Trade Resources Industry Views UK Health and Social Care Guidance Body NICE Has Again Rejected Benlysta

UK Health and Social Care Guidance Body NICE Has Again Rejected Benlysta

UK health and social care guidance body NICE has again rejected GlaxoSmithKline's (GSK) belimumab (Benlysta) as an add-on therapy in adults with active, autoantibody-positive systemic lupus erythematosus (SLE).

Commenting on the second draft guidance consultation in the belimumab appraisal, NICE chief executive Sir Andrew Dillon said the independent appraisal committee doesn't recommend belimumab because the evidence considered did not persuade it was good value for money.

"However, there were no reliable data to show the relative efficacy of belimumab compared with rituximab," Dillon added.

"Without this, the Committee could not reach a conclusion as to the cost effectiveness of belimumab compared with rituximab."

In September 2011, the first consultation also did not recommend belimumab, but was again taken up for second appraisal following an appeal in July 2012 on the final draft guidance (FAD).

Benlysta has been approved in the US, Canada and Europe.

Currently around 15,000 people in England and Wales are suffering with SLE, with 90% of cases occurring in women. 

 

 

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/uk-nice-rejects-gsks-benlysta-for-systemic-lupus-erythematosus-250713
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UK Nice Rejects GSK's Benlysta for Systemic Lupus Erythematosus