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
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 (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 |
|---|---|
| 11 April 2025 | For information, NICE has decided to pause the single technology appraisal of rozanolixizumab 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. |
| 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