In 2014, the Government therefore commissioned the Accelerated Access Review (AAR) led by Sir Hugh Taylor. The AAR was published in October 2016 and recommended a range of processes and opportunities for identifying and introducing innovations into the NHS. Key components included:
optimising the use of existing and emerging regulatory approval pathways
generation and use of patient data to establish and define the benefits of innovations
a much more streamlined approach to new product reimbursement including conditional licensing and new tools for pricing individual products
Professor Sir John Bell in his industrial strategy nudged the Government into a response at the end of August by reiterating that the AAR proposals should be adopted with streamlined and clarified national routes to market, including for digital products. The Government finally responded this month - 'broadly' accepting and agreeing to the AAR proposals.
The response promises from April 2018 a new Accelerated Access Pathway, a fast-track route into the NHS for 'breakthrough' selected medicines and technologies that would benefit from a support package of accelerate clinical development and through the NHS’s approval and reimbursement processes.
The Accelerated Access Collaborative led by Sir Andrew Witty, former Chief Executive of GlaxoSmithKline, will decide which products should have access to the pathway. In addition, a new Strategic Commercial Unit within NHS England will seek to negotiate cost-effective deals for such products.
The AAR comes in the wake of the European Commission's continuing work on the 'Adaptive Pathway' initiative, piloted last year. Medicines in areas of high medical need were proposed for an 'iterative' approval process, greater use of real life data and early involvement of health technology bodies to supplement clinical trial data.
Neither initiative envisages new product approval processes, but more frequent and creative use of existing procedures.
While the news has been welcomed in pharma and biotech circles, it is clear that the £86 million in funding is intended mainly for small-to-medium sized enterprises in the digital health field with products able to help the NHS budget go further, and to help the 15 regional Academic Health Science Networks (AHSNs) in the task of "encouraging grassroots adoption and uptake of new medical technologies". Only £6 million will support medtech, diagnostics and pharmaceutical products.
Importantly, the budget constraints imposed by the Pharmaceutical Price regulation Scheme (PPRS), the National Institute for Health and Care Excellence (NICE) and NHS England (through the Strategic Commercial Unit) on new products will be unaffected, as will the Budget Impact Test under which NHS England can negotiate with companies whose product has been approved by NICE, but could have an annual cost to the NHS of more than £20 million a year.