The UK Joint Committee on Vaccination and Immunisation (JCVI) has decided not to recommend Novartis' Bexsero for inclusion in the National Immunisation Programme at this time, and does not believe that the decision is in the interest of the public. Key feedback included in the JCVI interim position states that Bexsero is unlikely to prove cost-effective based on the current method of evaluation in the UK.
Novartis is disappointed by the interim position and was not asked for pricing information as part of the JCVI deliberation and intends to provide related input prior to the recommendation being finalized.
"The interim position by the JCVI is inconsistent with its recommendations for other meningococcal vaccines. The meningitis C vaccination campaign in the UK, following JCVI recommendation, was a tremendous public health success saving thousands from serious illness and death," said Andrin Oswald, division head, Novartis Vaccines and Diagnostics. "It is disappointing to see that the decision was mostly driven by financial considerations and without any pricing discussion with Novartis. The evaluation model does not do justice to the vaccine's ability to prevent babies and young children from dying or surviving with severe lifelong disabilities."
In January 2013, the EMA licensed Bexsero for active immunization of individuals from two months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. Results from robust phase III studies have confirmed the Bexsero safety and immunogenicity profile. Bexsero clinical trials have involved more than 8,000 people receiving at least one dose of the vaccine.
Novartis believes that the current method of evaluating the cost-effectiveness of Bexsero fails to fully capture the lifetime benefits of disease prevention and undervalues technologies that prevent diseases.
In the UK, children continue to die and suffer each year from meningitis B disease. Until Bexsero is included on the routine immunization schedule, which provides broad access to vaccines for children, meningitis B will remain a threat for youth in the UK causing needless death and disability. Bacterial meningitis and septicemia kill more children under five than any other infectious disease in the UK.
The repercussions of meningitis B disease for patients and families affected as well as national healthcare systems are significant. Bexsero is the only broad coverage vaccine against this often devastating disease, which can kill within 24 hours or cause serious, life-long disabilities. Prevention through vaccination is therefore the only defense against an aggressive disease that leaves little time for intervention.
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