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

Project Team

Project lead Greg O'Toole

Email enquiries

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
  Welsh Health Specialised Services Committee
Relevant research groups National Institute for Health & Care Research

Timeline

Key events during the development of the guidance:

Date Update
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