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A new, fast-track route into the NHS for ‘breakthrough’ medicines and technologies has been welcomed by Innovation Agency Chief Executive Dr Liz Mear.
Announced by the Government, the aim is to dramatically speed up the time it takes for patients to benefit from ground-breaking products for conditions such as cancer, dementia and diabetes.
From April 2018, the new Accelerated Access Pathway will mean selected products with the greatest potential to change lives could be available to patients up to four years earlier.
Under the scheme, each year a number of products would receive ‘breakthrough’ designation, unlocking a comprehensive package of support that will allow firms to accelerate clinical development and benefit from a fast-track route through the NHS’s approval processes.
It comes with funding for the Innovation Agency and its 14 fellow Academic Health Science Networks (AHSNs) of £39m to encourage grassroots adoption and uptake of new medical technologies. England’s 15 AHSNs are responsible for identifying high potential products, supporting their adoption regionally and sharing lessons across the wider NHS. The Innovation Agency is the AHSN for the North West Coast – Cheshire, Merseyside, Lancashire and south Cumbria.
Dr Liz Mear said: “Having been part of the review which led to this initiative I am delighted that AHSNs have been boosted in our role to speed up the spread of innovations.
“This extra support from the Government will help us to step up a gear in our work with local health care providers and commissioners, to improve the health of our local population.”
Health Minister, Lord O’Shaughnessy, said: “I want the UK to be the best place in the world to develop new drugs and medical technology – but despite the innovation happening here, our uptake in the NHS can be too slow.
“Today’s new measures will not only benefit patients by improving how quickly and easily we can get innovative products from the lab to the bedside, but will guarantee future collaboration between the life sciences sector and the NHS post-Brexit – benefiting the British economy and creating jobs.”
Sir Andrew Witty, former chief executive of GlaxoSmithKline will lead the Accelerated Access Collaborative, which will make decisions on which products should be granted access to the pathway, drawing on advice from patients, clinicians and industry. In return, life sciences firms will be expected to deliver additional value for the taxpayer, with a new Strategic Commercial Unit being created within NHS England to help negotiate cost effective deals with innovators.
Sir Andrew Witty, Chair of the Accelerated Access Collaborative, said: “Patients, scientists and the UK economy will all benefit from the positive steps outlined by the government today.
“The opportunity to ensure the NHS gets rapid access to cost effective breakthrough technologies is vitally important, and I’m delighted to help lead the effort to deliver this.”
UK Bio Industry Association CEO, Steve Bates, said: “This new fast track pathway should both speed up access for NHS patients to the latest therapies and help to ensure the UK remains a globally attractive cluster in which to start, scale and grow leading life sciences businesses.
“Sir Andrew Witty’s leadership of the Accelerated Access Collaborative means significant industrial insight into the selection process for products able to access this new accelerated route to market.”
Hilary Newiss, Chair of National Voices, said: “Speeding up access to effective medicines and technologies is good news for patients. For this to be a success, the products chosen for fast-tracking must meet genuine patient needs, and so it is welcome that patient groups will be formally involved in making those decisions.”
BIVDA’s Chief Executive Doris-Ann Williams MBE said: “Diagnosis led healthcare is the key to better outcomes but the uptake of innovative in vitro diagnostics (IVDs) within the NHS typically takes 10 years.
“BIVDA welcome’s the publication of the Government’s response to the Accelerated Access Review and through the creation of the new Accelerated Access Pathway, I hope we will see faster and wider adoption of IVDs across the NHS, for the benefit of patients, the health service and the British economy”.
The Government is providing an £86 million funding package to help innovators of all sizes to access the NHS market, and help ensure that these products get to the patients that need them.
More support for small and medium-sized enterprises to help them build a stronger evidence base for their products, with £35 million over four years to help SMEs with digital products, and a £6 million scheme to support medtech, diagnostics and pharmaceutical products.
£6 million to support clinicians to use new treatments and technologies in everyday practice.
£39m to encourage grassroots adoption and uptake of new medical technologies, driven by 15 Academic Health Science Networks which are responsible for identifying high potential products, supporting their adoption regionally and sharing lessons across the wider NHS.
Health tech helps patients avoid a stroke
Patients with long-time heart conditions can monitor and manage themselves at home and reduce their chances of having a stroke with an innovative new digital health service.
The technology is for people at risk of stroke (typically with a common condition called atrial fibrillation – an irregular heartbeat) who are prescribed the drug warfarin to prevent blood clotting. People with this condition typically have to attend medical clinics on a regular basis for blood tests to determine their correct dosage.
Under the new service, patients can test themselves at home and send in their results via a bluetooth mobile app, secure web portal or automated telephone call to receive their dosage information which means they can save time attending clinic appointments.
It is part of a stroke prevention programme led by the Innovation Agency, the Academic Health Science Network for the North West Coast. The Agency has secured funding to trial the use of innovative technologies to reduce the risk of stroke and has recruited a team of Ambassadors who are testing people in their communities throughout the North West Coast for AF using portable devices.
Three projects to identify and treat AF won Showcasing Best Practice Awards at the international Heart Rhythm Conference. One project involves Cheshire firefighters working with health professionals to carry out pulse checks and provide support and advice to vulnerable residents.
Similar testing technologies are being trialled in East Lancashire to improve the monitoring of warfarin.
Patient Yvonne Egan from Blackburn was diagnosed with atrial fibrillation (AF) in 2012. She said: “I think it’s going to be great once I’ve practised it a few times. It will save me the hassle of taking time off work to visit the clinic.”
The father of a teenager with the condition using the self-testing kit said: “Our son developed a rash on holiday and we were worried it was caused by him being on the wrong dose of warfarin.
“We spent a whole day in A&E waiting to be seen by medics. If we’d have had the kit then, we could have tested him at home and phoned the clinic to get the correct dose.”
Dr Julia Reynolds, Programme Manager at the Innovation Agency, added: “We are delighted to be working with such an innovative team at the hospitals and supporting their health staff to introduce technologies which help patients.
“Our aim is to prevent strokes and this collaboration will lead to helping better manage atrial fibrillation which is a major cause of stroke.”
Research has shown that self-testing can improve the quality of therapy, reduce the risk of blood clotting and therefore cut risk of stroke.
Inhealthcare, the UK digital health specialist, is supplying its technology for the service, which is being delivered by staff from the Royal Blackburn Hospital and Burnley General Teaching Hospital.
The service will be rolled out more widely in East Lancashire in the coming months.
Anticoagulant clinics will still be the first point of contact for patients if they have any problems or concerns.
Bryn Sage, chief executive at Inhealthcare, said: “Our technology allows people with long-term heart conditions to stay on top of their health without the hassle of inconvenient and time-consuming hospital or clinic appointments.
“This is exactly the sort of service that can reduce pressure on busy NHS clinics and allow staff to spend more time with patients who need care the most.
“We have rolled out similar services across England and are very pleased to see self-testing become accepted as a preference.
“We are looking forward to helping patients and the health service in East Lancashire and Blackburn with Darwen.
“In the last 12 months, we have enabled 78,000 digital consultations, connecting patients to clinicians remotely, freeing up much-needed capacity in the NHS.”
Patients are supplied with a handheld device to test their blood’s international normalised ratio (INR) at home. All they need to do is prick their finger using a special pen with a needle and put a drop of blood on a strip which is then inserted into the meter.
Patients are then asked a series of automated health questions as they send their readings to their clinics for analysis either by app or telephone. This yields the correct dosage information and clinicians approve the process before it is sent back to patients.
In East Lancashire and Blackburn with Darwen, around 6,300 people are being treated for AF. A further 2,765 people are estimated to have the condition and are currently untreated because they are unaware they have the condition.