To appraise the clinical and cost effectiveness of adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept within their marketing authorisations for treating moderate rheumatoid arthritis.
 
Status In progress
Process MTA Review
ID number 2710

Provisional Schedule

Final appraisal document 10 June 2021 - 24 June 2021
Expected publication 14 July 2021

Project Team

Project lead Louise Jafferally

Email enquiries

Evidence Review Group / Assessment Group School of Health and Related Research (ScHARR), University of Sheffield

Consultees

Companies sponsors AbbVie (adalimumab originator)
  Amgen (adalimumab biosimilar)
  Biogen (adalimumab biosimilar, etanercept biosimilar, infliximab biosimilar)
  Bristol–Myers Squibb (abatacept)
  Celltrion Healthcare United Kingdom Limited (infliximab biosimilar)
  Fresenius-Kabi (adalimumab biosimilar)
  Pfizer (etanercept originator, infliximab biosimilar)
  Sandoz (adalimumab biosimilar, etanercept biosimilar, infliximab biosimilar)
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

Commentators

Comparator companies Pfizer (methotrexate, sulfasalazine) (confidentiality agreement signed, participating)
  Accord Healthcare (methotrexate, hydroxychloroquine sulfate) (confidentiality agreement not signed, not participating)
  Advanz Pharma (methotrexate) (confidentiality agreement not signed, not participating)
  Aspire Pharma Ltd (leflunomide) (confidentiality agreement not signed, not participating)
  Blackrock Pharmaceuticals (hydroxychloroquine sulfate) (confidentiality agreement not signed, not participating)
  Bristol Laboratories Ltd (hydroxychloroquine sulfate) (confidentiality agreement not signed, not participating)
  Cipla (methotrexate) (confidentiality agreement not signed, not participating)
  Hospira UK (methotrexate) (confidentiality agreement not signed, not participating)
  Ipca Laboratories (hydroxychloroquine sulfate) (confidentiality agreement not signed, not participating)
  Medac (methotrexate, leflunomide) (confidentiality agreement not signed, not participating)
  Mylan (leflunomide) (confidentiality agreement not signed, not participating)
  Nordic Pharma Limited (methotrexate) (confidentiality agreement not signed, not participating)
  Orion Pharma (methotrexate) (confidentiality agreement not signed, not participating)
  Rosemont (methotrexate, sulfasalazine) (confidentiality agreement not signed, not participating)
  Sandoz (methotrexate, leflunomide) (confidentiality agreement not signed, not participating)
  Sanofi (leflunomide) (confidentiality agreement not signed, not participating)
  Therakind Limited (methotrexate) (confidentiality agreement not signed, not participating)
  Tillomed Laboratories (leflunomide) (confidentiality agreement not signed, not participating)
  Zentiva (hydroxychloroquine sulfate) (confidentiality agreement not signed, not participating)
General commentators All Wales Therapeutics and Toxicology Centre
  British Biosimilar Association
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
31 March 2021 - 28 April 2021 Appraisal consultation
10 March 2021 Committee meeting: 1
14 January 2021 Assessment report sent for information
03 September 2020 Invitation to participate
20 August 2020 The Invitation to Participate for this appraisal will be sent out during the week commencing 31 August 2020. The final Scope and Stakeholder list will be published on the NICE website at the same time.
31 March 2020 Due to operational reasons, there will be a slight delay to the start of the appraisal. We are aiming to send out the Invitation to Participate in early April 2020 with an anticipated evidence submission deadline to NICE in May 2020.
12 March 2020 Regarding the decision taken in September 2019 to conduct a partial review of TA375 for patients with moderate disease only https://www.nice.org.uk/guidance/ta375/evidence/review-decision--september-2019-6904907821?tab=evidence, the appraisal is now anticipated to begin during March 2020, with an anticipated evidence submission deadline to NICE of April 2020. For further information please visit the NICE webpage: https://www.nice.org.uk/guidance/proposed/gid-ta10586
10 January 2020 In progress. Decision to conduct a partial review of TA375

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