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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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Draft guidance consultation

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1 Recommendations

1.1

Cabotegravir is not recommended, within its marketing authorisation, for pre-exposure prophylaxis (PrEP) alongside safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults and young people who have a high risk of HIV and weigh at least 35 kg.

1.2

This recommendation is not intended to affect treatment with cabotegravir that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop. For young people, this decision should be made jointly by the healthcare professional, the young person, and when appropriate, their parents or carers.

Why the committee made these recommendations

PrEP are medicines that people who have a higher risk of HIV can take to prevent them getting HIV. This involves taking tablets every day (oral PrEP). But some people cannot have or tolerate oral PrEP, and there are no other options available (no PrEP). Cabotegravir is a long-acting injection for PrEP that is used every 2 months.

Evidence from clinical trials shows that cabotegravir reduces the risk of HIV infection compared with oral PrEP. Cabotegravir has not been directly compared in a clinical trial with no PrEP. An indirect comparison suggests that it is more effective compared with no PrEP.

There are difficulties in determining who would have cabotegravir in NHS clinical practice and how to identify people who cannot have or tolerate oral PrEP. There are also uncertainties about how the clinical evidence applies to these populations.

The evidence does not cover everyone who could have cabotegravir in NHS clinical practice. Because of this, it is not possible to determine the cost-effectiveness estimate for the whole population without further analyses from the company. So cabotegravir is not recommended.