Belimumab for Treating Active Autoantibody-Positive Systemic Lupus Erythematosus (TA397)

Technology Appraisal Guidance No. 397

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Belimumab is recommended as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in adults only if all of the following apply:

  • There is evidence for serological disease activity (defined as positive anti-double-stranded DNA and low complement) and a Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of greater than or equal to 10 despite standard treatment.

  • Treatment with belimumab is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more.

  • The company provides belimumab with the discount agreed in the patient access scheme.

  • Under the conditions for data collection, monitoring, patient eligibility and consent, ongoing treatment, cost to the NHS, and review by NICE as laid out in sections 5 and 6 of this document.

1.2 This guidance is not intended to affect the position of patients whose treatment with belimumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email:

Belimumab for treating active autoantibody-positive systemic lupus erythematosus

Issue Date: June 2016

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