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NHS England stalls plans for HIV prevention drug....."NHS England officials, who had been involved in early discussions about Prep, say providing it is not their responsibility."
  Consultation on Truvada will now be shelved, in move sexual health charities have described as 'shameful' and 'failing those at risk' of HIV
March 21 2016 - The Guardian
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.
Daily pill Truvada cuts spread of HIV by 86%, study shows
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." Gold 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.
Row over HIV prevention drug Prep
By Smitha Mundasad Health reporter, BBC News
22 March 2016
Charities say NHS England's "eleventh hour decision to pull the plug" on game-changing HIV prevention drugs is leaving people at risk.
The medication- known as Prep - has been shown in UK studies to reduce the chances of people getting HIV.
Charities claim they had expected it to start being rolled-out later this year. But NHS England officials, who had been involved in early discussions about Prep, say providing it is not their responsibility.
Instead they say under health regulations, preventative medicine (rather than treatment) falls to individual local authorities to consider.
Meanwhile NHS England says it will offer 2m worth of funds to treat around 500 people over the next two years.
It says the money, which local authorities will be able to bid for, will help them consider the overall feasibility and cost-effectiveness of offering the drugs. Prep (pre-exposure prophylaxis) is intended for healthy people who are at high risk of getting HIV. This would include, for example, men who have sex with multiple male partners without using condoms.
The medicine is already available to certain groups in the US, France, Israel, Canada and Kenya.
And a recent trial by the UK's Medical Research Council and Public Health England showed that giving the drugs to healthy gay men at risk, led to an 86% fall in new infections. Charities describe the approach as a game-changer and argue the decision by NHS England fails those who are vulnerable to HIV.
Dr Michael Brady, medical director at the charity Terrence Higgins Trust, said: "For the last 18 months charities, academics and patients have been lulled into a false sense of security.
"Because NHS England has been involved in all the discussions, we had expected the drug to go to a public consultation and then be commissioned and rolled-out - with guidance - towards the end of the year.
"Pulling the plug on this process at the eleventh hour is leaving people at risk who would otherwise have been protected.
"And the bottom line is that 8 or 9 gay men are infected with HIV in the UK every day. We see people every day in clinic who we know could benefit from this.
"We know it works."
Dr Mags Portman, who worked on the UK Prep trial and is part of the British Association for Sexual Health and HIV said the situation was extremely worrying.
She added: "Local authorities have already had huge cuts to their public health budgets and some could struggle.
"How will they decide who gets Prep if they can't give it to everyone who needs it?" Prep has so-far been available to people enrolled in a research trial taking place in six cities in the UK, and can also be bought privately.
Update on commissioning and provision of Pre Exposure Prophylaxsis (PREP) for HIV prevention
21 March 2016
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.

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