ABSTRACT
Objective: Genital warts are caused by human papillomavirus (HPV), principally types 6 and 11, and are highly contagious. This study assessed treatment patterns and costs of management of genital warts in Italy.
Research design and methods: This was a retrospective, observational study conducted among gynaecologists, dermatologists, and specialists at sexually transmitted disease clinics in Italy. Resource-use data related to genital warts were collected for patients at risk in the age range 14–64 years examined during 2005. Unit costs were assigned to resource use to provide estimates of the direct, indirect and total costs per case of genital warts.
Results: Twenty-eight investigators enrolled 341 patients aged 15–64 years, including 194 (56.9%), 81 (23.7%) and 66 (19.4%) patients with newly diagnosed, recurrent and resistant genital warts, respectively. Most patients (333/341; 97.7%) had at least one outpatient visit, while 43 (12.6%) patients were hospitalised, including 39 patients without an overnight stay (day-hospital cases, 11.4%). Self-applied medication was prescribed for 124 (36.4%) patients. Most outpatient cases (267/333; 80.2%) underwent an office-based procedure. Mean annual direct medical costs per patient, which were funded predominantly by the Italian National Health Service (there was some patient co-payment), were €242 for men and €332 for women. When productivity losses were included, mean total annual costs were €325 for men and €464 for women.
Conclusions: This is the first study of treatment patterns and costs for genital warts in Italy. Treatment patterns differ in some respects from those observed in other European countries, but costs generally appear similar. Despite the limitations of physician selection bias and over-representation of North Italy in the patient sample, the findings of this study may be useful in estimating the cost-effectiveness of introducing a quadrivalent HPV vaccination programme in Italy.
Acknowledgements
Declaration of interest: This study was funded by sanofi pasteur MSD SNC (Lyon, France). N. L. and C. C. are employed by sanofi pasteur MSD; they co-ordinated the study and validated the analysis and the study-report. Statistical analysis was funded by sanofi pasteur MSD and was provided by M. M. and L. T. (employed by Informa, Rome). F. B., A. M., L. N. and G. V. were members of the Scientific Study Committee and declare having received fees to be on the Advisory Board for sanofi pasteur MSD; they validated the protocol, design and final results of the study. All authors reviewed and approved the final version of the article. The authors would like to thank: Laurence Serradell, sanofi pasteur MSD, Lyon, France and Dario Corsini, Informa, Rome, Italy for their help in co-ordinating the study; Sarah Whitfield and Vijan Iyer, Communigen Ltd, Oxford, UK for medical writing support that was funded by sanofi pasteur MSD; and Alessandro Capone, Cristiana Conti Puorger and Maura Ilardi, sanofi pasteur MSD, Roma, Italy for their comments on a previous draft of this manuscript.
Notes
* Gardasil is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA
† The members of the Scientific Study Committee are: Dr Fausto Boselli, Dr Alberto Matteelli, Dr Luigi Naldi and Dr Giorgio Vittori
* Aldara is a registered trademark of 3M Health Care Limited, Loughborough, UK