U.K. rejection of Bexsero hits Novartis vaccine unit

Bringing a new vaccine to market in Europe is tough. After winning approval at the European level, manufacturers must show the value of the product to national decision makers. Novartis ($NVS) is in the middle of this process with its meningitis B vaccine, and still has a long way to go.

After receiving European approval for meningitis B vaccine Bexsero in January, Novartis looked to the United Kingdom as a possible early adopter. However, the U.K. Joint Committee on Vaccination and Immunisation (JCVI)--a similar body to the National Institute for Health and Care Excellence (NICE)--has advised against adding Bexsero to the routine vaccination program. The decision could have significant consequences for Novartis' struggling vaccine business, which was the only unit at the Swiss pharma to post an operating loss in the last quarter, Reuters reports.

"Today's decision represents a material setback to Novartis's beleaguered vaccine division. In the absence of a successful appeal, Bexsero revenue will likely be restricted to a minimal private-payer market. More importantly, it could force Novartis to sell, partner or more likely integrate its vaccine business within its pharmaceutical infrastructure," Citi analyst Andrew Baum said. Novartis expressed its disappointment with the decision, which it viewed as being more related to financial considerations than effectiveness. The company plans to submit price information before the decision is finalized, but this may prove insufficient to prompt a rethink by JCVI.

After considering two cost-effectiveness analyses--one independent, one from Novartis--JCVI concluded Bexsero is highly unlikely to meet U.K. value criteria at any price. JCVI also noted that antibody responses from Bexsero wane rapidly and its efficacy against disease is yet to be established. If Novartis is to overturn the decision, it must allay some of the concerns expressed by JCVI. "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," Department of Health immunization director David Salisbury said.

- here's the Reuters article
- read the JCVI ruling
- check out the Guardian Q&A
- view the BBC's take