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UK's NICE Rebuffs Glaxo's New Lupus Drug Benlysta

LONDON -(Dow Jones)- Lupus drug Benlysta from GlaxoSmithKline PLC (GSK, GSK.LN) and U.S.-based partner Human Genome Sciences Inc. (HGSI) doesn't represent value for money and should therefore not be made available on the publicly-funded National Health Service, Britain's healthcare watchdog NICE said on Friday. Benlysta, or belimumab, is the first new lupus treatment in 50 years. It won U.S. marketing approval in March and European approval in July. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. An estimated five million people worldwide have the disease. In draft guidance, the U.K.'s National Institute for Health and Clinical Excellence said, "NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE [Systemic lupus erythematosus], including the views of people with the condition, those who represent them, and clinical specialists. "The evidence considered did not persuade the committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high." NICE also said Benlysta should be compared with rituximab, sold by Roche Holding AG (ROG.VX), because some people with severe lupus currently receive rituximab, although it isn't licensed for this use. However, NICE noted there were no reliable data to show the relative efficacy of the two drugs. "Whilst recognizing the severity of the disease, the committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation," the agency said. --By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; [email protected]

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