To appraise the clinical and cost effectiveness of tezacaftor in combination with ivacaftor within its marketing authorisation for treating cystic fibrosis in people with the F508del mutation.
Please note that following on from information provided to NICE by the company in August 2018, the appraisal of Tezacaftor and ivacaftor combination therapy for treating cystic fibrosis with the F508del mutation [ID1303] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
- Status:
- Discontinued
- Technology type:
- Medicine
- Decision:
- Prioritised
- Process:
- TA
- ID number:
- 1303
Email enquiries
If you have any queries please email scheduling@nice.org.uk
Stakeholders
- Companies sponsors
- Vertex Pharmaceuticals (tezacaftor, ivacaftor)
- Others
- Department of Health and Social Care
- NHS England
- Welsh Government
- Patient carer groups
- Cystic Fibrosis Trust
- Professional groups
- Association of Chartered Physiotherapist in Cystic Fibrosis
- British Thoracic Society
- Cystic Fibrosis Nurses Association
- Royal College of Pathologists
- Royal College of Physicians
- UK Clinical Pharmacy Association
- UK Cystic Fibrosis Medical Association
- UK Cystic Fibrosis Pharmacy Group
- Comparator companies
- AbbVie (no CAU, not participating)
- Allergan UK (no CAU, not participating)
- Essential Pharmaceuticals (no CAU, not participating)
- Janssen (no CAU, not participating)
- Merck Serono (no CAU, not participating)
- Pari Medical (no CAU, not participating)
- Pharmaxis (no CAU, not participating)
- Roche Products (no CAU, not participating)
- Sanofi (no CAU, not participating)
- Teva (no CAU, not participating)
- Zentiva (no CAU, 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
- Welsh Health Specialised Services Committee
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 23 January 2023 | Discontinued. Please note that following on from information provided to NICE by the company in August 2018, the appraisal of Tezacaftor and ivacaftor combination therapy for treating cystic fibrosis with the F508del mutation [ID1303] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued. |
| 12 November 2019 | November 2019: Tezacaftor and ivacaftor combination therapy is available on the NHS for treating cystic fibrosis. NHS England has agreed an interim access agreement with Vertex Pharmaceuticals, which includes collecting further data through an interim data collection agreement - https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/data-collection-agreement. |
| 09 August 2018 | Suspended. Non submission |
| 09 August 2018 | The company, Vertex Pharmaceuticals, has not provided an evidence submission for this appraisal. Therefore, we are suspending the appraisal whilst we consider the next steps. Consequently the discussion of this appraisal at the committee meeting on the 8 November 2018 has been cancelled. We will update you on our progress and next steps as soon as possible. |
| 29 May 2018 | Invitation to participate |
| 22 May 2018 | In progress. In progress |
| 23 November 2017 - 21 December 2017 | Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators |
For further information on our processes and methods, please see our CHTE processes and methods manual