Reason for request

Renewal of inclusion on the list of proprietary medicinal products refundable by National Health Insurance. Further to the submission of new data and new vaccination recommendations from the Haut Conseil de la Santé Publique [High Council for Public Health (HCSP)], reassessment of the improvement in actual benefit, in compliance with Article R163-12 of the French Social Security Code. Inclusion on the list of medicines refundable by National Health Insurance and on the list of medicines approved for hospital use and various public services in the extension of indication: “premalignant genital lesions of the vagina”.


Clinical Benefit


The actual benefit offered by this vaccine remains substantial just in the MA indications recommended by the HCSP in the current vaccination schedule.

Clinical Added Value


The Committee believes that GARDASIL provides a moderate improvement in actual benefit (level III) in the strategy for preventing premalignant genital lesions (of the cervix, vulva and vagina) caused by certain types of oncogenic human papillomavirus and in preventing genital warts (condyloma acuminata) caused by specific types of HPV.

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