NHS England stalls plans for HIV prevention drug

[garbon]

There go my whore pills.

http://www.theguardian.com/society/2016/mar/21/nhs-england-hiv-prevention-drug-truvada-prep

Charities and campaigners have reacted with anger and disbelief that plans to roll out a widely anticipated HIV prevention drug have been stalled by NHS England.

The sector had been waiting for the announcement of the first ever public consultation on the use of pre-exposure prophylaxis (PrEP) in the UK, now overdue by a month. Instead today NHS England announced it was not their responsibility to commission the drug.

The HIV treatment pill Truvada containing PrEP can be taken on a daily basis – in a similar way that women take the contraceptive pill – by men who have sex with men to dramatically reduce the risk of HIV transmission. In February 2015, a Proud (pre-exposure option for reducing HIV in the UK: immediate or deferred) study reported that PrEP had effectively reduced the risk of HIV infection by 86%.

Terrence Higgins Trust, the largest provider of HIV and sexual health services in the voluntary sector, expressed shock and disbelief as structured plans for introducing the drug were shelved. Over 2,500 men who have sex with men are diagnosed with HIV each year in the UK, according to the trust.

Ian Green, chief executive officer of the charity said: "This figure has not changed in a decade. It is quite clear that although we have had some huge advances in HIV treatment, HIV prevention is something that we are still struggling with."

Described as a "HIV gamechanger" and already available in the US, France, Canada, Israel, and Kenya, the process of public consultation would have been one of the final steps before a decision is made on NHS availability. The consultation response forms part of a submission to the clinical priorities advisory group, the body that it had been thought would make a decision on PrEP at its next meeting in June.

Instead, and despite its insistence that it holds no responsibility to commission HIV prevention services, NHS England said it would provide £2m over the next two years to run a number of early implementer test sites for 500 men "most at risk".

Green said this will have very little impact compared to what had been planned. "By denying full availability of PrEP, we are failing those who are at risk of HIV. Today's decision by NHS England to depart with due process, and, instead, offer a tokenistic nod to what has the potential to revolutionise HIV prevention in the UK, is shameful."

Deborah Gold, chief executive of the National Aids Trust (NAT) agrees: "The decision is not informed by any due process; the amount of money is arbitrary; the claim that more 'testing' of PrEP is needed is disingenuous. 500 does not remotely cover the number of gay men at high risk of HIV nor meet the needs of heterosexuals at risk."

Green also said there was no clarity within the Department of Health, NHS or Public Health England as to who long-term is responsible to commission and fund PrEP and this was "simple maladministration" that would have "serious consequences".

She said: "Over 5,000 gay men will get HIV over the next two years – very many of whom would not have done so if PrEP had been delivered as proposed.

"NAT share the anger and distress felt by many thousands of people across the country at NHS England's decision to abandon its work to provide [the drug], near the very end of the process."

Gay men, campaigners and healthcare professionals reacted with anger on Twitter after NHS England released their shock statement.

Jake Bayley, a sexual health and HIV consultant at Newham University Hospital, Barts NHS Trust said the announcement was a "bitterly disappointing decision."


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He told the Guardian: "As a healthcare professional who sees patients who are newly diagnosed HIV positive every day, I witness the distress this causes both physically and emotionally.

"PrEP is the most revolutionary prevention tool we have had in the last 10 years. The current prevention tools we have - condoms, risk reduction - just aren't enough."

Describing the £2m funding as a short-term fix given the life time cost of one HIV infection can be up to £500k, Bayley said that "a long term, sensible and well funded solution is needed, not this meagre short sighted solution.

"NHS England is meant to protect and advocate for the population's health. PrEP needs to be made available to all those who are high risk immediately."

[Josquius]

Start handing them out like candy and the gays will be shagging on the streets.  Think of the children. Etc....

[garbon]

Given that it is a system that frowns in general on annual health checks, I shouldn't be surprised that it's preventative medicine clings to the dark ages.

[dps]

I originally read the headline as "New England stalls plans for HIV prevention drug" and wondered what Brady had done this time.

[Valmy]

I originally read the headline as "New England stalls plans for HIV prevention drug" and wondered what Brady had done this time.

He knows that Ravens players are more likely to have AIDS. Anything to win man.

[Berkut]

Be nice if the article said why they are delaying it...I could imagine valid public health reasons for not making something like this generally available.

I would not agree with them, but I can at least hypothesize valid concerns.

[garbon]

I'd imagine cost is the issue as often is the case with the NHS. Truvada is not a cheap medication.

Also, there was that case of that one person getting that very rare strain of HIV even while on it - so that punctured thoughts of it being oh so perfectly effective.

[DGuller]

It sounds like this drug is effective, but far from perfectly effective.  In such cases, a false sense of security can be worse than no security at all.  Then again, given that gay men still face astronomical odds of getting HIV in their lifetime, even after 30 years of AIDS awareness, maybe that isn't a concern.

[garbon]

Well a bit of good news.

http://www.buzzfeed.com/patrickstrudwick/nhs-to-reconsider-its-decision-not-to-provide-the-hiv-preven#.ti6EqZyJ1

NHS To Reconsider Its Decision Not To Provide The HIV Prevention Drug

The NHS in England is to reconsider its controversial decision not to provide the drug that prevents HIV, BuzzFeed News can reveal.

Faced with the threat of legal action by one of Britain's leading HIV charities, NHS England's lawyers have said a dedicated committee will meet next month to look again at the pronouncement.

The rethink represents a major victory for the National AIDS Trust (NAT), which sent NHS England a 17-page legal letter last week that laid out a string of reasons why the decision not to provide the drug was legally flawed.

Late on Monday – a week after NAT's letter was sent – NHS England's lawyers wrote to the charity to say their client would re-examine its position in light of the intervention.
NHS England's Specialised Services Committee will now meet in late May to consider whether the basis for the original decision was sound.

"We're delighted," Deborah Gold, the chief executive of NAT, told BuzzFeed News. "We're particularly delighted that when NHS England saw the strength of our legal case it made them rethink their position. But it's really important that when they do that reconsideration that it's a genuine, fair reassessment based on all of the facts, with an open mind."

NAT will be responding in writing to NHS England's lawyers to see if the review in May can be brought forward, Gold said.

The drug in question, Truvada, has been found to be highly effective, reducing the risk of infection by 86%. It is already available in the US, France, Canada, Kenya, and Israel, and when used in this prevention regime, is referred to as PrEP (pre-exposure prophylaxis).

On 21 March NHS England announced that just 500 gay men would be given the drug. The decision sparked anger and dismay among the medical community, the HIV charity sector, and sexual health campaigners, as it abandoned a widely anticipated public consultation into PrEP that would have ticked one of the last boxes in an 18-month process for the NHS to commission the drug.

Had this route been followed, the final referral to the NHS England Board – which makes the ultimate decision – was expected to have been made in June.

The reason given by NHS England for shelving this process was that it is not responsible for HIV prevention, only HIV medication, and that local authorities were instead responsible for providing PrEP. This too was roundly criticised as many HIV experts highlighted that the NHS already provides the drug to people who have recently been exposed to the virus, as part of an intervention known as PEP (post-exposure prophylaxis).

Meanwhile, local authorities denied it was their responsibility and pointed out that they had no budget to fund the medication. The Department of Health then admitted to BuzzFeed News that it did not know whose responsibility it was.

Documents unearthed by BuzzFeed News also showed an apparent contradiction between NHS England's position last year and its decision last month.

The legal letter sent from NAT to NHS England highlighted a wide range of areas in which the decision last month was open to legal challenge.

These included: that NHS England had until March conveyed to interested parties that it was responsible for commissioning PrEP; that the decision on 21 March was made with "no prior warning or consultation"; that the "rationale for this sudden change of position" was not explained; that NHS England had misinterpreted the law and does in fact have a legal duty to commission drugs in this field. And finally, that by not doing so, NHS England could be seen to be contravening the Equality Act of 2010, due to the minorities who are most at risk of HIV infection.

Monday's letter from NHS England's lawyers outlined the process moving forward. The meeting by the Specialised Services Committee next month will re-examine whether NHS England is in fact responsible for commissioning PrEP and whether it has the power to fund it. If the committee decides it does have the duty and authority, it will refer the ultimate decision to the Clinical Priorities Advisory Group (CPAG).

Because of the delay caused by the derailment of the original process, this referral will happen whether or not there is time for a public consultation. It is also possible, the letter said, that the CPAG meeting might be postponed a little in order to ensure PrEP is given proper consideration.

"We will still be watching and willing to instigate legal action at a later date if we aren't successful in their reconsideration in May," Gold told BuzzFeed News. "We're not walking away from this, but our preference is to solve it without having to take legal action."

Last week, just before NAT's letter was sent out, the charity met with NHS England to discuss its concerns. "At that point they didn't seem willing to reconsider," said Gold. "But after getting the letter from our solicitors I think it was then they realised what we've been saying all along – which is they've made an error in the law."

Gold said the wider background to the announcement, with the press exposing issues surrounding the decision, and a backlash from communities most affected by the virus, will have played a part in triggering NHS England's U-turn.

"They've very sensitive to this," she said. Ultimately, however, the charity remains focused on the final outcome. "I hope this reconsideration gives NHS England the opportunity to take a step back and make a better decision."

If HIV charities like NAT are successful and NHS England decides to fund PrEP, Gold said, people "currently at high risk of HIV could have this extraordinary new treatment that could be a game-changer for HIV. It's the most important thing that has happened in HIV prevention since the discovery of antiretrovirals. It could therefore turn the tide on the HIV epidemic in a way that nothing else has."

[Tamas]

If it is so expensive, I am quite sure there are more pressing health issues to spend NHS money on. I mean it is pretty well known how you can prevent/minimise your chance of getting AIDS, but there are other expensive and severe diseases/conditions to which exposure is not optional.

[garbon]

If it is so expensive, I am quite sure there are more pressing health issues to spend NHS money on. I mean it is pretty well known how you can prevent/minimise your chance of getting AIDS, but there are other expensive and severe diseases/conditions to which exposure is not optional.

Yes, probably better for the NHS to just bear the cost of paying for someone once they contract HIV as it'll surely be cheaper to cover medication once that happens...oh wait it isn't.

[Valmy]

Yes, probably better for the NHS to just bear the cost of paying for someone once they contract HIV as it'll surely be cheaper to cover medication once that happens...oh wait it isn't.

I was about to say...more expensive than treating somebody with HIV Tamas?

This is just a bureaucratic mix up with fund allocation seems to me.

[Berkut]

If it is so expensive, I am quite sure there are more pressing health issues to spend NHS money on. I mean it is pretty well known how you can prevent/minimise your chance of getting AIDS, but there are other expensive and severe diseases/conditions to which exposure is not optional.

Yes, probably better for the NHS to just bear the cost of paying for someone once they contract HIV as it'll surely be cheaper to cover medication once that happens...oh wait it isn't.

Well, from a strictly financial perspective, is it more costly to provide the preventive treatment to some number of men than it is to provide HIV treatment to the 2500/year who get the disease?

And will that 2500 go down a lot with the preventive treatment? What about other treatments for STDs that will inevitably increase if everyone thinks that taking this drug means they don't need to use condoms anymore?

I don't think the cost/benefit analysis is as simple as we think.

[Tamas]

It's just that on BBC1's morning show, every second day there is a condition mentioned that is struggling due to insufficient/suboptimal NHS funding, or just NHS funding problems in general.

A daily use HIV-preventative medicine designed for gay men who feel the need to take it sounds like a really low priority spending. You can DECIDE to have very low exposure to HIV. You can't decide in a similar way in regards to a lot of other serious conditions that could use extra money.

[garbon]

If it is so expensive, I am quite sure there are more pressing health issues to spend NHS money on. I mean it is pretty well known how you can prevent/minimise your chance of getting AIDS, but there are other expensive and severe diseases/conditions to which exposure is not optional.

Yes, probably better for the NHS to just bear the cost of paying for someone once they contract HIV as it'll surely be cheaper to cover medication once that happens...oh wait it isn't.

Well, from a strictly financial perspective, is it more costly to provide the preventive treatment to some number of men than it is to provide HIV treatment to the 2500/year who get the disease?

And will that 2500 go down a lot with the preventive treatment? What about other treatments for STDs that will inevitably increase if everyone thinks that taking this drug means they don't need to use condoms anymore?

I don't think the cost/benefit analysis is as simple as we think.

Truvada is due to come off patent. Already an Indian manufacturer's generic is 1/7th the cost of the branded version - a price which would only continue to drop with patent expiry and pressure from the NHS on drug manufacturer costs.  On the flipside, most patients with HIV are on a cocktail of expensive drugs as well as require more time from doctors and hospitals to treat their condition.

It would be a mistake of anyone using condoms to think that PrEP will be a replacement as it isn't as effective and is intended for use with condoms.