Suggested remit: To appraise the clinical and cost effectiveness of lenacapavir within its marketing authorisation for preventing HIV-1 in people aged 16 years or older.
- 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:
- 6495
Provisional Schedule
- Committee meeting:
- 09 December 2025
- Expected publication:
- 11 March 2026
Project Team
- Project lead
- Leena Issa
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Bristol Technology Assessment Group, University of Bristol
Stakeholders
- Companies sponsors
- Gilead (lenacapavir)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- HIV-i-Base
- National AIDS Trust
- Sophia Forum
- Professional groups
- British HIV Association
- English HIV and Sexual Health Commissioners Group (EHSHSG)
- Royal College of Physicians
- Associated public health groups
- None
- Comparator companies
- Advanz Pharma (emtricitabine/tenofovir disoproxil fumarate) (confidentiality agreement not signed, not participating)
- Amarox Ltd (tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate) (confidentiality agreement not signed, not participating)
- Aurobindo Pharma - Milpharm Ltd. (tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate) (confidentiality agreement not signed, not participating)
- Dr Reddy’s Laboratories (tenofovir disoproxil succinate, emtricitabine/tenofovir disoproxil succinate) (confidentiality agreement not signed, not participating)
- Gilead ([emtricitabine/tenofovir alafenamide fumarate], emtricitabine/tenofovir disoproxil fumarate, tenofovir disoproxil fumarate, emtricitabine) (confidentiality agreement not signed, not participating)
- Lupin Healthcare UK Ltd (emtricitabine/tenofovir disoproxil phosphate) (confidentiality agreement not signed, not participating)
- Mylan (tenofovir disoproxil maleate) (confidentiality agreement not signed, not participating)
- Orion (tenofovir disoproxil fumarate) (confidentiality agreement not signed, not participating)
- Sandoz (tenofovir disoproxil) (confidentiality agreement not signed, not participating)
- Thornton & Ross Ltd (tenofovir disoproxil succinate) (confidentiality agreement not signed, not participating)
- ViiV Healthcare (cabotegravir) (confidentiality agreement not signed, not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- None
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 20 May 2025 | Invitation to participate |
| 16 April 2025 | Referral |
| 05 March 2025 - 02 April 2025 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6495 |
| 05 March 2025 | In progress. Scoping commencing |
| 08 October 2024 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
| 08 October 2024 | Topic selection |
For further information on our processes and methods, please see our CHTE processes and methods manual