Patient Demographics
Out of the 85,126 patients in the database (2012–2016), 28,285 fulfilled the criteria of a pure or potential migraine population. The remaining patients either did not have data pertaining to all years from 2012–2016 or did not fulfill the criteria for the migraine population (Figure 2a). The mean age of migraine patients in the index year 2016 was 42.0 years and 33.7 years using the prevalence and incidence approach, respectively (Figure 2 b, c). The proportion of female migraine patients was 80.8% (prevalence approach) and 71.5% (incidence approach). On stratifying the patient population according to minors (aged 0–17 years), adults (aged 18–65 years) and elderly (aged ≥66 years), it was observed that migraine was most prevalent in the adult age group of 18–65 years and least prevalent in the elderly. This was true for both the prevalence (84% vs 7%) and incidence approaches (77% vs 3%).
Primary Endpoint
The migraine prevalence rate in the Czech Republic remained stable during the period of 2012–2016. Only 1% (n=14,030) of patients from the total insured population (n=1,288,409) had claims made towards migraine-related healthcare expenses in 2016. The migraine diagnosis rate among newly diagnosed patients, i.e. incidence approach patients, across 2012–2016 was 0.2%–0.4%. Hence, approximately one-third of the total migraine population was represented by newly diagnosed patients (Table 1).
Index year
|
Prevalence approach
|
Incidence approach
|
Average size of insured population
|
Number of migraine patients
|
Migraine prevalence rate (%)
|
Average size of insured population
|
Number of migraine patients
|
Migraine diagnosis rate (%)*
|
2012
|
1186766
|
12233
|
1.03
|
1186766
|
4379
|
0.37
|
2013
|
1205627
|
12384
|
1.03
|
1205627
|
3564
|
0.30
|
2014
|
1239890
|
13158
|
1.06
|
1239890
|
3623
|
0.29
|
2015
|
1260834
|
13528
|
1.07
|
1260834
|
3297
|
0.26
|
2016
|
1288409
|
14030
|
1.09
|
1288409
|
3049
|
0.24
|
Migraine prevalence/diagnosis rate calculated as the percentage of migraine patients out of the average insured population size covered by the Ministry of the Interior Health Insurance Fund healthcare insurance company
* The diagnosis rate decreases from 2012 to 2016 as for the reference year 2012, years covered were 2010-2011 whereas for the reference year 2016, years covered were 2010-2015
|
Table 1
Migraine prevalence and diagnosis rate in the population covered by government-paid healthcare
Secondary Endpoints
- Prophylactic treatment
Various antiepileptic and antidepressant drugs were prescribed to the migraine patients. Among the antiepileptic drugs, topiramate was predominantly used as a preventive treatment. Beta blockers were the only form of antihypertensive prescribed. For assessment of prophylactic treatment, cumulative medication lines (0, ≥1, ≥2, ≥3 and ≥4) were considered.
- Number of migraine patients treated with a particular number of prophylactic medications
The number of cumulative prophylactic lines assessed for the index year 2016 was 0 to ≥4. Upon stratifying by age and using the prevalence approach for analysis, the mean age of migraine patients ranged between 48 and 53 years of age (three- and seven-year recall periods) for the ≥1 to ≥4 prophylactic lines (Table 2 a). The proportion of patients treated with ≥1 prophylactic medication was 38.8% (three-year recall period) and 46.8% (seven-year recall period) (Table 2 b). The proportion of patients treated with ≥2 prophylactic medications was 11.2% (84.6% females; three-year recall period) and 19.8% (86% females; seven-year recall period) (Table 2 a, b).
a) Descriptive patient characteristics (age and sex) by cumulative prophylactic line (prevalence approach)
|
All age groups; N=14030
|
Prophylactic line*
|
Age (years)
|
Females
|
3-year recall
(2014–2016)
|
7-year recall
(2010–2016)
|
3-year recall
(2014–2016)
|
7-year recall
(2010–2016)
|
Mean (SD)
|
Mean (SD)
|
%
|
%
|
0
|
37.8 (15.6)
|
36.7 (15.7)
|
79.1
|
77.8
|
≥1
|
48.5 (14.6)
|
48.0 (14.4)
|
83.5
|
84.2
|
≥2
|
50.6 (13.2)
|
50.0 (13.4)
|
84.6
|
86.0
|
≥3
|
51.7 (12.5)
|
51.6 (12.6)
|
84.4
|
86.6
|
≥4
|
53.1 (12.6)
|
51.9 (11.7)
|
89.0
|
87.6
|
b) Number of migraine patients by cumulative prophylactic line (prevalence approach)
|
Prophylactic line*
|
All age groups
(N=14030)
|
Age group >18 years
(N=12780)
|
3-year recall
(2014–2016)
|
7-year recall
(2010–2016)
|
3-year recall
(2014–2016)
|
7-year recall
(2010–2016)
|
n (%)
|
n (%)
|
n (%)
|
n (%)
|
0
|
8584 (61.2)
|
7462 (53.2)
|
7452 (58.3)
|
6348 (49.6)
|
≥1
|
5446 (38.8)
|
6568 (46.8)
|
5336 (41.7)
|
6440 (50.4)
|
≥2
|
1567 (11.2)
|
2775 (19.8)
|
1558 (12.2)
|
2756 (21.6)
|
≥3
|
417 (3.0)
|
1087 (7.8)
|
415 (3.2)
|
1085 (8.5)
|
≥4
|
91 (0.6)
|
370 (2.6)
|
91 (0.7)
|
370 (2.9)
|
c) Descriptive patient characteristics (age and sex) by cumulative prophylactic line; 3-year recall period (2014–2016) (incidence approach)
|
All age groups
(N=3049)
|
Prophylactic line*
|
Age (years)
|
Females
|
Mean (SD)
|
%
|
0
|
32.7 (16.1)
|
70.6
|
≥1
|
40.1 (14.2)
|
77.4
|
≥2
|
43.6 (13.9)
|
83.9
|
≥3
|
44.2 (12.8)
|
91.7
|
≥4
|
48 (10.6)
|
66.7
|
d) Number of migraine patients by cumulative prophylactic line; 3-year recall period (2014–2016) (incidence approach)
|
Prophylactic line*
|
All age groups
(N=3049)
|
n
|
%
|
0
|
2651
|
86.9
|
≥1
|
398
|
13.1
|
≥2
|
56
|
1.8
|
≥3
|
12
|
0.4
|
≥4
|
3
|
0.1
|
*Cumulative prophylactic line: 0, no prophylactic medication substances used; ≥1, first and subsequent prophylactic line; ≥2, second and subsequent prophylactic line; ≥3, third and subsequent prophylactic line; ≥4, fourth and subsequent prophylactic line. n, umber of migraine patients by cumulative prophylactic line; N, total number of migraine patients; %, percentage of migraine patients with cumulative prophylactic lines out of the overall number of migraine patients with respect to the analysis approach and by the analysis population; SD, standard deviation
|
e) Proportion of migraine patients using prophylactic medication by therapeutic subgroup; 3-year recall period
|
Therapeutic subgroup
|
Prevalence approach
(N=14030)
|
Incidence approach
(N=3049)
|
n
|
%
|
n
|
%
|
Antiepileptics other than topiramate
|
2222
|
15.8
|
173
|
5.7
|
Beta blockers
|
2213
|
15.8
|
106
|
3.5
|
Botulinum toxin A*
|
49
|
0.4
|
4
|
0.1
|
Selected antidepressants
|
1015
|
7.2
|
66
|
2.2
|
Topiramate
|
1421
|
10.1
|
96
|
3.2
|
*Not reimbursable in the Czech Republic without special approvals; n, number of migraine patients in 2016 by therapeutic subgroup; N, total number of migraine patients in 2016; %, percentage of migraine patients in the therapeutic subgroup out of the overall number of migraine patients in 2016 with respect to the analysis approach and by the analysis population
|
f) Proportion of migraine patients using prophylactic medication; individual drugs, 3-year recall period
|
Substance
|
Prevalence approach
(N=14030)
|
Incidence approach
(N=3049)
|
n
|
%
|
n
|
%
|
No medication
|
8584
|
61.2
|
2651
|
86.9
|
Metoprolol
|
1342
|
9.6
|
60
|
2.0
|
Atenolol
|
138
|
0.9
|
5
|
0.2
|
Bisoprolol
|
868
|
6.2
|
44
|
1.4
|
Candesartan
|
115
|
0.8
|
6
|
0.2
|
Botulinum toxin A
|
49
|
0.4
|
4
|
0.1
|
Valproic acid
|
826
|
5.9
|
58
|
1.9
|
Topiramate
|
1421
|
10.1
|
96
|
3.2
|
Gabapentin
|
939
|
6.7
|
61
|
2.0
|
Pregabalin
|
791
|
5.6
|
68
|
2.2
|
Amitriptyline
|
341
|
2.4
|
28
|
0.9
|
Venlafaxine
|
722
|
5.2
|
40
|
1.3
|
n, number of migraine patients with the corresponding prophylactic medication prescribed in 2016; N, total number of migraine patients in 2016;
%, percentage of migraine patients with the corresponding prophylactic medication out of the overall number of migraine patients in 2016 with respect to the analysis approach and by the analysis population
|
Table 2
Prophylactic treatment patterns for migraine patients
When selectively considering the adults, about 41.7% (three-year recall period) and 50.4% (seven-year recall period) of the population were using ≥1 prophylactic medication (Table 2 b). At the same time, 12.2% (three-year recall period) and 21.6% (seven-year recall period) of the population were observed to be using ≥2 prophylactic medications.
Among the newly diagnosed patients (patients analyzed by the incidence approach and by the three-year recall period), 86.9% of the population did not use any prophylactic medication. The mean age of patients ranged between 40 and 48 years of age for the ≥1 to ≥4 prophylactic lines, and 13.1% and 1.8% of the total patients were using ≥1 and ≥2 prophylactic medications, respectively. Approximately 84% of patients using ≥2 prophylactic medications were females (Table 2 c, d).
- Proportion of each therapeutic subgroup/medication used among the migraine patients
The most prescribed therapeutic subgroups were antiepileptics (26% with the prevalence approach [antiepileptics other than topiramate: 15.8%, topiramate: 10.1%] and 9% with the incidence approach [antiepileptics other than topiramate: 5.7%, topiramate: 3.2%]) and beta blockers (15.8% for the prevalence approach and 3.5% for the incidence approach) (Table 2 e). The most prescribed prophylactic medications using the prevalence approach were topiramate (10.1%) and metoprolol (9.6%), while newly diagnosed patients mostly used topiramate (3.2%) and pregabalin (2.2%), followed by metoprolol (2.0%) (Table 2 f).
- Acute treatment
Acute treatment comprised only of triptans, and 4299 patients (30.6%, N=14,030; prevalence approach) and 788 patients (25.8%, N=3049; incidence approach) who used triptans were not on a prophylactic drug therapy (Figure 3). For assessment of concomitant prophylactics, distinct/exact medication lines (1, 2, 3, and 4) were considered. With the incidence approach, we observed that patients using more than one prophylactic drug chose (or were prescribed) only sumatriptan. In the case of patients using only one prophylactic drug, of the 164 triptan therapy patients (incidence approach), 155 were using only sumatriptan. Similar observations were made using the prevalence approach, wherein 1487 among the 1677 patients on triptans with one prophylactic drug were on sumatriptan.
Overall, sumatriptan was being used by 6021 patients (approximately 43%; prevalence approach) and 934 patients (30.6%; incidence approach) (Figure 3). In the prevalence approach, the proportion of patients using triptans decreased with an increase in the number of simultaneous prophylactic drugs used.
- Number of migraine patients with comorbidities
The insurance claims database did not register comorbidities for most migraine patients (98.6% by the prevalence approach and 99.2% by the incidence approach), and the comorbidities recorded were mostly cardiovascular disorders (1.34%, prevalence approach; 0.91%, incidence approach).
Number of patients who could be eligible for CGRP therapy
In the seven-year recall period, about 20% of patients (all age groups) and 21.6% of patients (adults only) used ≥2 prophylactic therapies. Considering the number of inhabitants in the Czech Republic (10.7 million), the 1% migraine prevalence rate (with respect to insured healthcare) and the 21.6% patients on ≥2 prophylactic medications, there could be up to 23,000 adult patients eligible for CGRP pathway‑targeting therapies (Figure 4).