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The UK's proposed Accelerated Access Review is being dogged by delay and disappointment, writes Leela Barham.
In November 2014, George Freeman-at the time the UK Minister for Life Sciences, a post which has subsequently been cut-announced the Innovative Medicines and Medical Technology Review. The name changed to the Accelerated Access Review, but the focus remained the same: how to speed up patient access to cost-effective and innovative medicines, devices and diagnostics. The final report took longer than expected and came out in October 2016. By July 2017, there’s no formal Government response, and only a little good news as a result of all the hard work that went into the review. In part, that’s because the focus has moved on with the next new hope being a life sciences sector deal.
The AAR was broad in scope-perhaps too broad-but made some recommendations particularly relevant to medicines (see box).
Source: Pharmaceutical Executive
It was also the result of a great deal of work from across Government and others, not to mention externally commissioned work worth over £500,000 ($649,300). This explains why there is both so much interest, and as time has gone on, disappointment about the review.
So far, there’s only been what amounts to a holding response from the Government to the final report of the AAR, and that was back in October 2016. Along with some warm words was the promise of the Government “respond[ing] more fully in due course.” Prescient in light of controversial changes tabled since the AAR on a budget impact test is the comment that the Government response would be “mindful of the need to ensure affordability” in considering it’s response.
On 14 July 2017 the Government announced how it is taking forward some of the AAR work. They’ve announced funding worth £86 million ($112m), £6 million ($7.8m) of which-over three years-is to help SMEs with innovative medicines and devices get evidence from real world testing. This includes funding that may be used as part of the Early Access to Medicines Scheme (EAMS).
The rest of the funding is to go to Academic Health Science Networks (AHSNs) (£39 million/$50m) to help them assess the benefits of new technologies and support NHS uptake of the good ones, a Digital Health Technology Catalyst for innovations (£35 million), and finally a Pathway Transformation Fund (£6 million) to help the NHS integrate new tech into practice.
What this means is that this falls way short of the AAR recommendation for £20 million ($26m) to £30 million ($39m) for SMEs and not-for-profits for EAMS. The exact amount for medicines, even within the £6 million, is unclear too, since that covers medicines and devices. Devices aren’t currently under EAMS.
Lord O’Shaughnessy, Health Minister, has said that this “investment in innovations show how much we value the UK life sciences sector.” Some may disagree, but at the same time, any extra money is welcome when money is short.
There’s a great deal in the final AAR report that could be helpful to industry, but it seems that it’s very much a case of the decelerated access review, as the next phase of the Government response to the AAR is awaited.
In practice, the AAR already seems to be over-shadowed by Brexit and it’s now time to focus on the life sciences report being worked on as part of the UK’s industrial strategy. This is a flagship effort to support industry and the UK economy. This is crucial as the UK departs from the EU. Sir John Bell is the author of the life sciences report as part of the industrial strategy-key as a precursor to a life sciences deal-and is finalizing his report. Will that be less disappointing?