2017 will see the UK Government formally respond to the Accelerated Access Review's Final Report, published on 24 October 2016. Only then will we know whether, when or how recommendations for implementation will be adopted and taken forward.
The AAR looked at how to speed up access to innovative drugs, devices, diagnostics and digital products to NHS patients. In a post-Brexit environment, with the UK looking to the life sciences industry to provide a crucial pillar for future economic
The Independent Review, commissioned in 2014 by the Life Sciences Minister, was chaired by Sir Hugh Taylor (former Permanent Secretary at the Department of Health, Chairman of Guy's and St Thomas').
The AAR has had to wrestle with the
The UK already has a number of fast track routes to bring products to market – eg Biomedical Catalyst (competitive challenge fund run jointly between Innovate UK and Medical Research Council), EAMS (Early Access to Medicines Scheme) where the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available which has been shown to save 12-18 months in the technology appraisal process, and the European Medicines Agency has PRIME (enhanced support for the development of medicines that target an unmet medical need based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier).
It is important to note that the review does not make any recommendations that change the evidential standards needed for regulation. Rather the priorities are on better horizon scanning and
The accelerated access pathway is then really about removing bureaucratic burdens (doing things concurrently not sequentially), getting commercial access plans in place quickly (with a new strategic commercial unit), simplifying processes and offering a flexible pricing framework to support early access schemes. The review team
There will be scope for conditional recommendations leading to a period of managed access (which is something the Cancer Drugs Fund did). There is then to
In an increasingly
There is also a call to make significant improvements to the digitalisation across the NHS including the electronic patient record and e-prescribing which has had a troubled recent history. Given the NHS
The UK is doing this first for its own patient population and health economics,
- world leading health and life sciences (punching above our weight),
- the "ideal" infrastructure in the NHS to test and adopt
- the most integrated health research systems in the world in the National Institute for Health Research
- the most integrated and biggest single payer healthcare system (potentially further integrating social care in certain geographies eg Greater Manchester)
- a leading health data and genomics platform
- a world leading system for value for money assessment
- existing innovators and good examples of bringing on innovation already
The debate for global providers of healthcare technologies including