A drug which prevents HIV could be made available on the NHS in England after a successful legal challenge by a leading HIV/AIDS charity.
NHS England decided in May that it would not offer "pre-exposure prophylaxis" (PrEP), a treatment that stops people from contracting HIV. Less than a week later, the National AIDS Trust (NAT) challenged the decision in the courts.
Deborah Gold, chief executive of the NAT, said in a statement that the ruling was "fantastic news" and "vindication for the many people who were let down" by NHS England's decision.
However, the NHS has said that the decision means that it may no longer be able to afford to pay for some other treatments.
The decision hinged on whether PrEP counts as "HIV prevention" or "HIV treatment". NHS England argues that while treating patients who have HIV is the NHS's responsibility, under the Health and Social Care Act 2012 preventing people from catching the virus is the role of local authorities.
The judge, Justice Green, said in his ruling that NHS England had "erred in
deciding that it has no power or duty to commission" PrEP. "In
my judgment it has a broad preventative role (including in relation to HIV)," he said.
He ruled that the process for deciding whether PrEP should be made available should be restarted immediately, beginning with a public consultation by the NHS's Clinical Priorities Advisory Group (CPAG).
He gave permission for an appeal against the ruling, and NHS England has confirmed that it will appeal. The public consultation will go ahead immediately and will only be stopped if NHS England wins its appeal, but the treatment won't be commissioned until the appeal is resolved.
PrEP uses a drug called Truvada. The NHS already provides "post-exposure prophylaxis", PEP, which is a combination of Truvada and another drug called Isentress. The NAT argued in a legal letter that the two treatments perform similar medical functions and both should be considered "treatment".
“Biologically they [PEP and PrEP] do exactly the same thing,” Deborah Gold, chief executive of the NAT, told BuzzFeed News in June. “In both cases you take them because you think you’re at risk of HIV, whether it’s before you have sex or afterwards. If you haven’t been exposed to HIV you’ve just taken a drug that’s had no effect on you. It only has an effect if you have been exposed to the virus.
“The way HIV works is first of all you become infected with it, then it replicates within your body. This drug doesn’t stop you from becoming infected – it stops the virus from replicating, thus allowing your immune system to fight it off. So, actually it’s treating the person with HIV. It’s treatment.”
But NHS England said in a statement that it had been advised it was not legally permitted to provide the treatment, saying: "Local authorities are the responsible commissioner for HIV prevention services." It added that if it made PrEP available it would be at risk of legal challenge from providers of rival treatments.
The decision does not mean that the NHS has to provide PrEP, just that it is legally allowed to. The drug will still have to be assessed for cost-effectiveness, just as any other treatment would be. The NHS said in May that "there is no guarantee" that a legal change would lead the health service "to invest millions of pounds in PrEP over new treatments and interventions in other service areas which are also competing for funding".
NHS England said in a statement following the ruling that in order to "ensure that sufficient funding remains available for PrEP", funding for some other treatments recommended by CPAG can no longer be confirmed.
Ian Green, chief executive of the HIV charity the Terrence Higgins Trust, said in a statement: “It is a vindication for the community after a long fight – but it should never have come to this.
"Because of the mess and delays created by NHS England, people at risk of HIV have spent the past 18 months fighting to be heard. Meanwhile, 17 people have been diagnosed with HIV with every day that has passed."
Will Nutland of the PrEP education and campaign website Prepster told BuzzFeed News it was an "excellent ruling by the judge" but that "it is a shame that NHS England will waste more time and public money seeking an appeal".
The World Health Organization recommended in 2014 that PrEp should be offered to people at "substantial risk" of contracting HIV, including men who have sex with men.
PrEP treatment involves one pill taken once a day, and costs about £400 a month per patient.