England NHS - August update on the commissioning and provision of Pre Exposure Prophylaxis (PREP) for HIV prevention
2 August 2016 - 11:33
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."
PrEP HIV drugs: fight for limited NHS funds takes unedifying turn.....Hard decisions have to be taken as long as the NHS has a limited pot of money to spend......https://www.theguardian.com/society/2016/aug/03/prep-hiv-drugs-fight-for-limited-nhs-funds-takes-unedifying-turn
Anger after NHS warns PrEP HIV drug could put other treatments at risk
A warning from NHS England that it cannot confirm funding for drugs to treat rare conditions including cystic fibrosis in children if it is to pay for an HIV prevention pill has been criticised as "invidious" by Aids campaigners, who say it calls into question the organisation's impartiality.....NHS chiefs immediately said they would appeal against the decision and warned that if the health service is to be responsible for providing the HIV therapy, at a cost of 10m-20m a year, it may not fund other treatments......https://www.theguardian.com/society/2016/aug/03/anger-after-nhs-warns-prep-hiv-drug-could-put-other-treatments-at-risk
Court Rules That NHS Can Fund HIV Prevention Drug PrEP
Aug 4 2016
A high court judge in the UK has ruled that there is no legal basis to prevent the NHS from providing PrEP to gay men most at risk of contracting HIV.
Earlier this year, UK health body NHS England caused outrage when, unexpectedly, it refused to fund the HIV prevention PrEP drug known as Truvada. The organization claimed that it was the responsibility of local health bodies to take charge of Truvada's rollout.
NHS England employees further argued that funding Truvada could leave them open to lawsuits from companies providing other HIV prevention drugs. It also argued that the NHS does not commission preventative measures and, instead, defers to local health authorities.
MPs and HIV/AIDS campaigners were alarmed at this decision. The National Aids Trust sought a judicial review from the High Court to have the NHS clarify its position and test whether its claims were accurate.
On Tuesday, August 2, Justice Green ruled that the legal analysis provided to and by NHS England had "erred in deciding that it has no power or duty to commission the preventative drugs in issue."
Green went on to contradict what HIV campaigners had called NHS England's spurious reasoning, noting that local authorities are already financially burdened: "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."
The British Medical Association has welcomed this ruling, emphasizing that PrEP can save lives.
The ruling, however, is not a simple matter of forcing the NHS to implement PrEP rollout. NHS England is appealing this decision and aiming for an expedited review .
In the meantime, NHS England has made a statement outlining several future steps originating from this ruling:
... 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 specialized commissioning prioritization 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 prioritization 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.
However, campaigners have criticized NHS England for reportedly telling the press that providing PrEP could mean cutting other lifesaving drugs - something that LGBT-hostile tabloids like the Daily Mail have seized upon.
The National Aids Trust points out several issues with this attack on PrEP access. Namely, by NHS England's own admission, it has yet to perform a cost analysis. Additionally, the patent on Truvada ends in 2018, meaning that the current 400 per month-per person price tag will plummet in the near future:
Every policy funded involves money being spent on that policy and not on a policy which in the end is not funded. 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.
NHS England has previously been criticized for casting doubt on PrEP's effectiveness, even when the government funded PROUD study found it to be highly effective. Several other studies have all backed the effectiveness of preventative treatment and concluded that LGBT people at high risk for HIV generally adhere well to the PrEP daily schedule.
The mood remains optimistic that NHS England's appeal will be unsuccessful. Therefore, campaigners are asking the NHS to begin at least the preliminary work for Truvada's rollout.
MPs have also written to health secretary Jeremy Hunt to ask for a timetable for the availability of PrEP and what that framework might look like:
The UK's Conservative government has been widely criticized for its austerity measures that have impacted institutions like the NHS. Analysts have warned that the dithering over PrEP is probably in part due to the lack of available funds that makes preventative medicine appear to be a luxury - despite the fact that they could save the NHS money in the long term.
While the fight for PrEP creeps closer to victory, the battle for this "game-changing" HIV prevention drug is not over yet.