17 November 2017
The Accelerated Access Review (AAR) was commissioned by the UK government in November 2014, to examine how best to speed up access to innovative diagnostics, treatments and digital products. Following a lengthy consultation process, the final report and recommendations were released in October 2016. A further year on and the government finally released their response, earlier this month. So was it worth the wait?
Unsurprisingly, the government and partner organisations (including NHS England and the Academic Health Science Networks or AHSNs) largely endorse the AAR report; the last year has been spent discussing how to take forward the recommendations. The response agrees that ‘it is critical that we take the opportunity to create a catalyst for change in the access landscape’ in the context of changes in demand for NHS services, the pace of scientific development and the emergence of more complex personalised technologies and health-related data. It also refers to imminent change in the UK’s relationship with the European Union.
Having made it clear that no more cancer drugs fund type approach is to be expected, the government then strongly supports the need for close partnership with the life sciences sector to deliver the accelerated access vision.
At the same time, the need for faster and simpler access to biomedical innovations in the NHS and ‘a better understanding of unwarranted variation in uptake’ are also supported, with the all-important caveat that this will need to take place ‘within the budgetary envelope’ set for the NHS. Having made it clear that no more cancer drugs fund type approach is to be expected, the government then strongly supports the need for close partnership with the life sciences sector to deliver the accelerated access vision. Happily, the views of Life Sciences Champion Professor Sir John Bell, that the government should accept and implement the final report of the AAR as a key element in the Life Sciences Sector Deal (yet to be finalised) meet with agreement.
In evidence on accelerated patient access to innovations, the PHG Foundation emphasised that so-called ‘diffusion’ of innovations from centres of clinical research and teaching excellence to standard NHS facilities does not happen automatically, or not in any equitable fashion. It is therefore pleasing that the Government has already committed to the provision of dedicated funds towards changes to clinical pathways dictated by the use of innovative diagnostics or interventions. Whilst this will not wholly solve the problem, it is a firm step in the right direction.
The 15 Academic Health Science Networks (AHSNs), are said to be already ‘tackling some of the causes of unwarranted variation in uptake’, but a further £39m has been committed to support local adoption. Better news for patients living away from an AHSN is that new Innovation Exchanges will be set up to establish greater collaboration between the AHSNs; to support innovators, clinicians and patients ‘to navigate the system to meet their needs’; and promote diffusion of those products that deliver real benefits to patients. Importantly, the Innovation Exchanges will partner with NHS Innovation National Networks (INNs) that will ‘connect AHSNs with clinical and national policy leads’ to identify and support the best innovations.
NHS England’s existing Innovation and Technology Tariff (ITT) is set to be joined from April 2018 by the new Innovation and Technology Payment (ITP) that will be responsible for uptake of a wider range of medical devices, digital platforms and technologies in the NHS.
The central element of the government proposals on accelerated access is the new Accelerated Access Pathway (AAP) – a fast-track route into the NHS for the most strategically-important and cost-effective new products, those that are expected to fill critical unmet clinical need, dramatically improve efficiency or make major differences to clinical outcomes for patients. Taking effect from April 2018, the AAP will have a streamlined process for regulatory and market access decisions that should accelerate speed to NHS patients by up to four years – a highly significant change. This potentially includes diagnostics, treatments and digital products, including existing medicines repurposed for the treatment of new indications, which is something that genomic stratification of patient sub-groups may allow.
Access to the AAP will be decided by the Accelerated Access Collaborative (AAC). This comprises all those organisations already charged with uptake of innovations to the NHS (NHS England, NHS Improvement, NICE, the MHRA, the NIHR) along with the government and ‘independent representatives for patients, industry and clinicians’. The first independent chair of the AAC will be Sir Andrew Witty, former head of global pharma company GlaxoSmithKline.
Before anyone gets too excited, there is a hefty caveat. This commitment to accelerated patient access to ‘life-changing innovations’ is set against the financial sustainability of the NHS. This is of course essential – indeed, the PHG Foundation specifically underlined the need for healthcare innovations to ‘provide solutions to financial limitations rather than exacerbating them’, so the requirement for innovations to be demonstrably cost neutral for the NHS in order to receive approval for the AAP is positive.
Since innovations are almost invariably more expensive, this is a tall order, but the expectation is clear - industry must provide a ‘cost proposition that delivers additional value for patients and the NHS beyond that achieved under the current system’. This does potentially allow room for cost increases in one budget area to be offset by greater cost reductions in another, which is more plausible than a zero upfront cost increase, but the government’s expectation that only around five products a year will be approved for the AAP is telling. Moreover, whilst there is scope for ‘cost-additive’ ‘breakthrough’ products to be approved for the AAP, subsequent candidate products will have to offset this by demonstrating greater savings.
So overall, the AAP is several steps in the right direction, but how far it will succeed in stimulating the life sciences industry and fast-tracking the best new diagnostics and treatments to NHS patients remains to be seen. In theory at least, a product offering clear improvements in clinical outcome for no cost, or clear cost reductions for the same outcomes should get to patients much faster– provided it isn’t crowded out by earlier, less cost-effective AAP candidates.
The good news is that the efficacy of the AAP will be scrutinized. The AAC is charged with making the NHS ‘one of the most pro-innovation healthcare systems in the world’ and providing innovations ‘at a price that industry and the NHS think is affordable and fair’ – quite a balancing act.
The good news is that the efficacy of the AAP will be scrutinized. The AAC is charged with making the NHS ‘one of the most pro-innovation healthcare systems in the world’ and providing innovations ‘at a price that industry and the NHS think is affordable and fair’ – quite a balancing act. It will also be responsible for measuring and evaluating the impact of the AAP and the industry response to it - something the PHG Foundation called for. Whilst it may seem an obvious step, commitments to evaluation of new initiatives are not always given.
Overall, the commitments to change are positive. However, many details have yet to be revealed – for example, whether funding-linked objectives and deliverables will be imposed on the new Innovation Exchanges.