Suggested remit: To appraise the clinical and cost effectiveness of zilucoplan 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:
- 4008
Project Team
- Project lead
- Jeremy Powell
Email enquiries
If you have any queries please email TATeam2@nice.org.uk
- External Assessment Group:
- Southampton Health Technology Assessment Centre (SHTAC), University of Southampton
Stakeholders
- Companies sponsors
- UCB Pharma (Zilucoplan)
- 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
- Comparator companies
- Accord UK – CAU not returned, not participating
- Advanz pharma – CAU not returned, not participating
- Alexion Pharma (ravulizumab)
- Alliance pharmaceuticals – CAU not returned, not participating
- Argenx (efgartigimod)
- Aspen – CAU not returned, not participating
- Bio Products Laboratory – CAU not returned, not participating
- Biotest UK – CAU not returned, not participating
- Cipla EU – CAU not returned, not participating
- CSL Behring UK – CAU not returned, not participating
- Dexcel Pharma – CAU not returned, not participating
- Ennogen Pharma – CAU not returned, not participating
- Grifols UK – CAU not returned, not participating
- Healthcare pharma – CAU not returned, not participating
- Hospira UK – CAU not returned, not participating
- Medac GmBH – CAU not returned, not participating
- Mylan – CAU not returned, not participating
- Napp Pharmaceutical – CAU not returned, not participating
- Nordic Pharma – CAU not returned, not participating
- Nova laboratories – CAU not returned, not participating
- Novartis – CAU not returned, not participating
- Octapharma – CAU not returned, not participating
- Orion Pharma – CAU not returned, not participating
- Pfizer – CAU not returned, not participating
- Roche – CAU not returned, not participating
- Sandoz – CAU not returned, not participating
- Teva UK – CAU not returned, not participating
- Tillomed laboratories – CAU not returned, 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
- Welsh Government
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 22 August 2025 | Appeal |
| 26 June 2025 - 10 July 2025 | Final draft guidance |
| 11 April 2025 | For information, NICE has decided to pause the single technology appraisal of zilucoplan for treatment of antibody-positive generalised myasthenia gravis. This is due to operational implications of an appeal for a single technology appraisal for another product being assessed for generalised myasthenia gravis. The appeal outcome will likely be known in late June. |
| 05 February 2025 | Committee meeting: 2 |
| 05 February 2025 | Declaration of interests |
| 14 November 2024 - 05 December 2024 | Draft guidance: 2 |
| 09 October 2024 | Committee meeting: 2 |
| 04 July 2024 - 25 July 2024 | Draft guidance: 1 |
| 13 June 2024 | Committee meeting |
| 23 April 2024 | This appraisal will now be discussed at the Committee B meeting on 13 June 2024. |
| 28 September 2023 | Invitation to participate |
| 30 June 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 in late September 2023 when we will write to stakeholders about how they can get involved. |
| 23 March 2023 - 24 April 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 4008 |
| 23 March 2023 | In progress. Scoping commencing |
| 20 July 2022 | 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