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PND74
Healthcare resource use of patients newly diagnosed
with multiple sclerosis initiating oral or self-injectable
disease-modifying drugs: a large, nationwide analysis
of US electronic health record data
Amy L Phillips,1 Frank A Corvino2
INTRODUCTION
●● Multiple sclerosis (MS) is a chronic neurodegenerative disease that leads to the
demyelination of axons within the central nervous system and causes a variety
of symptoms, depending on the neuroanatomical location of the lesions.1
●● Disease-modifying drugs (DMDs) for relapse–remitting MS (RRMS) have
been proven to reduce relapse rates and, in some cases, delay disability
progression.2–5
●● Historically, self-injectable DMDs have been most commonly used. In recent
years, newer DMDs, including oral formulations, have been approved for the
treatment of MS.
●● Electronic health records (EHRs) capture a variety of patient-level data that
represent integral components of provider care that may not necessarily be
available through other data sources such as administrative claims databases.6
●● To our knowledge, no existing studies have evaluated changes in healthcare
resource use (HCRU) in patients with MS treated with self-injectable versus
oral DMDs.
OBJECTIVE
●● To evaluate changes in HCRU among newly diagnosed patients with MS initiating
self-injectable versus oral DMDs in a large, nationwide US EHR database.
METHODS
Data source
●● This was a retrospective analysis of Optum-Humedica, a large US de-identified
EHR database that contains prescription and practice management data.7
–– Optum-Humedica has a network of provider organizations treating
approximately 30 million patients in 38 states, enabling the ability to access
multiple EHR systems and draw population-level data including medications,
laboratory results, vital signs, physician notes, diagnoses, procedures,
demographics, hospitalizations and outpatient visits.
–– A subset from the Optum-Humedica EHR database that included patients
with evidence of at least one healthcare encounter for MS (N=69,229) from
2008 to 2014 was used for this study.
EMD Serono, Inc.,* Rockland, MA, USA; 2Genesis Research, Hoboken, NJ, USA
Table 1. Baseline demographics and comorbidities for patients initiating self-injectable and
oral DMDs.
All
Characteristic
Total
Self-injectable initiators
Figure 2. Percentage change in HCRU encounters from baseline to 1-year follow-up for patients
initiating self-injectable and oral DMDs.
Oral initiators
N
%
N
%
N
%
7599
100.0
6958
100.0
641
100.0
Change in HCRU from baseline to 1-year follow-up (%)
1
Sex
Male
1711
22.5
1571
22.6
140
21.8
Female
5885
77.4
5384
77.4
501
78.2
Age at index, years
0–17
14
0.2
14
0.2
–
0.0
18–34
1006
13.2
921
13.2
85
13.3
35–44
1884
24.8
1710
24.6
174
27.2
45–54
2520
33.2
2300
33.1
220
34.3
55–64
1693
22.3
1554
22.3
139
21.7
65–74
439
5.8
417
6.0
22
3.4
75+
43
0.6
42
0.6
1
0.2
Unknown
–
0.0
–
0.0
–
0.0
64
0.8
61
0.9
3
0.5
Comorbidities
Myocardial infarction
Congestive heart failure
86
1.1
78
1.1
8
1.2
Peripheral vascular disease
140
1.8
119
1.7
21
3.3
Cerebrovascular disease
400
5.3
363
5.2
37
5.8
Dementia
33
0.4
31
0.4
2
0.3
Chronic pulmonary disease
759
10.0
666
9.6
93
14.5
Connective tissue disease –
rheumatic disease
135
1.8
117
1.7
18
2.8
Peptic ulcer disease
44
0.6
40
0.6
4
0.6
Mild liver disease
159
2.1
139
2.0
20
3.1
Diabetes without complications
514
6.8
483
6.9
31
4.8
Diabetes with complications
94
1.2
90
1.3
4
0.6
Paraplegia and hemiplegia
279
3.7
247
3.6
32
5.0
Renal disease
64
0.8
56
0.8
8
Cancer
211
2.8
193
2.8
18
2.8
3
0.04
2
0.03
1
0.2
20
0.3
17
0.2
3
0.5
6
0.1
5
0.07
1
0.2
Moderate or severe liver disease
Metastatic carcinoma
AIDS/HIV
1.2
●● Patient baseline demographics and comorbidities are presented in Table 1.
–– Three-quarters of patients were female and most were within the working
age group categories (35–44 years, 24.8%; 45–54 years, 33.2%; or 55–64
years, 22.3%).
–– Common comorbidities included chronic pulmonary disease (9.6% to
14.5%), diabetes without complications (4.8% to 6.9%), cerebrovascular
disease (5.2% to 5.8%), and paraplegia and hemiplegia (3.6% to 5.0%).
●● Comparing pre- and post-index, the proportion of self-injectable DMD initiators
with an inpatient admission decreased by 7.0%, from 10.0% to 9.3%, and the
proportion of self-injectable DMD initiators with ED visits increased by 11.2%,
from 11.6% to 12.9% (Table 2 and Figure 2).
0.0
0.5
0.5
0.0
0.2
–2.4
–7.0
–10.0
–10.1
–15.8
–20.0
Outpatient
Inpatient
Emergency
admissions department
Others
Unknown
MRIs
Blood tests
Oral initiators
–– C
omparing pre- and post-index, there was a decrease in the proportion of
self-injectable DMD initiators with inpatient admissions, and an increase in the
proportion of self-injectable DMD initiators with ED visits, MRIs and blood tests.
–– C
omparing pre- and post-index, there was an increase in the proportion of oral
initiators with inpatient admissions, ED visits and blood tests, and a decrease
in the proportion of oral DMD initiators with MRIs.
●● Further research is needed to better understand the reasons for these differences
in changes in HCRU after DMD initiation.
53,150 patients previously treated with DMD
REFERENCES
16,079 patients
11,077 patients
8447 patients
1. Compston A, Coles A. Lancet 2008;372:1502–17.
5002 patients without at least 1 year of enrolment prior
to first DMD initiation (first DMD initiation = index date)
2. Coles AJ, et al. Lancet 2012;380:1829–39.
3. Gold R, et al. N Engl J Med 2012;367:1098–107.
4. PRISMS Study Group. Lancet 1998;352:1498–504.
2630 patients without 1-year follow-up enrolment after
first DMD initiation
5. Sellebjerg F, et al. Acta Neurol Scand 2014;130:268–75.
6. Hayrinen K, et al. Int J Med Inform 2008;77:291–304.
7604 patients
843 patients with natalizumab, alemtuzumab or mitoxantrone
claim within 1-year of follow-up or any time prior
7. Optum. Humedica Life Sciences Detailed Clinical Data. 2016. Available at: http://www.humedica.com/
solutions/life-sciences/detailed-clinical-data/. (Accessed October 2016).
7599 patients
ACKNOWLEDGEMENTS
5 patients treated with both oral and self-injectable DMDs
on the index date
The study was sponsored by EMD Serono, Inc.,* Rockland, MA, USA. Medical writing
assistance in the preparation of this poster was provided by Natalie Edwards of Health Services
Consulting Corporation, Boxborough, MA, USA and funded by EMD Serono, Inc.,* Rockland,
MA, USA. Editorial assistance in the drafting and layout of this poster was provided by Caudex,
New York, NY, USA and funded by EMD Serono, Inc.,* Rockland, MA, USA.
6958 self-injectable
641 oral
DMD, disease-modifying drug; MS, multiple sclerosis.
Table 2. Baseline and follow-up HCRU for patients initiating self-injectable and oral DMDs.
Baseline HCRU of self-injectable initiators
Type of encounter
Outpatient
Inpatient admissions
ED
Others
Unknown
Total no. of encounters
Total unique patients
175,764
164,394
7536
3834
163,082
1312
6310
6272
631
730
6270
219
7012
127,181
2184
4324
Total no. of encounters
Total unique patients
24,306
23,435
482
389
23,200
235
623
622
49
89
621
40
709
13,463
254
470
Tests
MRIs
Blood tests
1-year follow-up HCRU of self-injectable initiators
%
Encounters per patients
Total no. of encounters
Total unique patients
%
Encounters per patients
99.4
10.0
11.6
99.4
3.5
27.9
26.2
11.9
5.2
26.0
6.0
253,460
240,276
9123
4061
239,517
759
6881
6873
639
889
6873
201
99.9
9.3
12.9
99.9
2.9
36.8
35.0
14.3
4.6
34.8
3.8
31.4
62.1
3.2
29.4
6265
169,640
2305
5029
33.1
72.3
2.7
33.7
%
Encounters per patients
Total no. of encounters
Total unique patients
%
Encounters per patients
99.8
7.9
14.3
99.7
6.4
39.0
37.7
9.8
4.4
37.4
5.9
32,098
30,854
653
591
30,684
170
638
637
60
119
637
40
99.8
9.4
18.7
99.8
6.3
50.3
48.4
10.9
5.0
48.2
4.2
39.6
73.3
2.8
28.6
520
18,869
228
513
35.6
80.0
2.3
36.8
6958
6958
Baseline HCRU of oral initiators
Type of encounter
Outpatient
Inpatient admissions
ED
Others
Unknown
Tests
MRIs
Blood tests
1-year follow-up HCRU of oral initiators
641
641
Patients may have more than one encounter in the same day.
DMD, disease-modifying drug; ED, emergency department; HCRU, healthcare resource use; MRI, magnetic resonance imaging.
LIMITATIONS
●● Comparing pre- and post-index, the proportion of oral initiators with an inpatient
admission increased by 19.0%, from 7.9% to 9.4%, and the proportion with ED
visits increased by 30.8%, from 14.3% to 18.7% (Table 2 and Figure 2).
●● The ICD-9-CM code for systemic MS does not distinguish between different MS
types, such as RRMS or primary progressive MS.
●● The proportion of patients with outpatient visits was high in both pre- and
post-index groups (self-injectables: 99.4% pre-index and 99.9% post-index;
orals: 99.8% both pre- and post-index) (Table 2).
●● The Optum-Humedica EHR database only captures the prescriptions written by
physicians and does not provide prescription claim information to confirm that
the patient obtained the medication.
●● The proportion of patients with MRI data increased by 5.4% for self-injectable
initiators, from 31.4% to 33.1%, and decreased by 10.1% for oral initiators,
from 39.6% to 35.6%.
●● The changes in HCRU observed may be a reflection of background variations
occurring irrespective of treatment.
●● The proportion with blood tests increased for both cohorts (self-injectables:
from 62.1% to 72.3% [16.4% increase]; orals: from 73.3% to 80.0%
[9.1% increase]) (Table 2 and Figure 2).
5.4
●● This EHR study showed that HCRU differs between newly diagnosed patients with
MS initiating self-injectable DMDs compared with those initiating oral DMDs.
69,229 patients with a diagnosis of MS from 1 January 2008
to 31 December 2014 in Optum-Humedica database
Analyses
●● Among the 7599 patients with newly diagnosed MS who met the inclusion
criteria, 6958 (91.6%) initiated treatment with a self-injectable DMD and 641
(8.4%) initiated treatment with an oral DMD (Figure 1).
9.1
10.0
●● Pre- and post-index studies, such as the current analysis, readily reflect patients’
naturalistic outcomes in ‘real-world’ settings of care.
●● Patients were required to have evidence of healthcare activity for at least 1 year
pre-index (baseline) and for at least 1 year post-index (follow-up period).
RESULTS
16.4
11.2
CONCLUSIONS
●● The date of first DMD was considered the index date.
●● The change in HCRU from baseline to 1-year follow-up was evaluated for
patients in the self-injectable and oral DMD cohorts.
19.0
DMD, disease-modifying drug; HCRU, healthcare resource use; MRI, magnetic resonance imaging.
Figure 1. Sample selection for the analysis.
●● Patients with newly diagnosed MS (International Classification of Diseases,
Ninth Revision, Clinical Modification [ICD-9-CM] code: 340.xx) (no evidence
of MS diagnosis or DMD treatment during the 1-year baseline period)
who initiated a self-injectable or oral DMD between 1 January 2008 and
31 December 2014 were included in the study.
●● Baseline and follow-up HCRU, including outpatient encounters, inpatient
admissions, emergency department (ED) visits, magnetic resonance imaging
(MRI) and blood tests, were stratified by self-injectable and oral DMD cohorts.
20.0
Self-injectable initiators
AIDS, Acquired Immune Deficiency Syndrome; DMD, disease-modifying drug; HIV, human immunodeficiency virus.
Patient population
●● Baseline demographics that were assessed included age, age category, sex
and presence of common comorbidities.
30.8
30.0
DISCLOSURES
ALP is an employee of EMD Serono, Inc.,* Rockland, MA, USA.
FAC is an employee of Genesis Research, Hoboken, NJ, USA.
●● There is a lack of generalizability of data, given the use of an individual cohort.
The patients included in the database received treatment in all regions of the
US. However, care should be exercised when extrapolating these findings to
other healthcare settings.
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 19th Annual European Congress; 29 October–2 November 2016; Vienna, Austria
*A business of Merck KGaA, Darmstadt, Germany.
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