BUDGET IMPACT ANALYSIS OF APIXABAN VERSUS OTHER NOACs FOR THE
PREVENTION OF STROKE IN ITALIAN NON-VALVULAR ATRIAL FIBRILLATION
PATIENTS
L.Pradelli1, MD, M.Calandriello2, MBA, R.Di Virgilio3, MD, M.Bellone1, PharmD, M.Tubaro4, MD 1 AdRes Health Economics & Outcomes Research, Turin Italy, ² Bristol-Myers Squibb, Rome Italy, ³ Pfizer, Rome Italy, 4 ICCU, Cardiovascular Department, San Filippo Neri Hospital, Rome Italy
• The different safety and effectiveness profiles of the available NOACs emerging from the adjusted indirect
comparison indicate that the introduction of apixaban could improve health care expenditure control while
maintaining or increasing therapeutic appropriateness in the Italian NVAF population, due to lower costs for
managing thromboembolic and bleeding events.
Conclusions
References
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Among available NOACs, apixaban is expected to be the least expensive at 1,2, and 3 years (Table II); the
excess pharmaceutical cost, due to improved persistence with the prescribed AC regimen with apixaban, is
completely offset by reduced costs for event management, leading to the overall saving.
In an estimated patient population of 363,994 Italian patients, the introduction of apixaban will temper the cost
associated with expanding market shares of NOACs, allowing for savings of over 5 million € by the third year
(Table III).
The analysis on a non-experimental population of NVAF patients confirms the estimates of the base-case
analysis (Figure II).
Exclusive use of apixaban for three years in the identified population would allow for savings of € 8,8 million, €
14,4 million and € 27,3 million when compared with dabigatran 110 mg, dabigatran 150 mg and rivaroxaban,
respectively.
Results
This study aims to perform a budget impact analysis (BIA) of the use of
three available novel oral anticoagulant agents (NOACs) for preventing
thromboembolic events in Italian patients with non-valvular atrial
fibrillation (NVAF).
The BIA evaluates the financial impact of apixaban introduction by
comparing expected 1,2, and 3 years costs in scenarios with and without
apixaban.
Objective
• This analysis was funded by Bristol-Myers Squibb and Pfizer. LP and MB are employees of AdRes which
received funding from Bristol-Myers Squibb and Pfizer in connection with conducting this analysis and
development of this poster.
Acknowledgements
Ischemic and hemorrhagic strokes are the main complication of non-
valvular AF (NVAF) [1]. Anticoagulation therapy is recommended to
prevent these thromboembolic complications [2].
Novel oral anticoagulant agents (NOACs) have been recently introduced
for prevention of stroke and systemic embolism in adult NVAF patients
who have one or more risk factors.
Apixaban and rivaroxaban are direct and highly selective active site
inhibitors of factor Xa, that reduce the conversion of prothrombin in
thrombin, whilst dabigatran is a potent, competitive, reversible direct
thrombin inhibitor [3].
Background
Estimated Italian population of patients is run through a previously
published decision tree/Markov model [4], simulating their treatment with
the available therapeutic options: dabigatran at two dose levels (110
mg/bid for the over 80 years old, 150 mg/bid for younger NVAF patients),
rivaroxaban, and apixaban.
The effectiveness and safety profile of apixaban reflects event rates
recorded in the ARISTOTLE trial [5].
For the competing NOACs (dabigatran 110 mg, dabigatran 150 mg and
rivaroxaban) effectiveness parameters derive from adjusted indirect
comparison, using warfarin as common comparator, due to lack of head-
to-head trials [4].
Main clinical outcomes monitored are ischemic (IS) and hemorrhagic
stroke (HS), systemic thromboembolism (SE), myocardial infarction (MI),
bleeds (Bs) (both major and clinically relevant minor), cardiovascular
hospitalizations (CV-H), and death. Expected survival is projected
beyond trial duration using national mortality data [6] adjusted for
individual clinical risks [4].
Direct health care unit costs (€), updated at 2013 values [6], include drug
acquisition [7], routine visits [8], IS and HS [9], MI [10], Bs management
and CV-H [11], and other health care costs associated with anticoagulant
(AC) management [11].
Italian NVAF patient population estimation (Table I) is based on official
apixaban reimbursement criteria issued by Italian Medicines Agency
(AIFA) [12,13,14], applying the characteristics of the trial population to
national epidemiologic data [15,16].
The expected penetration of NOACs on the market in the next years has
been estimated based on the market evolution in the first period from the
approval of NVAF as indication for the NOACs [16]; in the scenario with
apixaban, an increasing percentage of the NOAC – treated population is
prescribed apixaban, with shares subtracted proportionally to the
comparators.
Further simulation is performed on non-experimental population of NVAF
patients: clinical and demographic features, gathered by Olesen study
[17], are applied to Italian epidemiologic data [15,16].
A comparison analysis of cost accruing after three years for the
treatment of the whole identified patient population with one of the
available NOACs is performed, in order to highlight the total potential
budget impact of systematically choosing just one of the NOACs for this
indication.
Methods
% N
Residents Italy [6] 61,175,388
AF Prevalence [15] 1.70% 1,039,982
% NVAF [18] 70% 727,987
Eligible to NOACsa 50% 363,994
Year 1 Year 2 Year 3
Apixaban € 1,425 € 2,961 € 4,436
Dabigatran 110 mg € 1,449 € 2,992 € 4,461
Dabigatran 150 mg € 1,459 € 3,007 € 4,476
Rivaroxaban € 1,459 € 3,020 € 4,511
Scenarios 1st year 2nd year 3rd year
Target patients Common 363,994 363,994 363,994
Warfarin 292,790 230,513 213,435
Dabigatran (110 mg) w/o apixaban 20,107 36,551 40,654
w/ apixaban 9,414 14,093 11,407
Dabigatran (150 mg) w/o apixaban 25,383 46,144 51,323
w/ apixaban 11,884 17,792 14,401
Rivaroxaban w/o apixaban 25,714 50,786 58,582
w/ apixaban 12,039 19,582 16,437
Apixaban w/o apixaban 0 0 0
w/ apixaban 37,867 82,014 108,314
Budget Impact -€ 1,180,549 -€ 3,841,429 -€ 5,368,918 Figure II. Total costs of current scenario (w/o apixaban) and
alternative scenario (w/ apixaban) at 1st,2nd, and 3rd year. Yellow and
orange diamonds indicate the total costs on non-experimental (non-
Ex) patient population in w/o and w apixaban scenarios, respectively.
€ 420 € 927 € 1.417
1 year 2 year 3 year
€ M
ilio
n
Alternative scenario (w/ apixaban)
Alternative scenario (w/ apixaban)_non-Ex
€ 421 € 931 € 1.423
Current scenario (w/o apixaban)
Current scenario (w/o apixaban)_non-Ex
Table I. Patients flow for budget impact
analysis.
a. AIFA criteria for reimbursement:
• NVAF with both CHAD₂S ₂ -VASC ≥ 1 and
HAS-BLED >3 [12,13];
• time in therapeutic range (TTR) < 70% [14]
or objective difficulties in measuring INR
Table III. Budget impact: calculated as the difference among the total costs
expected without and with the introduction of apixaban.
Table II. Cumulative cost per patient for each NOAC. Cost details are shown
in panel A, B and C at 1st, 2nd and 3rd year, respectively.
€ 0
€ 300
€ 600
€ 900
€ 1.200
€ 1.500
Totalcost
AC IS HS SE Bs MICV-H
Othercosts
ApixabanDabigatran 110 mgDabigatran 150 mgRivaroxaban
€ 0
€ 600
€ 1.200
€ 1.800
€ 2.400
€ 3.000
Total cost AC IS HS SE Bs MICV-H
Othercosts
Apixaban
Dabigatran 110 mg
Dabigatran 150 mg
Rivaroxaban
€ 0
€ 800
€ 1.600
€ 2.400
€ 3.200
€ 4.000
€ 4.800
Totalcost
AC IS HS SE Bs MICV-H
Othercosts
ApixabanDabigatran 110 mgDabigatran 150 mgRivaroxaban
A.
C. B.
PCV39
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