NICE approves limited access to injectable cabotegravir PrEP in England and Wales

17 October 2025. Related: Early access, Treatment access, HIV prevention and transmission.

Simon Collins, HIV i-Base

On 17 October 2025, NICE announced that long-acting cabotegravir injections (CAB-LA) will be approved as PrEP for people in England and Wales who are not able to use oral PrEP.

The long-awaited decision is good news. It will help protect approximately 1000 people each year from becoming HIV positive, especially those at high risk. The injection is already available in Scotland, having been approved by the Scottish Medicines Consortium in February this year.

It is also a strong signal that NICE might approve other injectable versions of PrEP such as lenacapavir, which only requires a subcutaneous injection every 6 months, and has a 12-monthly version currently in development. CAB-LA is currently given as an intramuscular injection every 2 months.

The rationale for the NICE decision appears to be related to stakeholder comments stressing the limited likely demand for CAB-LA PrEP. The initial application was not approved because NICE wanted to guarantee that CAB-LA would be available equally throughout England and Wales. The new indication now specifies access will be limited to “people who cannot have the daily medication due to medical contraindications, difficulty swallowing tablets, or other challenges adherence [sic] such as partner violence or homelessness.”

This statement forgets that oral PrEP is not just a daily option but can be just as effective when used only at specific times somebody wants protection against HIV. On-demand dosing using either 2:1:1 or 2:7 dosing is now recommended in both UK and EU guidelines. [2, 3]

The announcement does not include any details on how this limited access will be managed and whether this will be based on quotas for specific populations, geographical regions, on estimates from clinics and whether access will need to be staggered over the year. Access also does not include people in Northern Ireland.

The NICE press release notes that access to CAB-LA for PrEP is “expected to begin three months after NICE publishes final guidance later this year, if not sooner.”

References

1. First HIV prevention injection for people unable to have daily PrEP recommended. (17 October 2025).
   https://www.nice.org.uk/news/articles/first-hiv-prevention-injection-for-people-unable-to-have-daily-prep-recommended
2. BASHH/BHIVA. Guideline on the Use of HIV Pre-exposure Prophylaxis. (4 July 2025).
   https://www.bashh.org/resources/5/hiv_preexposure_prophylaxis_2018 (sic)
   https://www.bashh.org/_userfiles/pages/files/prep_2025.pdf (PDF)
3. EACS guidelines, Version 13.0. (October 2025).
   https://www.eacsociety.org/guidelines/eacs-guidelines