To appraise the clinical and cost effectiveness of upadacitinib within its marketing authorisation for previously treated moderate active rheumatoid arthritis
 
Status In progress
Process STA 2018
ID number 3878

Project Team

Project lead Gavin Kenny

Email enquiries

Evidence Review Group / Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter

Consultees

Companies sponsors AbbVie (upadacitinib)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups National Rheumatoid Arthritis Society
Professional groups British Society for Rheumatology
  Royal College of Physicians
  Royal College of Radiologists
  UK Clinical Pharmacy Association

Commentators

Comparator companies Abbvie (adalimumab) (Confidentiality agreement not signed, not participating)
  Accord Healthcare (methotrexate) (Confidentiality agreement not signed, not participating)
  Amgen (adalimumab)
  Biogen (etanercept, infliximab biosimilar)
  Boehringer Ingelheim International GmbH (adalimumab) (Confidentiality agreement not signed, not participating)
  Bristol-Myers Squibb (abatacept)
  Celltrion (rituximab biosimilar) (Confidentiality agreement not signed, not participating)
  Concordia International (methotrexate) (Confidentiality agreement not signed, not participating)
  Genzyme, a sanofi company (sarilumab)
  hameln pharmaceuticals (methotrexate) (Confidentiality agreement not signed, not participating)
  Hospira (infliximab biosimilar, methotrexate) (Confidentiality agreement not signed, not participating)
  Janssen (golimumab, infliximab)
  Lilly (baricitinib)
  medac GmbH (methotrexate) (Confidentiality agreement not signed, not participating)
  Merck Sharp & Dohme (infliximab biosimilar) (Confidentiality agreement not signed, not participating)
  Napp (rituximab biosimilar, infliximab biosimilar) (Confidentiality agreement not signed, not participating)
  Nordic Pharma (methotrexate) (Confidentiality agreement not signed, not participating)
  Orion Pharma (methotrexate) (Confidentiality agreement not signed, not participating)
  Pfizer (tofacitinib, etanercept, methotrexate)
  Roche Products (tocilizumab, rituximab)
  Rosemont Pharmaceuticals (methotrexate) (Confidentiality agreement not signed, not participating)
  Sandoz (rituximab biosimilar, etanercept, methotrexate) (Confidentiality agreement not signed, not participating)
  Therakind (methotrexate) (Confidentiality agreement not signed, not participating)
  UCB Pharma (certolizumab pegol)
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
30 October 2020 In progress: Appraisal for severe disease available here. Following the committee discussion for upadacitinib for previously treated moderate to severe active rheumatoid arthritis on Wednesday 2 September 2020, the appraisal committee reached a conclusion to recommend the optimised use of upadacitinib for previously treated severe active rheumatoid arthritis. Also, the appraisal committee has reached a conclusion not to recommend upadacitinib for previously treated moderate active rheumatoid arthritis. Therefore, we have decided to split this appraisal into separate Single Technology Appraisals (STAs) for each population (moderate and severe disease). This is to ensure that people with severe active rheumatoid arthritis can have access to upadacitinib whilst the appraisal for moderate active rheumatoid arthritis continues. A final appraisal document (FAD) has been issued for severe disease [ID1400], and an second appraisal consultation document (ACD2) for moderate disease [ID3878] will be made available in due course. Appraisal for severe disease available here
03 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
31 January 2020 - 21 February 2020 Appraisal consultation: 1
04 February 2020 The company (AbbVie) has informed NICE that they intend to submit additional information in response to the ACD. Therefore, additional time will be needed by NICE to consider this information. The appraisal committee meeting will be rescheduled into the work programme and the updated appraisal committee meeting date will be communicated in due course.
07 January 2020 Committee meeting: 1
01 May 2019 Invitation to participate
24 September 2018 - 22 October 2018 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