A judicial review in the High Court has ruled that NHS England is responsible for funding pre-exposure prophylaxis (PrEP) and decisively rebutted all the arguments used by NHS England to avoid paying for the use of PrEP.
NHS England said today in response that the High Court ruling does not mean the medication will end up being funded by the NHS, and warned today that manufacturer Gilead Sciences now faces a blindfold bidding war with other pharmaceutical companies to make its product affordable enough to be prioritised by NHS England for funding.
The High Court ruling issued today by Mr Justice Green comes as a result of a judicial review sought by National AIDS Trust to determine whether NHS England is correct to say that it is not obliged to fund a preventative intervention, in this case PrEP.
The funding of PrEP became the subject of judicial review after NHS England announced in March 2016 that despite the recommendation of its own Clinical Reference Group that PrEP should be provided by the NHS on the basis of eligibility criteria, the responsibility for funding PrEP lay with local authorities. The NHS was not responsible for commissioning HIV prevention services, NHS England announced, and might lay itself open to legal action by "proponents of other 'candidate' treatments that could be displaced by PrEP if NHS England were to commission it."
Today Mr Justice Green ruled that NHS England does have the power to commission for preventative purposes, and that even if this interpretation of legislation is wrong, there is no material difference between pre-exposure and post-exposure prophylactic use of antiretroviral drugs. Since NHS England already funds the latter, it should also fund PrEP.
The judge dismissed the NHS England argument that it was only obliged to provide post-exposure prophylaxis (PEP) because it represented an individual clinical intervention in cases where a person was judged by a doctor to already have the infection and be in need of treatment. He pointed out that both interventions rely on the same mechanism to prevent infection – PrEP is only active at the point transmission has already taken place, while PEP is prescribed to prevent infection becoming established after transmission is assumed to have taken place. He concluded that there was no substantive difference in the use or the circumstances surrounding the prescription of PrEP and PEP, and that in any case, NHS England has failed to provide any evidence that providing PrEP undermines the performance of its functions.
Mr Justice Green also dismissed the claim that provision of PrEP is a public health responsibility that must be funded by local authorities. The claim that preventative treatment falls outside NHS England’s remit is contrary to Parliament’s intentions in the 2006 National Health Service Act, he argued; if Parliament had not intended NHS England to have any further responsibility for preventative treatments, it would have discussed the issue and made that explicit in the Act. There is no evidence that this was so, he concluded. Furthermore, the NHS Mandate for 2016/17, issued by the Secretary of State for Health, explicitly charges the NHS with a role in preventing ill health caused by smoking, alcohol, obesity and "preventable illness".
But, in response, NHS England said today that it is appealing against the judgement. In the meantime, NHS England is holding in readiness funding to cover PrEP – but has warned that this will come at the expense of funding some other specialised services provisionally identified as priorities by the NHS England Clinical Priorities Advisory Group, such as prosthetics for lower limb loss and ivacaftor (Kalydeco) for children (2 to 5) with cystic fibrosis.
The Clinical Priorities Advisory Group will now be asked to re-run the prioritisation process and NHS England will also ask all the pharmaceutical companies whose products are currently on hold to come back with 'best and final offers' – including Gilead. Companies will have to guess how much of a price reduction will be necessary to win prioritisation, not knowing how other bids will affect their own competitiveness. This 'blindfold' bidding war is intended to secure the best possible price for NHS purchasers.
The cost of each intervention will then be ranked and a final decision will be made from October onwards on what NHS England will fund.
"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," said Dr Jonathan Fielden, NHS England’s Director of Specialised Commissioning and Deputy National Medical Director.