4th October 2016
The Accelerated Access Review, commissioned by the Government and led by Sir Hugh Taylor, has been published today. The Review suggests how the UK can become a world-leader in in healthcare innovation, including in vitro diagnostics, through the adoption of 18 final recommendations.
The press release can be found below, and Jeremy Hunt, Secretary of State for Health, has issued a Written Ministerial Statement stating that the Government will respond in full in due course.
Government welcomes ambitious ideas to safely speed new treatments from lab to patient
Patients could get quicker access to innovative new diagnostic tools, drugs, digital healthcare and medical technologies under recommendations set out in an independent report published today (24th October).
Commissioned by the Government and led by an independent Chair, the Accelerated Access Review aims to make the UK a world-leader in healthcare innovation, with an NHS that embraces the new drugs and technologies that patients need and supports work with local areas to develop solutions to their specific healthcare needs.
The report says streamlined processes could bring forward patient access to drugs by up to four years and patients will benefit from quicker access to medical technologies too.
As the UK prepares to leave the EU, this report will help us embrace new opportunities. It will point the way to providing the best care to patients, supporting the NHS in its drive to use funds more effectively, and creating the conditions to help the life sciences industry further flourish.
Chair of the Accelerated Access Review Sir Hugh Taylor said:
“This ambitious plan will prepare the health system for an exciting era in medical innovation.
“We’ve listened to the views of the NHS, patients, clinicians, the life sciences industries and academia – and it is clear we need to act now to make the most of the tidal wave of new drugs and technologies that are being developed.”
The Review, developed in partnership with the Wellcome Trust, recommends the creation of a new Accelerated Access Partnership to speed up and simplify the process for getting the most promising new treatments and diagnostics safely from pre-clinical development to patients. Patients expect the NHS to provide life-changing innovations as soon as they become available – but evidence has shown that the UK sometimes lags behind other countries.
The Review says that accessing innovation in the NHS has become increasingly challenging. This creates frustration for clinicians and patients who often have to wait for life-saving treatments, and for innovators who must navigate multiple processes in order to bring their products to market.
Through the new Partnership, innovators would be able to access joined-up help with clinical development, regulation, and assessment of cost effectiveness. It is recommended that the Partnership includes NHS England, NHS Improvement, the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
Patient access to drugs could be brought forward by up to four years if a scientific opinion from the Early Access to Medicines Scheme is used (saving 12-18 months) and there is no delay at the NICE appraisal stage (which takes around two years) or during the process for NHS commissioning and adoption (which takes two years or more).
The review also recommends a simpler process for digital technologies which are often developed by smaller companies, such as healthcare apps for managing long-term conditions.
The Review also suggests that a new Strategic Commercial Unit should be created within NHS England to enter into commercial dialogue to create flexible arrangements with innovators who are working on transformative new products. The unit would aim for win-win scenarios where innovators benefit through earlier access to the NHS market and increased - and in some cases guaranteed – sales. In return innovators would offer better value to the taxpayer.
Health Minister Lord Prior said:
"This Government has a strong commitment to the life sciences and to building a long-term partnership with the life sciences industry. We are determined to make the UK the best place in the world to develop new drugs and other products that can transform the health of patients.
“The report provides us with a strong basis to make the right decisions about how the health system can be adapted to meet the challenges of the future, attract inward investment, grow the thriving life science industry and use innovation to improve patient outcomes and tackle the financial pressures on the NHS.”
NHS England Chief Executive Simon Stevens said:
“This review offers a win/win for NHS patients and for the UK economy. Across the NHS we're going to create headroom for faster and wider uptake of important new patient treatments. In doing so we’re going to create new opportunities in the run-up to Brexit for our globally successful UK life sciences sector. If we get this right there are huge gains within our grasp, both for patients across the NHS, and for the wider success of our country.”
Patients are central to the Review. Under the recommendations of the Review, patients are offered a greater say in determining what innovations are important to them, so that real experiences of conditions such as diabetes or cancer can be used to shape priorities for new drugs, techniques and treatments.
Cancer Research UK Chief Executive Harpal Kumar said:
“The voices of patients have been crucial to this review. They have a critical role in advising how research priorities should be set and how they would like to be involved in developing new treatments to meet their needs.
“I welcome the recommendations of this review in speeding patients’ access to new treatments and look forward to seeing patients reap the benefits of even closer relationships between the NHS and innovators.”
BIA Chief Executive Steve Bates said:
“We welcome the Review’s recommendation for a fully funded early access to medicines scheme for small and scaling companies , it's a key step in making the UK a great location to clinically develop highly innovative therapies at pace.” The Government will now consider the proposals and respond more fully in due course, mindful of the need to ensure affordability.
Notes to editors
1. The report makes 18 recommendations, covering:
- Improved horizon scanning for innovative new products, and a systematic approach to prioritising the best innovations coming down the pipeline
- A national ‘Accelerated Access Pathway’ for the most transformative products, where the system works together to bring these exciting innovations to patients more quickly including for digital products which are often developed by SMEs
- More streamlined local routes to market for all innovators, making the whole system clearer and simpler
- Stronger commercial capabilities within the NHS so that it can have the right conversations with innovators and secure the best deals for patients
- An ‘Accelerated Access Partnership’, bringing together the key national health bodies in a collaboration focused on bringing forward innovation
- Better data on the impact of technologies on patient outcomes and more easily accessible data on the uptake of innovative technologies
- Local support for the spread of innovation, through Academic Health Science Networks
- Stronger incentives for local NHS organisations to use and spread the benefits of innovation.
2. The Accelerated Access Review was supported by the Wellcome Trust.
Jeremy Farrar, Director of the Wellcome Trust said:
“The UK can become the best place in the world to develop, test and roll out new healthcare innovations if we realise the full potential of the research base, industrial partnerships, patient capital and the NHS.
“The Review is a first step towards building the right environment and infrastructure within the NHS. It sets out an achievable strategy for getting the most promising drugs, devices, digital products and diagnostics to patients quickly, and transforming lives. Its success will depend on the close involvement of all stakeholders, and will need dedicated funding from the Government to support implementation.”
3. Examples in the AAR document of the sort of innovative work that should be fostered include:
- Innovative medical technologies with cost saving potential
NeoTract’s UroLift system is recommended by NICE for treating the symptoms of benign prostatic hyperplasia, a condition where an enlarged prostate can make it difficult for a man to pass urine, which can lead to urinary tract infections and, in some cases, renal failure.
Existing treatments involve cutting away excess tissue, which risks loss of sexual function and requires a hospital stay. The UroLift system uses implants to move excess tissue away and prevent it from blocking the flow of urine. NICE’s Medical Technology Advisory Committee concluded that, as well as benefiting patients, for example by preserving sexual function, it could also save up to £286 per patient through, for example, carrying out the surgery as a day procedure. The treatment can also be delivered under local anaesthetic, thus avoiding the risks of general anaesthesia and further reducing costs.
- Using digital health to redesign care delivery
Digital health products can transform models of care to simultaneously provide excellent patient outcomes and NHS cost-savings. Big White Wall is a digital platform and community offering a range of therapeutic mental health interventions to support members to self-manage their care with support from clinicians, caregivers and peers. It allows members to access mental health services instantaneously and anonymously, eliminating waiting times. Recovery rates for Big White Wall therapy services in the UK are 12 per cent above the national average and 8 per cent above the national target. An independent review of the economic savings to the NHS from Big White Wall’s support network service found an average saving of £36,935 per 100 members. Due to its clinical and economic benefits, it has been widely commissioned; it is currently available to 31 per cent of the UK adult population.
- How innovative diagnostics can save money and improve patient experience
Innovative diagnostic tools have the potential to improve patient experience and save operational costs. High sensitivity troponin assays, for example, can lead to rule-out or confirmation of a type of heart attack.
In 2014 NICE recommended the use of Elecsys Troponin T high-sensitive (Roche Diagnostics) and ARCHITECT STAT High Sensitive Troponin-I (Abbott Diagnostics), alongside other investigations, to help emergency clinicians determine whether patients experiencing chest pain are having a heart attack. Both these tests measure the level of troponin, a protein released into the blood when heart muscle is damaged. Standard cardiac troponin tests have to be carried out on admission and 10-12 hours later, but the high-sensitivity troponin tests are able to detect a change in levels of troponin much earlier, within as little as three hours.
Ruling out heart attacks earlier means patients can be discharged from A&E sooner and fewer patients need to be admitted to hospital for observation while the testing is carried out, saving the cost of unnecessary admissions. It reduces length of hospital stay and improves patient experience by reducing waiting time for results and putting patients on the appropriate treatment pathway sooner. Based on NICE’s assessments and industry data, it is estimated using these tests with the earlier discharge protocol has the potential to save the NHS £30-40 million per year.
4. Hilary Newiss is chair of National Voices, a coalition of health and care charities, and has been working with the Review to ensure a focus on the needs of patients, service users and carers. As part of the Review, National Voices worked with voluntary sector organisations and people with lived experience to develop a series of ‘I Statements’ which define, from the patient and service user’s perspective, how people should be engaged at every stage of the innovation pathway.