The Government has published its long-awaited response to the Accelerated Access Review (AAR), a blueprint for speeding up the process of getting cost-effect medical breakthroughs into the NHS. The Government says it aims to ensure that NHS patients are among the first in the world to get life-changing treatments. For companies working on products from early-stage proof of concept and design, through to those seeking market access, the array of accelerated access policies creates a variety of opportunities worth pursuing.
SMEs stand to be the main beneficiaries of AAR policies. The Government’s response to the AAR acknowledges that over 95% of companies in the UK life sciences sector are SMEs and indeed explicitly states it is prioritising help for these companies. Health Minister Lord O’Shaughnessy acknowledged that despite the wealth of innovation taking place across the UK, often many innovators find that uptake in the NHS can be too slow. This will be a familiar scenario for many SMEs seeking to access the NHS market, for whom the speed of such market access can be critical to survival as a business. This is not just crucial for business, but for improving the health outcomes of those patients that the NHS seeks to serve.
The headline announcement – the new ‘Accelerated Access Pathway’ (AAP) – will be introduced in April 2018 and offers a new route to market for health technologies. This will streamline regulatory and market access decisions. The appointment of Sir Andrew Witty, former CEO of GSK, to oversee its implementation is a nod to business that the Government acknowledges that industry should be the leaders of the process. With only 5 products a year receiving breakthrough product designation, it is crucial for companies to develop compelling cases to put forward. Much of the Pathway is still to be decided, so SMEs themselves should be shaping the route and engaging in these early, formative moments. If the Pathway is to be successful, this input will be key.
An array of other programmes and money pots were also announced in the response, including over £86 million of funding to help firms get new technologies into the NHS. For companies with market-ready products, the Pathway Transformation Fund provides a good opportunity. This £6 million programme will help adoption and integration of health technologies into everyday practice. With a health service struggling to meet demand for services, the programme promises much needed capacity to ensure that new technologies, once purchased, actually get used on the ground. Meanwhile, tor those already with a foot into the door of the market, the NHS RightCare review of clinical practice across the country could ease expansion in what is a fragmented market of different NHS trusts. Yet this review could pose a threat, as well as an opportunity, for pharma companies as NHS England’s Regional Medicines Optimisation Committees (RMOCs) are to accelerate decommissioning of outdated medicines to reduce NHS drug costs.
For digital tech, the policy package contains little new – Innovate UK’s Digital Health Technology Catalyst grant fund and the Innovation and Technology Tariff (ITT) are past announcements. However, a focus on delivering existing commitments rather than churning out new announcements is to be welcomed. Both these initiatives should still be of interest to SMEs working on digital health tech at the R&D stage and at market access. These initiatives, and others like them, have been put in place to realise the Health Secretary’s ambition for a “digital NHS” by the end of 2018.
Whilst the Government’s response to the AAR has been broadly welcomed by the sector, it has not been immune from criticism. Sceptics point out that the number of treatments that get designated as “breakthrough” by the Accelerated Access Pathway is quite small. Others have pointed out that the Pathway’s requirement for a new “budget impact test” for treatments, which means that products on the pathway must collectively have a cost-neutral return on investment at worst, may hinder costly but ultimately effective treatments. One glaring omission was the lack of any specific support for products which seek to address antimicrobial resistance, a Government priority which the Chief Medical Officer has warned “could spell end of modern medicine”.
Despite its limitations and the delayed response to the Accelerated Access Review from the Government, the policy package should be welcomed by the life sciences and health tech sector. Not only does it provide clear indication that accelerating market access is a Government priority, but the array of initiatives being rolled out by the Government offer opportunities for a broad spectrum of companies at different stages of product development to access the NHS market. Both for business and for patients who stand to benefit from cutting edge technology and medicine, this is welcome news.
If you are interested in finding out more about how accelerated access policies might help your organisation, please contact Edward Jones at firstname.lastname@example.org or on 020 7340 1150.