Number of PrEP users in Germany
Drug prescription data
By end of October 2017, the company producing blister pack PrEP had filled prescriptions for 513 monthly PrEP doses. In July 2018 this number had increased to 3,125 doses, and in May 2019 to 4,022 doses [personal communication by E. Tenberken].
By the end of 2019, the number of drug prescriptions assumed to be used for PrEP and covered by statutory health insurance companies had increased to 10,176 monthly doses. For the first two quarters of 2020 we calculated an average of 10,788 monthly prescriptions (see Table 1).
Survey data
The number of EMIS-2017 respondents living in Germany who indicated current PrEP use was 452, representing 2.1% of the survey respondents, 17 of whom did not provide information on their place of residence. In rounds 1 (July-September 2018), 2 (April/May 2019) and 3 (March-May 2020) of the PrApp-Survey a total of 2,118, 3,071 and 964 PrEP users participated, of whom 2,252 and 790 in rounds 2 and 3 provided information on their place of residence, round 1 did not collect this information (see Table 1).
PlanetRomeo PrEP profiles
In June 2020, PlanetRomeo provided information on the geographical distribution of 15,633 user profiles in Germany who had indicated PrEP use (n=9,207) or the combination of PrEP and condom use (n=6,426) as their “safer sex” preference [personal communication by PlanetRomeo Chief Operating Officer].
For the interpretation of these data we considered two important pieces of information from other sources: 1) the PrApp-Survey provided information that a proportion of 30% PrEP users does not provide PrEP use information in their online profiles. This would argue for an underestimate of PrEP users by the number of PrEP profiles on PlanetRomeo. 2) A survey conducted in 2020 among people diagnosed with HIV and living in Germany found that a substantial proportion (11.5%) of MSM using online dating reported communicating PrEP use to their potential partners[2] [personal communication by Franziska Hartung]. While the representativeness of these data for MSM diagnosed with HIV is unknown, a proportion of 11.5% of MSM diagnosed with HIV could amount to approximately 3,450 PrEP profiles (for the calculation see Table S1). Considering these two biases for the PlanetRomeo profiles, the PrEP profile number on PlanetRomeo would support a number of approximately 17,400 current PrEP users among MSM in Germany.
Estimating the number of PrEP users
We defined two scenarios to describe a possible range for the total number of PrEP users in Germany.
In scenario 1 we make the following assumptions: the proportion of on-demand/intermittent PrEP users was 33% for the time period before PrEP became reimbursable by statutory health insurance and dropped to 20% after September 2019 (based on respective responses in the PrApp-Survey rounds 1-3). Intermittent/on-demand PrEP users will only obtain another prescription when they run out of medication, thus they will be underrepresented in the monthly prescription data. We assumed that the actual number of intermittent/on-demand PrEP users will be on average three-fold higher than the monthly prescriptions for men from these two groups (i.e. a monthly PrEP dose suffices for three months intermittent/on-demand PrEP use on average).
In scenario 2 we assume that (1) a monthly PrEP dose meets the needs of six on-demand/intermittent PrEP users for one month and (2) that – due to a possible systematic survey participation bias – the proportion of on-demand/intermittent PrEP users is 40% , and thus higher than indicated by respondents of the PrApp-Surveys, and that the proportion of self-payers who are not reimbursed by statutory health insurance might also be slightly higher than among the PrApp-Survey respondents.
Data from the PrApp-Surveys on the number of PrEP pills used per months by daily, intermittent, and on-demand users, and on the proportion of participating PrEP users indicating PrEP use on their online profiles is presented in supplemental Tables S2 and S3.
Table 1 shows our calculation of the estimated number of PrEP users in Germany at 5 different points in time (early November 2017, end of July 2018, end of May 2019, end of December 2019, and end of June 2020) based on drug prescriptions, proportions of daily and on-demand/intermittent PrEP use, assumptions on how many on-demand/intermittent PrEP users are supported by a monthly dose, and the proportion of additional drug sources as indicated by respondents of online surveys. We arrive at estimates of approximately 15,600 PrEP users in Germany by end of June 2020 for scenario 1, and of approximately 21,600 PrEP users in Germany by end of June 2020 for scenario 2.
Table 1: Data on PrEP access from online surveys in Germany, 2017-2020, and estimation of absolute number of PrEP users
|
EMIS-2017
|
PrApp round 1 (07/2018)
|
PrApp round 2 (05/2019)
|
PrApp round 31,
PrEP prescription data 12/2019
|
PrApp round 31,
PrEP prescription data 06/2020
|
Scenario 2** 06/2020
PrEP prescription data 2020, presumed self-pay 20%, informal sources 5%
|
a) survey data
|
%
|
%
|
%
|
%
|
%
|
%
|
medical prescription in Germany
|
56
|
81
|
83
|
94
|
94
|
95
|
"blister pack PrEP"
|
56
|
54
|
58
|
n.a.
|
n.a.
|
n.a.
|
other sources (informal, self-pay non-Blister-PrEP generics, trials)
|
44
|
46
|
42
|
n.a.
|
n.a.
|
n.a.
|
prescription on statutory health insurance
|
n.a.
|
n.a.
|
5
|
80
|
80
|
75
|
prescription self-pay (blister pack PrEP + other generics)
|
56
|
81
|
82
|
14
|
14
|
20
|
informal
|
44
|
19
|
13
|
6
|
6
|
5
|
proportion PrEP on demand
|
29
|
29
|
30
|
19
|
19
|
40
|
proportion of PrEP users participating in survey
|
37%
|
28%
|
34%
|
|
6%
|
n.a.
|
|
Scenario 1 (based on survey-result)*
|
Scenario 2 **
|
b) estimation of absolute number of PrEP users
|
N
|
N
|
N
|
N
|
N
|
N
|
number of blister pack PrEP/ private self-pay prescriptions
|
513
|
3,125
|
4,022
|
1,796
|
1,904
|
2,877
|
number of monthly health insurance prescriptions
|
|
|
10,176
|
10,788
|
10,788
|
number of PrEP users on prescribed PrEP
|
660
|
4,018
|
5,171
|
13,814
|
14,644
|
20,497
|
number of PrEP users on informal sources/other (non blister pack) self-pay generics
|
518
|
3,423
|
3,745
|
882
|
935
|
1,079
|
estimated total number of PrEP users
|
1,178
|
7,440
|
8,916
|
14,695
|
15,579
|
21,576
|
n.a. = not applicable
1 data from PrApp-Survey round 3 was collected in 03/2020
* assumptions scenario 1: 33% (20%) on-demand/intermittent users, 3 on-demand/intermittent users supported by one full monthly dose
** assumptions scenario 2: 40% on-demand/intermittent users, 6 on-demand/intermittent users supported by one full monthly dose
Regional distribution of PrEP users
Figure 1 and Table 2 provide the estimated absolute numbers of PrEP users by federal state based on the regional distribution in the respective online surveys and the estimated totals from scenario 1 at the time points 1) early November 2017; 2) end of July 2018 (PrApp-Survey round 1); 3) end of April 2019 (PrApp-Survey round 2); 4) end of December 2019 (PrApp-Survey round 3 distribution); 5) June 2020 (PrApp-Survey round 2-3 distribution), and for scenario 2 in June 2020 (PrApp-Survey round 2-3 distribution). As a sensitivity analysis we also provide for comparison scenario 1 and 2 with a regional distribution based on the PrEP profile distribution of the PlanetRomeo PrEP profiles for June 2020. PrEP user profile distributions on PlanetRomeo are not available for earlier time points.).
Fig.1: Estimated number of PrEP users at different time points stratified by federal state
[insert Fig.1 here]
Table 2: Estimated absolute numbers of PrEP-users by federal state at different time points and for scenario 1 and 2
|
Online survey-based distributions
|
PlanetRomeo profile-based distribution
|
|
Scenario 1
|
Scenario 2
|
Scenario 1
|
Scenario 2
|
|
November 2017 (EMIS-2017)
|
July 2018
|
Apr-May 2019
|
December 2019
|
June 2020
|
June 2020
|
June 2020
|
June 2020
|
Baden-Wurttemberg
|
86
|
533
|
639
|
1,061
|
1,126
|
1,560
|
990
|
1,371
|
Bavaria
|
149
|
982
|
1,239
|
2,184
|
2,318
|
3,210
|
2,146
|
2,972
|
Berlin
|
447
|
2,427
|
2,474
|
3,668
|
3,892
|
5,389
|
4,590
|
6,356
|
Brandenburg
|
14
|
78
|
84
|
162
|
172
|
238
|
155
|
214
|
Bremen
|
17
|
70
|
44
|
82
|
87
|
121
|
148
|
204
|
Hamburg
|
63
|
435
|
568
|
864
|
917
|
1,269
|
952
|
1,318
|
Hesse
|
102
|
637
|
763
|
1,302
|
1,382
|
1,914
|
1,198
|
1,659
|
Mecklenburg-Western Pomerania
|
3
|
28
|
48
|
123
|
130
|
180
|
95
|
131
|
Lower Saxony
|
39
|
256
|
324
|
684
|
725
|
1,004
|
678
|
938
|
North Rhine-Westphalia
|
190
|
1,403
|
1,939
|
3,109
|
3,299
|
4,568
|
3,197
|
4,427
|
Rhineland-Palatinate
|
19
|
160
|
239
|
475
|
504
|
698
|
456
|
631
|
Saarland
|
8
|
57
|
76
|
108
|
115
|
159
|
140
|
193
|
Saxony
|
25
|
229
|
364
|
548
|
582
|
806
|
431
|
597
|
Saxony-Anhalt
|
6
|
44
|
64
|
98
|
105
|
145
|
123
|
170
|
Schleswig-Holstein
|
30
|
126
|
76
|
155
|
165
|
228
|
211
|
292
|
Thuringia
|
3
|
34
|
60
|
77
|
82
|
113
|
91
|
126
|
Total number of PrEP users
|
1,200
|
7,500
|
9,000
|
14,700
|
15,600
|
21,601
|
15,600
|
21,601
|
Figure 2 shows 6 correlation graphs, demonstrating high correlations of the proportional distribution by federal state in Germany of EMIS-2017 participants using PrEP, PrApp-Survey participants using PrEP, PlanetRomeo PrEP profiles, and PrEP prescription data. However, the correlations between the state distribution of PrApp-Survey participants using PrEP and PrEP prescription data as of end of 2019 and for 2020 show major deviations for Berlin with a higher proportion of prescriptions in Berlin (38.9% in the first two quarters of 2020) compared to the proportion of PrApp-Survey participants using PrEP (27.5% in round 2 (05/2019) and 22.4% in round 3 (03/2020)).
Fig.2: a-c) Correlation of the regional distribution of PrEP use intention in 2017 with PrEP use in 2020 as indicated in the PrApp Survey, in GayRomeo PrEP profiles, and by statutory health insurance PrEP prescriptions in 2020; d-f) Correlation of the regional distribution of PrEP users in 2020 between PrApp Survey respondents and GayRomeo PrEP profiles, and between PrApp Survey
respondents and GayRomeo PrEP profiles with statutory health insurance PrEP prescriptions.
[insert Fig.2 here]
Table S4 provides the proportional regional distributions (by federal state) of all EMIS-2017 participants, EMIS-2017 participants using PrEP, PrApp-Survey participants using PrEP, all PlanetRomeo profiles in Germany, and PlanetRomeo PrEP profiles.
Estimating PrEP needs in Germany
To estimate the total size of the four PrEP needs groups in the MSM population in Germany, we made assumptions about self-selection biases for these groups in EMIS-2017. Based on the PrEP user estimates at different time points, we determined that 30-35% of all PrEP users at these time points in Germany participated in EMIS-2017 and the first two rounds of the PrApp-Survey surveys, suggesting very high self-selection biases for actual PrEP users (see Table 1). For comparison, 20,000 male participants not diagnosed with HIV took part in EMIS-2017 which corresponds to almost 6% of the estimated non-HIV-diagnosed population of gay men living in Germany (N = 350,000, 1.5% of adult males aged 15-64).
We assume that the intention to use PrEP is associated with a self-selection bias that lies in-between the self-selection bias for PrEP users (30-35%) and the average self-selection bias for survey participants (6%). We also assume that the size of the bias is associated with factors such as PrEP use intention, partner numbers, self-perceived risk, and PrEP awareness – the key factors we identified in a multivariable regression analysis (see Table S5). We chose weights of a magnitude of 2-2.5 as a combined effect of higher partner numbers and PrEP use intention, which is slightly lower than the empirically derived weight of 3 for EMIS-2017 respondents with a syphilis diagnosis in the previous 12 months. The distribution of partner numbers, PrEP awareness, and recency of HIV testing that we consider a surrogate for self-perceived risk in this context, in the four groups is shown in Figure S1.
Table S6 provides absolute data for the size of the four PrEP need groups in EMIS-2017.
Based on these assumptions we provide range estimates for the sizes of all four PrEP need groups in Table 3. The minimum size for the PrEP need groups would reflect a self-selection bias similar to actual PrEP users, the maximum size would reflect no specific self-selection bias for PrEP use intention. The two intermediate variants represent two different – arbitrary – assumptions of intermediate self-selection biases. The estimated PrEP need ranges between 49,500 and 109,000 men, the unsatisfied PrEP need between 33,500 and 93,000 men for scenario 1 as of June 2020, and between 27,500 and 87,000 for scenario 2, assuming no change in PrEP needs between end of 2017 and June 2020, and using a total population size estimate of 350,000 adult gay men not diagnosed with HIV living in Germany (16).
Comparison of expressed PrEP need in 2017 with PrEP use in 2020
In the next step, we compare how this estimated PrEP need from 2017 compares to the number of estimated PrEP users in 2020. To calculate a regional PrEP need distribution in Table 4, we used the totals from variant 1 shown in Table 3 and apply it to the scenario 1 total of current PrEP users (N=15,600) and the scenario 2 total of current PrEP users (N=21,600). The variant 1 estimate assumes that PrEP use intention and the number of sex partners in the last 12 months are the main determinants for the selection bias.
Table 4 shows proportions of satisfied intention to use PrEP and unmet needs with no intention to use PrEP by federal state by June 2020. Fig.3a shows the almost perfect correlation between the regional distribution of intention to use PrEP in November 2017 and the distribution of the gay population in Germany, while Fig.3b shows how intention to use PrEP correlates with actual PrEP use by mid-2020, suggesting an unequal regional distribution of unmet needs, regardless which of the two scenarios is used.
Fig.3: a) Correlation between the regional distribution of PrEP use intention in 2017 and the regional distribution of the gay population in Germany; b) Correlation between regional distribution of PrEP use intention in 2017 and PrEP use as indicated by the PrApp Survey in 05/2019
[insert Fig.3 here]
BW: Baden-Wurttemberg, BY: Bavaria, BE: Berlin, BB: Brandenburg, HB: Bremen, HH: Hamburg, HE: Hesse, MV: Mecklenburg-Western Pomerania, NI: Lower Saxony, NW: North Rhine-Westphalia, RP: Rhineland-Palatinate, SL: Saarland, SN: Saxony, ST: Saxony-Anhalt, SH: Schleswig-Holstein, TH: Thuringia.
Analysis of PrEP prescriber density and correlation with PrEP use
There were a total of 246 licensed HIV specialists listed on the DAGNÄ website in early 2021. We use this information as proxy for the number of licensed PrEP prescribers in Germany. Since this number differs regionally by federal state, it might explain the unequal distribution of unsatisfied PrEP needs. Thus, we analysed the correlation between satisfied PrEP needs and number of HIV specialists per 10,000 gay men practicing in the respective federal state and found a strong correlation between these two parameters (Fig 4).
Fig.4: Correlation between the number of PrEP prescribers per 10,000 gay population by federal state and PrEP needs met as estimated using scenario 2 PrEP user estimate and variant 1 PrEP need estimate.
[insert Fig.4 here]
BW: Baden-Wurttemberg, BY: Bavaria, BE: Berlin, BB: Brandenburg, HB: Bremen, HH: Hamburg, HE: Hesse, MV: Mecklenburg-Western Pomerania, NI: Lower Saxony, NW: North Rhine-Westphalia, RP: Rhineland-Palatinate, SL: Saarland, SN: Saxony, ST: Saxony-Anhalt, SH: Schleswig-Holstein, TH: Thuringia.
Table 3: Estimating the size range of PrEP need groups in Germany
|
intention, no reported risk*
|
intention and risk
|
no intention, but risk
|
no intention, no reported risk
|
|
estimated PrEP need
|
unmet PrEP need (scenario 1, 16,000 PrEP users)
|
unmet PrEP need (scenario 2, 22,000 PrEP users)
|
absolute number, assumption: no self-selection bias
|
40,000
|
37,000
|
32,000
|
241,000
|
109,000
|
93,000
|
87,000
|
self-selection
|
6%
|
6%
|
6%
|
6%
|
|
|
|
absolute number, assumption: medium self-selection bias, determined by PrEP use intention > partner numbers (variant 1)
|
22,000*
|
17,000*
|
27,000**
|
284,000
|
66,000
|
50,000
|
44,000
|
self-selection
|
11%
|
13%
|
7%
|
5%
|
|
|
|
absolute number, assumption: medium self-selection bias, mainly determined by partner numbers > PrEP use intentions (variant 2)
|
20,000
|
15,000
|
17,000
|
298,000
|
52,000
|
36,000
|
30,000
|
self-selection
|
12%
|
15%
|
11%
|
5%
|
|
|
|
absolute number, assumption: extreme self-selection, only determined by PrEP use intention
|
7,500
|
7,000
|
35,000
|
300,500
|
49,500
|
33,500
|
27,500
|
self-selection
|
31%
|
32%
|
5%
|
5%
|
|
|
|
* N with intention in Table 4
** N with risk, no intention in Table 4
Table 4: Regional need distribution und unmet needs by federal states
|
|
|
Scenario 1*
|
Scenario 2*
|
|
N with intention (variant 1 from Tab.3)
|
N with risk, no intention (variant 1 from Tab.3)
|
PrEP-user =15,600
|
% of intentional users actually using PrEP
|
in need of PrEP^
|
% in need with no intention (demand generation required)
|
PrEP-user = 21,600
|
% of intentional users actually using PrEP
|
in need of PrEP^
|
% in need with no intention (demand generation required)
|
Baden-Wurttemberg
|
4,494
|
2,978
|
1,126
|
25.1%
|
6,346
|
46.9%
|
1,560
|
34.7%
|
5,912
|
50.4%
|
Bavaria
|
5,382
|
3,276
|
2,318
|
43.1%
|
6,340
|
51.7%
|
3,210
|
59.6%
|
5,448
|
60.1%
|
Berlin
|
6,140
|
4,215
|
3,892
|
63.4%
|
6,462
|
65.2%
|
5,389
|
87.8%
|
4,966
|
84.9%
|
Brandenburg
|
857
|
432
|
172
|
20.0%
|
1,117
|
38.7%
|
238
|
27.8%
|
1,051
|
41.1%
|
Bremen
|
392
|
357
|
87
|
22.3%
|
662
|
54.0%
|
121
|
30.9%
|
628
|
56.8%
|
Hamburg
|
1,614
|
1,355
|
917
|
56.8%
|
2,053
|
66.0%
|
1,269
|
78.6%
|
1,700
|
79.7%
|
Hesse
|
2,846
|
1,966
|
1,382
|
48.6%
|
3,430
|
57.3%
|
1,914
|
67.3%
|
2,898
|
67.8%
|
Mecklenburg-Western Pomerania
|
548
|
477
|
130
|
23.8%
|
895
|
53.3%
|
180
|
32.8%
|
845
|
56.4%
|
Lower Saxony
|
2,726
|
1,683
|
725
|
26.6%
|
3,684
|
45.7%
|
1004
|
36.8%
|
3,405
|
49.4%
|
North Rhine-Westphalia
|
7,871
|
5,600
|
3,299
|
41.9%
|
10,171
|
55.1%
|
4,568
|
58.0%
|
8,903
|
62.9%
|
Rhineland-Palatinate
|
1,341
|
745
|
504
|
37.6%
|
1,582
|
47.1%
|
698
|
52.1%
|
1,388
|
53.7%
|
Saarland
|
471
|
402
|
115
|
24.3%
|
759
|
53.0%
|
159
|
33.8%
|
714
|
56.3%
|
Saxony
|
1,901
|
1,325
|
582
|
30.6%
|
2,644
|
50.1%
|
806
|
42.4%
|
2,420
|
54.8%
|
Saxony-Anhalt
|
668
|
506
|
105
|
15.6%
|
1,070
|
47.3%
|
145
|
21.7%
|
1,029
|
49.2%
|
Schleswig-Holstein
|
1,132
|
1,087
|
165
|
14.5%
|
2,054
|
52.9%
|
228
|
20.1%
|
1,991
|
54.6%
|
Thuringia
|
617
|
596
|
82
|
13.3%
|
1,131
|
52.7%
|
113
|
18.3%
|
1,100
|
54.2%
|
Total
|
39,000
|
27,000
|
15,600
|
40.0%
|
50,399
|
53.6%
|
21,600
|
55.4%
|
44,400
|
60.8%
|
* Regional distribution according to PrEP-user distribution in PrApp-Surveys round 2
^ includes men with intention to use PrEP and/or with reported sexual risk minus those men already using PrEP
[2] Online survey among people living with HIV in Germany in 2020 (https://www.idz-jena.de/forschung/positive-stimmen-20/)