News that NHS England will fund a PrEP clinical trial for 10,000 people over next 3 years costing £10million receives cautious welcome.
NHS England are to fund a major extension to the national HIV prevention programme led by Public Health England with the aim of supporting those most at risk and reducing the incidence of HIV infection.
Ten new specialised treatments have also been commissioned as part of the annual prioritisation process for specialised treatments.
The new HIV initiative will be a partnership between NHS England and Public Health England, and follows the recent Court of Appeal ruling that NHS England, alongside local authorities, has the power, although not the obligation, to fund the provision of anti-retroviral drugs for the prevention of HIV, known as pre-exposure prophylaxis (PrEP).
The first phase of implementation will be the launch of a large-scale clinical trial in early financial year 2017/18.
Although the evidence around the clinical effectiveness of PrEP is strong, advice from Public Health England has highlighted outstanding implementation questions that should be answered prior to using PrEP in a sustained way on a substantial scale in England.
These questions will be answered by the clinical trial, paving the way for full rollout.
The US Government approved PrEP in 2012, with Canada, France, South Africa, Kenya and Israel all following. Norway became the first country last month to make PrEP available on their National Health Service.
It is anticipated that the clinical trial phase will include at least 10,000 participants over the next three years. NHS England will fully fund the cost of the clinical trial phase and will work in partnership with local authorities, the Local Government Association and Public Health England to implement the findings as part of a wider national rollout.
Detailed planning will now take place to ensure the launch and the clinical trial phase can begin as swiftly as possible. Up to £10 million will be made available over the next three years to fund all aspects of the trial.
Next steps will include asking both the manufacturer of the branded PrEP drug Truvada, as well as generic manufacturers to make proposals to participate in the trial.
Caroline Lucas, Green MP for Brighton Pavilion, said: “With thousands of people living in the UK with undiagnosed HIV, and 5000 new cases a year, this news is welcome. For too long now the roll out of PrEP has been delayed and this national programme of treatment will, we hope, benefit the thousands of people who have waited far too long.
While there are still questions to be answered about how this will work in practice, this is a step forward.
I congratulate the many campaigners who will welcome this small step forward in the roll out of a drug that has the potential to save thousands of lives of those most at risk from HIV.”
Dr Jonathan Fielden, Director of Specialised Commissioning and Deputy National Medical Director, NHS England said: “We’re pleased to be able to announce funding not only for ten new specialised treatments but also a new ground breaking national programme for PrEP that will benefit at least 10,000 people.
“This has, in part, been made possible by the willingness of many pharmaceutical and device companies to come forward with lower and more responsible prices. Continuing this constructive joint working will enable us to fund more new drugs and treatments in the future.
“We have however, had to make some tough decisions over what we are not able to fund at this point in time within the resources we have available. We will ensure those treatments have the opportunity to be considered as part of the next annual prioritisation round in spring 2017.”
Professor Kevin Fenton, Director of Health and Wellbeing at Public Health England, added: “Currently 13,500 people are living in the UK with undiagnosed HIV and we are still seeing around 5,000 new infections each year. Given we are in the fourth decade of this epidemic there are too many new infections occurring, and we need to use all tools available to save lives and money. 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 trial.
“We encourage all those who may be at risk of HIV to ensure they get tested and we are again working with local authorities to fund the HIV home-sampling test kit as well as issuing joint guidance for the first time with NICE, which supports increased uptake of HIV testing.”
Cllr 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.
“PrEP is a ground-breaking method of treatment that has the potential to save lives and councils want to work with the NHS to help roll out the trial.
“Local authorities have invested millions in providing sexual health services since taking over responsibility for public health three years ago, and we firmly believe that PrEP could significantly reduce levels of HIV in the community.”
Dr Ian Williams, Senior Lecturer and Hon Consultant Physician, Central and North West London NHS Foundation Trust and Chair of NHS England’s Clinical Reference group for HIV, said: “This announcement demonstrates NHS England’s commitment to fund PrEP and provides the chance to best prepare England for optimal roll out following this large-scale clinical trial. For now, the trial will provide access to PrEP for thousands of people most at risk of acquiring HIV.
“I’m delighted that the work of many people from the HIV Clinical Reference Group, including clinicians and patient advocates, is providing the foundations for this trial. Now we look ahead to working with partners in PHE, the voluntary sector and local government to get the trial underway across England, helping us to better understand how to integrate PrEP as part of comprehensive HIV prevention service aimed at preventing transmission of HIV and other STIs.”
The Clinical Reference Group met throughout 2015 and were led to understand a decision would be made in June this year whether to make PrEP available on the NHS, following a period of consultation.
Without warning NHS England announced in March 2016 it was not their responsibility to commission HIV prevention services, but they would provide £2m over the next two years to run a number of early implementer test sites for 500 men “most at risk”.
Following the success of a challenge of that decision to the Court of Appeal by National AIDS Trust last month, £10million pounds will now be made available over the next three years to provide PrEP to 10,000 people.
Ian Green, Chief Executive of Terrence Higgins Trust, said: “With 17 new HIV diagnoses made every day, we need to be bold and ambitious in our approach to HIV prevention – and this must include access to PrEP for all who need it.
“For two years we’ve been calling for a long-term, stable home for PrEP within the NHS, so it can be used as a vital tool in our HIV prevention armoury alongside condom use, regular testing and early treatment.
“We welcome the fact that PrEP will be made available to 10,000 people who are at risk over three years. Preventing the spread of HIV is good news for everyone. Not only will this make a life-changing difference to each of these individuals by protecting them from an incurable and highly stigmatised condition, but for every person who would have become HIV positive without PrEP, the NHS will save £360,000 in lifetime treatment costs.
“However there are many questions that need to be answered about the proposed trial. 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. Only then can we look forward to a future without HIV transmissions, which would be a stunning achievement in terms of public health.”
The decision to also routinely commission ten new specialised treatments is based on advice from NHS England’s clinical priorities advisory group which assessed the relative priority of investing in a new range of specialised treatments and interventions. This took into account revised prices submitted by some manufacturers since provisional investment decision were published in July.
Ivor Caplin, former MP for Hove & Portslade and Minister for Veterans at the Ministry of Defence, added: “At last NHS England is not only listening to the many voices who have said that PrEP works but is finally going to commission the game changing drug. This trial is to be welcomed because it will over this next 3 years give clear answers to I hope all the Public health questions.
It must be remembered that regular testing is still at the heart of making sure status is known to all and is a key part of the recent Proud study and will need to be part of this major programme.
This is major step forward as the fight to reduce or maybe eradicate new HIV infections across Brighton & Hove goes on.”
Simon Kirby MP for Brighton Kemptown MP, concluded: “I welcome the announcement of the large scale clinical trial and especially as I understand they will be asking both the manufacturer of Truvada and generic manufacturers to take part. This is good news for many people in Brighton Kemptown.”
Treatments that will now be routinely commissioned by NHS England:
♦ Pegvisomant for acromegaly as a third-line treatment for adults
♦ Auditory brainstem implants for congenital abnormalities of the auditory nerves or cochleae
♦ Haematopoietic stem cell transplant : Lymphoplasmacytic lymphoma /Waldenstrom’s Macroglobulinaemia (adults)
♦ Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
♦ Rituximab for immunoglobulin-G4 related disease (IgG4-RD)
♦ Microprocessor controlled prosthetic knees
♦ Tolvaptan for hyponatraemia secondary to the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) for patients who require cancer chemotherapy
♦ Ivacaftor for children (2-5 years) with cystic fibrosis (named mutations)
♦ Sodium oxybate for symptom control for narcolepsy with cataplexy (children)
♦ Pasireotide for Cushing’s Disease
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