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NHS can fund 'game-changing' PrEP HIV drug, court says NHS can fund 'game-changing' PrEP HIV drug, court says
(about 2 hours later)
A leading Aids charity has won a high court battle over whether a preventative treatment for HIV that charities say is a “game-changer” can legally be funded by the NHS. Aids campaigners are celebrating a watershed victory after the high court ruled that NHS England can pay for “game-changer” drugs that prevent people being infected with HIV by their partners.
NHS England said it had received advice that it did not have the legal power to fund pre-exposure prophylaxis (PrEP), a “highly effective” anti-retroviral treatment used to stop HIV from becoming established in the event of transmission. But NHS England made it clear that the fight to get PrEP – pre-exposure prophylaxis – to everyone at risk is far from over. Not only will it appeal against the judgment, but it will weigh up the cost of PrEp – which could be £10m – £20m a year – against other calls on NHS funding for specialised services. It will also put pressure on the pharmaceutical companies manufacturing the drugs to drop their prices.
But Mr Justice Green, sitting in London, ruled that NHS England “has erred in deciding that it has no power or duty to commission the preventative drugs in issue”. The health secretary, Jeremy Hunt, has already asked Nice – the National Institute for Health and Care Excellence – to consider the cost-effectiveness of PrEP. Trials have shown the once-a-day pill is highly effective in protecting gay men whose partners are HIV positive. But the cost of the pill, called Truvada, is high.
The ruling was a victory for the National Aids Trust (NAT), which brought the case to court. Condoms are cheap, but among some high-risk populations they are not used consistently. About 4,000 more people acquire HIV in the UK every year. The average cost of a lifetime of treating each one is put at about £360,000.
Deborah Gold, the NAT chief executive, said: “This is fantastic news. It is vindication for the many people who were let down when NHS England absolved itself of responsibility for PrEP. The judgment has confirmed our view that it is perfectly lawful for NHS England to commission PrEP. Now NHS England must do just that. The National Aids Trust brought the high court case following anger and consternation among campaigners after NHS England said it would not fund PrEP because it did not have the power to do so. It argued that it was the role of local authorities, which have been given control of public health measures including reducing smoking and family planning, as well as HIV prevention. Local authorities said they did not have the money to pay.
“Over 4,000 people are getting HIV every year in the UK – we desperately need further prevention options to add to condom use. PrEP works. It saves money and it will make an enormous difference to the lives of men and women across the country who are at risk of acquiring HIV. The delay to commissioning PrEP is both unethical and expensive.” Mr Justice Green in the high court said NHS England had erred and that both it and the local authorities were able to fund the drugs if they so chose.
When taken consistently, PrEP has been shown to reduce the risk of HIV infection in people who are at high risk by more than 90%. “No one doubts that preventative medicine makes powerful sense,” he said in his judgment. “But one governmental body says it has no power to provide the service and the local authorities say that they have no money. The clamant [the National Aids Trust] is caught between the two and the potential victims of this disagreement are those who will contract HIV/Aids but who would not were the preventative policy to be fully implemented.”
Deborah Gold, the chief executive of NAT, said: “This is fantastic news. It is vindication for the many people who were let down when NHS England absolved itself of responsibility for PrEP. The judgment has confirmed our view – that it is perfectly lawful for NHS England to commission PrEP. Now NHS England must do just that.”
NAT said, however, it was “enormously disappointing” that NHS England intended to appeal.
NHS England has said it will put aside money to fund PrEP in case it loses in the court of appeal. It will ask Gilead, which makes Truvada, to submit its “best and final price” so the cost of PrEP can be compared with the cost of other calls on NHS specialised funding. It will be competing with drugs for a number of other diseases, including one for children with cystic fibrosis and a form of stem cell transplantation.
Dr Jonathan Fielden, NHS England’s director of specialised commissioning and deputy national medical director, said they were setting the ball rolling so PrEP can be considered for funding following the high court ruling.
“Of course, this does not imply that PrEP – at what could be a cost of £10m-20m a year – would actually succeed as a candidate for funding when ranked against other interventions. But in those circumstances, Gilead – the pharmaceutical company marketing the PrEP drug Truvada – will be asked to submit better prices, which would clearly affect the likelihood that their drug could be commissioned,” he said.
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A row erupted earlier this year after NHS England said it would not routinely fund the drug. In March, the body decided the treatment was a preventative service and was therefore not its responsibility. It has said local councils are in charge of funding preventative health services. Campaigners say that while the majority of gay men use condoms to prevent being infected with HIV, there is also an “ethical duty” to provide PrEP to those who do not. They believe the drug would provide an additional defence against HIV – and would not be used simply as an alternative to safe sex.
However, NHS England agreed to a re-evaluation after the NAT launched a legal challenge. Then in May it said it had “considered and accepted NHS England’s external legal advice that it does not have the legal power to commission PrEP”, and that under 2013 regulations “local authorities are the responsible commissioner for HIV prevention services”. It comes after the results of a trial, published in February 2015, suggested that rates of HIV infection could be slashed by treating gay men with the anti-viral drug when they are healthy.
Allowing NAT’s application for judicial review, Green said on Tuesday the core of the legal challenge was about “the allocation of budgetary responsibility in the health field”. Dr Michael Brady, the medical director at the HIV/Aids charity Terrence Higgins Trust, welcomed the findings and described the drug as a game-changer.
He said: “No one doubts that preventative medicine makes powerful sense. But one governmental body says it has no power to provide the service and local authorities say they have no money. He said PrEP offered another line of defence against HIV, alongside condoms and regular testing. Brady said: “It is not a vaccine and it won’t be for everyone, but, once approved, we expect it to significantly increase the momentum in our fight against the virus.
“The claimant is caught between the two and the potential victims of this disagreement are those who will contract HIV/Aids but who would not were the preventative policy to be fully implemented.
“In my judgment the answer to this conundrum is that NHS England has erred in deciding that it has no power to commission the preventative drugs in issue.”
Alternatively, said the judge, NHS England has “mischaracterised the PrEP treatment as preventative when in law it is capable of amounting to treatment for a person with infection”.
In any event NHS England had power to commission preventative treatments because that facilitated, or was incidental to, “the discharge of its broader statutory functions”.
Campaigners have said that while the majority of gay men use condoms to prevent being infected with HIV, there is also an “ethical duty” to provide PrEP to those who do not.
And they said the drug would provide an additional defence against HIV – and would not be used simply as an alternative to safe sex.
It comes after the results of a trial, published in February 2015, suggested that rates of HIV infection could be slashed by treating actively gay men with the anti-viral drug when they are healthy.
Dr Michael Brady, medical director at the HIV/Aids charity Terrence Higgins Trust, welcomed the findings and described the drug as “a game-changer”.
He said PrEP offered “another line of defence” against HIV, alongside condoms and regular testing. Brady said: “It is not a vaccine and it won’t be for everyone, but, once approved, we expect it to significantly increase the momentum in our fight against the virus.
“We urge the government, NHS England and local authorities to make PrEP a key priority in the fight against HIV.”“We urge the government, NHS England and local authorities to make PrEP a key priority in the fight against HIV.”