LONDON, Aug 3 (APM) - The National Health Service (NHS) in England warned that a UK court ruling on Tuesday that it can fund a preventative drug for HIV means that funding for other specialised services could be affected.

NHS England said in a Tuesday statement that it "cannot now confirm funding for those treatments and services" in levels three and four of the Clinical Priorities Advisory Group (CPAG), which considers services, treatment and technologies to be prioritised for investment.

It follows Tuesday's high court ruling that NHS England is responsible for funding pre-exposure prophylaxis (PrEP) therapy for adults with HIV, despite NHS England insisting it was the responsibility of local authorities to fund the drug for this use under their public health purview (APMMA 49008).

NHS England has launched an appeal against this decision, saying the cost of PrEP could be 10-20 million pounds (11.9-23.8 million euros ) a year. The only approved PrEP treatment in Europe is Gilead's Truvada (emtricitabine+tenofovir disoproxil fumarate), which costs about 5,000 pounds (5,960 euros) per year per patient.

The appeal is based on advice from lawyers that the court's ruling interprets the legislation governing NHS England's role and functions in a way that is inconsistent with parliament's intention.

While the appeal process is carried out, NHS England confirmed that funding will remain available for those new treatments and services in levels one and two of CPAG prioritisation. Drugs for rare conditions are categorised by both their costs and their effectiveness and are ranked from levels one to five.

Funding for treatments in levels three and four is in doubt, however, potentially impacting their availability in England. Treatments ranked at this level include auditory brainstem implants for children with deficient or missing auditory nerves, Vertex's Kalydeco (ivacaftor) for children with cystic fibrosis and haematopoietic stem cell transplantation for adults.

NHS England said it plans to invite the manufacturers of treatments placed at levels three, four and five, as well as Gilead, to submit their 'best and final' prices, so that the cost of each policy can be properly compared.

"In the event that PrEP does end up being ranked against alternative interventions by CPAG, the prices by Gilead will affect the likelihood that it is able to be commissioned," said the statement.

CPAG will also be asked to re-run the prioritisation process as soon as practicable, likely in October.

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 pounds 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's comments were criticised by the National AIDS Trust, which took the funding case to court.

"To single just PrEP out as a policy which would be funded at the expense of others is invidious, prejudices NHS England's position in relation to PrEP and raises serious questions as to the integrity and impartiality of NHS England's approach," said the charity.

Deborah Gold, chief executive of NAT, added: 'We call on NHS England to abandon its appeal, to allow the commissioning process to take its course and to stop pre-empting publicly the discussions and decisions which should properly take place in the Clinical Priorities Advisory Group.2

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