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BioDrugs
Published in: BioDrugs 3/2014

Open Access 01-06-2014 | Original Research Article

The Cost Effectiveness of Biologic Therapy for the Treatment of Chronic Plaque Psoriasis in Real Practice Settings in Italy

Authors: Federico Spandonaro, Fabio Ayala, Enzo Berardesca, Sergio Chimenti, Giampiero Girolomoni, Patrizia Martini, Andrea Peserico, Barbara Polistena, Antonio Puglisi Guerra, Gino Antonio Vena, Gianfranco Altomare, Piergiacomo Calzavara Pinton

Published in: BioDrugs | Issue 3/2014

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Abstract

Background and Objectives

Biologic therapies are considered to be cost effective by leading Health Technology Assessment (HTA) agencies and, therefore, eligible for reimbursement by public health services. However, biologic therapies entail sizable incremental costs and, besides, have a considerable financial impact that in Italy amounts to 13.7 % of the national health service’s pharmaceutical expenditure. In the reimbursability decision process, an important role is played by both the drug efficacy data observed in pre-licensing RCTs and the economic modelling assumptions, as they give evidence on cost effectiveness. The administration of therapies in real practice settings is likely to produce a significant deviation from the results predicted by the models, theoretically outweighing the assumption on which the decision process is founded. This is a matter of concern for public health services and, consequently, an interesting topic to investigate.

Methods

To overcome the lack of knowledge concerning the actual cost effectiveness of biologic therapies for the treatment of plaque psoriasis in the clinical practice setting in Italy, an observational study was conducted in 12 specialist centres on patients switching to biologic therapy within a 6-month enrolment window.

Results

The study confirms in clinical practice the efficacy of the switch to biologic therapies, analysed using a number of clinical [Psoriasis Area and Severity Index (PASI), pain visual analogue scale (VAS) and itching VAS] and quality-of-life parameters. A general health-related quality of life (HR-QOL) improvement, with a 0.23 quality-adjusted life-year (QALY) mean gain per patient, has been reported in the 6-month observation period. The direct medical costs to treat plaque psoriasis with biologic therapies amount to €15,073.7 per year (prior to their enrolment, the same patients cost €2,166.2 on an annual basis). After the switch to biologic agents, the cost per QALY during the first year of treatment amounts to €28,656.3.

Conclusion

At least in the short-term, the clinical practice of the specialised Italian centres taking part in the study confirms that switching patients to a biologic drug produces an incremental cost-effectiveness ratio comparable with the values predicted by the HTA bodies.
Footnotes
1
The Psocare project was launched as part of a programme promoted by the Italian Agency of Drugs (AIFA) and organised in association with dermatology societies and patient associations, under the technical coordination of the GISED (Gruppo Italiano Studi Epidemiologici in Dermatologia) research centre. Psocare was based on the philosophy that the psoriasis treatment strategies devised thus far have resulted in the consolidation of habits or behaviour amongst doctors rather than in clear outcomes in terms of efficacy. The aim of the project was therefore to evaluate the long-term efficacy and safety of the treatments available. The approach used is based on comparisons between different care strategies, with a view to obtaining a realistic estimate of their benefits and risks. The information collected in the Psocare project is therefore of great value when evaluating the outcomes of the treatments provided to psoriatic patients.
 
2
To avoid statistical bias due to patients’ lack of memory regarding minute resource utilisation, data on laboratory services and visits were collected, asking for consumption in the previous 3 months, then assuming constant treatment.
 
3
Efalizumab, which was considered an alternative at the time the research protocol was devised, was not prescribed to any patient due to publication of a pharmacovigilance order by AIFA before enrolment started.
 
4
It should be noted that in real practice we observe switches between drugs, and that patients have been assigned to the drug group at enrolment (first biologic agent prescribed).
 
5
Consider that the average cost-effectiveness analysis in Italy amounted to €28,000. In the literature this is reported as £30,000 (approximately €36,000) [26].
 
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Metadata
Title
The Cost Effectiveness of Biologic Therapy for the Treatment of Chronic Plaque Psoriasis in Real Practice Settings in Italy
Authors
Federico Spandonaro
Fabio Ayala
Enzo Berardesca
Sergio Chimenti
Giampiero Girolomoni
Patrizia Martini
Andrea Peserico
Barbara Polistena
Antonio Puglisi Guerra
Gino Antonio Vena
Gianfranco Altomare
Piergiacomo Calzavara Pinton
Publication date
01-06-2014
Publisher
Springer International Publishing
Published in
BioDrugs / Issue 3/2014
Print ISSN: 1173-8804
Electronic ISSN: 1179-190X
DOI
https://doi.org/10.1007/s40259-014-0084-3

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