Rheumatoid arthritis - tofacitinib [ID526]

Tofacitinib for the treatment of rheumatoid arthritis after the failure of disease modifying anti-rheumatic drugs

Status: Suspended
Expected date of issue: TBC
Referral date: May 2012
Process: STA

Scoped as part of Batch 22

Topic area:
  • Musculoskeletal

NICE project team

Executive Lead: Andrew Dillon
Technical Lead: Richard Diaz
Communications manager: Tonya Gillis
Project manager: Kate Moore


Provisional schedule

Closing date for invited submissions / evidence submission: TBC
1st appraisal committee meeting: TBC


Consultees and commentators

Consultees Commentators (no right to submit or appeal)


  • Pfizer (tofacitinib)

Patient/carer groups

  • Action on Pain
  • Afiya Trust
  • Arthritic Association
  • Arthritis & Musculoskeletal Alliance (ARMA)
  • Arthritis Care
  • Arthritis Research UK
  • BackCare
  • Black Health Agency
  • Counsel and Care
  • Equalities National Council
  • Leonard Cheshire Disability
  • Muslim Council of Britain
  • Muslim Health Network
  • National Rheumatoid Arthritis Society
  • Pain Concern
  • Pain Relief Foundation
  • South Asian Health Foundation
  • Specialised Healthcare Alliance

Professional groups

  • Association of Surgeons of Great Britain
  • British Association for Services to the Elderly
  • British Geriatrics Society
  • British Health Professionals in Rheumatology
  • British Institute of Musculoskeletal Medicine
  • British Institute of Radiology
  • British Orthopaedic Association
  • British Pain Society
  • British Society for Rheumatology
  • British Society of Rehabilitation Medicine
  • Physiotherapy Pain Association
  • Primary Care Rheumatology Society
  • Royal College of Anaesthetists
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians
  • Royal College of Radiologists
  • Royal College of Surgeons
  • Royal Pharmaceutical Society
  • Royal Society of Medicine
  • Society and College of Radiographers
  • United Kingdom Clinical Pharmacy Association


  • Berkshire PCT cluster
  • Department of Health
  • Bath & North East Somerset, and Wiltshire PCT Cluster
  • Southampton, Hampshire, Isle of Wight & Portsmouth PCT Cluster
  • Welsh Government


  • Board of Community Health Councils in Wales
  • British National Formulary
  • Care Quality Commission
  • Commissioning Support Appraisals Service
  • 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 Commercial Medicines Unit
  • NHS Confederation
  • Public Health Wales NHS Trust
  • Scottish Medicines Consortium

Comparator manufacturer(s)

  • AbbVie (adalimumab)
  • Actavis UK (azathioprine, sulfasalazine, penicillamine)
  • Alliance Pharmaceuticals (penicillamine)
  • Almus Pharmaceuticals (sulfasalazine)
  • Arrow Generics (azathioprine)
  • AstraZeneca (chloroquine)
  • Bristol-Myers Squibb (abatacept)
  • Focus Pharmaceuticals (azathioprine)
  • GlaxoSmithKline (azathioprine)
  • Kent Pharmaceuticals (azathioprine, sulfasalazine, penicillamine)
  • Merck Sharp & Dohme (golimumab, infliximab)
  • Mylan (azathioprine, sulfasalazine, penicillamine)
  • Novartis Pharmaceuticals UK (ciclosporin)
  • Pfizer (etanercept, sulfasalazine)
  • Roche Products (tocilizumab, rituximab)
  • Sandoz (azathioprine)
  • Sanofi (hydroxychloroquine, leflunomide, sodium aurothiomalate)
  • Teva UK (azathioprine, sulfasalazine, penicillamine)
  • UCB Pharma (certolizumab pegol)
  • Waymade Healthcare (sulfasalazine)

Relevant research groups

  • Chronic Pain Policy Coalition
  • Cochrane Musculoskeletal Group
  • MRC Clinical Trials Unit
  • National Institute for Health Research
  • Research Institute for the Care of Older People

Evidence Review Group

  • Centre for Reviews and Dissemination, York (CRD)
  • National Institute for Health Research Health Technology Assessment Programme

Associated Guideline Groups

  • National Clinical Guideline Centre

Associated Public Health Groups

  • None



Project history

Date Update
1 August 2013

The Department of Health asked the Institute to conduct an appraisal of tofacitinib for the treatment of moderate to severe active rheumatoid arthritis after failure of disease-modifying anti-rheumatic drugs and to provide guidance on its use to the NHS in England and Wales. 

The Institute has noted that the Committee for Medicinal Products for Human Use (CHMP) recently re-examined its initial negative opinion for tofacitinib and has confirmed the refusal of the marketing authorisation. Further information.

NICE has therefore decided to suspend this appraisal indefinitely.

As this topic has been referred to the Institute we will continue to monitor any developments and will provide an update if the situation changes.

07 May 2013

Following an update on the regulatory status of this technology which has received a negative CHMP opinion, we are suspending the appraisal whilst awaiting outcome of re-examination by CHMP.

We will update you further when more information is available.

27 December 2012 Due to an update from the manufacturer, this appraisal is currently paused as the regulatory process is ongoing.


Key documents

This page was last updated: 01 August 2013

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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.