England to Selectively Accelerate Innovation

England’s Accelerated Access Review (AAR) – an independent review to look at how to speed up adoption of the best innovation in the NHS – has finally reported. Set up in November 2014, it has faced delays as the UK voted on leaving the European Union (EU), but has finally made its debut, almost two years on. It has also cost over £500,000 ($610,000) in externally provided input according to a freedom of information response from the Department of Health.

The report has probably been re-drafted a few times over the months. Not least is placing an even greater emphasis on the importance of the life sciences sector to the UK in the light of Brexit. It may lay the foundation for life sciences to be given prominence in the development of a new, post-referendum, industrial strategy.

There are 18 recommendations made by the review, although not all are relevant to medicines (see box).

The final report has some golden threads running through it. The first is that life sciences is to be nurtured, but not at any cost. The vision is ‘getting the best technologies to patients more quickly and more cheaply’ (emphasis added).

The Government has yet to respond, but it would be a surprise to hear that there would be much new money to support the reviews ambitions. Instead, it will be tempting for Government to latch on to the comments made by Prof Sir John Bell in a foreword, that savings released, for example, by using biosimiliars and delisting, can be used to provide ‘headroom’ for innovation (or in new terms, ‘value exchange’). Disinvestment should already have been a watch-word throughout the NHS in any case.

Another thread is that the NHS will only support the really good innovations. Not said, but implicit, seems to be that innovation is a label used far too often. Those companies that bring the really good innovations can then benefit from the ‘most integrated research system in the world’ and the ‘biggest and most integrated single payer healthcare system’ (and they list more benefits).  Only a small number of innovations are expected to be designated transformative: five to ten a year. Put that against the over 100 new chemical entities forecast to launch for 2018 – let alone the many other types of innovation too – and you can see that most ‘innovations’ won’t be the innovations that the NHS will support.

Even where innovations are strategically important, affordability concerns may lead to commercial deals where perversely, access might be delayed, not speeded up, if a deal can’t be struck. NHSE will be able to ask NICE to delay the implementation of positive guidance. This reinforces the proposals from NICE and NHSE released just a days before the AAR final report.

The criteria to decide what is transformative, or not, have yet to be defined. It will be for the new Accelerated Access Partnership (AAP) to do that, with the suggestion that they might like to build on criteria ranging from magnitude of health gain, impact on unmet need and perhaps tellingly alignment with NHSE’s clinical and national priorities and impact on system efficiency, and cost impact.

The report won’t just sit on the shelf with “NHS England..fully committee to playing our part,” according to a letter included in the review written by Simon Stevens, Chief Executive of NHS England (NHSE). That includes NHSE “support[ing] the AAR’s streamlined pathway to identify high value innovations. We’ll then help pull them through into mainstream care…and where it makes sense, we’ll increasingly be open to agreeing innovative win/win product-specific reimbursement models, incorporating a mix of outcomes-based, annuity-based and volume-based pricing deals.” That might sound positive but Stevens adds, “none of which is to pretend this is easy. Or that there aren’t hard choices, and difficult trade-offs along the way.”

The report also builds on much of what already exists – for example, early dialogue, commercial agreements, managed access and real world data generation – so in that sense it will be a refinement, not revolution. It can be seen as perhaps more of an extension of the evolution already seen with the Cancer Drugs Fund (CDF). In July 2016 the CDF turned into a managed access fund. This review may well be more of opportunity for others innovations, not medicines.  

It feels a little bit like double counting the benefits of Government policy to suggest that the AAR can speed up access by up to four years; for medicines that would apply only when schemes like the Early Access to Medicines Scheme (EAMS) is in place, a scheme introduced in April 2014. What is new is funding for EAMS products, which were previously expected to be given at no charge to the NHS during the EAMS period. The review suggests Government finds £20million to £30million is allocated for EAMS – but only for medicines manufactured by small and medium sized companies and not-for-profit organizations.

New too is the AAP that might provide a new forum to work through any product specific issues; the danger could be that it becomes a talking shop. Key will be who is chosen to chair the partnership and how well they’ll corral six agencies.

The recommendation that NICE reviews its methods and processes to ‘ensure they are fit for purpose to enable access to the products the NHS needs most’ probably won’t lead to any different to the business-as-usual reviews NICE already conducts every three years, at least for medicines. This is because the recommendation is for NICE to do it’s own review, rather than someone else.

The last of NICE’s own reviews resulted in refreshed methods guidance in 2013, and NICE has been doing review work this year too. NICE has also already tabled changes through a consultation on an Abbreviated Technology Appraisal (ATA) process already, alongside proposals with NHSE on changes including consideration of affordability. The review also recommendations NICE considers recovering the costs of its assessments: that train has already left the station with NICE consulting on that back in September.

Time will tell if the AAR will really accelerate adoption of innovation; even if it does, it will be most likely for a very small number of new medicines that generate cost savings. Less accelerated access, and more selected access?