HPV vaccination in France: Uptake, costs and issues for the National Health Insurance
Introduction
The quadrivalent vaccine Gardasil® (Sanofi Pasteur MSD) has been given European marketing authorisation on 20 September 2006. Gardasil® is effective against precancerous lesions in the genital area, cancer of the cervix and genital warts that are caused by infection with the HPV types 6, 11, 16 or 18. One year later, the European Commission also authorised throughout the European Union the bivalent vaccine Cervarix® (GlaxoSmithKline) to be marketed to protect against precancerous lesions in the cervix and cancer of the cervix that are caused by infection with HPV types 16 or 18.
Three doses are required within a 6-month period for complete vaccination. Both vaccines have demonstrated high efficacy [1], [2] against persistent infection due to genotypes 16 or 18 which collectively are associated with 70% of all cervical cancers. They were also highly efficient against 16/18-related precancerous lesions [1], [2]. Since HPV vaccines do not eliminate the risk of cervical cancer, cervical screening will still be required to minimize cervical cancer incidence. Screening is cytologic and still individual in most areas in France. However in July 2010, the French National Authority for Health has recommended to implement a national organized screening program [3].
In France the permanent Vaccines Advisory Committee (Comité Technique des vaccinations) and the Superior Council for Public Hygiene (Conseil Supérieur d’Hygiène Publique de France) have published guidelines about Gardasil® vaccination against HPV 6, 11, 16 and 18 on 9 March 2007 [4]. Currently, these guidelines recommend vaccination of girls from the age of 14 years in order to protect them before being exposed to the risk of infection with HPV. However, no school-based program was implemented. The guidelines further recommend offering vaccination to girls and women aged 15–23 who have not yet had sexual relations, or in the year following the start of their sexual activity at the latest. Recommendations about Cervarix® vaccination have been published on 14 December 2007 [5], with a preference for the quadrivalent vaccine to prevent morbidity and mortality related to oncogenic HPV types as defined in March 2007 recommendations. However, the latest guidelines published in December 2010 no longer indicate a preference for one or the other vaccine [6]. Gardasil® and Cervarix® have been reimbursed in France since 11 July 2007 and 8 July 2008 respectively. One and half year later, Gardasil® was already the fifth drug in 2008 in terms of annual spending of the general scheme of the French National Health Insurance [7].
The purpose of this study is to provide data on vaccination coverage and costs in France until 31 December 2009. In addition, the current vaccination coverage rate is compared with the coverage rates assumed in cost-effectiveness studies.
Section snippets
Methods
Data were extracted from the National Health Insurance Information System (SNIIRAM: Système national d’information inter régimes de l’Assurance maladie) [8], [9], which contains individualized and anonymous data on all health spending reimbursements for the whole French population since 2004. According to the French law these individual data can be stored for a maximum period of 2 years plus the year being. Any form and dosage of a reimbursed medication is coded with a specific 7-digit number.
Results
The total number of females in the target and catch-up groups was 4.2 million in the general scheme of National Health Insurance. Overall, 1,204,588 girls and young women have been reimbursed for at least one vaccine dose on 31 December 2009, of these 96.5% were 14–23 years old during the study period.
Discussion
At the end of 2009, HPV vaccination of the target population as well as of the catch-up population is insufficient in France. Overall, only an average of 28.5% of girls at the target age of 14 years has been vaccinated with 3 doses in 2007 and 2008. Even if success of vaccination could theoretically be measured only after several years – a large part of the target group has been vaccinated after the age of 14 as shown in Fig. 5 – it is questionable whether the coverage rate for 3 doses in the
Conclusion
HPV vaccine coverage rates in France are much lower than expected. Reasons for this might have to do with both acceptability and affordibility of the vaccines. Considering the low coverage rate, the cost-effectiveness of vaccination in combination with opportunistic screening or organized screening needs to be re-evaluated. Other assumptions in models might be useful, such as the eventuality of booster doses and lower prices for these vaccines in order to be as compatible as possible with the
Acknowledgements
The authors thank Saskia Van Der Erf for assistance in the writing of this paper.
Conflict of interest: JPF, AB, PR, AW, HA declare no conflict of interest.
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