A guarded yes to Gardasil – and a door open to Cervarix
pharmafile | July 17, 2007 | News story | Sales and Marketing |Â Â Â
After 18 months of deliberation by an expert committee, the UK government has agreed in principle that girls aged 12-13 should be given Gardasil, the vaccine which cuts incidence of cervical cancer by up to 70%.
But even if and when a final decision is made, it is likely to be autumn 2008 before the vaccine is routinely given to girls in the UK.
Experts on the Joint Committee on Vaccines and Immunisation (JCVI) recommended Gardasil last month, but the government has held back from giving the jab its definitive approval, saying that further cost-effectiveness data is needed before a final decision is made.
Already lagging behind other European countries in adding the vaccine to its immunisation schedule, the UK is thought to be the only EU nation asking for further cost-effectiveness data.
Manufacturer Sanofi-Pasteur MSD said Gardasil's cost-effectiveness is already clear, but it has submitted a NICE-style health technology document to the committee.
Richard Stubbins, Managing Director of the UK company, commented: "This announcement by the JCVI is a welcome first step towards protecting the women of the UK against human papillomavirus, which is the cause of cervical cancer and a whole range of other conditions, such as vulval cancer and genital warts."
But he added: "It is surprising that a final decision will not be taken until later in the year, despite data showing that the vaccine is highly cost-effective."
Minutes of the JCVI meeting, which have been made publicly available, suggest one major reason for delaying the final decision further is to allow GSK to launch its rival product, Cervarix.
GSK is expected to launch Cervarix in the UK by late 2007/early 2008, and having two rival products will help the expert committee evaluate their relative merits and give the government bargaining power on the cost.
Richard Stubbins told Pharmafocus that the introduction of the vaccine nationally will require a a great deal of planning and preparation at a local NHS level, with the company aiming to raise awareness among health service chief executives and public health leaders.
The company is reluctant to criticise the UK process, but Stubbins expressed his disappointment that another whole year of 12-13 year-old girls, who have the potential of being exposed to the virus, would go unvaccinated this year.
The provision of a catch-up vaccination to girls who are a little bit older is also recommended by the company, but this is not currently being considered in the UK, in contrast to some other European countries.
Stubbins added that his company was still in the dark as to how the JCVI process worked: "We don't know their agenda, we don't know their priorities and we don't know where we are in the process."
He also called for a new, unified plan for public health and vaccination, a subject on which the government has published nothing since 2002.
Gardasil and Cervarix are just two of a number of new vaccines expected to emerge from pipelines in the next few years. These promise to transform public health and healthcare, but funding and the health service infrastructure will need to adapt if they are to successfully accommodate the new vaccines.
