper
develops a more comprehensive health
economic model that encompasses the
full spectrum of costs, outcomes, risks
and benefits associated with BTP and
its management. The authors provide a
rubric within which stakeholders—
including providers, institutional
leaders, administrators, and policy-
makers—can systematically balance
the myriad potential effects of different
treatment scenarios to guide decision-
making. The paper then extends this
model to the population level, provid-
ing a template for health economic
analysis of alternate strategies for man
aging BTP, and delineating steps for
accomplishing the analysis.
(Am J Manag Care. 2008;14:S129-S140)
For author information and disclosures,
see end of text.
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Impact of BTP
BTP exacts a significant toll on patients, their
families, caregivers, and social networks; the health-
care system; and society at large. These consequences
are physical, emotional, spiritual, social, and financial
in nature. BTP in cancer patients is reported to be
associated with decreased functional status, increased
levels of anxiety and depression, greater dissatisfac-
tion with opioid treatment, and poorer medical out-
Studies to date, however, have not yet taken
a comprehensive approach to delineating the impact
of BTP on patients, providers and institutions, and
society. Additional work is needed to describe and
enumerate the full aspects of suffering caused by BTP;
a critical first step will be the development of instru-
ments that are sensitive and specific to quality-of-life
(QOL) domains differentially affected by BTP.
The primary purposes of this paper are as follows:
(1) to summarize the costs and benefits associated
with BTP and its treatment, as described to date in
the cancer population; (2) to present a framework
that clinicians can use to guide their decision-making
for patients with BTP; and (3) to provide a model for
health economic analysis, on a population level, of
alternate strategies for the management of BTP, and
to delineate steps for accomplishing the analysis. We
begin by drawing on the pharmacoeconomic approach,
which entails systematic quantification of the costs,
risks, and benefits of medical interventions.
Pharmacoeconomic Analysis: The Foundation for
a BTP Health Economic Model. Most pharmaco-
economic analyses employ 1 of 4 methods: cost-
minimization analysis, cost-effectiveness analysis,
cost-benefit analysis, and cost-utility analysis. All of
these approaches measure costs in monetary units,
but they differ in how they value outcomes
). Pharmacoeconomic analyses typically categorize
costs into 3 basic types—direct, indirect, and intan-
gible. Direct costs include fixed and variable medical
costs (eg, hospital capital expenses, costs of medical
treatment) and nonmedical costs (eg, transportation
to the clinic). Indirect costs encompass the costs of
morbidity and mortality because of the illness or
health event, and include lost income and time spent
in the waiting room. Intangible costs comprise the
toll of psychosocial states resulting from the illness or
health event, such as suffering, pain, or depression.
Once costs have been defined, pharmacoeconomic
analyses proceed to assign values to cost items and
outcomes, determine outcome probabilities, and com-
pare costs with benefits. One such process, presented
by Jolicoeur et al, delineates a method for conducting
pharmacoeconomic analysis in 10 steps:
(1) defining
the problem, (2) determining the study’s perspective,
(3) determining the alternatives and outcomes, (4)
selecting the appropriate pharmacoeconomic method,
(5) placing monetary values on the outcomes, (6)
identifying study resources, (7) establishing the prob-
abilities of the outcomes, (8) applying decision anal-
ysis, (9) discounting costs or performing a sensitivity
or incremental cost analysis, and (10) presenting the
results, along with any limitations of the study.
structures may prove equally useful, the critical step
in any such analysis being the balancing of costs
against benefits. The utility of this step will depend
n Table 1. Difference in Methodology of Pharmacoeconomic Approaches*
Approach Measurement of Benefit/Outcome End Point of Analysis
Cost-benefit analysis Always valued in monetary units Net benefit (benefits minus costs)
(eg, amount the patient is willing to or benefit-cost ratio (benefits/costs)
pay to avoid pain)
Cost-effectiveness analysis Measured in similar natural units Cost per unit (eg, cost per life-year
(eg, life-years gained) gained)
Cost-utility analysis Valued based on individual Cost per unit (eg, cost per QALY)
preference-based units (eg, quality-
adjusted life-years [QALYs])
Cost-minimization analysis Assumed equivalent, regardless of unit Compare cost of strategy X
vs strategy Y
Adapted from Reference 10.
Health Economic Model of Breakthrough Pain
fundamentally on the extent to which both sides of
the equation thoroughly capture the impacts of the
imitations of Pharmacoeconomic
Studies to Date
Most pharmacoeconomic studies in pain have
focused on the cost repercussions of chronic pain
rather than on BTP. In 1994, the Cancer Pain Panel
of the Agency for Healthcare Policy and Research
(renamed the Agency for Healthcare Research and
Quality; AHRQ) developed a 13-point framework
for cost analysis related to cancer pain. This AHRQ
framework covers medical costs, cost savings associ-
ated with different settings of care, morbidity-related
costs, and indirect costs to patients and families and
was part of a highly cited monograph on cancer pain
management and best practice guidelines (now re-
Extending the AHRQ model, Chandler and
Payne classified types of cost impact of unrelieved
cancer pain into the following categories: direct
medical (hospital personnel, overhead, treatment,
complications), direct nonmedical (travel, hotels,
meals, lost wages), indirect personal (decreased pro-
ductivity, QOL), and intangible personal (pain, suf-
fering, demoralization).
In 2003, Fortner et al
sought to quantify the costs set out in these 2 mo
els by gathering, directly from patients, data related
to the direct and indirect costs of cancer pain.
the same year, Abernethy et al published a clinical
decision and economic analysis model of cancer pain
management that compared the effectiveness and
cost of 3 cancer pain management strategies—guide-
line-based care that incorporated the AHRQ cancer
pain management guidelines, oncology-based care,
and usual care.
Overall cancer pain has been the focus of most
cancer pain–related pharmacoeconomic studies; the
costs of BTP, specifically, remain poorly understood.
The lack of a model that depicts the true costs versus
benefits of BTP management presents a very real
impediment to good clinical practice, hindering con-
sideration of cost-effectiveness and appropriate cost
containment. This article builds on prior work in
general cancer pain to develop a broader health eco-
nomic framework that comprehensively captures the
costs and other impacts of BTP in 3 key domains.
This framework is intended to provide physicians
with a guiding tool for clinical decision-making in
BTP scenarios, thereby averting the underdiagnosis
and undertreatment of BTP that are common today.
It may also support institutional and national efforts
to maximize cost-effectiveness and to allocate
resources in a way that best optimizes patients’ QOL.
A Comprehensive Health Economic
Model of BTP
Structure of the Model. Our suggested health ec-
onomic framework overlays the traditional tripartite
cost domains (direct, indirect, intangible) with 3 im-
pact domains (patients, providers, society) and 3 end
point domains (costs, outcomes, benefits) (
Figure 1).
The resulting 3
x 3 x 3 rubric offers healthcare re-
searchers, clinicians, institutions, and consumers a
rational schematic depiction of BTP costs, that also
integrates the potential outcomes and benefits of
BTP management, and itemizes these costs, out-
comes, and benefits for the full array of stakeholders
affected. It offers a tangible mechanism for organizing
evidence in clinical decision-making.
The mo
s first major domain (patients, pro
viders, society) defines the participants affected by
BTP and encompasses patients (including family
members and caregivers), providers, and society at
large. Cancer is experienced within a social context;
hence, the consequences of the pain and the corre-
sponding benefits of its amelioration are experi
enced throughout the patient’
s immediate social
network. On the second level, providers are affected
directly in that they bear the resource requirements
for management of BTP, accrue many benefits of
n Figure 1. Health Economic Model of Breakthrough Pain
End Point
Nature of Impact
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improvement in management, or suffer the provider-
level stress of treating intractable pain. Third, society
at large, which includes payers and employers, expe-
riences the impact of BTP on productivity, finances,
psychosocial distress, community engagement, and
opportunity costs.
The second major domain of the model (direct,
indirect, intangible) denotes the nature of BTP im-
pact. Direct effects are those that have an immedi-
ate and unmediated impact. For example, a patient’s
experience of pain is a direct effect of BTP pain; a
medical visit and the cost of a BTP medication are
direct, patient-domain impacts of BTP. Downstream
effects that occur as mediated consequences of BTP
are indirect costs. Examples of indirect consequences
are the lost productivity of a caregiver or the impact
on a coworker of the patient’s absence from work; in-
direct benefits include secondary gains experienced
from increased sympathy for a patient in pain. Fi-
nally, intangible aspects are those impacts that are
currently beyond our ability to measure. BTP draws
from societal energies, resulting in foregone oppor-
tunities and advances; these, and the intricacies of
human suffering, are currently intangible costs of BTP.
The third domain of the model (costs, outcomes,
benefits) structures the end points of analysis. The
most recognizable end points are the costs of BTP
associated with the BTP itself. Outcomes related to
BTP include the results of BTP management, and
range from clinical (eg, unrelieved pain, insomnia,
increased inflammation) to humanistic (eg, emotion-
al distress, reduced social interaction). Benefits repre-
sent those direct, indirect, and intangible positive
effects and cost offsets attributable to effective BTP
Data to Populate the Model
The cost data necessary to perform a comprehen-
sive health economic assessment of BTP are chal-
lenging to obtain. With respect to direct costs, the
primary challenge revolves around the necessity to
differentiate the costs that are attributable to BTP
and that are incurred more than the costs of care for
the cancer itself, chronic pain associated with the
cancer, and comorbidities unrelated to the BTP. In
the case of BTP, direct medical costs might include
hospital charges, cost of analgesics and other med-
ications, radiotherapy, surgery, and clinician time;
direct nonmedical costs might include the cost of
gas to drive to the clinic, parking during a clinic visit,
highway tolls, overnight lodging for family or care-
givers, and meals for these individuals while attend-
ing to the patient in the hospital. Direct medical
costs can be obtained from institutional and clinical
accounting systems; however, diagnostic and clini-
cal variables that link the expense to episodes of
BTP are nonexistent, making direct accounting for
BTP much more problematic than it first appears.
Direct nonmedical costs can be calculated once the
types of costs are enumerated and the corresponding
direct medical event is linked to the BTP episode.
Indirect costs become more difficult to identify in
full and, likewise, to compute. Indirect costs for BTP
might encompass, for example, lost income as a result
of time taken off work for a BTP episode, a spouse’s
or caregiver’s lost income because of time off work, or
the expense of extra household help. These costs
carry a monetary price tag but are not directly relat-
ed to the health issue at hand. Many indirect costs
can be documented only through the direct report of
patients; obtaining this information is becoming more
feasible with recent advances in data collection.
Specifically, novel information tech
nology allows for
the gathering of information directly from patients
regarding how they value various costs and outcomes.
Patient-reported values can now be integrated into
the analysis to create a more comprehensive model of
costs and benefits, one that can guide clinicians in
their decision-making with a truer depiction of the
impact of possible treatment paths.
Intangible costs, which by their nature elude
quantifying, have typically been omitted from many
pharmacoeconomic studies. For BTP, intangible costs
include the patient’
s pain, suffering, depression, anx
iety, loss of sleep, and fatigue, as well as the family’s
and/or caregiver’s distress. Recent developments in
clinical/research methodology enable capture of
these intangibles in ways not previously possible.
New technologies such as the e/Tablet—a wireless
notebook-and-pen–style personal computer—have
been validated as metho
ds for collecting research-
quality, patient-reported outcomes; these data can
include scores for intangible costs such as depres
sion, fatigue, anxiety, and QOL.
In our model, costs are balanced against the val-
ues assigned to benefits of appropriately preventing,
managing, or treating BTP. Benefits attributable to
BTP are direct and indirect cost savings, symptom
Health Economic Model of Breakthrough Pain
improvement, positive qualitative outcomes, and any
improvement in intangible factors above and beyond
baseline expectations established for the care and
the outcomes of underlying chronic cancer pain.
Application of the Model. To use this framework
in a clinically meaningful way, the clinician must
pull together all of the diverse costs, benefits, and
outcomes associated with the BTP phenomenon;
apply currently best-available methods for assigning
values to those factors; and present the values in an
accessible, functional format that facilitates clinical
evaluation of treatment options. We will demonstrate
this method below, after briefly describing available
evidence to assist in the process.
Current State of Knowledge for
Pharmacoeconomics of BTP
Pharmacoeconomic studies have examined the
cost-utility and cost-effectiveness of a variety of pain
types, including chronic spinal pain,
chronic low
back pain,
neuropathic pain,
pain postcranioto-
and anterior cruciate ligament reconstruction.
In parallel, BTP itself, as distinct from chronic cancer
pain and other nonmalignant pain, has been charac-
terized and described in the literature.
It is reason-
able to assume that BTP is included in more general
studies of cancer pain, and accounts for a significant
portion of the variance in, or effect of, pain intensity,
character, and impact. Few studies, however, have
assessed the cost and benefit elements associated with
BTP specifically
, and none have presented a pharma-
coeconomic framework for or analysis of BTP. The
preliminary evidence that does exist uniformly sug
gests the following: (1) BTP results in financial bur-
den on multiple levels, in addition to significant
indirect and intangible costs; and (2) the financial,
psychosocial, logistical, and symptom-related impact
of BTP for diverse stakeholders may be ameliorated
through improved clinical care and effective pharma-
cologics of BTP.
The current, albeit limited, available pharmaco-
economic data for BTP derive from the studies de-
scribed below. Results from these studies have been
used to populate
ables 1 through 3
, delineating the
impact of BTP in each of the model’s domains. An
analytic, health economic approach to BTP begins
with itemization of, and assignment of value to, the
costs on one hand, and the cost offsets and benefi-
cial outcomes on the other. The domains in our
model clarify in which the burden of costs falls, and
for which the benefit of savings and outcomes ac-
crues. This format will facilitate communications
and make information readily accessible to interest-
ed parties in decision-making.
Principal Studies Providing Pharmacoeconomic
Data for BTP.
A multicenter trial studied adult pa-
tients who suffered from noncancer pain and who
took (1) an opioid medication on a regularly sched-
uled basis for persistent pain, plus (2) a stable dose
of short-acting oral transmucosal fentanyl citrate
(OTFC) for BTP for at least 2 weeks.
Patients com-
pleted a structured assessment of the impact of BTP
on their QOL; this assessment specifically included
the dimension of “finances.” Patients indicated that
2 of the 4 most frequent negative impacts of BTP
were “ability to work (both outside the home and
housework)” (93%) and “finances” (81%). These fac-
tors ranked alongside QOL constructs such as “en-
joyment of life” and “general activity level.”
One-hundred forty-four responses to a survey of
373 cancer outpatients attending regularly scheduled
oncology visits demonstrated that BTP predicts
greater costs in cancer patients.
Patient-rated se-
verity of BTP pain was measured by the first item of
the Brief Pain Inventory (eg, worst pain in the past
24 hours)
; simultaneously, patients completed a
questionnaire developed to measure direct and indi-
rect costs of pain incurred during the previous 3
months. Of the 373 cancer patients, 144 (39%) re
ported experiencing cancer-related pain, and 33 of
these (23%) reported BTP
. Sixty-nine percent of
patients had experienced some type of direct med-
ical cost related to pain; these patients reported di
rect medical costs averaging $825 per month. BTP
patients had higher direct pain-related costs (mean
for patients with BTP $1080 vs $750 for patients
without BTP) and indirect costs (mean for patients
with BTP $88 vs $53 for patients without BTP).
The largest study designed to measure the costs
of BTP utilized a computerized, semistructured, tele-
phone survey of 1000 community-based cancer pa-
tients, 160 of whom had clinically significant BTP
requiring pharmacologic treatment.
BTP patients
reported more hospitalizations (1.0 hospitalization
per year vs 0.4 among cancer patients without BTP),
with longer hospital stays per event (7.1 vs 4.1 days).
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The BTP patients’ total cost per year for reported
pain-related hospitalizations was $1.7 million versus
$192,000 for non-BTP patients. BTP patients also
reported more emergency department visits for pain
(1.3 vs 0.5 per year), resulting in greater estimated av-
erage cost per year for emergency department visits
($84,000 vs $19,000). BTP patients reported more
outpatient doctor visits per year for pain (4.2 vs 0.6), re-
sulting in a greater cost per year for physician office vis-
its ($103,000 vs $7000). BTP patients averaged higher
total pain-related costs per year ($12,000 vs $2400).
Examination of total pain-related costs for the entire
sample revealed that BTP patients accounted for
90% of costs, and that these costs were primarily
attributable to BTP-related hospitalizations.
In the context of these findings, an additional study
suggests that quality improvement in BTP clinical
management may reduce BTP-related medical costs.
The Zero Acceptance of Pain Quality Improvement
Project examined 207 patients before and 211 patients
after the implementation of a pain improvement pro-
gram focusing on assessment and education of patients
with pain in community oncology. Patients completed
the Brief Pain Inventory and a survey (similar to that
described previously) evaluating direct and indirect
costs related to pain. Pre- and post-results showed sig-
nificant improvement in decreasing pain-related costs,
particularly direct costs
; the preceding study suggests
that these costs, and cost savings, are largely attributa-
ble to BTP and its management.
Preliminary evidence suggests that treatment
with short-acting OTFC reduces BTP-related costs.
A multicenter study conducted by Taylor et al ad-
ministered a patient-reported survey to 43 patients
who had a mean BTP intensity score of 9 on a 0 to
10 scale.
These patients reported that the areas of
their lives most affected by BTP were “general ac
tivity level” (93%) and “ability to work, both outside
the home and housework” (93%). Among these
tients, 37% reported that short-acting fentanyl had
n Table 2. BTP Costs
Patient/Caregiver Provider/Institution Society/Payer
Direct Copayments, deductibles,
Provider portion of: $1550/day Payer portion of: $1550/day
medical out-of-pocket expenses
average of published costs average of published costs
costs for: analgesics, for hospitalizations for for hospitalizations for
BTP-related office visits, uncontrolled cancer pain
uncontrolled cancer pain
BTP-related emergency $400/day average cost of $400/day average cost of
department visits, and emergency department visit
emergency department visit
BTP-related $150 average cost of office visit
$150 average cost of office visit
Costs of analgesic medication Costs of analgesic medication
for BTP (eg, $204/mo for for BTP
transdermal fentanyl,
$381/mo for IV morphine
Direct Transportation to BTP- Administrative time for Third-party administrative load
nonmedical related medical visits
; scheduling, billing, and for handling insurance claims
costs increase or change in pain related functions
medication; child care;
household help; pain therapy
not covered by insurance;
special items for pain
(eg, hot water bottle);
alternative pain relief
(eg, massage)
Indirect Educational materials for pain Preparation and delivery Allocation of medical technology
costs management; counseling, of medications,
medical and capacity to BTP vs other
psychotherapy related procedures, and technologies; needs; higher taxes; higher
to pain
; lost earnings preparation and delivery to insurance premiums
or productivity
patients and families/caregivers
of cancer pain education
Intangible Reduction in quality of life, Clinician stress; additional Ethical “cost” of not adequately
costs including: pain, suffering, burden on clinic operations; caring for patients with pain
anxiety, depression; impaired clinic or hospital crowding
function; stress; strain
on family and friends
BTP indicates breakthrough pain; IV = intravenous.
Health Economic Model of Breakthrough Pain
improved their finances “very much” or “somewhat,”
and 53% reported that it had improved their ability
to work “quite a bit” or “very much.”
Evidence from a retrospective chart review eval-
uating the efficacy of short-acting fentanyl for man-
agement of BTP in an outpatient cancer pain center
indicates areas of potential cost savings. Burton et al
analyzed records of 39 patients experiencing recent-
onset severe pain (7 or higher on a 0-10 scale); in
most cases, OTFC obviated the need for hospital
admission, an emergency department visit, and par-
enteral opioids.
Application of the Health Economic Model
for BTP
Using data from the foregoing studies, we pro-
ceed to populate the model framework in
Tables 2
through 4
, with values assigned to costs and benefits
as provided in the manuscripts reporting results of
those trials. Note that the cost/outcome/benefit ele-
ments reported in the literature are footnoted; the
many additional elements appearing in these tables
warrant inclusion in a comprehensive health eco-
nomic analysis, and are presented here as suggestions
for future inquiry, although they have not yet been
published. Suggested elements are not meant to be
exhaustive, but rather this framework is presented as
a working template that the clinician, administrator,
institution, or policymaker can adapt and complete
so as to best inform treatment and policy decisions.
Case Illustration of Model Application
Megan is a 61-year-old woman with multiple mye-
loma. She has experienced usual pain rating 2 to 3 on
a 0 to 10 scale for the past 5 months, due to a tumor
deposit in her right ribs. Three months ago, Megan
began experiencing episodes of shooting pain in her
ribs lasting 20 to 60 minutes per occasion and rating
9 to 10 in intensity; she has suffered 4 such episodes.
Because of these BTP episodes, Megan visited her
doctor twice per month for 3 months. Her oncologist
adjusted long-acting opioids, short-acting opioids,
nonopioid analgesics, and her anticancer treatments;
eventually, radiotherapy in combination with ade-
quate long- and short-acting opioids succeeded in
relieving her pain. Megan spent approximately 2
hours in round-trip travel for each of her visits to her
doctor; she also underwent 5 radiotherapy sessions,
each requiring 2 hours in travel time; and she had to
quit her part-time job because of the unpredictable
pain and the time required for additional clinic visits.
Her travel time related to BTP thus totaled 22 hours.
n T
able 3.
TP Outcomes (due to results of BTP management)
Direct Impact Patient/Caregiver Provider/Institution Society/Payer
Direct medical Change in patient-borne Change in clinician time; Change in payer obligation
costs related to BTP hospitalizations; emergency due to BTP outcome
department utilization
Direct nonmedical Change in expenditures Hospital/clinic overhead; Impact on administrative
on: transportation
; administrative costs
load for payers
parking; lodging; meals;
other items directly
related to BTP outcome
Indirect impact Impact on income (patient); Impact on efficiency of Impact on worker
impact on income (family services and on quality of productivity; insurance
or caregiver)
; additional care; changes made to premiums; taxes
downstream expense due patient education and
to change in sleep,
support activities
inflammation, other
health factors
Intangible impact For patients and caregivers, Impact on provider stress Contribution of patients
change in QOL including: and workload burden; and caregivers to society;
anxiety, depression, fatigue, opportunity costs and creation/alleviation of
insomnia; impact on social allocation of resources scarcity in health resources;
interactions; change in opportunity costs
functional status
BTP indicates breakthrough pain; QOL, quality of life.
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By the time Megan’s BTP had abated, with relief
defined as usual pain levels of <2 on a scale of 0 to 10
and manageable BTP of fewer than 4 episodes daily
at an intensity of <2 on the same scale after 20 min-
utes, Megan had cycled through 3 different opioids
(morphine, oxycodone, fentanyl) for differing
lengths of time. She finally ended up on transdermal
fentanyl, at a dose of 75 mcg every 72 hours, with
short-acting OTFC at a dose of 400 mcg every hour
as needed; she self-administered between 2 and 4
doses of the latter drug, daily. Additional manage-
ment strategies for Megan’
s BTP included 800 mg of
ibuprofen taken 3 times per day, guided imagery with
a local counselor, and yoga class 3 times per week.
Her total drug costs were $1730 monthly
, experienced
by Megan as a monthly copay of $60. The total radio-
therapy cost was $8000; Megan’s personal payments for
radiotherapy totaled $300. The nonpharmacologic
costs of yoga and guided imagery amounted to $164
out of pocket monthly ($11 per yoga class, $30 per
imagery session). A summary of her treatment costs is
able 5.
After achieving analgesia from the com
bination of opiates, nonopioids, nonpharmacologic
strategies, and radiotherapy
, Megan at
tained a goo
measure of freedom from pain flare-ups. She was able
to cut her outpatient office visits in half, return to
work at the local middle school, and once again par-
ticipate in the care of her 2 grandchildren.
Given the current stage and severity of Megan’s
multiple myeloma, she is expected to live approxi-
mately 3 years with currently available therapies;
hence, monthly costs would be multiplied by 36 to
derive a total cost for managing Megan’s BTP. The
total cost calculation should factor in an anticipated 2
to 5 further episodes of severe BTP requiring additional
attention over baseline. The clinician would consider,
alongside this figure, the qualitative (unquantified)
costs in terms of negative intangible impacts of her
BTP. Balanced against these comprehensive costs
would be the quantifiable and qualitative benefits and
positive cost offsets of pursuing this aggressive BTP
management strategy. This analysis will arm the clini-
cian with a sound basis for decision-making, which
will inform his discussion with Megan concerning
course of treatment and adherence to regimen.
Building a Population-based
Cost-effectiveness Analysis
e have now demonstrated the application, on
an individual patient basis, of our health economic
framework for analyzing the impact of BTP and its
management. This mo
del provides a decision-sup
port tool for clinical practice, taking into fuller
account the array of factors associated with the BTP
phenomenon, across multiple stakeholders.
A next, and important, step in establishing a ra-
n Table 4. BTP Benefits and Cost Offsets
Direct Cost Savings Patient/Caregiver Provider/Institution Society/Payer
Direct medical
Fewer BTP episodes Fewer hospitalizations, Fewer reimbursement
and less severity of emergency department claims
result in less visits, office visits
out-of-pocket costs less use of parenteral
to the patient/caregiver opioids
Direct nonmedical Fewer related expenses Lower administrative Lower administrative costs
such as transportation to costs (eg, billing,
parking scheduling, arranging
urgent visits)
Indirect cost savings Ability to return to work
; Clinic/hospital space Improved work capacity
less expenditure on adequate to handle patients and productivity
; income
downstream supports needs; clinic/hospital taxes paid
(eg, education, staffing adequate to
handle patients’ needs
Intangible beneficial Sleep, pain relief, QOL, Smoother operations; Perception of healthcare
outcomes emotional w
ell-being, greater predictability of system working to address
functional st
atus, relief patients’ needs; efficiency; patient needs; perception
of f
less st
aff stress; less of rational, proactive
clinic and hospit
al crowding health system
BTP indicates breakthrough pain; QOL, quality of life.
Health Economic Model of Breakthrough Pain
tional approach to decision-making with regard to
BTP is to develop a population-based decision-ana-
lytic model that allows extension of the identified
tential costs, outcomes, and benefits to broader po
ulations. The advantages of developing a population-
based model include the ability to (1) project the
burden of cancer-related BTP in large, user
populations, and (2) estimate the cost-effectiveness
of employing different pain management strategies
in the user-specified cohort. Audiences with a direct
interest in these applications will be healthcare poli-
cy decision makers, managers of health
care organiza
tions, pharmacy and therapeutics committees, and
active clinicians. The model assumes the perspective
of the healthcare organization, such as a clinical prac
tice setting or health insurer.
n T
able 5.
egans BTP Health Economic Profile
Direct Costs Patient/Caregiver Provider/Institution Society/Payer
Direct medical Out-of-pocket expense of generic 6 hr oncologist time Insurer costs of $204/mo for
ibuprofen, $12/mo; analgesic copay @ $150/hr*; transdermal fentanyl and
$60/mo*; $30 copay on outpatient 12 hr radiotherapist time $1526/mo for OTFC before
visits for BTP*; $50 copay for radiology @ $35/hr* copay for analgesics,
(rib films)*; $50 copay for each medical between $7000 and $9000
oncology and radiotherapy visit*; for outpatient visits,
$132/mo for yoga classes; radiology, and radiotherapy*
120/mo for guided imagery*
56 travel/mo for outpatient Clinic overhead for direct Costs for paperwork process-
nonmedical visits for BTP* medical care ing, customer service calls
Indirect costs Loss of part-time job earnings 45 minutes of human resource Increase in group plan
of $1000/mo time for tertiary support expenditure and resulting
staff in billing records and increase in group premium
facilities management; indirect
cost portion of clinical overhead
Intangible costs Insomnia; psychosomatic toll on Clinic time devoted to BTP Use of limited plan resources
husband (develops migraines); care rather than innovations diverted away for plan
inability to attend church due in disease treatment improvement or from
to worry about BTP flare-up investment in coverage for
lower-income participants
Direct Cost Savings Patient/Caregiver Provider/Institution Society/Payer
Direct medical Reduced outpatient visits by 50%/mo Reduced time spent in office Reduced outpatient expense
results in $150 less in copays visits with patient by 50% of 50% ($300/mo)
Direct Savings in transportation costs, Reduction in clinic overhead Reduction in paperwork and
nonmedical parking, meals while in clinic (eg, incremental addition customer service costs
to facility maintenance,
utilities, and others)
Indirect cost Able to return to her part-time job Lowered costs due to Increased revenue for plan;
savings @ $800/mo; able to continue self-care tertiary staff support improved figures for group
at home rather than relying on classes of billing, records, claims, premium
and support group; resumes providing and facilities upkeep
10 hr/wk childcare for grandchild,
saving $50/mo for grown daughter
Intangible Husband’s migraines subside; Increased available resources Increases resources for
beneficial she returns to church; resumes for practice improvement development of disease
outcomes w
alking f
or exercise; her sleep and program development management programs and
es; anxiety abates increased supportive care
*The copays and cost/hour of providers is a general estimate of what is observed in our local practice. There is a large variance of copays and
providers across hospital systems, states, and insurers. The scope of this paper does not include a global assessment of payment practices.
Over-the-counter drug information, complementary therapy costs, and actual cost of prescription drugs is readily accessible, and consequently
was recorded here.
BTP indicates breakthrough pain; OTFC, oral transmucosal fentanyl citrate.
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Y 2008
Figure 2 depicts the steps involved in applying
the population-based model, with the cost/outcome/
benefit values delineated in Tables 2 through 4 em-
bedded at Steps 4 to 6.
Model application begins with definition of the
population to which the model will be applied. The
probability of cancer within the target cohort is
defined by the user or estimated from United States
cancer prevalence counts published by the National
Cancer Institute. Prevalence of specific tumor types
and stages of illness within the population should be
used, since the rate of BTP will differ by tumor type
and stage. Stratification by socio
demographic factors
such as sex, race, and age will improve the model’s
, since cancer prevalence rates differ by these
distributions. The total number of cancer cases by
tumor type and stage constitutes the overall burden
of cancer in the defined population.
The user then applies the rate of BTP by cancer
type and stage, referring to published reports, to the
defined cohort. In cases in which data are unavail-
able or uncertain, prevalence can be estimated using
tumor types with similar invasion patterns likely to
cause similar degrees of pain (eg, rate of BTP in gas-
tric cancer can be used to approximate that in
esophageal cancer). Cumulative probability of BTP
is calculated as the sum of estimates generated for all
included subpopulations by tumor type. Assumptions
used in estimates should be carefully noted, because
this is a fertile area for future research.
Probability of developing BTP is then multiplied
by probability of using various strategies to treat the
BTP. Strategies used with varying frequencies
among cancer subpopulations include analgesics,
cancer-pain procedures, complementary and alter-
native approaches, and anticancer approaches. The
efficacy of each strategy is estimated, ideally from
published studies. As more research becomes avail-
able, new information can be added to the model.
Costs of various BTP management strategies are
estimated using the pharmacoeconomic inputs
described in this article. Individual costs, outcomes,
and benefits would be tallied using direct, indirect,
and intangible inputs. Typical daily doses of each
medication are calculated using the mean number
of morphine equivalents prescribed per day for each
short-acting opioid type, per expert guidance. Pharm-
acy costs are estimated from the payer’s formulary
costs, or through
Red Book values for average whole-
sale price using unit drug costs; generic costs can be
used if a generic product is available. For parenteral
opioids, Medicare fee schedules are used for medical
services and durable medical equipment (DME).
Although this article, and the model description
it contains, have focused on pharmacologic inter-
ventions, procedural interventions are often used
for BTP as well and should be included in both the
individual-level and population-based analysis. Per-
patient costs by intervention category (eg, surgery)
are based on the probability that a particular type of
procedure (eg, percutaneous cordotomy) would be
used in the intervention category and the summa-
tion of procedural costs. Judgments can be solicited
from cancer
, pain, anesthesiology
, surgery, radio-
therapy, and psychology specialists about the most
common procedures that they perform and the rela
tive frequency of each procedure. Specialists can also
provide information about the services (described in
terms of the
Current Procedural Terminology [CPT]
codes and/or Diagnostic Related Groups [DRG])
and DME that would be required to complete the
n Figure 2. Application of the Health Economic Model for
BTP on a Population Level
BTP indicates breakthrough pain; ICER, incremental cost-effectiveness ratio.
Step 1: Define the population and its rate of cancer.
Step 2: Determine the probability of BTP in the target population.
Step 3: Multiply the population’s probability of developing BTP by its
probability of using a strategy to manage BTP. (Repeat process
separately for each management strategy.)
Steps 1-3 yield the proportion and number, in the defined pop-
ulation, of patients using various strategies to manage BTP.
Step 4: Estimate the efficacy and corresponding cost offsets of each
BTP management strategy.
Step 5: Assign values to other positive outcomes/benefits of BTP
management strategy.
Step 6: Estimate the costs of the BTP management strategy.
Step 7: Multiply the per-patient cost/outcome/benefit by the number
of patients expected to use the BTP management strategy.
Steps 4-7 yield an aggregate health economic assessment
of the BTP management strategy of interest.
Step 8: Calculate ICER for BTP management strategies being compared.
Step 9: Perform sensitivity analysis.
Steps 8 and 9 yield: (a) the increased per-patient expense
of more vs less effective BTP management strategies, and
(b) an assessment of the range of variance in this figure
that might be attributable to differing inputs such as prob-
abilities, cost estimates, and benefit values.
Health Economic Model of Breakthrough Pain
procedure. Each procedure type is built into a sce-
nario based on the required components and the
typical period of effectiveness; the total cost of the
scenario is then determined using the Medicare
or DRG reimbursement for each component. A
weighted per-patient cost is generated for each pro-
cedure scenario by multiplying the scenario cost
with the relative frequency for the scenario; sce-
nario costs are tallied to generate the total per-
patient cost within each intervention category.
Users can tailor (a) the likelihood that a nonphar-
maceutical intervention category is prescribed, and
(b) the cost of the intervention, based on their par-
ticular healthcare organization.
The product of (a) the probability that the med-
ication or other action (“intervention”) will be re-
quired, times (b) the probability that the intervention
will be prescribed if it is required, yields the likelihood
that the intervention will be used. Multiple assump-
tions behind this approach need to be explicitly stat-
ed. For example, the user should specify whether the
probability of patient compliance with a prescribed
medication is included, whether a medication or ser-
vice that is prescribed is purchased within the system,
and whether it is assumed that patients who do not
require an intervention do not receive it.
When the user is deciding whether to add new
services, medications, or BTP management strate-
gies to the patient’s current portfolio, an incremen-
tal cost-effectiveness ratio (ICER) can be calculated.
The ICER reflects the increased expense incurred to
effectively treat one more BTP patient when chang-
ing from a less effective cancer pain management
strategy (strategy Y) to a more effective strategy
(strategy X). The ICER is calculated according to
the following formula:
cost X – cost Y
effectiveness X – effectiveness Y
In all cases, sensitivity analyses should be con-
ducted to evaluate the effect of variations in clinical
probabilities and cost estimates on the results. For
pharmaceutical and nonpharmaceutical utilization
parameters, factors with expected variations likely
include the probability ranges and costs as recom-
mended by clinical experts in these areas. One to 2
inputs are varied at a time. Worst-case and best-case
scenarios are examined using cumulative changes in
the likelihood an intervention would be used and in
the intervention cost. The influences of various prob-
abilities and cost inputs on model outputs can be
compared to each other by normalizing the results to
a standard unit, according to the following formula:
% change in model output
% change from baseline model input
Amplification of this population-based model
lies beyond the scope of this article, but represents a
valid subject for further research. The ability to gen-
erate population-specific estimates of the impact of
various BTP management strategies could serve to
better inform institutional and policy leaders as they
make decisions on healthcare resource allocation,
reimbursement policy, and clinical guidelines.
From the patient/caregiver perspective, BTP exacts
a well-documented toll on QOL and incurs personal
expense. For providers and institutions, treatment of
unmanaged BTP substantially raises the costs of
care and places undue demands on healthcare re-
sources. On the societal level, BTP hampers produc-
tivity and its costs strain an already overburdened
payer system. By delineating the full array of factors
that, taken together, describe the impact of BTP on
patients, providers, and society, a comprehensive
health economic model will improve clinical decision-
making, optimize outcomes, and enhance satisfaction
with the processes of care across all stakeholder levels.
Extension of this mo
del to population-level
analyses will help to improve institutional and soci-
etal/payer decision-making, thereby minimizing the
negative effects of BTP while maximizing potential
benefits and offsets of good BTP management. The
results will be sound management, in aggregate, of
this troubling and widespread phenomenon.
Author Affiliations: (AP
A) Assistant Professor of Medicine—
, Attending Physician, Center for Palliative Care, Duke
University School of Medicine, Durham, NC; (JL
W) Research
Associate, Duke Cancer Care Research Program, Duke University
School of Medicine, Durham, NC; (BVF) Senior V
ice President,
Scientific Affairs and Provider Services, P4 Healthcare, Lakeland,
TN, and Adjunct Professor of Graduate Psychology
, University of
Memphis, Memphis, TN.
Author Disclosures: The author (AP
A) reports a
grant/research support from Cephalon. The authors (JL
, BVF)
report no relationship or financial interest with any entity that
would pose a conflict of interest with the subject matter of the
of input
S140 n www
n MA
Y 2008
Authorship Information: Concept and design (APA, JLW,
BVF); acquisition of data (APA, JLW, BVF); drafting of the man-
uscript (APA, JLW, BVF).
Address Correspondence to: Amy P. Abernethy, MD, Assistant
Professor of Medicine—Oncology, Attending Physician, Center
for Palliative Care, Duke University School of Medicine, DUMC
3436, Durham, NC 27710. E-mail: abern003@mc.duke.edu.
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    • "Patients who have higher function may be more active and consequently may be more prone to having episodes of BTPc. Conversely, BTPc can impact a patient's ability to perform normal daily activities , and unrelieved BTPc can be debilitating (Abernethy et al., 2008). Among patients with controlled background cancer pain, those who have BTPc had more functional impairment than those without BTPc (Portenoy et al., 1999). "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Patients with breakthrough pain in cancer (BTPc) experience impaired activities of daily living and quality of life. Both function and satisfaction with treatment can impact patients' abilities to use products, and likely impact response to therapies. Objective: This exploratory analysis examined the relationship between functional status and satisfaction with ability to use fentanyl pectin nasal spray (FPNS) for BTPc. Methods: Treatment satisfaction data were analyzed from a multicenter, open-label, long-term study using FPNS for managing BTPc in patients with Eastern Cooperative Oncology Group (ECOG) grade ≤ 2. Satisfaction with ease of use, convenience, and reliability of FPNS were assessed on three-question, four-point scales (1 = not satisfied, 2 = not satisfied or dissatisfied, 3 = satisfied, 4 = very satisfied) at the end of 1, 4, 8, and 12 weeks. For each domain, percentage of patients who reported being "satisfied or very satisfied" (score 3 or 4) with FPNS was analyzed based on ECOG grade. Results: Overall, > 90% of patients with ECOG 0-2 reported being satisfied or very satisfied with FPNS across all three domains. Differences in patient satisfaction with FPNS by ECOG grade were clinically small though statistically significant (ease of use: p = 0.0022, convenience: p = 0.0057, and reliability: p = 0.0012). Conclusion: The FPNS device was well accepted irrespective of ECOG grade (0-2). Statistically, patients with higher performance status (lower ECOG grades) reported higher satisfaction scores, though effect size was small. Results imply the FPNS device provides a high level of usability irrespective of functional status, which is likely to promote use and thus likelihood of success in controlling BTPc.
    Full-text · Article · Aug 2014
    • "BTP may impact on patients' quality of life since it is associated with impairments in daily physical functioning and psychological distress [6, 8]. BTP places a high economic burden on society and healthcare services [9, 10], and may be a significant predictor of increased pain-related costs [11]. Successful management of BTP is an important unmet need in the treatment of cancer patients. "
    [Show abstract] [Hide abstract] ABSTRACT: Instanyl® (intranasal fentanyl spray) is a novel treatment for breakthrough pain (BTP) in cancer patients. It has shown a rapid onset of pain relief in clinical trials. This study examines the use of Instanyl® in real-life settings. A 3-month observational, prospective, cohort study of cancer patients with BTP receiving Instanyl® (50, 100, or 200 μg) under routine clinical practice. Data were collected at three time points corresponding with routine clinic visits - baseline, Week 4, and Week 13. Primary outcomes: success of titration and maintenance dose after titration. Secondary outcomes: change in maintenance dose of Instanyl® and level of background pain medication; Brief Pain Inventory-Short Form (BPI-SF) and Patient Treatment Satisfaction Scale (PTSS) scores; adverse drug reactions (ADRs). Titration with Instanyl® was successful in 84.5 % of 309 patients; most patients were titrated at the lowest dose (50 μg). The majority showed no change in maintenance dose, with little change in the level of background pain medication. BPI-SF and PTSS scores significantly improved from baseline to Week 4. The main reason for terminating Instanyl® was death, as expected due to the underlying disease; incidence of ADRs was low and no fatal ADRs were reported. In a real-life group of cancer patients with disease progression, Instanyl® was titrated successfully at doses <200 μg in the majority of patients, requiring only one dose, with no further change in maintenance dose. Pain severity, impact of pain on daily life, and treatment satisfaction significantly improved with Instanyl® treatment. No unexpected ADRs occurred.
    Full-text · Article · Feb 2014
    • "b IG perception refers to the number of patients estimated themselves to be allocated to the intervention group. reduce patient distress and also pain-related health care costs of pain-related consultations or re-hospitalizations [2,3,21,22]. "
    [Show abstract] [Hide abstract] ABSTRACT: Patients' self-management skills are affected by their knowledge, activities and attitudes to pain management. This trial aimed to test the SCION-PAIN program, a multi modular structured intervention to reduce patientś barriers to self-management of cancer pain. 263 patients with diagnosed malignancy, pain > 3 days and average pain ⩾ 3/10 participated in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients on the intervention wards received, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic-, non-pharmacologic pain management and discharge management. The intervention was conducted by specially trained cancer nurses and included components of patient education, skills training and counseling. Starting with admission patients received booster sessions every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group received standard care. Primary endpoint was the group difference in patient related barriers to self-management of cancer pain (Barriers Questionnaire - BQ II), 7 days after discharge. SCION-PAIN program resulted in a significant reduction of patient related barriers to pain management one week after discharge from hospital: mean difference on BQ II was - 0.49 points (95%CI, -0.87 points to -0.12 points; P=0.02). Furthermore patients showed improved adherence to pain medication odds ratio 8.58 (95%CI 1.66 to 44.40; P=0.02). A post hoc analysis indicated reduced average and worst pain intensity as well as improved quality of life. This trial reveals the positive impact of a nursing intervention to improve patients' self-management of cancer pain.
    Full-text · Article · Jan 2014
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