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PSY30
Povero M, Pradelli L
AdRes HE&OR, Turin, Italy
Biologic treatments for moderate to severe naïve
psoriatic patients: a budget impact analysis in Italy
Objective
Evaluate the current prescription trend of biologics for the treatment of
Adalimumab
Persistence
 Biologics currently reimbursed in Italy for psoriasis include tumor necrosis
40%
0%
0
 A deterministic Markov model was developed to simulate the evolution of
6
12
18
24
30
36
42
0%
0
6
12
18
24
30
36
42
48
Ustekinumab
100%
0.81
0.6
1.03
1st line†
0
0.48
0.42
post 1st line‡
0.93
80%
60%
40%
S tj
20%
S tj−1
0%
1st line ─ median=5.3 years
2nd line ─ median=1.8 years
3rd line ─ median=2 years
Time on therapy (months)
0
6
12
18
24
30
36
42
Persistence
persistence curves (Figure 1) specific for each drug according to the formula
1st line ─ median=3.4 years
2nd line ─ median=1.8 years
3rd line ─ median=1.5 years
Time on therapy (months)
0.28
Persistence
 Transition probabilities (switch between lines) were calculated applying
40%
20%
80%
 Demographic, epidemiological and clinical data from literature [2, 3, 1].
Ustekinumab
0.74
0.74
0.64
0.51
Malignancy*
60%
48
Infliximab
100%
bio-naïve psoriatic patients in Italy for 3 years:
pswitch tj :=P T ≤ tj T > tj−1 =1 −
1st line ─ median=3.6 years
2nd line ─ median=3.7 years
3rd line ─ median=2.3 years
Time on therapy (months)
20%
the interleukin-12/23 inhibitor ustekinumab [1].
Infliximab
80%
60%
factor (TNF)-α inhibitors adalimumab, etanercept, and infliximab, as well as
Etanercept
MACE
80%
hypotheses, including the introduction of infliximab biosimilars.
Methods
Cumulative AEI rates
Etanercept
100%
Persistence
psoriasis in Italy and estimate the impact of alternative market
Adalimumab
100%
1.88
1.67
Infections•
60%
2.77
0.95
40%
1st line ─ median=20.1 years
2nd line ─ median=15.4 years
3rd line ─ median=8.7 years
Time on therapy (months)
20%
0%
48
0
6
12
18
24
30
36
42
0.42
0.42
0.45
0.36
Mortality*
48
0
Events/100 PYs
1
2
3
where S(·) is the survival distribution (time on therapy) for each treatment [4, 5].
 Adverse events of interest (AEI) and mortality (Figure 2) were modeled for
Figure 1. Persistence of Biologic Therapy in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) for each biologic considered
in the analysis.
each biologic drug (1st, 2nd and 3rd line), basing on published data from The
3-years resulting AEI (current vs alternative scenario)
Psoriasis Longitudinal Assessment and Registry (PSOLAR) [6, 7, 8].
 All costs were calculated from the perspective of National Health Service:
 Hospitalization costs were calculated as average of Italian DRGs weighted for
event-related frequency [9, 10].
Current scenario
Alternative scenario
30
100%
27
80%
48.3%
24
 The cost of a dermatological visit was considered every two months and in
Savings (alternative vs current)
21
 Drug costs [1] included eventually administration costs [13].
 The current Italian market mix of biologic treatments (Figure 4) was
40%
20.5%
11.8%
compared with the total substitution of infliximab with its biosimilars
0%
12
20%
3
expenses of the remaining biologics, proportionally to their current shares.
0
13
7
4
6
2
MACEs
biological treatment annually.
Malignancy
€ 60,000,000
€ 50,000,000
€ 683
2.92%
€ 713
€ 663
€ 684
€ 665
€ 40,000,000
€ 671
 Annual savings per patient corresponds to about € 670; regional analysis
(Figure 6) do not show significant differences: 95% CI € 629 ─ 672, p=0.10.
€ 637
€ 684
infliximab biosimilars lead to estimated savings of almost 2 millions in 3
years (Figure 5).
Regional savings per patient
(alternative vs current scenario)
3.76%
 Total cost results in about 45.7 million Euro for 3 years in the current
scenario; increasing in ustekinumab market shares and the introduction of
Figure 4. Current Italian market mix of biologic treatments [14]
Cumulative total cost (alternative vs current scenario)
 Adverse events, generally rare, are reduced in the alternative scenario:
-21% of infections, -48% of MACEs and -12% of malignancies (Figure 3).
48.8%
80%
100%
Figure 3. Resulting total adverse events of interest (AEI): comparison between current and alternative scenario.
 In the next three years, 515 bio-naive patients are expected to start a new
4.5%
60%
Infections
Results
Adalimumab
Etanercept
Infliximab
Ustekinumab
27,1%
40%
17
6
combined with ustekinumab increasing its market share to 40% at the
19.6%
20%
15
9
Current scenario (2014 market share mix)
60%
18
case of therapy switch [11, 12].
Figure 2. Cumulative unadjusted incidence of adverse events of interest per 100
patient-years (PYs).
* Rates were based on patients who never exposed to a given biologic therapy. • Rates
were based on patients who were exposed to a given biologic therapy within 91 days of
the event. † Patients who began a new biologic and had never received any biologic in
the past. ‡ Patients who began a new biologic therapy and had never received that
specific biologic in the past.
MACEs: Major adverse cardiovascular events, AEI: Adverse events of interest.
1.76%
€ 30,000,000
€ 628
€ 691
€ 652
€ 672
€ 621
€ 618
Conclusions
€ 20,000,000
The cost of biologically treated psoriasis depends almost entirely on drug
€ 652
€ 602
€ 10,000,000
€ 732
acquisition and administration. Changes in the current prescribing scenario,
with adoption of the most persistent biologic (ustekinumab), can lead to
€ 605
€0
valuable savings through lower cost of maintenance phase, avoided reinductions, and reduced visits. Ustekinumab market increase accounted for
50% of total savings, while the remainder came from biosimilars substitution.
Acknowledgements
The study was funded by Janssen-Cilag SpA, Italy
€ 532
Total cost (€)
Visits/AEI (€)
Drugs (€)
Current
scenario
Alternative
scenario
Year 1
8,213,471
8,068,714
60,053
52,910
8,153,419
8,015,804
Current
scenario
Alternative
scenario
Year 2
23,633,741
22,942,480
139,960
126,190
23,493,781
22,816,290
Current
scenario
Alternative
scenario
Year 3
45,685,039
43,968,431
262,179
238,411
45,422,860
43,730,019
Total savings (alternative vs current scenario)
Figure 5. Budget impact results: total cumulative cost in the current and alternative scenarios for 3-years analysis.
€ 602
National mean € 668, p=0.10
Figure 6. Annual cost per patient: regional trend in Italy.
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