NHS England, in collaboration with Public Health England,
has announced in a press release today that a major new implementation trial of
pre-exposure prophylaxis (PrEP) will start next year. It is planned to enrol at least
twice as many as previously anticipated and the funding announced is five
times higher than the money for a trial originally announced in March this
NHS England says that the three-year trial will start in
“early financial year 2017/18”, which implies next April-June. It will seek to
enrol “at least” 10,000 participants over the three years, and will not be
directed exclusively at gay men or any other population.
Up to £10 million will be provided for the trial by NHS
England. This is five times the previous offer of £2 million for a two-year
PrEP pilot, though considerably less than the £16-20 million a year for five
years originally recommended by a PrEP development committee. The money will
cover all aspects of the trial including both the treatment costs that NHS
England would normally cover anyway, and the monitoring and clinic costs which
would normally be borne by local authorities as part of their public heath remit. It is hoped that this will cushion the impact on local authorities' budgets and allow them time to prepare for fully supporting PrEP in three years' time.
Only a few details of the trial have been settled. “Detailed
planning will now take place to ensure the launch and the clinical trial phase
can begin as swiftly as possible,” say NHS England’s press release.
What this means in practice is a good deal more hard
bargaining with both Gilead, manufacturers of the branded PrEP drug Truvada, and other companies that make
generic versions of the same tenofovir/emtricitabine combination pill. NHS
England are clear that a bidding process will take place to supply drug for the
trial. NHS England say: “Next steps will include asking both the manufacturer
of the branded PrEP drug Truvada, as
well as generic manufacturers to make proposals to participate.”
Routinely commissioned NHS services could not use generic
versions of Truvada while it remains
protected by a patent, but a research study is able to use generics.
Despite the upbeat tone of the press release, members of NHS
England and Public Health England have told aidsmap.com that the trial’s
feasibility still depends on a good deal being struck. One said: “The real
crunchpoint is whether or not we can obtain suitable antiretrovirals at a price
that makes the proposed trial feasible. There remain roadblocks to the
quotations I’ve heard about so far.”
According to the press release, the study aims to answer a number of questions about the
implementation of PrEP in England. PrEP will primarily be delivered through
sexual health clinics, but it remains unknown what proportion of clinic
attendees would be assessed as eligible for PrEP and what proportion would
actually accept an offer of PrEP. The trial may assess methods to identify and
engage potential PrEP users, including in other settings.
While the study will not seek to make direct comparisons
between daily and event-based PrEP dosing regimens, it will gather data on who
chooses to use each approach and on their outcomes.
Finally, the study will assess the incidence of new HIV and
STI infections in individuals who get PrEP (including individuals who stop
taking it), and this could be compared with data from other people using sexual
NHS England and Public Health England hope that a large
trial, with many participants, will produce a large amount of data on all these
points. However more precise details of how the trial will be run in practice have
not yet been developed.
The figure of the trial enrolling 10,000 people over three
years is broadly in line with the estimations of demand that were made for the
PrEP commissioning proposal that was submitted to NHS England earlier this
year. It relies on the expectation that people will go on and off PrEP as their
needs evolve, with most people only needing PrEP for about a year. Most of all,
the number of people who could take part will depend on the price of the drug
that is negotiated.
The previous commissioning plan found that the number of people in England whose HIV risk suggests eligibility
for PrEP is considerable; between 8000 and 12,000 gay men per year, plus in the region of 1000 people from other groups. However it is
assumed that actual uptake will be lower, and the commissioning model assumed no more than 50% uptake in those
eligible. So uptake for the study may build over time – perhaps 2000 people enrolling
in its first year of availability, 3000 in the second, 5000 in subsequent years.
Will Nutland of activist group PrEPster told aidsmap.com that
the 10,000 figure would probably meet a large part of the current demand for
PrEP but a smaller proportion of the actual need. Moreover, those conducting the
trial would need to make particular efforts to engage individuals and
communities who are not already aware of the benefits of PrEP. While affluent gay men may seek PrEP quite readily, the trial needs also to reach black communities, trans people and those on low incomes.
Eligibility criteria for PrEP are likely to be similar to
those used in the earlier commissioning proposal – men who have sex with men
who have recently had anal sex without a condom, trans people who have done the
same, heterosexuals assessed to be at similar high risk to men who have sex
with men, and partners of HIV-positive people who are not taking treatment.
The decision follows the Court of Appeal’s ruling on 10
November that NHS England, alongside local authorities, has the power, although
not the obligation, to fund PrEP and should plan how to provide it. Deborah
Gold, Chief Executive of the National AIDS Trust, who took the case to the court, said
that the trial would not be happening without the legal challenge, a series of
parliamentary questions and strong community pressure for PrEP.
“We are absolutely delighted that following our wins in
Court, NHS England, working with Public Health England and local government
will be now making PrEP available on a large scale, and quickly, to those who
need it,” she said.
NHS England says that in addition to PrEP it has still been able to
commission a list of ten new specialised treatments for uncommon conditions
ranging from cystic fibrosis to lymphoma. The list includes two new high-tech
advances: microprocessor-controlled artificial knee joints, and brainstem
implants for congenital deafness. However, three specialised commissioning
proposals formerly on the list will now have to wait till spring 2017 to be
Kevin Fenton, Director of Health and Wellbeing at Public
Health England commented: “We’re delighted to be working in partnership with
NHS England on this major new addition to the national HIV prevention
programme. This comes after much planning and preparation to ensure we can
successfully coordinate this extremely important and large-scale clinical
He urged local authorities to fund another innovative HIV
prevention method, home testing kits.
Greg Owen of iwantPrEPnow commented: "Today's announcement is the next step in getting PrEP to people who will most benefit from it. PrEP has been available in the USA for 4 years. England, the UK, and the rest of Europe now have the opportunity to use PrEP to turn the tide of HIV infections across the continent." However, he noted that the plans are not a permanent solution to wider PrEP provision and called on NHS England to ensure that the limited availability of PrEP is targeted so it does not enhance existing health inequalities.
Izzi Seccombe, Chairman of the Local Government
Association’s Community Wellbeing Board, said: "We are pleased that NHS
England has acted quickly and chosen to fund the commissioning of this trial
and rollout of PrEP. We now want to stand united with the NHS to defeat the
spread of HIV.”
Ian Green, Chief Executive of Terrence Higgins Trust welcomed
the fact that PrEP will be made available to 10,000 people who are at risk over
three years. “However there are many questions that need to be answered about
the proposed trial,” he said. “We need to know how it will work in practice and
understand how those at risk, no matter where they live, will be able to access
PrEP. This trial alone does not provide the long-term stability that is needed
– NHS England must make a commitment now that when the trial ends they will
fully fund PrEP for all those who are at risk.”
Dr Jonathan Fielden, NHS England’s Director of Specialised
Commissioning commented that this “groundbreaking national programme for PrEP
that will benefit at least 10,000 people…has, in part, been made possible by
the willingness of many pharmaceutical and device companies to come forward
with lower and more responsible prices.”