NHS England blames possible legal action for decision not to fund HIV prevention pill

To the disappointment of clinicians and campaigners, NHS England has determined that its responsibilities do not include the commissioning of pre-exposure prophylaxis (PrEP) for HIV prevention.

HIV prevention is the job of local authorities, NHS England said, and it could be open to legal challenge if it were to include such prevention among specialised services competing for funds. Proponents of other specialised services displaced by PrEP might challenge the decision in the courts.

The decision has surprised many of those involved in HIV prevention, because NHS England had long been discussing the issue without such a legal obstacle being raised. In a comment on NHS England’s website, two of the investigators in the PROUD trial,1 which showed the benefits of PrEP, said that the risk of legal challenge was negligible compared with the potential benefits, “which are financial for NHS England and personal for the thousands of individuals destined to otherwise catch HIV in the next two years.”

Sheena McCormack, the trial’s chief investigator, its statistician David Dunn, and its social scientist Mitzy Gafos, urged NHS England to think again. They said that the trial’s results had been “astounding,” because it had shown an 86% reduction in HIV infection among those given the HIV drug Truvada daily, when compared with those who had not taken it. The trial’s success, they added, had inspired other countries to accelerate implementation or initiate national programmes.

In its statement, NHS England said that PrEP using antiretroviral drugs can be highly effective, especially for men who have condomless sex with multiple male partners, and that on present evidence it does not lead to increases in other sexually transmitted infections. While it is not NHS England’s job to commission HIV prevention services, it will provide £2m (€2.5m; $2.9m) over the next two years for a number of early implementation test sites.

This statement won it few plaudits, however. Ian Green, chief executive of the Terrence Higgins Trust, said, “By denying full availability of PrEP we are failing those who are at risk of HIV. The decision by NHS England is shameful.

“£2m over two years for 500 gay men ‘most at risk’ is an arbitrary figure which seems ill thought out and will still deny the protection that PrEP offers to the people who most need it. We know that PrEP works and already have substantial data from a real world setting from the PROUD trial. PrEP has already been approved in the US, Kenya, Israel, Canada, and France.”

Green continued, “NHS England’s statement makes it no clearer who is responsible—is it the Department of Health, local authorities, the NHS, or Public Health England? We need answers, we need access, and we demand both.”

Deborah Gold, chief executive of the National Aids Trust, agreed. “The decision is not informed by any due process; the amount of money is arbitrary; the claim that ‘more testing’ of PrEP is needed is disingenuous. Five hundred does not remotely cover the number of gay men at high risk of HIV nor meet the needs of homosexuals at risk,” she told the Guardian. “Over 5000 gay men will get HIV over the next two years, many of whom would not have done so if PrEP had been delivered as proposed.”