1. health and fitness
2. therapy

PROCEEDINGS
ECONOMICS OF MULTIPLE SCLEROSIS AND ITS TREATMENT*
—
Jacquelyn L. Bainbridge, PharmD, FCCP†
ABSTRACT
Multiple sclerosis (MS) is a chronic, severely
disabling disease that typically makes its first
appearance during young adulthood or early
middle age. The lifetime treatment costs of MS
exceed the costs of other disabling neurologic
conditions, such as stroke or Alzheimer’s disease.
Patients with MS have healthcare expenses that
far exceed the expenses of typical patients with
health insurance, with some studies suggesting
average annual direct treatment costs exceeding
$20 000 per patient. Nationwide treatment costs
in the United States exceed $7 billion per year,
and MS treatment costs have risen during the
past several years with the introduction of disease-modifying agents, such as interferon beta
and glatiramer acetate. Treatment algorithms or
guidelines have recently been proposed to
improve the cost-effective delivery of MS care.
These approaches include the use of a steppedcare treatment algorithm that is based on a “platform” of immunosuppressive therapy. The
stepped-care approach provides recommendations or interventions to improve treatment adherence, at-home treatment of MS exacerbations,
and the use of specialty pharmacy companies to
administer complex and costly MS treatments.
(Adv Stud Pharm. 2007;4(11):330-333)
*This article is based on a presentation at a roundtable
on April 10, 2007, in San Diego, California.
†Associate Professor, Department of Clinical Pharmacy,
University of Colorado at Denver and Health Sciences
Center, Denver, Colorado.
Address correspondence to: Jacquelyn L. Bainbridge,
PharmD, Associate Professor, Department of Clinical Pharmacy,
University of Colorado at Denver and Health Sciences Center,
Academic Office 1, 12631E–17th Avenue, Room L15-1419,
School of Pharmacy C238-L15, PO Box 6511, Aurora, CO
80045. E-mail: [email protected].
330
M
ultiple sclerosis (MS) is associated with
considerable economic impact in the
United States due to the chronic and
progressive course of the disorder,
unpredictability of exacerbations, extensive disability,
high cost of treatment, and effects on employment and
job performance. The typical age of onset of MS is relatively young (20–35 years), and the total lifetime economic impact is therefore greater than other severe,
disabling neurologic conditions, such as stroke or
Alzheimer’s disease.1 This paper provides an overview
of the costs associated with MS care in the United
States, and describes methods that have been developed to optimize the use of newer MS therapies in
managed care settings.
DIRECT AND INDIRECT COSTS OF MS
Recent studies have attempted to define the direct
treatment costs of MS, as well as the indirect economic impact that the disorder has on the lives of patients
with MS. Although these studies vary in the specific
patient populations that they have enrolled, in the
ways that costs are estimated, and in the definitions of
direct and indirect costs, they consistently describe MS
as a disease with considerable long-term economic
impact for patients, healthcare systems, and society as
a whole. Prescott et al recently estimated direct MS
treatment costs using data from 80 private and public
health plans in the United States, with a total of more
than 9 million patients.1 These investigators estimated
that direct treatment costs totaled an average of $12 879
per patient in 2004, and that direct costs had increased
by 35% between 1995 and 2004. Other studies that
have used data from health plans or patient surveys
have estimated average direct treatment costs of
approximately $20 000 to $30 000 per year.2,3 The
direct medical costs to treat a single MS relapse have
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been estimated to vary from a mean of $243 for a mild
episode, to $1847 for a moderately severe episode, and
$12 870 for patients requiring the most intensive care.4
It has been estimated that patients with MS have total
treatment costs that are approximately 3 times the costs
of patients without MS, with out-of-pocket healthcare
expenditures that are approximately double those of
individuals without MS.5,6
Indirect treatment costs that fall outside the healthcare system (eg, sick leave, early retirement, environmental home modifications, and informal care from
family and friends) are important contributors to the
total economic impact of MS, but have not been analyzed consistently from study to study.7 A patient survey of the total economic impact of MS found that the
annual average cost of MS (direct and indirect costs)
was more then $34 000 per patient (in 1994 dollars),
with a lifetime per-case cost of approximately $2.2
million.8 The total cost of MS care in the United States
was conservatively estimated by these investigators at
nearly $7 billion. Kobelt et al, in a recent large US
nationwide survey, estimated that MS was associated
with lost productivity costs of approximately $15 000
per patient per year, largely due to the effects of early
retirement.3 Finally, despite differences in specific
study patient populations or analysis methods, the
direct and indirect costs increase markedly with worsening MS disability (as measured using scores on clinical rating scales, such as the Expanded Disability
Status Scale).9 This suggests that treatments intended
to slow or prevent MS disability have the potential to
significantly reduce the total economic burden of MS.9
COST OF CARE:
DRUGS, MONITORING, AND SIDE EFFECTS
The proportion of MS treatment costs that are
accounted for by drug costs has increased over the past
decade, as a result of the introduction of newer disease-modifying drugs.3 Drug costs are now the largest
single contributor to direct treatment costs for patients
with MS.3 A study of MS spending in 55 health plans
found that drug costs accounted for approximately
50% of total per-patient treatment costs.2 An analysis
of healthcare claims data from more than 10 000
patients with MS found that pharmacy costs accounted for approximately 65% of direct healthcare costs for
MS treatment overall, and 75% of total costs for
patients who had a prescription for at least one diseasemodifying agent.1 In this study, total annual per-
University of Tennessee Advanced Studies in Pharmacy
n
patient treatment costs were estimated at $16 928 for
glatiramer acetate, $17 987 for interferon beta-1a for
intramuscular (IM) administration, $19 616 for interferon beta-1b, and $22 557 for interferon beta-1a for
subcutaneous (SC) administration. The current average wholesale price for these agents per year when
given at the standard dose are $19 632 for interferon
beta-1b, $18 360 for interferon beta-1a (IM), $21 163
for interferon beta-1a (SC), and $19 749 for glatiramer acetate. Natalizumab, which has recently reentered the marketplace, costs approximately $30 000
per year.10 In addition, estimates of patient out-ofpocket costs to obtain MS medications have varied
from $500 to more than $3000 per year, a considerable economic barrier for many patients.2,11 Costs are
also associated with treatment monitoring and side
effects, although these costs have not been extensively
studied in patients with MS.
Total direct and indirect treatment costs associated
with MS in a recent nationwide US study are summarized in the Table and Figure.
TREATMENT ALGORITHMS
TO IMPROVE COST-EFFECTIVE DELIVERY OF MS CARE
Direct treatment costs increase in proportion to the
frequency of exacerbations and severity of MS.
Therefore, treatment algorithms that effectively reduce
the number and severity of exacerbations have the
potential to help managed care organizations to treat
MS more effectively and with lower total cost.9 For
example, Morrow has outlined a process to control
costs of MS treatment in the managed care setting.12
The author emphasized that patients should be monitored for poor treatment adherence, and interventions
should be employed as needed to improve treatment
adherence (eg, home visits by specially trained MS
nurses). Another component of cost control is to
anticipate that a certain number of relapses will occur
and to plan for home care, rather than hospitalization,
for as many of these expected events as possible. Many
managed care organizations are partnering with specialty pharmacy companies, which specialize in the
administration of high-cost, difficult-to-administer
medications. Rich et al have described the use of a
stepped-care approach to MS treatment to reduce the
number of MS exacerbations.13 This approach is based
on the selection of a “platform” therapy to provide a
basic degree of immunosuppression throughout the
course of the disease, with the addition of other agents
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PROCEEDINGS
Table. Mean Total Cost Per Patient and Year
Costs
Total costs (SD)
Cost per Person
Share of
and Year ($, 2004)
Total Cost, %
47 215 (35 292)
100.0
Total direct costs (SD)
29 634 (17 553)
62.8
Hospital inpatient care
1245
2.6
Ambulatory care
1582
3.4
Day stays
165
0.3
Physicians
565
1.2
Nurses/physiotherapists
419
0.9
Paramedical
436
0.9
Tests
857
1.8
Drugs
18 628
39.5
Disease-modifying drugs
(94% of sample)
16 050
34.0
Services
822
1.7
Adaptations
1885
4.0
Informal care
4614
9.8
Total indirect costs (SD)
17 581 (23 640)
37.2
Short-term absence
533
1.1
Reduced working time/
income
3362
7.1
Early retirement
13 685
29.0
may be used in addition to platform therapy if necessary; however, natalizumab is to be used only as
monotherapy.
CONCLUSIONS
Due to the young age at onset, chronic course,
severe disability, unpredictability of exacerbations, and
other factors, treatment costs for MS total several billion dollars per year in the United States. Per-patient
direct medical costs have been estimated at approximately $20 000 to $30 000 per year in recent studies,
due largely to the cost of disease-modifying drugs.
Indirect costs (eg, lost productivity and early retirement) also contribute to the considerable economic
burden of MS for society as a whole. Approaches to
improving the cost effectiveness of treatment in managed care settings have focused on the development of
algorithms or other procedures to reduce the number
and severity of MS relapses.
Figure. Distribution of Costs
Hospital inpatient care
3%
Ambulatory care
4%
Reprinted with permission from Kobelt et al. Neurology. 2006;66:16961702.3
Tests
2%
as needed as the disease progresses. In this approach,
interferon beta preparations or glatiramer acetate are
recommended as platform therapy because they can
decrease the number of relapses and brain lesions on
magnetic resonance imaging. Treatment for several
months may be required before therapy is completely
effective, and patient education is therefore essential to
help patients set realistic expectations about the effects
of treatment. A number of other agents may be combined with platform therapy as needed to address specific symptoms, including baclofen or tizanidine for
spasticity, stimulants for fatigue, selective serotonin
reuptake inhibitors or other antidepressants for
depression, and anticholinergic agents or alpha adrenergic antagonists for bladder dysfunction. Additional
immunosuppressive or immunomodulatory agents
(eg, mitoxantrone or natalizumab) may be used to
treat breakthrough MS symptoms. Mitoxantrone
332
Early retirement
34%
Disease modifying drugs
22%
Prescription and OTC
drugs
6%
Sick-leave and reduced
working time
10%
Informal care
12%
Services
2%
Adaptations
5%
Distribution of costs on different types of resources, adjusted for estimated national use of disease-modifying drugs (DMD). To estimate average costs for patients
with multiple sclerosis in the United States, we adjusted the use of the new DMD
to an estimated national average of 52%. No other costs were changed in the
absence of data, as Expanded Disability Status Scale has been shown to be by far
the strongest predictor of total costs (in the absence of a relapse). Under this
assumption, mean total costs per patient and year would be approximately
$40 000.
OTC = over the counter.
Reprinted with permission from Kobelt et al. Neurology. 2006;66:1696-1702.3
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