PrEP is a measure to prevent HIV transmission, particularly for men who have high risk condomless sex with multiple male partners.

A hearing was held in the High Court on Wednesday 13 July 2016 to consider whether NHS England had the legal power to commission the PrEP service. At the hearing, NHS England contended that it did not have the power to commission the service, and that whether or not it should be commissioned was a matter for local authorities.

The judge has now handed down his judgement, and has concluded that both local authorities and NHS England have the power to commission PrEP.

NHS England has considered the judgement carefully and has taken legal advice. Queen’s Counsel has advised 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.

On this basis, NHS England requested permission to appeal the judgement, which was granted with a commitment to expedite the hearing as far as possible.

Next steps on PREP and implications for other services

Pending a ruling from the Court of Appeal, NHS England will take the following actions with relation to PrEP and other services.

First, NHS England is able to confirm funding for those new treatments and services in levels one and two of the Clinical Priorities Advisory Group 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, NHS England cannot now 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.

Second, without prejudice to the outcome of the appeal, NHS England will publish a draft policy proposition for the potential commissioning of PrEP for public consultation as soon as possible. This does not imply that PrEP – at what could be a cost of £10-20million a year – would actually succeed as a candidate for funding when ranked against other candidate interventions in this year’s annual specialised commissioning prioritisation round, but it is a necessary condition for such an assessment to take place.

Thirdly, we will invite, where appropriate, the manufacturers of the drugs and treatments previously placed in levels 3, 4 and 5 of the provisional prioritisation decisions, as well as Gilead (the pharmaceutical company marketing the PrEP drug Truvada) 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.

Fourthly, the Clinical Priorities Advisory Group (CPAG) will be asked to re-run the prioritisation process as soon as practicable, likely in October. They will assign each policy to one of five priority levels relative to the other policies considered, and produce their advice to NHS England at the earliest opportunity.

Fifthly, and again without prejudice to the outcome of legal proceedings, funding decisions based on CPAG’s advice will be made by NHS England’s Specialised Commissioning Oversight Group and assured by the Specialised Services Commissioning Committee of the Board.

Should the Court of Appeal consider and uphold the judge’s decision such that there are no more questions to be resolved, then those treatments and services provisionally identified for funding by this process will be made available as soon as is practicable after the judgement is received, which may or may not include Truvada for the reasons given above.

Early implementer sites and continuation of provision to PROUD participants

In the meantime, NHS England remains committed to working in partnership with Public Health England to run a number of early implementer test sites, backed with up to £2m investment over the next two years, to research how PrEP could be commissioned in the most clinically and cost effective way. This will include exploring linking testing to the previous PROUD study.

Of course, this will be reviewed should the Court of Appeal consider and uphold the High Court’s ruling.

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.”