NICE Draft Decision on Twice-Yearly HIV PrEP Explained

NICE has issued draft guidance that does not recommend routine NHS funding for lenacapavir, the twice-yearly injectable HIV pre-exposure prophylaxis branded Yeytuo. NICE judged the treatment's cost-effectiveness to be above the range it considers an acceptable use of NHS resources, according to reports published on 9 and 10 September by pharmaphorum and Fierce Pharma.

The draft is open to consultation, and NICE is due to review the position on 3 November 2026. The decision is not final: this is a draft NHS funding decision, not a withdrawal of the product's regulatory licence.

The Medicines and Healthcare products Regulatory Agency licensed Yeytuo in December 2025. NICE is now considering whether it should be recommended for routine NHS funding. Those are separate stages.

The MHRA licensing decision concerns whether the product can be placed on the UK market under its authorised use, while the current NICE process concerns routine NHS funding and cost-effectiveness. NICE's draft position is negative because its cost-effectiveness estimate sits above the acceptable range.

Because the guidance remains under consultation, readers should not treat the September draft as the final outcome of the appraisal.

The British Association for Sexual Health and HIV and Terrence Higgins Trust have criticised NICE's draft position. Their objections were reported by pharmaphorum and Fierce Pharma, and BASHH also set out its own response. It is important to report those positions without turning them into clinical advice.

NICE remains the body conducting the appraisal, and its review is scheduled for 3 November 2026. BASHH and Terrence Higgins Trust are stakeholder voices arguing against the draft recommendation. The consultation process is therefore still active, with the final NHS funding position not yet settled as of 11 September.

NICE's draft guidance is open for consultation. The review date given is 3 November 2026. That means the immediate policy question is whether the appraisal changes after consultation and further review. No final recommendation should be assumed before that process is completed.

Readers may see strong reactions from professional and advocacy organisations, but those reactions do not themselves change the official funding status. Likewise, the existing MHRA licence does not mean routine NHS funding has been approved.

The clearest way to follow the story is to keep those three elements separate: licensed by the MHRA, not recommended for routine NHS funding in NICE's current draft, and still under consultation ahead of the November review.

Separate public-health updates were also published by the UK Health Security Agency this week. On 11 September, the UKHSA official blog explained RSV vaccine eligibility. On 9 September, it published information about eligibility for the 2026 COVID-19 autumn booster.

UKHSA has also highlighted a time-limited MenB vaccination offer for eligible young people who are starting university as undergraduates or entering residential further education for the first time this autumn.

These are separate vaccination programmes and should not be confused with HIV PrEP policy. Their relevance here is simply that several official prevention and immunisation updates are appearing at the same time in the UK health calendar.

People with questions about HIV prevention, PrEP access or their own circumstances should use NHS sexual health services for individual information and support. Existing daily oral PrEP remains available through NHS services.

The current NICE draft concerns routine funding for twice-yearly injectable lenacapavir, branded Yeytuo, and the appraisal remains open for consultation ahead of the 3 November 2026 review.

This article does not provide personal medical advice or recommend one form of PrEP over another. NHS sexual health services can explain currently available options and the access route that applies to an individual.