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INNOVATION
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.
Accelerated pathway
The ‘accelerated pathway’ for transformative products is a key aspect of the report. This accelerated access pathway should allow products with a ‘transformative designation’ to meet regulatory requirements, agree commercial arrangements, receive revenue and achieve market access as quickly as possible. This should be enabled by the Accelerated Access Partnership, which will provide specific, tailored support from an early stage of the pathway. The Accelerated Access Partnership should support innovators with strategically important products to navigate the system, hold early dialogue with national decision- makers 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
MARCH 2017
Recommendations
l The NHS should develop an enhanced horizon scanning process and clarify its needs to innovators.
l A new transformative designation should be applied to those innovations with the potential for greatest impact.
l Patients should be involved in horizon scanning and prioritisation, and this involvement should continue along the whole innovation pathway.
l An Accelerated Access Pathway for strategically important, transformative products should align and co-ordinate regulatory, reimbursement, evaluation and diffusion processes to bring these transformative products to patients more quickly.
l A new strategic commercial unit should be established in NHS England.
l The accelerated access pathway should be suitable for medical technologies, diagnostics and digital products as well as medicines and emerging forms of treatment.
l There should be a single set of clear national and local routes to get medical technologies, diagnostics, pharmaceuticals and digital products to patients.
l National routes to market should be streamlined and clarified.
l Many products will benefit from regional and local routes to market, which should be enhanced to operate consistently across the NHS.
l The route for digital products should build on the Paperless 2020 simplified app assessment process.
l The digital infrastructure should enable the system to capture information on the use of innovations and associated outcomes.
l The process of assessing emerging technologies should be evolved so that it is fit for the future.
l A range of incentives should support the local uptake and spread of innovation, enabling collaboration and with greater capacity and capability for change.
l AHSNs, tertiary academic teaching hospitals and clinical leaders across the NHS should drive and support the evaluation and diffusion of innovative products.
l Improved accountability and transparency around uptake of innovation should be supported by NICE.
l An Accelerated Access Partnership should align national bodies around accelerating innovation.
l The Accelerated Access Partnership should be established immediately.
l Implementation of the report’s recommendations should be led by the Accelerated Access Partnership and clinicians.
(Source: Accelerated Access Review: Final Report. October 2016. ©Crown copyright 2016)
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