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Accelerated Access Review Report Published: Faster Access to Innovative Medicines and Medtech Promoted

on Wednesday, 26 October 2016.

The Accelerated Access Review (AAR), originally commissioned by the Government in November 2014, has published its final report.

It provides various recommendations to make it easier for NHS patients to access innovative medicines, medical technologies, diagnostics and digital products, improving efficiency and patient outcomes.

The AAR has been led by an independent chair, Sir Hugh Taylor, and supported by Professor Sir John Bell as Chair of the External Advisory Group. Throughout the process, there has been extensive engagement with industry, the NHS, patients, academia and clinicians.

Ambitious Vision for the Future

The report seeks to set out an ambitious framework for how to transform the NHS, pulling all forms of innovation through the system for the benefit of patients and improving the international competitiveness of the UK.

Professor Bell said: "The approach to accessing innovation in the NHS has become increasingly challenging; creating frustration for innovators who see the NHS as an interesting environment for demonstrating the value of their products, for patients who often have to wait long periods of time before life-saving therapies are available, and for clinicians who are frustrated by the multiple barriers to both approval and adoption. We wanted to obtain the views of these varied constituencies and create a new and more agile approach to the prioritisation and adoption of NHS innovation. Now more than ever, with a tidal wave of exciting new technologies approaching, the system needs a way to do this."

Professor Bell identified opportunities for acceleration at every stage of approval and adoption. This involves identifying and pulling transformative innovations into the NHS quickly, using emerging regulatory pathways and patient data. The recommendations also encourage easier reimbursement for innovators, both through conditional licensing and a new mechanism for pricing individual products. For example, a large single payer could benefit from volume-based contracts, and payment could be made based on outcomes.

More Collaboration Encouraged

The report encourages the NHS to work more collaboratively with patients and innovators so that all three win. Patients will provide the data that all innovators and health care systems need in order to make decisions about the real benefits of innovation. The old model where innovators could simply throw new products at health care systems is no longer viable. Health care systems and innovators must work together to change pathways and improve outcomes together. This is especially the case with digital, medtech and diagnostic innovations, but also for pharma. The report says that if the NHS will see continued benefits of such innovation, it must contribute more actively to its development.

The Importance of the Life Sciences Industry Post-Brexit

On the impact of Brexit, Professor Bell was even more emphatic about the importance of the report to the life sciences industry, saying: "When we began this report, the UK was firmly in the European Union, and had a strong life sciences industry based on outstanding biomedical research in both world-class universities and internationally-renowned teaching hospitals. We also perceived the NHS as being a potentially crucial asset in further developing the life sciences industry. Some of the £120 billion spent annually on the NHS should be helping to drive success in this sector, fuelling economic growth and generating increased tax income on which to base our public services. Since the UK voted to leave the European Union, the importance of these principles have, if anything, been amplified. It seems clear that the life sciences industry will provide a crucial pillar for future economic growth."

A Reality Check

These are very positive statements for the life sciences industry. But then came the reality check. Professor Bell said it would not be easy to reach these 'sunny uplands'. More effort and resource would be needed. The AAR was merely a first essential step in ensuring that the UK builds a capability in life sciences that leads to strong economic growth and provides patients and the NHS with much needed tools and technologies at an affordable cost. NHS England must engage at the highest level in this agenda and the early signs are positive, but a sustained focus and engagement would be essential. NHS Improvement has a key leadership role to play as the lead agency for innovation, working closely with reinvigorated Academic Health Science Networks.

Professor Bell called for more resource to make this happen. He added that most major recommendations of the report would need enhancement of digital capabilities within the NHS, and this must happen more quickly so the benefits of the review could take place.

Positive Support so far from NHS England

Professor Bell said there had been difficulties with previous attempts to resolve the issue through Innovation, Health and Wealth. This time, it was crucial to obtain strong support from NHS England and he praised the support so far from Simon Stevens, the Chief Executive of NHS England.

Mr Stevens said: "First, we must actively support new discovery and further development of innovative treatments and care. Second, we have no choice other than to drive value and affordability across the NHS if we're going to create headroom for faster and wider uptake of important new patient treatments. And third, in the run-up to Brexit we need not only to secure - but actually enhance - our vibrant and globally successful UK life sciences sector. Sometimes these three goals are thought to be in tension. By contrast, this Accelerated Access Review provides practical and welcome proposals for squaring the circle. NHS England is fully committed to playing our part in doing so."

The 18 Recommendations

The full list of recommendations in the report are as follows:

  1. The NHS should develop an enhanced horizon scanning process and clarify its needs to innovators.
  2. A new transformative designation should be applied to those innovations with the potential for greatest impact.
  3. Patients should be involved in horizon scanning and prioritisation, and this involvement should continue along the whole innovation pathway.
  4. An Accelerated Access Pathway for strategically important, transformative products should align and coordinate regulatory, reimbursement, evaluation and diffusion processes to bring these transformative products to patients more quickly.
  5. A new strategic commercial unit should be established in NHS England.
  6. The accelerated access pathway should be suitable for medical technologies, diagnostics and digital products as well as medicines and emerging forms of treatment.
  7. There should be a single set of clear national and local routes to get medical technologies, diagnostics, pharmaceuticals and digital products to patients.
  8. National routes to market should be streamlined and clarified.
  9. Many products will benefit from regional and local routes to market, which should be enhanced to operate consistently across the NHS.
  10. The route for digital products should build on the Paperless 2020 simplified app assessment process.
  11. The digital infrastructure should enable the system to capture information on the use of innovations and associated outcomes.
  12. The process of assessing emerging technologies should be evolved so that it is fit for the future.
  13. A range of incentives should support the local uptake and spread of innovation, enabling collaboration and with greater capacity and capability for change.
  14. AHSNs, tertiary academic teaching hospitals and clinical leaders across the NHS should drive and support the evaluation and diffusion of innovative products.
  15. Improved accountability and transparency around uptake of innovation should be supported by NICE.
  16. An Accelerated Access Partnership should align national bodies around accelerating innovation.
  17. The Accelerated Access Partnership should be established immediately.
  18. Implementation of the report’s recommendations should be led by the Accelerated Access Partnership and clinicians.

For more information, please contact Paul Gershlick on 01923 919 320.