Suggested remit: To appraise the clinical and cost effectiveness of efgartigimod within its marketing authorisation for treating generalised myasthenia gravis.
 
Status In progress
Technology type Medicine
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process STA Standard
ID number 4003

Project Team

Project lead Louise Jafferally

Email enquiries

External Assessment Group Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Stakeholders

Companies sponsors Argenx (efgartigimod)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Muscular Dystrophy UK
  Myaware
Professional groups British Society for Clinical Neurophysiology
  Royal College of Physicians
  UK Clinical Pharmacy Association
Comparator companies Accord UK (azathioprine, methotrexate, mycophenolate mofetil) – confidentiality agreement not signed, not participating
  Advanz pharma (methotrexate) – confidentiality agreement not signed, not participating
  Alliance pharmaceuticals (neostigmine) – confidentiality agreement not signed, not participating
  Aspen (azathioprine) – confidentiality agreement not signed, not participating
  Bio Products Laboratory (plasma exchange) – confidentiality agreement not signed, not participating
  Biotest UK (plasma exchange) – confidentiality agreement not signed, not participating
  Cipla EU (methotrexate) – confidentiality agreement not signed, not participating
  CSL Behring UK (human immunoglobulin, plasma exchange) – confidentiality agreement not signed, not participating
  Dexcel Pharma (ciclosporin) – confidentiality agreement not signed, not participating
  Ennogen Pharma (azathioprine) – confidentiality agreement not signed, not participating
  Grifols UK (human immunoglobulin, plasma exchange) – confidentiality agreement not signed, not participating
  Healthcare pharma (azathioprine) – confidentiality agreement not signed, not participating
  Hospira UK (methotrexate) – confidentiality agreement not signed, not participating
  Medac GmBH (methotrexate) – confidentiality agreement not signed, not participating
  Mylan (azathioprine, ciclosporin, pyridostigmine) – confidentiality agreement not signed, not participating
  Napp Pharmaceutical (rituximab) – confidentiality agreement not signed, not participating
  Nordic Pharma (methotrexate) – confidentiality agreement not signed, not participating
  Nova laboratories (azathioprine) – confidentiality agreement not signed, not participating
  Novartis (ciclosporin, mycophenolate mofetil)
  Octapharma (plasma exchange) – confidentiality agreement not signed, not participating
  Orion Pharma (methotrexate) – confidentiality agreement not signed, not participating
  Pfizer (methotrexate, rituximab) – confidentiality agreement not signed, not participating
  Roche (mycophenolate mofetil, rituximab) – confidentiality agreement not signed, not participating
  Sandoz (methotrexate, mycophenolate mofetil, rituximab) – confidentiality agreement not signed, not participating
  Teva UK (mycophenolate mofetil, plasma exchange) – confidentiality agreement not signed, not participating
  Tillomed laboratories (azathioprine, mycophenolate mofetil) – confidentiality agreement not signed, not participating
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
  Medicines and Healthcare Products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
05 December 2024 Committee meeting: 4
17 October 2024 Please note the confirmed date for a further committee meeting of 5 December 2024.
23 September 2024 For unforeseen operational reasons, the meeting planned for 3 October 2024 will not be going ahead. NICE is urgently investigating alternative options, and will confirm when we have any information to share about a revised committee discussion date.
06 September 2024 Please note the confirmed date for a further committee meeting of 3 October 2024.
14 August 2024 This appraisal is still paused while further information from the company is being considered. We will provide an update in August 2024.
06 June 2024 Declaration of interests
17 May 2024 Following the committee meeting on 9 May 2024, this appraisal will be paused while further information is provided by the company. An update is expected in June 2024.
09 May 2024 Committee meeting: 3
12 December 2023 - 29 February 2024 Draft guidance: 2
29 January 2024 Please note the consultation on the second draft guidance has been extended to 5pm on Thursday 29 February 2024.
16 November 2023 Committee meeting: 2
01 September 2023 - 22 September 2023 Draft guidance
10 August 2023 Committee meeting
30 November 2022 Invitation to participate
03 May 2022 (14:00) Scoping workshop
15 March 2022 - 12 April 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
15 March 2022 In progress. Scoping commenced
24 November 2021 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

For further information on our processes and methods, please see our CHTE processes and methods manual