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High Court rules NHS England must fund HIV drug

Campaigners hail 'historic victory' in battle for PrEP to be funded by NHS

Mark Gould

Tuesday, 02 August 2016

A High Court judge has today ruled that NHS England acted unlawfully in deciding not to fund a drug that can reduce the risk of HIV infection in more than 90% of cases.

NHS England argued that it was up to local authorities to provide the pre-exposure prophylaxis (PrEP) drug. But this was challenged by the National AIDS Trust (NAT) which has today won what its chief executive Deborah Gold called a "historic victory".

“This is fantastic news," she said. "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 once-a-day pill, which costs £400 a month per person, works by disabling the virus to stop it multiplying. Amid rising rates of unsafe sex among men who have sex with men, the idea is to give the drug to uninfected men who are having unprotected sex with other men, which is how it is being used in America, Canada, Australia and France. NAT says that with over 4,000 people contracting HIV every year in the UK there is a desperate need for further prevention options to add to condom use.

In his judgement, Mr Justice Green wrote: "No one doubts that preventative medicine makes powerful sense. But one governmental body says it has no power to provide the service and the local authorities say that they have no money. 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." He concludes that in all the possible scenarios that were explored in the judicial review, NHS England does have the power to commission PrEP.

In May, NHS England said it had received legal advice which concluded that it did not have the "legal power to commission PrEP" and that under 2013 regulations "local authorities are the responsible commissioner for HIV prevention services". NHS England has also warned that if it prioritises PrEP, there is a risk of a legal challenge from people wanting similar access to other preventative treatments. But NAT has argued that local authorities do not have sole responsibility for HIV prevention in England.

NAT said that it was "enormously disappointing" that NHS England has decided to appeal this judgment, "especially given the wide ranging and well-reasoned arguments it contains". NAT said the appeal will further delay clarity in this area, and mean that any potential commissioning of PrEP will not take place for months. The NHS in Wales, Scotland and Northern Ireland have not yet made a decision on PrEP.

Dr Jonathan Fielden, NHS England’s Director of Specialised Commissioning and Deputy National Medical Director, said: "Queen's Counsel has advised NHS England that it should seek to appeal against the conclusions reached by the judge as to the scope of NHS England’s legal powers under the National Health Service Act 2006. In parallel with that we will set the ball rolling on consulting on PrEP so as to enable it to be assessed as part of the prioritisation round. 

“Of course, this does not imply that PrEP - at what could be a cost of £10-20 million 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."

NHS England will work with Public Health England to run a number of early implementer test sites to research how PrEP could be commissioned in the most clinically and cost effective way.

And pending a ruling from the Court of Appeal, NHS England will confirm funding for those new treatments and services in levels one and two of the Clinical Priorities Advisory Group (CPAG)  prioritisation round, meaning that they will be available to patients immediately, and will not be affected by any subsequent decision from the courts. 

However, given the ruling, it cannot confirm funding for those treatments and services in levels three and four. This is to ensure that sufficient funding remains available for PrEP should it be prioritised in the event that the Court of Appeal upholds the judge’s decision. 

NHS England is inviting manufacturers of the drugs and treatments previously placed in levels three, four and five of the provisional prioritisation decisions, as well as Gilead to submit their "best and final" prices, so that the cost of each policy can be properly compared. 

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