The Accelerated Access Review final report, commissioned by the Government, has outlined a number of key recommendations to improve the adoption of innovation in the NHS.
Patients expect the NHS to provide emerging, transformational innovations as soon as they become available and for health outcomes to keep pace with those of other countries. However, an independent review of innovative medicines and medical technologies acknowledges that the UK lags behind other countries in the adoption of innovation.
To address this issue, the Government appointed Sir Hugh Taylor, chair of Guy’s and St Thomas’ NHS Foundation Trust, to oversee a review of ‘how the UK could speed up access to innovative drugs, devices, diagnostics and digital products’, in November 2014. The Accelerated Access Review has now published its final report, having sought the views of over 600 people and organisations – ranging from clinicians, NHS commissioners, patient groups and charities, to the life sciences industries, academia and national bodies that influence the innovation pathway.
The report comments 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 treatment, and for innovators who must navigate multiple processes before their products can be used. Developed in partnership with the Wellcome Trust, the review 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.
Through the new partnership, innovators would be able to access joined-up help for 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 to 18 months) and there is no delay during the technology appraisal (which can take up to two years) or during the process for NHS commissioning and adoption (which can take two years or more).
The review recommends a simpler process for digital technologies which are often developed by smaller companies, such as healthcare apps for managing long-term conditions. Among the recommendations is the establishment of a ‘digital health technology catalyst’ to deliver digital solutions that offer the opportunity to provide improved outcomes at a lower cost.
The report suggests that this should be modelled on the Biomedical Catalyst and aligned with the work of Innovate UK. The Biomedical Catalyst is a competitive challenge fund, run in partnership by Innovate UK and the Medical Research Council. It supports the translation of research into therapies, devices and diagnostics into commercial success and increases the confidence of those private investors who can help support a product to reach the market. It is considered to be highly successful; during phase one, companies in its portfolio realised over £1bn in post-project financing, licensing deals and acquisitions.
A catalyst could provide matched public sector funding, alongside private investment, to address areas of failure in the digital healthcare market and support the growth of those promising small companies who are developing the digital technologies that the NHS and patients need and help bring their products to market.
Identifying strategically important products
The report also recommends that a ‘transformative designation’ should identify the most strategically important products (medical technologies, diagnostics, pharmaceuticals or digital innovations) that have the potential to deliver significant benefits in cost or outcomes. The transformative designation should “signal, within the UK and internationally, a product’s strategic importance to the NHS”. It should be reserved for the small number of products that have the potential to provide significant benefits in either patient outcomes or NHS costs, and its immediate practical effect should be to act as a trigger for these strategically important innovations to enter an accelerated pathway to patients, receiving additional support and guidance to navigate the market and to reach patients.
Determining which products should receive a transformative designation will be of critical importance, and the Accelerated Access Partnership should develop a transparent and robust process for this, bringing together skills in NICE and NHS England and drawing on a range of evidence. The report states that only around five to 10 innovations per year will receive the transformative designation.
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 sales. In return innovators would offer better value to the NHS and patients.
The Accelerated Access Partnership should support innovators with strategically important products to navigate the system, hold early dialogue with national decisionmakers such as NICE, NHS England, NHS Improvement and MHRA, and increase understanding of product impact.
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.”
Patients are central to the review. Under the recommendations of the review, they 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. The Government will now consider the proposals and respond more fully in due course, mindful of the need to ensure affordability.
Commenting on the publication of the Accelerated Access Review, Aisling Burnand, CEO, Association of Medical Research Charities, said: “We welcome the publication of the Accelerated Access Review and its recommendations for getting the best technologies for patients more quickly. We know patients and their families want early and fast access to new life-changing and life-enhancing innovations. The review offers patients the opportunity to have a say about what innovations are important to them, which is a good outcome for patients. As the beneficiaries of new health technologies, patients have important experiences to share in developing routes to access innovations.
“The recommendations are a step in the right direction in supporting the UK’s position as a leader in the life sciences, as we prepare to leave the European Union. We need to continue to work together to ensure the UK remains not only a great place to do research, but also enables patients fast and effective access in the NHS to the best technologies as they emerge.”
Jeremy Farrar, Wellcome’s director, 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.”
To download the full report, visit: https://www.gov.uk/government/uploads/ system/uploads/attachment_data/file/ 565072/AAR_final.pdf
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