| 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 | 6164 |
Provisional Schedule
| Expected publication | 17 January 2024 |
Project Team
| Project lead | Celia Mayers |
Email enquiries
- If you have any queries please email TATeam6@nice.org.uk
| External Assessment Group | Health Economics Research Unit and Health Services Research Unit, University of Aberdeen |
Stakeholders
| Companies sponsors | Servier Laboratories (ivosidenib) |
| Others | Department of Health and Social Care |
| NHS England | |
| Patient carer groups | AMMF – The Cholangiocarcinoma Charity |
| Together Support Group | |
| Professional groups | Association of Cancer Physicians |
| Cancer Research UK | |
| Cholangiocarcinoma-UK | |
| Royal College of Physicians | |
| Royal College of Radiologists | |
| Associated public health groups | None |
| Comparator companies | AAH Pharmaceuticals (calcium folinate) – confidentiality agreement not signed, not participating |
| Accord Healthcare (fluorouracil, oxaliplatin) – confidentiality agreement not signed, not participating | |
| Alliance Healthcare (calcium folinate) – confidentiality agreement not signed, not participating | |
| Consilient Health (oxaliplatin) – confidentiality agreement not signed, not participating | |
| Fresenius Kabi (oxaliplatin) – confidentiality agreement not signed, not participating | |
| Medac Healthcare (fluorouracil, oxaliplatin) – confidentiality agreement not signed, not participating | |
| Medihealth (calcium folinate) – confidentiality agreement not signed, not participating | |
| Pfizer (calcium folinate, fluorouracil, oxaliplatin) – confidentiality agreement not signed, not participating | |
| Seacross Pharmaceuticals (oxaliplatin) – confidentiality agreement not signed, not participating | |
| Sigma Pharmaceuticals (calcium folinate) – confidentiality agreement not signed, not participating | |
| Sun Pharmaceutical Industries (oxaliplatin) – confidentiality agreement not signed, not participating | |
| Teva (calcium folinate) – 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 | |
| Scottish Medicines Consortium | |
| Welsh Health Specialised Services Committee | |
| Relevant research groups | Institute of Cancer Research |
| National Institute for Health Research |
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 10 November 2023 | Following the issue of the draft guidance on 26 October 2023, the company conducted additional analysis and accepted the committees assumptions, updating the value proposition accordingly. This has been reviewed by the Chair of the appraisal committee, who has taken Chair’s action to change the recommendation. Ivosidenib is now recommended, within its marketing authorisation, for treating locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation in adults after 1 or more systemic treatments. As such, the draft guidance has been withdrawn from NICE Docs and the NICE website and final draft guidance will be produced. The meeting scheduled for 12 December 2023 will not be going ahead. |
| 10 October 2023 | Committee meeting |
| 10 February 2023 | Invitation to participate |
| 10 February 2023 | In progress |
| 31 January 2023 | Topic selection. The topic routing was discussed at the Topic Selection Oversight Panel (TSOP) in January 2023. The panel concluded that the topic was suitable for a Technology Appraisal. Please see project documents for further details. |
| 23 November 2022 - 21 December 2022 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
| 23 November 2022 | In progress. Scoping commenced |
| 11 August 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