Status Complete
Process STA
ID number 416
Referral date November 2010
Topic area
  • Musculoskeletal

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Timeline

Key events during the development of the guidance:

Date Update
22 June 2016 Expected publication
22 June 2016 Guidance published
10 May 2016 - 24 May 2016 Final appraisal determination
05 May 2015 6th Appraisal Committee meeting is timetabled for 23 June 2015.
19 September 2014 The company, GlaxoSmithKline, has submitted additional evidence for this technology appraisal and a review of this evidence has been commissioned by the Evidence Review Group (ERG) and the Decision Support Unit (DSU). The additional evidence and the reports from the ERG and DSU will be discussed at the Technology Appraisal Committee meeting in Manchester on 14 October 2014.
16 October 2013

The manufacturer of belimumab, GlaxoSmithKline, requested to submit additional evidence in relation to the appraisal of belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus. This request has been considered and agreed by NICE (Section 3.5.34, Guide to the single technology appraisal process, October 2009).

To allow this evidence to be submitted and to commission a review of the new evidence, the next committee meeting will be arranged for early 2014. We will update this webpage when we have more specific timings for the appraisal.

30 July 2013 The committee meeting discussion of belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus, scheduled for 28 August 2013 has been delayed because of operational reasons. We will provide a further update with the rescheduled committee meeting discussion date in due course
11 April 2013 Following the committee meeting in November 2012, NICE has commissioned additional work from the Decision Support Unit (DSU). This additional work will be considered at a further committee meeting to be held on 27 June 2013.
11 October 2012

The manufacturer of belimumab, GlaxoSmithKline, has requested to submit additional analyses in relation to this appraisal. This request has been considered and NICE has agreed to accept this new evidence.

A committee discussion was scheduled for Wednesday 24 October 2012 for the Appraisal Committee to consider and address the issues on which the appeal was upheld. This discussion has now been rescheduled to enable the manufacturer to submit the additional analyses and for an evidence review of the new analyses to be undertaken. The next committee discussion for this appraisal is now scheduled for Tuesday 27 November 2012.

7 September 2012

The Appeal Panel met on 18 July 2012 to consider the appeals lodged by GlaxoSmithKline, Lupus UK and Primary Care Rheumatology Society against the Final Appraisal Determination (FAD) for this appraisal.

The Appeal Panel concludes that it upholds the appeal on two grounds. The first upheld point (ground one) was that the reasoning on whether a continuation rule based on an improvement of at least 6 points in the SELENA-SLEDAI score was appropriate was not sufficiently well explained in the FAD for appellant to engage fairly with the range of issues considered. The second upheld point (ground two) was that the conclusions in the FAD regarding the comparison of belimumab with rituximab were not reasonable in light of the evidence submitted.

A further committee discussion is scheduled for Wednesday 24 October 2012 at which the Appraisal Committee will consider and address the issues on which the appeal has been upheld.

12 December 2011

Following the cancellation of our November committee meeting, we are now able to confirm the newdate for the second committee meeting for this appraisal.

The second discussion of this topic will be at our committee meeting on 22 February 2012.

22 November 2011

Due to illness of the Committee chair, the Appraisal Committee meeting on 23 November 2011 to discuss belimumab for the treatment of active autoantibody-positive systemic lupus erythematosushas been cancelled. All alternative options were explored; however, we were unable to control for this situation.

The topics planned to be discussed at this meeting will be re-scheduled into the work programme. We will update here as soon as further details are available.

22 August 2011

Please note that the publication of the Appraisal Consultation Document (ACD) for belimumab has been postponed pending confirmation of ratification of the PPRS price.

The second committee meeting discussion, due to be held on 27 September 2011, has been cancelled.

We will update this webpage when we have more information on the timelines for this appraisal.


For further information on how we develop guidance, please see our page about NICE technology appraisal guidance