The cervical cancer vaccine Gardasil, sold in Europe by Sanofi Pasteur MSD, is going to be reimbursed in France but controversially coverage may depend on the patient’s sexual history.
The vaccine is being mandated for 14-year-old girls as in many countries, but girls and women aged 15 to 23 will qualify for 65%coverage from the French government only if they are virgins, or lost their virginity within the past year.
The human papilloma virus that is blamed for causing most cases of cervical cancer is sexually-transmitted, so the vaccine provides the best protection in girls or women who have never had sex. The policy has been established by the French health authorities, not the joint venture, which was set up by Merck & Co and Sanofi-Aventis.
Analysts have noted that sales of Gardasil will be boosted by the reimbursement decision though they might also be affected by the fact that girls and young women will face rather personal and indeed invasive questions about their sex lives.
Review date set for Merck & Co’s Isentress
Sticking with Merck and an advisory panel of the US Food and Drug Administration will meet to review the safety and efficacy of the firm’s investigational HIV treatment, Isentress (raltegravir), on September 5.
Merck is seeking approval for Isentress in combination with other antiretroviral agents for treatment-experienced patients with HIV-1, who have evidence of virus replication despite ongoing therapy.
The FDA granted the integrase inhibitor priority review last month, and a final decision is due to be made by mid-October.