ISPOR 18th Annual European Congress
PSS40
7-11 November 2015, Milan, Italy
Cost-effectiveness analysis of topical field treatment
therapies for the treatment of Actinic Keratosis in Greece
Athanasakis K1, Boubouchairopoulou N1, Tarantilis F1, Tsiantou V1, Kontodimas S2, Kyriopoulos J1
1Department
of Health Economics, National School of Public Health, Athens, Greece
2 LEO Pharmaceutical Hellas S.A, Athens, Greece
Introduction
 Actinic keratosis (AK) caused by chronic exposure to ultraviolet radiation, is
the most common premalignant dermatological disease in adults over 60.
Objective
 The objective of the present study was to perform a
 Topical field treatments are effective in clinical and subclinical lesions.
cost-effectiveness analysis of IM vs other topical
 There are currently three topical treatment options available in Greece:
alternatives for the treatment of AK from a Greek
diclofenac gel (3%), imiquimod (5%) and a recently launched agent:
healthcare perspective.
Ingenol mebutate gel (IM).
Methods
Decision-tree model:
Model Schematic
 The model considers a hypothetical cohort of
immunocompetent adult patients with clinically
confirmed AK covering an area on the face/scalp or
trunk/extremities.
 AK first-line treatments included IM (2-3 days) –IM
0,015% for the face/scalp and IM 0,05% for
trunk/extremities, imiquimod (5% for 4 or 8 weeks) –
scalp/face only and diclofenac (3% for 8 or 12
weeks) .
 24-month time horizon, divided in 6-month cycles.
 Greek third-party payer perspective.
Model inputs:
 Clinical data on the relative efficacy of the different strategies under consideration obtained from a network meta-analysis.
 Data concerning the resource use and reflecting the clinical practice derived from an expert panel.
Model outputs:
 Clinical effects, associated costs and incremental cost-effectiveness ratios (ICER) of AK first-line treatments.
Sensitivity analysis
 Univariate (Parameters that impact on the cost-effectiveness) (USA): Disutility for AE, pack price of IM, % referred to secondary care for
IM/for comparator, utility value for complete clearance, utility value for AK, probability of recurrence for IM, average AE duration for
comparator, log odds ratio of complete clearance for IM, number of primary care contacts for IM/for comparator.
 Probabilistic (PSA): Monte Carlo simulations. Costs and utilities were assumed to follow gamma distributions. Utilities and probabilities
were assumed to follow beta distributions.
Results
 IM 0.015% and 0.05% were both cost-effective compared to diclofenac
Cost-effectiveness analysis of IM vs. comparators:
cohort level analysis
and below a willingness- to-pay threshold of 30,000€/QALY :
o 7,857 €/QALY and 4,451 €/QALY gained for IM 0.015%
Comparators
ICER Ingenol
Mebutate(0.015%) VS.
ICER Ingenol
Mebutate(0.05%) VS.
Diclofenac 3%
(8 weeks)
7,857 €/QALY
8,473 €/QALY
Diclofenac 3%
(12 weeks)
4,451 €/QALY
3,626 €/QALY
Imiquimod 5%
(4 weeks)
22,964 €/QALY
Imiquimod 5%
(8 weeks)
787 €/QALY
Not relevant comparison
Imiquimod 5% is indicated
for the treatment of scalp
and face only
o 8,471 €/QALY and 3,626 €/QALY gained for IM 0.05%
compared to diclofenac 2xdaily for 8 and 12 weeks respectively).
 Comparing IM on face/scalp AK lesions for 3 days versus imiquimod (4
or 8 weeks) resulted in equivalent results (22,964€ and 787€/QALY
gained).
 USA: Key drivers of the model: utility inputs, price of IM, % referred for
treatment to secondary care, number of contacts associated with
administration. IM always remained a cost-effective strategy.
 PSA: At a willingness-to-pay threshold of 20,000€, IM 0.015% and
0.05% presented greatest probability of being optimal (probabilities
ranging from 22,5% to 88,3%)
Conclusion
From a social insurance perspective in Greece, IM 0.015% and IM 0.05% could be the most cost-effective first-line topical filed
treatment options in all cases for the treatment of Actinic Keratosis.
The study was supported by LEO Pharmaceutical Hellas S.A.