Committee rules against UK use of Novartis' meningitis B vaccine Bexsero

The UK's Joint Committee on Vaccination and Immunisation (JCVI) recommended Wednesday against including Novartis' meningitis B vaccine Bexsero on routine immunisation programmes as it is unlikely to be cost-effective. Bexsero was approved in Europe in January to protect individuals from 2 months of age and older against meningococcal serogroup B disease, making it the first vaccine authorised in the region to prevent meningitis B.

However, in its interim decision, the JCVI said the vaccine has been licensed "in the absence of key data to support an assessment of effectiveness and cost-effectiveness." The committee added that "on the basis of the available evidence, routine infant or toddler immunisation using Bexsero is highly unlikely to be cost-effective at any vaccine price based on the accepted threshold for cost-effectiveness used in the UK and could not be recommended." The JCVI suggested that the vaccine could be given to people who are at particularly high risk of meningitis B and also laboratory workers who could be exposed to the infection.

David Salisbury, director of immunisation at the Department of Health, remarked "this is a very difficult situation where we have a new vaccine against meningitis B but we lack important evidence." He said "we need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person." Salisbury added "we need to work with the scientific community and the manufacturer to find ways to resolve these uncertainties so that we can come to a clear answer."

In response to the decision, Andrin Oswald, head of Novartis' vaccines and diagnostics unit, commented that "it is disappointing to see that the decision was mostly driven by financial considerations and without any pricing discussion with Novartis." The drugmaker said it believes that the current method of evaluating the cost-effectiveness of the vaccine fails to "fully capture the lifetime benefits of disease prevention and undervalues technologies that prevent diseases." The company added that it would supply information on pricing before the JCVI's recommendation is finalised.

Citi analyst Andrew Baum remarked that the ruling "represents a material setback to Novartis' beleaguered vaccine division. In the absence of a successful appeal, Bexsero revenue will likely be restricted to a minimal private-payer market." He noted that "more importantly, it could force Novartis to sell, partner or more likely integrate its vaccine business within its pharmaceutical infrastructure."

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