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August update on the commissioning and provision of Pre Exposure Prophylaxis (PREP) for HIV prevention

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.”

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35 comments

  1. Dean says:

    We are behind you 100%. This is a slippery morally incomprehensible travisty – what is the wider message being made here – a select few can do what they want and the wider uk will pick up the bill because they prefer sex without a condom. Or, if you take drugs it’s ok because you can now take a pill that reduces your chance of getting HIV. The long term affects will cost the NHS more because a select few do not have the will to use alternatives whilst we promote a zero consequence message for their behaviour.

    To us there are two examples where it could be used:

    A. Where two people of any sex (where one of both have HIV) fall in love and decide to get married and have children. This protects the other partner and safeguards the future of the child.

    B. Where a drug user enters a rehab programme and remains on the high risk register – after such time within a successful rehab programme that individual is no longer allowed the drug.

  2. Sharon Byrne, Co chair HIV Pharmacy Association says:

    The HIV Pharmacy association are pleased that the review means that PrEP can be considered equally alongside other NHS services for funding.The NHS as an entity should be working with patients,other organisations and pharma companies to fulfil its commitment to an equitable and non-discriminatory service for everyone.We would question why there is a need to conduct further evidence reviews and duplicate the excellent and extensive work that has already been done by the NHSE PrEP policy task and finish working group that included detailed cost effectiveness and cost benefit analysis. The group comprised specialist doctors, pharmacists, commissioners from NHSE and local authorities, patient reps and PHE. We hope that NHSE recognise that it would be the sole beneficiary of the cost avoidance (resulting from the treatment and care costs of those who would become HIV+ without PrEP) from such a highly cost effective intervention and thereby consider equitable access for PrEP for everyone.

  3. Damian Harper says:

    I as a lower limb amputee have been directly impacted by this decision other than to deliberately pit patient groups against each other and demonise one particular demographic. To suspend all levels 3 and 4 priorities and basically start the process again is bit, in my opinion devicive and mean spirited. In the mean time patients are suffering. Clinicians are in disarray and everyone is in limbo. The microprocessor knees etc has been in chaos since this national commissioning was introduced. Stop procrastinating and get on with it. NHSE has no plausible excuse not to fund the agreed level 3 and 4 priorities. You are playing with people’s lives. You risk now being served with another class action from the groups now being impacted by this latest decision.

  4. R. E says:

    This drug is actually very cost effective, when you look at the price and the rate at which it protects against contracting HIV. It’s much cheaper to provide this for people going through particular periods of risk in their lives, for whatever reason, than the cost of having antiretrovirals for the rest of their lives.

    I don’t think it incites people to take more sexual risks, but you can say that about anything, the argument isn’t soley related to PrEP.

    Absolutely this drug should be available on the NHS, it would be part of the whole HIV prevention package (I’ve been told) not instead of condoms, or testing, or support. Can you imagine the uproar if this was some amazing new immunotherapy that was 86% effective in preventing those at risk of getting a certain type of cancer?

  5. Ben says:

    I don’t think the statement is ‘disgusting’; the NHS DO need to carefully consider how they spend money, and they are on a limited budget. That said, the organisation ought to take a more long-term view and pay attention to data which strongly suggests there will be an overall saving of money, due to fewer cases of HIV to treat.

    Results happen in the real world when people don’t moralise or say how people SHOULD act, but look instead for effective solutions to problems arising from quite predictable behaviours.

  6. Christabelle Birritteri says:

    Why encourage anyone to have unprotected sex? I think it is irresponsible because HIV isn’t the only think that can be transmitted through sexual conduct. There is still about 15% chance it will not work for someone taking Prep. If the NHS ends up offering this drug, it should be prescribed as a controlled drug with strict criteria for prescribing. This should reinforce to people to not get into the habit of not using protection during sex and then having assumptions that can just take prep when they want to. I don’t think this drug should be available to everyone because I think that people would or could abuse the initial purpose of this drug. In addition, this is NOT a affordable drug for the over stretched NHS.

    • I believe it is essential that the PrEP is made available to those that are at risk.

      While all the legal wranglings are going on. bear in mind 3000 people are being infected in this country with HIV every year. The cost of treatment for those that become HIV positive is far in excess of The stop gap that many will use PrEP for.

      I urge that this gets implemented as soon as the final decision is made.

      The health of this nation and the increased infections makes this single issue of extremely high priority.

      Please Implement and stop procrastinating

    • Andrew Perley says:

      Youre suggesting HIV infected persons that will spend the rest of there lives on ARTs is the solution here?

      PrEP is considered to be 98/99% affective. To date of The 60-80,000 on PrEP world wide there has been only one case where a user with correct adherence became HIV positive. This was a case in Canada this year I believe. That is staggering.

  7. Paul Kirwan says:

    What a prejudiced comment. PrEP is for anyone at risk of contracting HIV, so why the mention of high-risk condomless sex between gay men? Why not mention sex-workers as well? Or sero-discordant heterosexual couples? Is this sour-grapes on losing the court case? It certainly reads that way. Whoever wrote and approved this statement is in need of re-education and strong words about not allowing personal prejudices to find their way into press-releases.

    Please rescind, rewrite and reissue this blatantly homophobic statement immediately. There should be no room for such judgemental comments from NHS England. The statement, in it’s current form, is a disgrace and possibly illegal. Shocking behaviour from a public body.

  8. Olivier Pecon says:

    NHS through its “live well” page appears to try to fight homophobic abuse or help people victims of homophobia. Publishing such an article demonstrates a level of hypocrisy and hidden homophobia, which should not be acceptable and consistent with the values of the NHS.
    All people regardless of their sexual orientation are at risks and all groups use condoms regularly. Considering Prep would only be used by promiscuous careless gay people is ignoring the fear that anyone is facing when something unplanned happens. The number of straight individuals having a night out they regret is nothing to compare to the gay men population and they will benefit from Prep. This article is full of judgment and bigotry that does not belong to our time.
    Hopefully NHS England realised how deeply offensive this article is and will act accordingly in its future communication.

  9. Anthony West says:

    So why do the NHS commission the contraceptive pill and the morning after pill for heterosexual woman who sleep with multiple partners and won’t use condoms? It’s the same thing is it not? Also prep would not only be required by gay males but in fact anyone at risk of hiv. I think the fact that the nhs are even considering to appeal this decision is descusting.

  10. Marcus says:

    absolutely disgusting remark with completely homophobic undertones! the author of this “rant” should be brought before the legal system and explain how a public figure can make such homophobic remarks and blantey lie! the NHS should be ashamed of their actions

    I hope someone is able to sue the authors of this article and bring the responsable parties who wrote this homophobic rant to justice!

    The NHS needs a masive shakeup and get rid of the out of touch homophobes sacked

  11. Kathleen says:

    First of all why should I be denied funding for my thyroid medication which I have to pay for. Is it fair that HIV partners are funded for a far more expensive drug when they have brought about their own demise. Sex is not a health need and there are already Condoms that can be used. There are also test kits available to test for HIV.Discrimination occurs when HIV sufferers are not honest about their condition, and it is up to their partner if they wish to take that risk of getting HIV.Now why should others who suffer a condition be turned down for their treatment in favour of a persons partner to prevent them from getting HIV.Why too should children with other illnesses be turned down for their treatment in favour of a drug to prevent HIV when there are already ways to prevent HIV. On top of this we already have patients over here from abroad receiving free treatment for HIV and to prescribe a drug on the NHS as a preventative for their partners more will flock into the UK.

    • Paul Decle says:

      Actually Kathleen,
      You do not need to pay for your thyroid medication. You are entitled to a medical exemption certificate as hypo and hyperthyroidism are recognised for exemption. Furthermore an exemption certificate covers all costs for all medications so you should not be paying for any medications.

      I hope you can accept this information from someone who is living with HIV. Maybe you could save some of the money you spend on your thyroxin and use it to buy some book or education for your self.

  12. Your QC is certainly not a preferable choice a QC for NHS should have patient health and welfare as a goal, so he/she can help you achieve the goal for which you were founded.

    PrEP should AT THE VERY LEAST be continued for all participants in the PROUD-study; and slowly rolled out further, according to risk selection as so astutely done in the PROUD-study itself. Consult with the HIV policy agencies and don’t duck away.
    I further refer to the comments of Mr Matt Williams and Mr Fergus Cairns

  13. M.J Howes says:

    If the spread of hiv can be stopped with a condom why would anyone risk side effects of tablets . The national health has over the years spent more and more on minority sections of our society with highly active representatives who use the public funds like their own
    Backed by the political correctness that covers all ills

  14. Tristan Barber says:

    Government sleight of hand to encourage division is grim indeed. Those who post about the limited supply of money for the NHS are quite right, and PrEP has been shown to be cost saving, even if we reduce the argument to the economic. Asking Local Authorities to fund sexual health is counterintuitive to good public health, putting good local services with (non ring fenced) tight budgets against more macro prevention priorities that can and should be NHS funded. Pretending that doing one good will prevent another is a political tactic tantamount to inciting hatred. These decisions are artificial. Stop pitching one against the other; see good for good, take the chance to reduce HIV infections, and fund this evidence based intervention.

  15. Roger Brown says:

    This release withdraws Stem Cell Transplantation for Waldenstrom Macroglobulinemia (identified as LPL in your lists by CPAG with only level 4 priority) It has been a standard modest cost treatment for WM for relapsed patients with no further options for 10 years and is on the published BSH clinical guidelines. This leaves clinicians in disarray and uses patients as counters whilst the NHS fights the PReP ruling in the high court. This is totally unacceptable and unethical, particularly as the release implies that it is proposed new treatments that are being considered, not withdrawal of existing. Velcade has already been withdrawn for these patients by the ‘old’ Cancer Drugs Fund, so options for these blood cancer patients are again reduced. WMUK intend to publicly call for this to be reversed forthwith and ask that NHS England call us to clarify the issue immediately.
    Roger Brown, Chair WMUK

  16. Matt Williams says:

    This looks to me like NHS England is briefing against gay men for stealing from children to cover up a resistance to commissioning PrEP, something that has been evident since the stunning results of the trial to test the PrEP intervention (the PROUD study) were known in September 2015. Shameful. It also forgets (to be kind) PrEP for women, which was rightly included in the well-developed commissioning plan derailed by NHS England in March 2016. Shameful. Pitting one group of people against another, shameful. NHS England should treat all people with dignity and respect. Every innovation in care should be considered fairly and transparently, with decisions based on the merits of the interventions regardless of who benefits. A shameful statement and a shameful state of affairs.

  17. Collette Brydon says:

    This statement is so obviously prejudiced its disgusting.

    As Paul says below PrEP isn’t just for gay men, there are other high risk groups whose lives would change with access to PrEP.

    I think this loaded statement is totally unethical leading up to a public consultation.

    • Kathleen says:

      There is one section of our society that needs protecting and that is our police force who are having a lot to contend with. PrEP is far too expensive to hand out to all who cannot be bothered to take precautions. Why should people who are seriously ill have to go without their treatment so that others can indulge in sexual activities. The NHS has only so much money to go round.

  18. Justin says:

    This is absolutely disgusting. HIV is a public health inequality which is a result of systematic discrimination and lack of appropriately funded public health responses. Branding an inequality as some sort of optional choice for a community completely ignores the systematic drivers for such inequalities. You are supposed to be healthcare professionals led by evidence – start acting like it.

    Also, pitching health inequalities against each other? You should be thoroughly ashamed of yourselves as healthcare professionals.

  19. The tone of this statement is hugely regrettable, and has contributed to skewed and homophobic press coverage, which also inaccurately reports the implications for NHS England. Setting PrEP as an issue for MSM in the opening paragraph ignores the potential the intervention offers other at-risk communities including sero-discordant, monogamous, heterosexual partners. NHS England should consider how their wording frames the (legitimate) debate on clinical prioritisation unfairly.

    It is disingenuous to suggest that it is the outcome of the legal action that has delayed other commissioning decisions; this delay is entirely a consequence of NHS England’s own decision to withdraw PrEP from the CPAG process in the first place.

    Those campaigning for PrEP are sensitive to the complex issues involved in clinical prioritisation, and to the financial pressures on the NHS. Our ask is to apply the appropriate prioritisation processes fairly.

  20. There is only one objective way to look at PrEP: it is a very effective prevention method for a serious, potentially lethal, pandemic viral disease, which happens to be spread mainly sexually.
    That’s the way bodies like the WHO view it, not to mention countries ranging from France to South Africa who have implemented PrEP provision via the healthcare system or are preparing to.
    Yes, PrEP will require significant upfront spending (though the amounts are small compared to the HIV treatment spend), but cost-effectiveness studies show that it will soon start to recoup its investment in the savings from HIV infections that did not happen, especially if targeted at the small number of people at highest risk.
    It is valid to discuss the cost of PrEP and how it can be implemented in the NHS. It is not valid to issue a press release which is likely, in the eyes of many people, to make gay men trying to protect themselves from HIV look immoral and selfish.
    Gus Cairns
    co-Chair, PROUD study

  21. Kieran says:

    I hope you are truly proud of yourselves for using this innovation in HIV preventation as an opportunity to turn different patient groups against each other and promote homophobia and HIV hatred on a level we haven’t since the 1980s. Any one of you working in the NHS should hang your heads in shame this day for the horrible way you have betrayed your own values, attacking a minority, baiting prejudice and discrimination, and undermining the realities you have spent decades researching on the impacts of HIV and how it has spread. Absolutely disgusting.

  22. Lisa Power says:

    The opening line of this release has led directly to grossly homophobic and discriminatory front page coverage in the Mail and Times this morning. I would like to hope that the NHS England comms team involved in agreeing this phrasing reflect on what you have done and feel some shame; it is years since we had to deal with stuff like this, so openly judgemental from health services. Additionally, your decision to halt stages 3 and 4 pits patient groups against each other and has also inflamed the coverage. This is precisely what CPAG, as an open, equitable and transparent process, was intended to halt. You really need to think about how you’re behaving on this one. There are much less inflammatory and less prejudicial ways of handling it.

  23. Mark Smeaton says:

    I think the article is factual.
    People need to calm down.
    The NHS does not have a bottomless pit of money.
    On the contrary, the NHS needs to make careful decisions about how things are funded.
    It is sad that funding for children’s drugs will be compromised because people cant/wont use condoms (cheaper than PREP)

    • Gus Cairns says:

      PrEP doesn’t have to be financed through the CPAG mechanism at all. There are other ways of doing it. Mentioning the groups PrEP would compete with is designed to turn peopel against gay men.

  24. Anonymous says:

    The NHS does not have a bottomless put of money. It is unfortunate that funding for drugs for children is being out at risk because people cant/wont use condoms (much cheaper than PREP)

  25. Paul Decle says:

    I find the tone of this statement decisive, inflammatory and discriminatory.

    PrEP is not “particularly for men who have high risk condomless sex with multiple male partners.”

    PrEP is for all who are at high risk of becoming infected with HIV. This includes women who may not be able to safely negotiate their partners use of condoms as well as young men and women who do not yet have the confidence to insist on condom use.

    When did the NHS start this sort of anti gay propaganda?

    • John O'Callaghan-Williamson says:

      Absoutely agree, the use of language is “disgusting”.

      It’s clear this was considered and written with the intent to “stoke the fires of bigotry” towards gay men.

  26. Liz Hurley says:

    I’m appalled that the NHS intend to appeal against the ruling. Of course PrEP should be available on the nhs! I’d much rather my tax money be used for that than cosmetic boob jobs for “emotional distress”

  27. Alex says:

    To start the article stating “particularly for men who have high risk condomless sex with multiple male partners” brings the discussion back to the dark ages of the 80-ies when prejudice against AIDS victims and gay men in general ran high. Very unfortunate.

  28. Jillian Pritchard says:

    In view of the significant cut in the PHE budget for sexual health there seems little likelihood they will be able to contribute financially to PrEP.
    Since NHSE will benefit financially if the anticipated reduction in new HIV infections occurs as a result of PrEP surely that is the only realistic source of funding

  29. Paul Masters says:

    Where is the promised support for Proud participants? I finished on the study today and there is NO support on offer whatsoever. Either this was a lie, or you have severely messed up. Either way you have serious questions to answer, and continuing to promise support for Proud study participants is insulting, unethical and wrong.