Suggested remit: To appraise the clinical and cost effectiveness of rozanolixizumab within its marketing authorisation for treating antibody-positive 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 5092

Provisional Schedule

Committee meeting: 2 12 December 2024

Project Team

Project lead Jeremy Powell

Email enquiries

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

Stakeholders

Companies sponsors UCB Pharma (rozanolixizumab)
Others Department of Health and Social Care
  NHS England
Patient carer groups Muscular Dystrophy UK
  Myaware
Professional groups Association of British Neurologists
  Royal College of Physicians
  UK Clinical Pharmacy Association
Comparator companies Accord UK – not participating
  Advanz pharma – not participating
  Alexion Pharma (ravulizumab)
  Alliance pharmaceuticals – not participating
  Argenx (efgartigimod)
  Aspen – not participating
  Bio Products Laboratory – not participating
  Biotest UK – not participating
  Cipla EU – not participating
  CSL Behring UK – not participating
  Dexcel Pharma – not participating
  Ennogen Pharma – not participating
  Grifols UK – not participating
  Healthcare pharma – not participating
  Hospira UK – not participating
  Medac GmBH – not participating
  Mylan – not participating
  Napp Pharmaceutical – not participating
  Nordic Pharma – not participating
  Nova laboratories – not participating
  Novartis (ciclosporin, mycophenolate mofetil)
  Octapharma – not participating
  Orion Pharma – not participating
  Pfizer – not participating
  Roche (mycophenolate mofetil, rituximab)
  Sandoz – not participating
  Teva UK – not participating
  Tillomed laboratories – 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 Government
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
13 September 2024 - 04 October 2024 Draft guidance: 1
14 August 2024 Committee meeting
14 August 2024 Declaration of interests
02 May 2024 This appraisal will now be discussed at the Committee B meeting on 14 August 2024.
09 January 2024 Invitation to participate
15 September 2023 Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin during early January 2024 when we will write to you about how you can get involved.
02 June 2023 - 30 June 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 5092
07 July 2022 In progress. DHSC referral received
04 May 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
22 March 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
22 March 2022 Topic selection

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