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.
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 growth, and the NHS battling to balance its books, we look at the key ideas from the Review and give our preliminary assessment of the proposals to streamline processes and pull cost-effective transformative innovations into the NHS quickly.
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 age old problems of safety first, proof of viability and the costs of bringing products to market, which have slowed access versus the frustrations of innovators, patients and clinicians about the length of time and the amount of bureaucracy involved for what may be dramatic and cost effective benefits.
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 prioritisation (and not just in pharmaceuticals). The process would involve the annual/ongoing selection of about 50 products that fit essential criteria - significant improvement to patient relevant outcomes, improves affordability and impact for NHS, unmet need, and strategically important. Of these, 5-10 which meet NHS priorities, show clear and measurable outcomes and to which the accelerated process will have real impact, would be identified as "transformative" and selected for accelerated access.
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 estimate this could bring forward reimbursed access by up to 4 years in some cases.
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 be support to encourage uptake and diffusion of products and clearer/simplified commissioning routes. The new process will draw on new Academic Health Science Networks to support standard frameworks for evaluation and local spread of adoption. (AHSNs have been established to deliver a step-change in the way the NHS identifies, develops and adopts new technologies and are predicated on partnership working and collaboration between the NHS, academia, the private sector and other external partners within a single AHSN context and across AHSNs. They are seen as system integrators and organisations which link different parts of the health ecosystem to ensure that a range of aspects to improve health outcomes are considered using proven methodology and improvement in science to lead large scale, sustainable transformational change across traditional boundaries).
In an increasingly cash strapped NHS there are issues with creating the "headroom" to have funds to spend on innovation. There is a new Innovation and Technology Tariff to provide a reimbursement route for a selected number of value proven, strategically important medical technologies and digital products. There is also recognition that the UK will need to disinvest in outdated products and services – creating a value exchange.
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 system there is recognisedimmense potential in harnessing the power of health information technology to generate date on product impact at scale.
The UK is doing this first for its own patient population and health economics, however it is also clearly seeking to be a post Brexit beacon for Life Sciences innovation. The AAR would no doubt seek to highlight the assets of having
world leading health and life sciences (punching above our weight),
the "ideal" infrastructure in the NHS to test and adopt innovation,
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 pharmaceuticals, will be whether, once implemented, this offers an attractive (and sufficiently large once we are no longer in the EU) platform for trying to bring innovation through quickly and whether it potentially makes the UK a destination location for innovation as a result.
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