Suggested remit: To appraise the clinical and cost effectiveness of cabotegravir within its marketing authorisation as pre-exposure prophylaxis of HIV-1 infection in adults and young people.
- 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:
- 6255
Provisional Schedule
- Expected publication:
- 11 September 2025
Project Team
- Project lead
- Leena Issa
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Warwick Evidence, Warwick Medical School, University of Warwick
Stakeholders
- Companies sponsors
- ViiV Healthcare (cabotegravir)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Community organisations
- aidsmap
- National AIDS Trust
- Sophia Forum
- Terrence Higgins Trust
- UK-CAB
- Professional groups
- British Association for Sexual Health and HIV
- British HIV Association
- English HIV and Sexual Health Commissioners Group (EHSHSG)
- Royal College of Physicians
- Associated public health groups
- UK Health Security Agency
- Comparator companies
- AAH Pharmaceuticals Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Accord Healthcare Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Advanz Pharma (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Alliance Healthcare (Distribution) Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Amarox Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Aurobindo Pharma (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Aristo Pharma Ltd (tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Dr Reddy’s Laboratories (UK) Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Gilead Sciences Ltd (emtricitabine, tenofovir disoproxil, tenofovir alafenamide))
- Glenmark (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Laurus Generics GmbH (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Lupin Healthcare (UK) Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Macleods Pharma UK Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Medihealth (Northern) Ltd (tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Sandoz Ltd (tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Teva UK Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating Thornton & Ross Ltd (tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Tillomed Laboratories Ltd (emtricitabine, tenofovir disoproxil) – confidentiality agreement not signed, not participating
- Viatris UK Healthcare Ltd (emtricitabine, tenofovir disoproxil) – 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
- Medicines and Healthcare products Regulatory Agency
- Scottish Medicines Consortium
- Welsh Government
- NHS Wales Joint Commissioning Committee
- Relevant research groups
- National Institute for Health & Care Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 08 July 2025 | Committee meeting: 3 |
| 23 May 2025 | The third committee meeting for this appraisal will no longer take place on 11 June 2025, and will be rescheduled to a later date. This date clashes with the British Association for Sexual Health and HIV (BASHH) conference, and so several of the clinical experts selected to participate in the appraisal will be unavailable. NICE is in the process of rescheduling the meeting and will provide an update as soon as possible. |
| 04 April 2025 | NICE has requested additional evidence from stakeholders. This will be reviewed ahead of a 3rd committee meeting in June 2025. |
| 19 December 2024 | At the technology appraisal committee meeting on Wednesday 04 December 2024, the committee was unable to make a recommendation, because further information is needed. The appraisal will be paused whilst NICE gathers additional information, and stakeholders will be updated in due course. The expected publication date is now TBC. |
| 04 December 2024 | Committee meeting: 2 |
| 26 September 2024 - 17 October 2024 | Draft guidance |
| 03 September 2024 | Committee meeting |
| 03 September 2024 | Declaration of interests |
| 26 April 2024 | After receiving the external assessment report, NICE has assessed the evidence submissions and report to decide how this appraisal will progress. This appraisal will continue as a single technology appraisal and progress to technical engagement before preparation for the committee meeting. To accommodate the addition of technical engagement, the committee meeting will now be held on 3 September 2024. |
| 20 November 2023 | Invitation to participate |
| 17 July 2023 - 14 August 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6255 |
| 15 June 2023 | In progress. DHSC referral received |
| 20 March 2023 | 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