Update on commissioning and provision of Pre Exposure Prophylaxis (PREP) for HIV prevention
Work to date
Over the last year, doctors, patient groups, Public Health England (PHE), NHS England and the Department of Health (DH) have worked together to investigate the role that Pre Exposure Prophylaxis (PrEP) could play in preventing HIV in those at the highest risk
PrEP is a new way of using anti-retroviral drugs (ARVs) – usually used for treating people with diagnosed HIV – to stop those at very highest risk from contracting the virus.
Recent evidence – including from the UK PROUD study – shows this approach can be highly effective in preventing HIV as long as the drugs are taken regularly. Evidence of effectiveness is strongest for men who have condomless sex with multiple male partners.
So far, published studies suggest that PrEP does not lead to increases in other sexually transmitted infections, although longer term data is needed to be certain that PrEP can make a significant contribution to sexual health and well-being.
Commissioning PrEP – the legal framework
As set out in the Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) Regulations 2013, local authorities are the responsible commissioner for HIV prevention services.
Including PrEP for consideration in competition with specialised commissioning treatments as part of the annual CPAG prioritisation process could present risk of legal challenge from proponents of other ‘candidate’ treatments and interventions that could be displaced by PrEP if NHS England were to commission it.
Expanding PrEP funding – next stages of rollout
While NHS England is not responsible for commissioning HIV prevention services, we are committed to working with local authorities, Public Health England, the Department of Health and other stakeholders as further consideration is given to making PrEP available for HIV prevention.
Specifically, given the potential benefits in this area, NHS England is keen to build on the excellent work to date and will be making available up to £2m over the next two years to run a number of early implementer test sites.
These will be undertaken in conjunction with Public Health England and will seek to answer the remaining questions around how PrEP could be commissioned in the most cost effective and integrated way to reduce HIV and sexually transmitted infections in those at highest risk. These test sites will aim to provide protection to an additional 500 men at high risk of HIV infection as well as inform future arrangements for the commissioning and provision of this innovative intervention.
In addition, NHS England is keen to explore how a period of further support can be offered to the participants enrolled in the PROUD study and is committed to making funding available where there is a clinical need for additional help.
NHS England and Public Health England will launch a process to seek expressions of interest for the test sites from local authority areas with a view to confirming successful applications by June 2016. These will run over the next two years and will aim to test the ‘real life’ cost effectiveness and affordability of PrEP as part of an integrated HIV and STI prevention service.
The DH and partners will consider the relevant findings from the test sites to inform respective commissioning responsibilities for HIV care and treatment and HIV prevention.
In July 2015 NHS England approved a policy for the earlier treatment of people with diagnosed HIV to help reduce the onward transmission of the virus. It is intended that the benefits of this policy together with the PrEP early implementer sites will continue to reduce new HIV infections.
64 comments
Am disgusted in the comments that some people compare pre diabetes and statins to prep. Statins is available to ALL. Yes – unprotected sex is a choice gay or straight. Pre diabetics have no choice.
And the other concern – using prep (Travuda) could this over use by individuals who don’t give a damm give rise to drug resistance?
I am concerned about a different group of people ( both genders)who are at risk of HIV. They are the users of injected “recreational” drugs. Are they also to have this preventive treatment? Will the NHS have money to finance the treatment of any illness?
I’ve read all the below comments. Some very well thought through and others abusive because someone has a different opinion. It seems there is a lot more research needed. If people who currently use condoms decide not to that cannot be a good thing. Demonising condoms is just mad. They aren’t the same as ‘barebacking’ obviously but that’s the price you pay for keeping yourself safe. Barebacking is a lifestyle choice, no two ways about it. Should someone else shoulder the burden of your own lifestyle choice? I’m not so sure. It MAY save the NHS money in the long run. If this is true it needs consideration but there doesn’t seem to be enough evidence on the end cost once you factor in a new generation who will eventually, in many years to come, disregard condoms altogether. In which case leaving themselves open to other forms of STI. Will this drug encourage a superstrain of HIV? Just like antibiotic overuse is threatening. Until these questions are answered they can’t make a decision.
If there was a magic pill to prevent all negative effects from smoking, would the NHS or local authorities be required to provide it free of charge or would people be required to look after their own health by giving up smoking at no charge to anyone? It seems to me that if people are that worried they are at risk shouldn’t they use condoms? Paid for by themselves and no cost to taxpayer. I know we provide the pill on NHS funding but in that case there is the innocent life of babies at risk. I’m not preaching I just want to know why there is a legal challenge for this to be paid for when some cancer drugs are witheld. Surely by providing prep it will only encourage more men to have unsafe sex, perhaps leading to other issues. I just feel we should be empowered to look after our own selves and our health and think about consequences which may affect us in the future.I feel it’s a valid point worthy of discussion and would love someone to put a valid pro argument across.
as an african who has seen and lost many friends and family from aids it has become quite clear that while a lot of progress is being made in trying to find a cure for the disease ,we here in africa must forget about what our brothers and sisters in the west with good intentions are trying to do to assist.
IT MOSTLY ABOUT MONEY AND UNTIL SUCH TIME THAT MEDICAL ORGANISATIONS INVOLVED IN THE MANUFACTURE AND SELL OF ARV ARE NOT MAKING PROFIT IS WHEN WE SEE A REAL PUSH TO FIND A CURE DONT HAVE SEX DONT HAVE BLOOD TRANSFUSIONS JUST WEAR A CONDOM OR DIE
Unbelievable! For the last 6 years or so all we have been hearing is “cuts cuts cuts…” No Cameron, you have no rights to have cuts on our lives! PrEP as it stands is the only method to ERADICATE the virus at its early stages before it settles in blood cells! Gay, straight, bi, old, young, men, women anybody may catch this awful virus. Or are we talking about numbers and discrimination on the basis of someone’s sexual orientation here??? Since its introduction in England, PrEP has always been the most popular (and the only effective treatment) for GAY men who were exposed to this virus. I believe what is imposed on NHS by “Public Health England, the Department of Health and other stakeholders” is totally CRIMINAL and DISCRIMINATORY! Considering a poor country like Kenya provides HIV prevention and PrEP services to its public what these so called public bodies are trying to achieve for public in England is extremely worrying.
“While NHS England is not responsible for commissioning HIV prevention services…” total nonsense! NHS has always been and will always be the NO1 responsible authority for prevention of any disease in the country!
I hope NHS takes below points of Dr J Petersen-Camp seriously before this whole thing turns into a public campaign against NHS and Mr Cameron.
Dr Joseph Petersen-Camp says:
25 March, 2016 at 6:02 pm
This is an entirely disingenuous take on the commissioning framework. Please refer back to NHS England’s Specialised Services Circular SSC1516:
“NHS England is the responsible commissioner for all antiretroviral drugs (ARVs), including
where they are used in HIV prevention either in preventing mother to child transmission or as
post exposure prophylaxis following sexual or occupational exposure to HIV infection (PEP /
PEPSE).”
Please also note that you have spelt ‘prophylaxis’ incorrectly.
The moralising vitriol of some contributors knows no bounds. As far as I am aware the HIV virus doesn’t give a toss whether you have sex once or a ‘hedonistic’ number of times. What is more if you are taking PrEP the number of times one has sex makes no difference to HIV transmission.
The pious serial condom users seem to believe if you don’t just use that type of protection you deserve what the roll of the dice gives you. At family planning clinics the state pays for condoms and also the pregnancy pill. People have the choice as to which protection they use. If people have a choice with regards to stopping life why should it be different when one is seeking to preserve life? There may be a cost difference but with the cost of a condom being circa £1 and the costs of a Truvada pill being £1.30 (£40/30 in the grey market) the difference may not be so great especially when one considers the number of condoms one may use. Of course as at present the NHS does not routinely pick up this cost of PrEP however it does pick up the cost of PEP which requires treatment with 2 drugs for a month. In this context prescribing the 1 drug for PrEP versus 2 for PEP seems sensible. These costs are also likely to fall as patent protection ends.
If we are to rid the world of this horrible virus we need to be mindful of the broad spectrum of human behaviours. The reality is that many in a moment of passion act as biology has always intended without protection. This is the natural/normal state of the human condition. For HIV prevention measures to be effective they need to work with our innate predisposition otherwise as we see both in HIV and pregnancy they fail. PrEP provides us with a means for stopping the chain reaction of infection and so free the world from HIV.
So far we see the PROUD study showing that with condom usage and supported by safer sex counselling PREP is the most efficient regime against HIV. However, people then go on to cite PREP as a panacea and ignore the fact that regular testing & condoms already present barriers, whether social or personal, to being accessed and adopted by those groups deemed most at risk. Not one of the studies addresses these known issues.
The NHS has made the right decision to carefully asses and phase out the role out of PREP in trials to ensure it is actually meeting its targeted objective.
The USA and france already offer this free to anyone deemed at risk. Why? If the UK government have a cost objection why can’t they use the cheaper generic version being offered in other parts of the world? Or negotiate with the manufacturers to reduce their price. Or is it the influence the pharmaceutical companies lever at senior level to help maximise their profits hmmm!
Whyou should funds be diverted from more needy patients so a small group can indulge in unprotected sex.
The choice is there’s to make on whether to use protection or not and if they don’t that’s their roll of the dice.
There’s a huge problemishes in society where people expect there to be a constant safety net on every decision they make.
I for one would rather see the funds used for people who haven’t put themselves in the position in the first place.
This is an entirely disingenuous take on the commissioning framework. Please refer back to NHS England’s Specialised Services Circular SSC1516:
“NHS England is the responsible commissioner for all antiretroviral drugs (ARVs), including
where they are used in HIV prevention either in preventing mother to child transmission or as
post exposure prophylaxis following sexual or occupational exposure to HIV infection (PEP /
PEPSE).”
Please also note that you have spelt ‘prophylaxis’ incorrectly.
Surely, just from the financial point of view the cost of one tablet per day for a year to prevent the HIV virus from taking hold will be much cheaper than the full treatment require to hold the established virus at bay.
Gay men are so concerned about Prep encouraging a culture of barebacking they have set up a Facebook page. GMAP Gay Men Against Prep
GMAP’s facebook page is not run by gay people. This is a fake facebook account set up on the 23rd of March 2016. Their only aim is to support NHS’s decision for NO PrEP practice that is in force since 21st of March 2016. If they were genuine and believed that PrEP was doing harm to gay men they would have run this GMAP campaign long long ago, not just after 21st of March! GMAP facebook page actually proves that there is discrimination against certain people from non-majority backgrounds. If PrEP was popular amongst straight people (don’t tell me they don’t have sex!) would NHS still impose this injustice on them???
I suggest if you really want to know what gay men think of the NHS’s decision, follow GMFA’s facebook page, which was founded in 1992!
This is exactly why NHS England is wise to be cautious.
As usual with the gay community, we see the demonisation and attempted discrediting of anyone whose point of view differs. We must all conform to the opinion which the gay London elite has decided is the “right” one and which suits its vested (and usually commercial) interests. Charity jobs and funding depend on PReP being approved. Metropolitan chemsexing media pals are in favour.
Someone who is against PrEP can’t possibly be gay! But yes they can. Some of us have been promoting condoms since the 1980s and we’re mad as hell at seeing decades of good work being undermined.
The zealots are patroling the internet on the look out for anyone who dares not to agree and isn’t a mindless repeater.
People have choices in life they don’t have to have upsi , we all know what could happen if we do with high risk partners ! ? the Chem sex scene is full of risk takers . I don’t think the NHS should fund this .
We all want to reduce HIV transmission but this is not the right message to give Prep.
GOOD FOR YOU NHS ENGLAND !!! Show some spine !!!
What an outburst below!!
So taxpayers are now expected to pay for the drug simply so that a certain small part of the population want to indulge their hedonistic lifestyle of choice by having an expensive pharmaceutical form of protection, rather than a latex condom.
Where is personal responsibility in all this?
Has anyone considered how using PrEP will prevent the transmission of syphilis, gonorrhoea, chlamydia, hepatitis B, Hepatitis C, HTLV-1, and other sexually transmitted infections? and will it prevent unwanted pregnancies?
Are there sufficient studies to show that this will not lead to other unwanted or unanticipated effects? …or whether it will lead to any form of drug resistance?
How will this reduce incidence in poor African countries with greater burden of disease? What a typical selfish, self-centred, egocentric approach to this by a powerful lobby of shameless people with connections !
Pure lifestyle choice by a vociferous few should not be allowed to dictate the expenditure of tax payers money that has been demarcated for those in genuine clinical need.
“Has anyone considered how using PrEP will prevent the transmission of syphilis, gonorrhoea, chlamydia, hepatitis B, Hepatitis C, HTLV-1, and other sexually transmitted infections? and will it prevent unwanted pregnancies?” – Yes, studies show use of PrEP shows no decrease in condom use or increase in risk taking behaviour. PrEP is used in combination with condoms and other preventative measures, not in stead of.
“Are there sufficient studies to show that this will not lead to other unwanted or unanticipated effects? …or whether it will lead to any form of drug resistance?” Yes, numerous.
“How will this reduce incidence in poor African countries with greater burden of disease?” many african countries already offer PrEP (kenya, south africa) and others are en route to commissioning it as part of their HIV/AIDS strategies.
Why not allow the PreP meds to be sold ‘over the counter’ to those who are want to take precautions? I’m sure many gay men would be happy to pay to protect themselves.
Why oppose PreP on the NHS when it funds expensive infertility treatments at a time when other services like life saving cancer treatment suffers cuts.
Thats a good idea as long as the pharmacist was provided with proof of associated blood tests etc. I was against this at first but we have to consider that contraception is provided free and straight men and women therefore have the choice to use condoms or not. Having said that we are talking about the risk of bringing an unwanted child into the world. We have to take some personal responsibility which includes whether we have unprotected sex, whether we smoke, drink or eat 30 bags of chips a day
I am strongly opposed to PrEP on the NHS except possibly for very specific circumstances.
In the 1980s we gay men worked very hard to promote condoms and it was a great success.
Some of the demonisation of condoms that has been going on in the frenzy to promote PrEP has been absolutely disgraceful and I would go as far as to say really quite evil.
It’s been suggested that they are unsafe, that they break all the time. The fact that new cases of HIV haven’t fallen beyond a couple of thousands has been described as a failure of condoms!
I’m sorry but the numerous gay men aged in their 40s and 50s who are not HIV+ are proof that condoms have been a great success. And speak to those men and many will tell you that in 20 or 30 years they have rarely or never experienced a split condom.
Around 93% of gay and bi men in the UK are NOT HIV+. That speaks for itself. Compare to some cities in the USA where 50% of black gay men are positive. That shows what happens when the condom message has failed for a particular group for whatever reason.
I am extremely concerned that the gay heath charities and gay media are dominated by men who are HIV+. When nationally positive men only make up some 7% of all gay and bi men. Who is speaking up for the interests of negative men?
Some of the stats and videos are dubious. To what extent do the drug companies have a hand in these? When they have every reason to push for PrEP?
I believe there is a false idea that PrEP will create some wonderful stigma-free world where no one needs to ask about HIV status or condoms anymore. And that is the agenda of some of the campaigners. In fact it may well result in much higher levels of other STIs including hep and maybe even drug resistant strains.
The reason HIV took off in places such as New York in the early 80s was because of the extreme behaviour. The UK is much more like that now and if widespread condom use declines we may see men very ill or even dying from drug resistant STIs.
It’s claimed that PrEP will reduce new HIV infections. However, if there is a broad cultural change towards less condom use then men who are not on PrEP may be less likely to use condoms. In which case new HIV infections could increase.
Many issues aren’t discussed due to political correctness. One being the number of HIV+ me who hate condoms and don’t use them. And if positive men are dominating the debate then you can see what one hidden agenda might be.
Discracful and unethical decision made. You have the ability to reduce all new infections of HIV and prevention is cheaper safer and creates a culture of regular sti testing and support network that is invaluable.
What an absolute disgrace, and to call it off a truly deplorable excuse being given. The NHS funds lots of preventative measures, so why not this one?
The invisibility of women in this discussion is astounding. The issues facing women at risk, and sex workers in particular, are very different from gay men and they have not been adequately researched. The right dose for women has not even been identified, let alone the research needed to predict intended and unintended consequences PrEP will have for women when it becomes available from the NHS -as it clearly should. To fail to consider how women in various situations will be affected by this partially effective, non contraceptive, non STI protective replacement for condoms is to risk a range of sub optimal outcomes for women’s sexual and reproductive health, including new HIV infections. For this reason I am pleased to see a delay in the reduction in the price while further information is being gathered. I hope both NHS UK and gay community advocates recognise that women have legitimate and different interests in PrEP that are deserving of proper attention. Simply asserting that women will benefit on the coat-tails of men because the medication ‘works’ in all HIV negative humans is not good enough.
PrEP has been available in the US since 2012, and first users were predominantly women. There is a wealth of data out there with several trials conducted with women (FEM-PREP, VOICE, TDF, ASPIRE…) and numerous acceptability, feasibility and potential impact studies conducted. More studies would not hurt but to say that women are invisible is flying in the face of the facts. Whilst we wait, women are being infected…
Prevention is always better than the cure. Preventing HIV by giving PrEP to those at risk will cut the rates overall in the population, reducing the costs of treating HIV in the newly diagnosed, not to mention the morbidity and mortality associated with HIV. Long term use of HAART is associated with other problems (notably cardiovascular events), which if PrEP is provided to someone while they are young for a few years and a few years only could be avoided.
Disgraceful you provide the pill to prevent pregnancies but when it comes to HIV you would rather ignore prep , it’s insane that you would rather pay for HIV treatment rather than HIV prevention , obviously prevention is not better than cure in the NHS
This is a terrible decision; the NHS has made a dreadful mistake.
PrEP works, but instead of embracing its potential to dramatically reduce HIV transmission rates, the NHS has decided to dissemble, delay, and obfuscate. The PROUD study provided exactly the information you claim to still require regarding the cost-effectiveness of widespread provision of PrEP by the NHS. The offer of 500 additional candidates for funded PrEP treatment is insultingly paltry.
Most worryingly, though, the explanation for why the NHS has taken this decision seems to indicate the its motivation for taking public health decisions is not scientific evidence or the public good, but cheapness and cowardice. You cite the “risk of legal challenge from proponents of other ‘candidate’ treatments and interventions that could be displaced by PrEP if NHS England were to commission it” as your reason not to fund PrEP. This implies you are fearful of a lawsuit. But from whom are you expecting this challenge to come? Who would sue the NHS for funding a regimen that will save lives? And even if ‘they’ did, are you seriously saying that the mere possibility of a lawsuit is justification for continuing to deny countless thousands of people access to medicine that could save their lives?
The NHS needs to reconsider this policy immediately. PrEP must be made available and affordable to everyone who is at risk.
EVERYBODY NEEDS PREP NOW THERES LOTS AND LOTS OF PEOPLE WHO NEED TOO USE IT.
I don’t need it, mate.
This decision is a massive cop out. The NHS does not find prevention so why the decision to fund diabetes prevention one to ones program ( I applaud this)
We need to activate and march on Downing Street as per the marches on Washington in the 1980’s demanding funding for HIV treatment and research.
All gay men need to become activists and turn this decision around. You can get prep online for £50 per month. I do but am lucky enough to afford it.
Where can you buy it for £50 a month?
I’ve been quoted £500 per month.
The evidence is in that this will save lives, and reduce costs to the NHS in the long run. This decision to delay looking at the matter will cost lives and will cost the NHS money. It seems bizarre to make such a call therefore. More money would ultimately be available for non HIV patients in the long run.
In the meantime there is a growing off piste market in this drug, which will no doubt lead to people taking it intermittently, and without any medical supervision or oversight. The end result will possibly be new strains of resistant HIV, and this therapy will no longer be effective.
This is absurd. The NHS was founded to prevent ill-health. PrEP is much cheaper than the cost of treating someone for HIV for life. PROUD clearly showed that the men who come forward for PrEP are those most at risk. This will not go to the worried well, but will prevent thousands of gay men becoming HIV positive. We don’t need any more studies! France has made PrEP available, why can’t we?
The majority of gay men are against Prep being rolled out as it will create a culture of unprotected sex and peer pressure on those who would use a condom. Read any thread on facebook on articles and you will see what the majority of gay men think about this. It is not the NHS failing these “high risk” men but they who are failing themselves in taking responsibility for their actions. Just taking Prep is a symptom of something deeper, barebacking is self harming and the individual needs counselling not drugging to empower their destructive behaviour. The whole Prep study is flawed as it does not “protect” the individual but hangs on “transmission” rates which it sees as reducing them through monitoring the patient so that when they are eventually infected with HIV, and they will, the truvada will go some way to reducing the viral load and then proper treatment at the next visit, along with contacting partners he has barebacked with. The drug itself is about 44% effective according to Sheena McCormacks findings and she herself thinks it will probably get those who used condoms to experiment. These HIV charities are full of HIV positive gay men who do not have the best interests of HIV negative men and shamefully demonise condoms as not as effective as Prep. I fully support the decision by NHS England as do the majority of gay men whatever this shouty minority of gay men say. These “high risk” gay men should be given counselling on their irresponsible behaviour and told to wear a condom. The best and cheapest option.
this repsonse is like giving a diabetic patient counselling and telling them not to eat sugar and then withholding thier medication.
totally misjudged
Utter rubbish the majority are against PReP ???? Take if your rose tinted glasses
Away from the pages of the London-based gay news websites with their extreme journalists, most gay men are using condoms and are not having mentally ill “chemsex” parties. Quite rightly they see PrEP as bringing yet another pressure/excuse for sex partners not to use condoms. And we have gone too far down that road already.
What a disappointing and depressing piece of reading the overall conclusion to this statement makes. When a treatment has such a proven efficacy as PreP, and when providing PreP to all who may need it has the potential to save not only lives but also a very considerable amount of money for the NHS, then a refusal to make this nationally available is not only misguided and foolish but actually bordering on criminal.
I hope that those responsible for making this decision will quickly come to realise that in many ways a large percentage of new HIV infections will be down to them and their appalling decision making. Taking this even further the responsibility for those whose lives are ruined or even lost due to contracting HIV in England post this decision being made will fall squarely into the hands of the people who decided that it was not a good idea to allow access to PreP to absolutely anyone who thinks they may be at risk of contracting HIV.
If the suggestion by another replier in this comments section is true, that this delay in approving PreP is in some ways down to a deliberate ploy to allow time for cheaper generic medication to become available, then this is an incredibly ill-thought and misguided thing to do. As any saving made by being able to offer generic medication in place of the branded drugs currently used for PreP will be massively outweighed by the extra costs incurred by the NHS in providing a lifetime of treatment to all those new cases if HIV that will arise between now and when the generic medicine is available.
The last point I would like to raise is in relation to the following passage from the NHS’s statement.
“Including PrEP for consideration in competition with specialised commissioning treatments as part of the annual CPAG prioritisation process could present risk of legal challenge from proponents of other ‘candidate’ treatments and interventions that could be displaced by PrEP if NHS England were to commission it.”
Would the NHS be able to clarify what these other candidate treatments are and where it is possible to find details of the currently existing studies that prove these other treatments to be at least as effective as PreP is in preventing new HIV infections, and that they are no more expensive. If these studies do not exist then surely that is reason enough to go ahead with the introduction of PreP as a nationally available preventative medicine, and if these other treatments do exist and are as effective and economical in preventing HIV infection as PreP then why are they not already as well known as PreP is. And if the makers of these other treatments were to sue the NHS for supporting PreP is there any evidence that the financial cost of this legal action would exceed the financial cost of HIV treatment for those who will become infected with the virus while free access to PreP is still denied.
Over 5000 people over the next two years will be infected by HIV because of this decision T.T
…only if they refuse to use a condom
This is a waste of resources to support lifestyle choices. There are super strains of syphillis, chlamydia and gonnorhea out there. Also of note is the JCV virus and herpes which is thought can lead to altzheimers and fybromyalgia. Condoms are the way forward. Education is lacking in schools and public health awareness is the way forward. As a gay man I am incensed by this ridiculous proposals. No long term studies have been made on long term use of antivirals on healthy individuals and whether a later withdrawl will have a negative impact on the way the body immune system subsequently copes with viral attacks.
6000 new cases each year obviously condoms are not the answer . The break they come off guys have sex when out partying and have unsafe sex , I take prep not because I have unsafe sex I take it because I control my sexual Heath I don’t rely on others to do it of me
well said..
however NHS is NOT there to pay for someone else’s lifestyles! It is YOUR RESPONSIBILITY to protect yourself from HIV (and other diseases ) not the NHS!
Failure to roll out this evidence based, cost effective intervention will cost lives. Some folk at risk are already accessing PrEP online from abroad, without the vital wrap around medical support to monitor liver and kidney fucntion. Not only will the decision not save lives, it will also support an online black market in self-service PrEP with the very real potential to damage those doing so without mdeical supervision.
Why would someone need to access PrEP when the NHS is using other other drugs that do a similar job?
“competition with specialised commissioning treatments as part of the annual CPAG prioritisation process could present risk of legal challenge from proponents of other ‘candidate’ treatments and interventions ”
That above statement shows that there are other drugs on the market that would do the same thing.
Xx
Whilst we are pleased to see NHS England’s willingness to explore how further support can be provided to the PROUD participants, we are disappointed that PrEP will not be more widely available to people at risk of HIV in England and Wales. We strongly disagree with the inference that more ‘real-life’ evidence is required to assess the cost-effectiveness and affordability of PrEP as part of an integrated service. This is exactly what PROUD has already established – and in the most astounding and scientifically robust way due to the very high rate of HIV among those who came forward for PrEP, but did not have access to drug for the first year. All participants had access to the rest of the integrated service, including behavioural interventions. The added public health benefit of PrEP was an 86% reduction in HIV – a large effect that has inspired other countries to accelerate implementation or initiate national programmes. The PROUD study demonstrated that you could avert one HIV infection per year by offering PrEP to just 13 men at high risk of HIV. This is a powerful HIV prevention tool and avoids the need for NHS England specialist services to fund a lifetime of treatment. The risk of legal challenge is negligible compared to the benefits, which are financial for NHS England, and personal for the thousands of individuals destined to otherwise catch HIV in the next 2 years. Please think again.
1) Ong et al. cost effectiveness model suggests that cost effective only under certain circumstances (any thoughts?), and not so cost effective if lower risk individuals use which is likely in real world. Also can’t access full text of this article (we need to have open access to this information in order to make informed decisions)
2) Cost effectiveness not the same as affordability.
3) In addition, practical commissioning considerations need to be thought through before any roll out: how, to whom, for how long, appropriate clinical governance oversight etc.
4) Are there really no other combinations of primary prevention interventions that have been shown to be effective?
5) You mention that s bigger study would be required to more accurately define differences in STI rates – do you mean your study is underpowered to detect these differences? (STI rates higher in immediate group even though not statistically significant)
Dear Anonymous,
In answer to your unevidenced comments;
1: The PROUD study results are open access, just type in PROUD results in google and you can obtain them free of charge. Yes it is true that low risk individuals would not benefit, but PrEP is given to high risk individuals via GUM clinics and they would have to engage in order to get it.
2: Without going into an argument regarding QALY’s, cost-effective does mean that the out lying cost will bring you more benefit then dis-benefit. In other words this treatment is affordable as you prevent people from having to have lifetime HIV treatment. The effectiveness is further demonstrated by the Number Needed to Treat which was 13. which is a very low number compared to the majority of medications the NHS pays for.
3: Commissioning would be very easy as PEP is currently commissioned via the same NHSE team and it is rolled out usually via GUM clinics. We can also learn lessons from countries that have already commissioned PrEP. These are USA, France, Israel, Canada and Kenya, to my knowledge there are no legal challenges in any of these countries currently.
4: Yes they are but they are still undergoing clinical trials. So far it is only Truvada that has passed the high bar of evidence needed. There will be others in the near future. In the mean time lets use what is show to work now.
5: Studies are powered to detect the effect they are trying to measure. In this case it was the effect of Truvada to prevent HIV transmission. However they noticed that STI transmission rates did not increase. It is possible that a trial which is much larger MAY detect a change. However as the rates of some STI’s are very high in the MSM community (over 18,000 cases of Gonorrhoea compared with 2,276 cases of HIV in 2014 in MSM’s) it is good to see that there was not a rise and as gonorrhoea is much more common you would of expect to see a rise in such an easily transmissible disease. Therefore you can draw the conclusion that use of PrEP does not increase transmission of other STI’s.
6: I understand that for what ever reason you maybe scared or not like the idea of PrEP, but it is about giving men security over their sexual health. Exactly like the pill/coil/CAP/femidom is for women. You use a range of devices to protect yourself not just one.
Regards
Bret
I am sorry you believe my comments are unevidenced – it was based on reading of your study and what I could find regarding cost effectiveness analyses.
1) Yes, I have read the Proud Study – it is the cost effectiveness analysis that I was referring to: https://www.researchgate.net/publication/283790276_Cost_and_cost-effectiveness_of_an_HIV_pre-exposure_prophylaxis_PrEP_programme_for_high-risk_men_who_have_sex_with_men_in_England_results_of_a_static_decision_analytical_model
2) My point was cost effective does not mean net cost saving. Appreciate the cost effectiveness analysis suggests it could be cost saving if the very highest risk are targeted, but not lower risk MSM, which is likely to happen in the real world. I understand what a QALY is.
3) As a commissioner, I don’t believe roll out of PrEP is as simple as you say. It is quite a different model to PEP. The other countries you mention have very different health systems to ours.
4) Yes, isn’t stating that something didn’t increase, if the study was insufficiently powered to detect this change, misleading?
5) I do not fear PrEP, but the message it may give about lifestyle choices and longer term changes in behaviour that may be encouraged.
This does not seem to be a well thought through approach that raises a number of important questions. It risks being bad medicine as well as bad policy.
1) How should the 500 men be selected in participating sites? Well-informed men might well come forward to access PrEP but less well-informed men with poorer access to healthcare, who are likely to be at as great if not greater risk, will miss out. This seems to represent officially sanctioned inequity, creating winners and losers. Has NHS England considered an ethical review of this approach? If not, then I would strongly recommend that it is done.
2) How will cross-charging and open access to sexual health services work with respect to PrEP in early implementer sites? Will it only be available to residents in the early implementer local authority?
3) Can NHS England be certain that this approach will not create a perverse incentive for men to exaggerate or even increase their risk in order to be one of the “lucky” 500?
4) Could NHS England clarify and give more detail on the questions that remain to be answered? The PROUD study was explicitly designed as a pragmatic study aiming to mirror routine GUM services and provides a model for implementation more widely, with the PHE recommended 3 monthly visits for STI screening in MSM most at risk. The benefits of PrEP are as a public health intervention, suggesting that a population approach is needed. Could NHS England clarify how cost-effectiveness can be evaluated in more detail with only a sample size of 500 (or even 1000 including those on PROUD)? What power calculations have been done?
I would be grateful if you could address these questions as soon as possible, given that 18 months have already been spent working on PrEP policy development and in the context of ongoing high levels of HIV transmission in MSM.
This announcement by NHSE would seem to be economically unsound.
Given that one year of medications to treat a person who is living with HIV costs around £20,000 and, as some commentators have suggested, 5000 may well become infected each year due to this announcement. This may increases the cost to the NHS by £100,000,000 each year.
This cost is for medications alone and does not reflect any additional cost for staff, nor does it reflect the life changing affect that receiving an HIV positive diagnoses can have on an individual regardless of cultural, religious or sexual identity.
Furthermore it is my personal belief that this decision has been kicked into the long grass allowing time for the main medication in question to come to the end of its patented life and a generic version becomes available.
Whilst I am not adverse to the use of generic drugs I cannot see the moral or economic sense in making people wait until at least 2017 before any practical policy for PreP is put in place.
After 18 months, this decision can only be regarded as passing the buck. Making resource-starved local authorities the responsible commissioner for what should be a national prevention program will have the predictable consequence – no PrEP for all but these additional 500. NHS England is aware of this in their decision and are officially denying healthcare.
NHS England states that they want to “answer the remaining questions around how PrEP could be commissioned in the most cost effective and integrated way”. The proposed approach can’t possibly achieve this. Firstly, how are these 500 to be selected? Further clarification is required but it’s likely that they will be those at the highest risk of HIV who are already the most aware of PrEP. Such a population will be unable to answer any of the questions raised by the two cost-effectiveness analyses done to date. There already exists a ~500 population at high risk of HIV on PrEP and cost effectiveness is well understood in this population. What additional information can possibly be answered with another small high risk group?
PrEP is required nationally to reach all those at high risk of HIV. This includes those who are currently unaware of PrEP to avoid “drifting in a direction that divides society rather than unites it” and leading to an unfair society.
Astounded by this decision! Internationally Truvada has proven itself to be a very effective tool our ongoing battle against HIV/AIDS. It saddens me to see the NHS turn its back against the people and the undisputed evidence and take a decision based on fear of being sued. Today is a sad day for this country.
This is disgraceful. Shame on you. The US, Canada, France, Israel, Kenya have all made PrEP available. Why can’t you do the same. The message this gives out is that gay men are still second class citizens. This decision is going to mobilise a generation of activists and those who made it will be remembered in history with the same fondness given to Nancy Reagan.
Dear Sirs,
If the NHS is not responsible for making available NHS prevention treatments, then what exactly is NHS England’s involvement in this? Is this just an ambiguous way of saying that the NHS will not make the money available to local authorities – does the NHS give local authorities the funds for healthcare? Exactly who is responsible for deciding if PrEP is made publicly available? Clarity is urgently needed to those of us not professionally involved in the workings of healthcare in the UK.
If NHS England is responsible for making PrEP available or making its funding available, then you have failed to properly explain the reasons for your decision. As a publiy-funded body, you have a civic duty to explain how public money is spent.
We all await your response. Prove us wrong and give us one.
Yours,
Ross Duffy
Shocking decision. Typical short sighted decision making in relation to the public’s health. Adreess the symptoms not the cause
One step backwards for creating a HIV free generation.
This is a grotesque decision by NHS England. Within the next year, 5000 gay men will catch HIV. NHS England could stop many of these infections by approving PrEP. Whoever made this decision has 5000 ruined lives per year on their conscience.
I’m absolutely astounded and devestated at this news. A totally short-sighted decision that will cost the country more in treating new HIV infections.
This is an inexplicable and damaging decision. Whoever is responsible should be ashamed.
Prep has been widely studied, found to be effective and implemented in other countries. There is no need for any further study in the UK. It should be rolled out without further ado.
On cost grounds alone, Prep will save the NHS money. Money that could be used for many other purposes.
Hang your heads. You are condemning some people to difficult and expensive long-term treatment at great cost to the Public purse with this unnecessary delay.
I am disgusted.
This poor decision by NHS England will be indirectly causing an increase in HIV diagnoses with those in high risk communities, if Truvada was available then the benefits would outweigh the costs. Very disappointed.
Thanks for the update