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NHS to consider funding PrEP HIV medication and make price plea after ruling

NHS England will "formally consider" whether to fund PrEP, a "game changer" service in the fight against HIV/Aids, after losing a "who pays" legal battle in the Court of Appeal.

The public body responsible for the planning and commissioning of NHS services is also to ask a drug manufacturer involved to reconsider its proposed "excessively high pricing".

Three appeal judges rejected its argument that it could not legally commission PrEP because local authorities have the responsibility to arrange services to "prevent" the spread of HIV, while its own responsibilities are limited to treating those already assumed to be infected.

Three Court of Appeal judges upheld a High Court ruling that it did have the power.

PrEP was described in court as being short for "pre-exposure prophylaxis" - a prevention strategy which involves people who are HIV negative but at high risk of infection taking the anti-retroviral drug Truvada to reach optimal levels of protection.

The anticipated cost of providing PrEP services is £10 million to £20 million a year.

Used consistently, it has been shown to reduce the risk of HIV infection in people who are at high risk by more than 90%.

The legal decision is of wider importance because of its potential impact on the provision of other services, including hearing implants for children with deficient or missing auditory nerves, prosthetics for lower limb loss, and a drug for treating certain mutations in children aged two to five with cystic fibrosis.

Nine new treatments and services NHS England had planned to make available to patients were put on hold pending the court's ruling.

In May, NHS England's specialist services commissioning committee decided not to commission PrEP, on the basis that it lacked power to do so under NHS legislation and regulations.

It argued that, as PrEP medication was "essentially preventative", it belonged in the realm of public health, which was the responsibility of local authorities.

But High Court Mr Justice Green said it did have the power under the NHS Act 2006 and under regulations made in 2012 which came into effect in April 2013.

On Thursday three appeal judges - Lord Justice Longmore, Lord Justice Underhill and Lady Justice King - unanimously agreed.

They declared that PrEP could be legally commissioned by NHS England because, by reducing the number of HIV infections, it made it "easier and less expensive" to deal with the overall HIV problem facing the health service.

Lord Justice Longmore said about 103,700 individuals were living with HIV in the UK.

Medication was expensive and estimated at £360,000 for treating a single person over their lifetime.

That expenditure might reduce through the use of medication "which goes by the somewhat mystifying acronym of PrEP", said the judge.

The judge described the case as one of the "bureaucratic squabbles" over the apportionment of responsibility for health services which were an inevitable consequence of the Lansley reforms which altered the way the NHS works in England.

He called for an internal mechanism to sort out such disputes, rather than them going to court and "taxpayers' money being spent on expensive barristers and solicitors".

NHS England said in a statement it would quickly take three actions.

"First, we will formally consider whether to fund PrEP. Second, we will discuss with local authorities how NHS-funded PreP medication could be administered by the sexual health teams they commission.

"Third, we will immediately ask the drug manufacturer to reconsider its currently proposed excessively high pricing, and will also explore options for using generics."

The appeal court decision was a victory for the National Aids Trust (NAT) with backing from the Local Government Association (LGA).

Deborah Gold, chief executive of the NAT, said: "We are delighted to have been vindicated by the court a second time.

"HIV is a critical issue in the UK where over 4,000 people acquire HIV every year.

"PrEP works, it saves money, and most importantly it has the power to prevent HIV acquisition for thousands of people, at the same time as beginning to end the HIV epidemic. This judgment brings that possibility one step closer."

The LGA said it was pleased with the ruling but disappointed that NHS England had taken the case all the way to the appeal court.

Izzi Seccombe, chairman of the LGA's community wellbeing board, said: "We were disappointed that NHS England chose to challenge the High Court decision, at great expense to the taxpayer and at a time when council and health budgets are under huge pressures."

Chloe Orkin, chairwoman of the British HIV Association (BHIVA), said the appeal judge's decision was "in line with World Health Organisation recommendations and the view of Nice (National Institute for Health and Care Excellence), which has evaluated PrEP using Truvada, finding it to be highly effective".

Rob Cookson, deputy chief executive of the LGBT Foundation, expressed delight with the court ruling and said: "We believe that PrEP would be a really important addition to the range of prevention options for gay, bisexual and other men who have sex with men."

Ian Green, chief executive of the Terrence Higgins Trust, said: "PrEP is nothing short of a game-changer and, if used alongside condoms, regular testing and treatment, it could be the vital piece of the puzzle to help end the HIV epidemic for good."

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