Suggested remit: To appraise the clinical and cost effectiveness of anifrolumab within its marketing authorisation for treating systemic lupus erythematosus (active, autoantibody positive)
Status In progress
Process STA 2018
ID number 3804

Provisional Schedule

Committee meeting: 1 10 February 2022
Expected publication 27 April 2022

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group Kleijnen Systematic Reviews Ltd


Companies sponsors AstraZeneca (anifrolumab)
Others Department of Health and Social Care
  NHS England
  NHS Lincolnshire West CCG
  NHS Mansfield and Ashfield CCG
  Welsh Government
Patient carer groups Action on Pain
  Anticoagulation UK
  AOFAC Foundation
  Arthritis and Musculoskeletal Alliance
  Arthritis Action
  Black Health Agency for Equality
  British Sjögren’s Syndrome Association
  Genetic Alliance UK
  Kidney Alliance
  Kidney Care UK
  Lupus Trust
  Lupus UK
  Pain Concern
  Pain UK
  National Kidney Federation
  National Rheumatoid Arthritis Society
  Scleroderma and Raynaud's UK
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Thrombosis UK
  Versus Arthritis
Professional groups Association of British Neurologists
  Association of Genetic Nurses & Counsellors
  Association of Renal Industries
  Association of Renal Technologists
  British Association for Surgery of the Knee
  British Dermatological Nursing Group
  British Geriatrics Society
  British Institute of Musculoskeletal Medicine
  British Isles Lupus Assessment Group
  British Myology Society
  British Orthopaedic Association
  British Orthopaedic Foot and Ankle Society
  British Pain Society
  British Renal Society
  British Skin Foundation
  British Society for Allergy and Clinical Immunology
  British Society for Gene and Cell Therapy
  British Society for Genetic Medicine
  British Society for Haematology
  British Society of Haemostasis and Thrombosis
  British Society for Human Genetics
  British Society for Rheumatology
  British Society of Rehabilitation Medicine
  British Thoracic Society
  British Urological Foundation
  Clinical Leaders of Thrombosis
  Physiotherapy Pain Association
  Primary Care Dermatology Society
  Primary Care Rheumatology and Musculoskeletal Medicine Society
  Renal Association
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society for Endocrinology
  Society for Vascular Technology
  Society for Vascular Ultrasound
  Society of Vascular Nurses
  The Vascular Society of Great Britain and Ireland
  UK Clinical Pharmacy Association
  UK Primary Immunodeficiency Network
  UK Renal Pharmacy Group
  Urology Foundation


Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare (hydroxychloroquine, methotrexate, mycophenolate mofetil, prednisolone)
  ADVANZ Pharma (methotrexate, prednisolone)
  Aspen (azathioprine)
  Baxter Healthcare (cyclophosphamide)
  Blackrock Pharmaceuticals (hydroxychloroquine)
  Bristol Laboratories (hydroxychloroquine)
  Cipla EU (methotrexate)
  GlaxoSmithKline (belimumab)
  Hospira UK (methotrexate)
  Ipca Laboratories (hydroxychloroquine)
  Logixx Pharma Solutions (prednisolone)
  Medac GmbH (methotrexate)
  Morningside Healthcare (methotrexate)
  Mylan (azathioprine)
  Napp Pharmaceuticals (rituximab)
  Nordic Pharma (methotrexate)
  Orion Pharma (methotrexate)
  Pfizer (methotrexate, rituximab)
  Phoenix Labs (prednisolone)
  Roche Pharmaceuticals (mycophenolate mofetil, rituximab)
  Sandoz GmbH (cyclophosphamide, rituximab)
  Teva Pharma (mycophenolate mofetil)
  Tillomed Laboratories (azathioprine, mycophenolate mofetil)
  Wockhardt UK (prednisolone)
  Zentiva (hydroxychloroquine, prednisolone)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Cell and Gene Therapy Catapult
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  NHS England Specialised Rheumatology Clinical Reference Group
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
  Welsh Kidney Patients Association
Relevant research groups Bone Research Society
  British Epidermo-Epidemiology Society
  British Society for Immunology
  Centre of Evidence-Based Dermatology, University of Nottingham
  Chronic Pain Policy Coalition
  Cochrane Cystic Fibrosis & Genetic Disorders Group
  Cochrane Musculoskeletal Group
  Cochrane Skin Group
  Cochrane Vascular
  Genomics England
  Kidney Research UK
  MRC Clinical Trials Unit
  National Institute for Health Research
  Orthopaedic Research UK
  Pain Relief Foundation
  Skin Treatment and Research Trust
  Thrombosis Research Institute


Key events during the development of the guidance:

Date Update
10 June 2021 Invitation to participate
10 June 2021 In progress. In progress.
05 March 2021 The Department for Health and Social Care has asked NICE to conduct an appraisal of anifrolumab for treating active autoantibody-positive systemic lupus erythematosus. Please note that following on from a request from the company, the timelines for this appraisal have been revised to facilitate a suitably comprehensive submission. The invitation to participate is now scheduled to be sent out in early June 2021 with submissions due in early August 2021. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
24 November 2020 - 21 December 2020 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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