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Treatment with Biological Agents among Patients with Ankylosing Spondylitis in Germany: A Claims Data Analysis
Schleich W1, Rex J2, Vollmer L1,3, Walzer S1,4
1 MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany2 Elsevier Health Analytics, Berlin, Germany3 University of Applied Sciences, Rottenburg/Neckar, Germany,4 State University Baden Wuerttemberg, Loerrach, Germany
Corresponding author:Dr. Stefan Walzer
MArS Market Access & Pricing Strategy GmbH
Geffelbachstr. 6
79576 Weil am Rhein
Germany
Contact: [email protected]
BACKGROUND: l The availability of anti-tumor necrosis factor inhibitors has altered the treatment
approach of ankylosing spondylitis (AS) over the past 15 years [1].l AS is associated with significant costs for health care systems, which vary by
country, and have generally increased dramatically since the introduction of anti-TNF therapy [2].
l This study provides information on the current supply with biological agents and its related costs (other medication, outpatient care, hospital admission) in Germany.
METHODS: l The design is a retrospective claims data analysis.
• The data source is the database of the Institute for Applied Health Research (InGef) Berlin, formerly HRI Health Risk Institute, which includes approximately 6.7 million insured anonymities who originate from 63 statutory health insurances in Germany. The observation period was from 2012 to 2016 and analyses were performed by the InGef institute. A sample with approximately 4 million insured persons was drawn and stratified by age and gender according to the official demographic structure of the German statutory health insured population (DeStatis, Dec 31st, 2013).
• The target population consists of patients who met following criteria with regard to the observation period from 2012 to 2016:
1. Main diagnosis of AS (using relevant ICD-10 codes according to Table 1), and/or
2. Treatment with approved biological agent for AS at least for three months
• If the diagnosis occurred before 2012 patients were only selected if they were already on treatment at the beginning of the observation period in 2012.
• The relevant patient sample was then split into three groups with regard to the observation period from 2012 to 2016:
1. Patients who start a biological treatment (“New”)
2. Patients who get continuous treatment with the same biological (“Repeater”)
3. Patients who switch biological (“Switcher”)
• In sum, 1743 patients could be included in the sample.
• The study evaluated direct medical costs (drugs, outpatient care and hospital admission), hospital admission and change in medication.
• Treatment costs included costs for biological agents which were approved for the treatment of AS (as of April 2017, see also Table 2). Furthermore, the following medication groups were considered to be AS related (see also Table 3): Corticosteroids acting locally (ATC-Code A07EA), Aminosalicylic acid and similar agents (ATC-Code A07EC), selective immunosuppressants (ATC-Code L04AA), non-steroidal anti-inflammatory drugs (ATC-Codes M01AB, M01AE, M01AH) and analgesics (ATC-Code N02BE). Frequency of hospital admissions and related costs are based on DRGs which are relevant for AS.
• In case that a patient changed therapy during the observation period, he was further included only if he continued receiving a biological agent.
• Figure 1 depicts an overview of the analysis of the sample.
Table 1: Selection criteria of target population according to ICD-10-GM-2017 codes [3]
Code Definition
M45.- Ankylosing spondylitis
Includes: Chronic polyarthritis of the spine, Non-radiographic axial spondyloarthritis Excludes: Arthropathy in Reiter‘s disease (M02.3-), Juvenile (ankylo-sing) spondylitis (M08.1), Behçet‘s disease (M35.2)
M45.0- Ankylosing spondylitis Includes: Ankylosing spondylitis of multiple sites in spine (M45.0) Ankylosing spondylitis of occipito-atlanto-axial region (M45.1) Ankylosing spondylitis of cervical region (M45.2) Ankylosing spondylitis of cervicothoracic region (M45.3) Ankylosing spondylitis of thoracic region (M45.4) Ankylosing spondylitis of thoracolumbar region (M45.5) Ankylosing spondylitis lumbar region (M45.6) Ankylosing spondylitis of lumbosacral region (M45.7) Ankylosing spondylitis sacral and sacrococcygeal region (M45.8) Ankylosing spondylitis of unspecified sites in spine (M45.9)
Table 2: Overview of approved biological agents for AS [4]
Product Active substance ATC-Code
Humira® adalimumab L04AB04
Cimzia® certolizumab pegol L04AB05
Benepali® Enbrel®
etanercept L04AB01
Simponi® golimumab L04AB06
Flixabi® Remicade®
Remsima®/Inflectra® infliximab L04AB02
Cosentyx® secukinumab L04AC10
Table 3: AS-related medication groups
Medication group ATC-Codes
Corticosteroids acting locally A07EA01 – A07EA07
Aminosalicylic acid and similar agents A07EC01 - A07EC04
Selective immunosuppressants L04AA06
Non-steroidal anti-inflammatory drugs M01AB01 - M01AB17, M01AB51, M01AB55, M01AE01 - M01AE17 , M01AE51 - M01AE53, M01AE56, M01AH01 - M01AH06
Analgesics N02BE01
Figure 1: Overview of analysis
RESULTS:
l Most patients with AS are aged above 18, thereby the proportion below 17 years’ account for less than 1%. The average age of all age cohorts is 44.7 years with no difference by gender (44.7 yr men vs. 44.8 yr women).
l The proportion of men is higher than of women (63.6% male vs 36.4% female) (see also Figure 2).
Figure 2: Patient characteristics
Figure 2: Patient characteristics
48,7%
17,7% 31,0%
50,8%
18,6%
32,2%
0,5%
0,2%
0,3%
0%
20%
40%
60%
80%
100%
Total Female Male
Age distribu>on of total popula>on (in %)
Age 0-‐17 Age 18-‐45 Age 46+
36,4%
63,6%
Sex distribu>on of total popula>on (in %)
Female Male
Figure 2: Patient characteristics
48,7%
17,7% 31,0%
50,8%
18,6%
32,2%
0,5%
0,2%
0,3%
0%
20%
40%
60%
80%
100%
Total Female Male
Age distribu>on of total popula>on (in %)
Age 0-‐17 Age 18-‐45 Age 46+
36,4%
63,6%
Sex distribu>on of total popula>on (in %)
Female Male l The total number of patients, number of hospitalizations and total treatment costs including all individual cost domains (costs of biological agents / other medication / outpatient care / hospitalizations) grew yearly on average between 5.4 % and 11.1 % (2012 – 2015)**.
The poster is available on www.marketaccess-pricingstrategy.de
Figure 3: Yearly treatment costs of patients with AS (in €)
0
200
400
600
800
1.000
1.200
1.400
1.600
0 €
5.000.000 €
10.000.000 €
15.000.000 €
20.000.000 €
2012 2013 2014 2015 2016
N
Costs
Biologics Other medica=on Outpa=ent care Hospitalisa=on Total number of pa=ents
l Figure 3 shows the yearly treatment cost of patients over the time period. The total costs add up to € 22’565’535* in 2015 and the total treatment cost grew yearly on average by 9.9% from 2012 to 2015*. The total number of patients grew yearly on average by 10.0% from 2012-2015*. As expected, the key cost driver were biological agents which account for 90.0% of total cost (in 2015).
Figure 4: Yearly numbers of hospital admissions / patients with hospital admission(s) due to AS, and their costs
0 €
300.000 €
600.000 €
900.000 €
1.200.000 €
1.500.000 €
0
200
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600
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1.000
2012 2013 2014 2015 2016
Costs
N
Pa4ents with hospitalisa4on(s) Number of hospitalisa4ons
Costs of hospitalisa4on (€)
l Figure 4 depicts the results regarding the hospital admissions. Overall, both the number of hospitalisations and the patients with hospital admissions rose gradually from 2012-2015**. The average number of hospital admissions per patient per year remained constant at 0.6 from 2012 to 2015**. The costs of hospital admissions increased yearly on average by 7.1% from 2012 to 2015**. The very slight drop of costs from 2014 to 2015 may be due to the small change in patients with hospital admissions (383 in 2015, 379 in 2015).
l The study demonstrated that the leading biological agents for 1st line treatment are adalimumab and etanercept at a low level of share of prescriptions (Q2/2016: 1,84% and 1,55% respectively).
l Both agents are administered mostly to patients who are already on treatment (in 2015 adalimumab 42.1 % vs. etanercept 30.0 %).
Notes:* The costs could be slightly overestimated due to potential intersections of patients
who begin, repeat or switch the therapy. ** With regard to 2016, comprehensive data sets only exist for Q1/2016 and
Q2/2016, data from Q3/2016 is incomplete. This has to be taken into account when interpreting the data.
CONCLUSIONS:
l Adalimumab and etanercept are those biological agents who are mainly used for treating AS.
• The total treatment costs grew steadily over the last four years. Hereby, the key cost driver were the biological agents.
• The total costs in 2015 were € 22.5 million and on average € 16’793 per patient.
REFERENCES:
[1] Ward et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016; 68(2): 282-98.
[2] Reveille, Ximenes, Ward. Considerations of the Treatment of Ankylosing Spondylitis. Am J Med Sci. 2012; 343 (5): 371-374.
[3] International Classification of Diseases, German Modification, 10th Version, 2017.
[4] EMA, April 2017.
Figure 2: Patient characteristics
48,7%
17,7% 31,0%
50,8%
18,6%
32,2%
0,5%
0,2%
0,3%
0%
20%
40%
60%
80%
100%
Total Female Male
Age distribu>on of total popula>on (in %)
Age 0-‐17 Age 18-‐45 Age 46+
36,4%
63,6%
Sex distribu>on of total popula>on (in %)
Female Male
