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Systemic lupus erythematosus (autoantibody-positive) - belimumab [ID416]

Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus

Status: In development
Expected date of issue: TBC
Referral date: November 2010
Process: STA
Notes:

Scoped within batch 14

Topic area:
  • Musculoskeletal
 

NICE project team

Executive Lead: Andrew Dillon
Technical Lead: Ella Fields
Communications manager: Tonya Gillis
Project manager:

Kate Moore

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Provisional schedule

Closing date for invited submissions / evidence submission: 13 April 2011
1st appraisal committee meeting: 26 July 2011
2nd appraisal committee meeting 22 February 2012
3rd appraisal committee meeting: 27 November 2012
4th appraisal committee meeting: 27 June 2013
5th appraisal committee meeting: TBC
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Consultees and commentators

 

Consultees

 

Commentators (no right to submit or appeal)

 

Manufacturers/sponsors

  • GlaxoSmithKline (belimumab)

Patient/carer groups

  • Lupus UK
  • National Kidney Federation

Professional groups

  • British Association of Dermatologists
  • British Health Professionals in Rheumatology
  • British Renal Society
  • British Society for Rheumatology
  • Primary Care Rheumatology Society
  • Renal Association
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians

Others

  • Department of Health
  • Welsh Government
  • NHS Bolton
  • NHS England

General

  • British National Formulary
  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • Health Improvement Scotland

Comparator manufacturer(s)

  • Baxter Healthcare (cyclophosphamide)(Confidentiality agreement not signed, not participating)
  • Pfizer (cyclophosphamide) (Confidentiality agreement not signed, not participating)
  • Roche Pharmaceuticals (rituxumab) (Confidentiality agreement not signed, not participating)

Relevant research groups

  • Arthritis Research UK
  • Cochrane Skin Group, Centre of Evidence-based Dermatology, University of Nottingham
  • Kidney Research UK

Evidence Review Group

  • National Institute for Health Research Health Technology Assessment Programme
  • Warwick Evidence

Associated guideline groups

  • None

Associated public health groups

  • None

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Project history

Date Update
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 new date 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 erythematosus has 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.

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Key documents

This page was last updated: 03 April 2014

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Selected, reliable information for health and social care in one place

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.