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No-one can say England's Accelerated Access Review, which aims to “ensure that the UK is the fastest place in the world for the design, development and widespread adoption of medical innovations" isn't aiming high, writes Leela Barham.
Back in November 2014, George Freeman, Minister for Life Sciences, announced the Innovative Medicines and Medical Technology Review that has been renamed the Accelerated Access Review (AAR). The intention was to consider how to speed up patient access to cost-effective and innovative medicines, devices and diagnostics. By March 2015, with the publication of the Terms of Reference of the Review, the ambition was for the review to “ensure that the UK is the fastest place in the world for the design, development and widespread adoption of medical innovations. This will help stimulate new investment, jobs and economic growth to support a stronger NHS.” No-one can say that the Review is not aiming high!
The Review came hot off the heels of the National Institute for Health and Care Excellence’s (NICE) September 2014 acknowledgement that just fixing NICE’s methods, and moving to Value Based Assessment (VBA), would not be enough to tackle stakeholders concerns about access to medicines. NICE’s proposals in turn, were the result of the conceptually appealing but ultimately too difficult to implement ideas of Value Based Pricing (VBP). VBP has been promised in the Conservative Manifesto in 2010. VBP in turn, built on earlier ideas of the Office of Fair Trading (OFT) following their investigation of the Pharmaceutical Price Regulation Scheme (PPRS). So the AAR is the last of a long line of efforts to look at the knotty issue of balancing access to today’s innovative medicines, encouraging valuable innovation for the future, and the not so small matter of affordability.
There are high hopes among industry that AAR can really take an end to end perspective and consider issues such as regulatory burden and duplication of assessment (although the latter would really need to take a UK perspective as whatever the AAR says, we’ll still have the same drugs assessed by up to three national agencies across the UK in any case).
The initial plan was for the AAR to provide an interim report in September of this year, and then a final one before the year was out. It seems that even the AAR can’t be that fleet of foot and a delay was announced. Now a final report from the review will emerge in April 2016.
However, in the mean time, the review has published the barriers that it has identified so far to speed up uptake. These include 7 main themes, and no less than 50 detailed points. These are not separated out between medical technology and medicines and no context is provided (although to a degree some of that is tucked away in the review’s initial outputs including insights on earlier adoption of medical innovations and a UK mapping of existing innovative pathways for medicines, devices and diagnostics). The 7 main themes are:
The final one is a focus on the pharma industry, which seems to imply that those producing other types of new technologies are at a disadvantage.
Some of the detailed points are likely to particularly resonate with the pharmaceutical industry. Mismatch between evidence for licensing and reimbursement is cited, so too is lack of outcomes data to drive uptake (presumably real world outcomes given that some evidence is usually available to a lesser or greater degree for many medicines, although it not be perfect).
EAMS is also just for pharmaceuticals. The AAR suggests that the benefits of EAMS are not persuasive in its current form; presumably giving away the drug for free is part of its lack of appeal to industry and the source of it’s appeal for the NHS. Other factors also feel pertinent to the pharmaceutical industry such as lack of accountability for innovation; this is diffuse as it currently sits uneasily between the Department of Health (DH) with commitments in the current PPRS under their auspice, but also with NHS England and NICE as well as the local NHS.
There’s not yet a clear sense of which of these many barriers are priorities. Perhaps culture, capacity to innovate, and helping innovators to identify a real need for new products, might be. These are all cited by the Chair of the Review’s blog as being of particular interest to him. To be fair he also acknowledges that the next step is to identify priorities; these will be included in an interim report due to published later this month.
The long list of barriers is at first glance off putting; hard to imagine how to overcome some of these without starting again with a blank sheet of paper to redesign the landscape. Today’s landscape - which is painstakingly set out in the UK mapping – shows it’s not simple nor straightforward to navigate what happens from initial ideas to prescription of a new medicine.
Whatever the Review comes out with, it should shape the environment for good – or bad – for at least half the time that the current PPRS is in place. In turn, that means it will shape just what kind of negotiation the industry can expect in the run up to a new agreement in 2019. So much rests on the AAR and how far it can deliver against the ambitions set out by George Freeman. It’s one to watch.
Leela Barham is an independent health economist and policy expert. You can access her website here and contact her at firstname.lastname@example.org