UK Government Responds to the AAR

The Accelerated Access Review explored how to speed up adoption of innovation across the NHS in England, be that a new drug, device or digital way of doing things. It’s with some irony that it has taken the UK Government a year to fully respond. That’s in addition to the AAR itself taking two years, with the final report published in October 2016 after the Review was launched in November 2014.

The AAR set out 18 recommendations, with most of these relevant to the pharmaceutical industry (see Table 1). Sir John Bell also supported the AAR recommendations in his vision for the life sciences in the UK, in his report the UK’s Life Sciences Industrial Strategy, published in August 2017. Collectively there has been much pressure to get on with making change happen, instead of just talking-and writing-about it.

The tricky balance is that speed cannot come at any cost; instead it’s speedy access to those innovations that offer value for money and are affordable. The Government’s response underlines this challenge by saying that changes need to “be delivered within the budgetary envelope set by the Government for the NHS”.  

The practical steps that will be taken to take the vision of speedy access to the ‘best’ innovations include an Accelerated Access Pathway (AAP): a streamlined route to market for around five innovations a year that are ‘truly transformative’ and ideally cost neutral. Such a limited number suggests it’s not accelerated access, but selected access.

The streamlining will come through both an earlier and single-but flexible-commercial discussion balanced against the expectation that industry will offer a cost proposition that offers additional value versus the current approach. NHS England (NHSE) will have an enhanced commercial function to support commercial discussions, and to push for the better value that is expected. NHSE holds the purse strings for much of the complex care delivered by the NHS, including specialized medicines.

A new Accelerated Access Collaborative (AAC) will oversee the AAP process. The AAC will include all the big players: the UK regulator the MHRA, NICE, NHSE, as well as NHS Improvement who set payment scales for hospitals and other key functions for the NHS in England, as well as Government. The AAC will also have representatives for patients, industry and clinicians too.

The AAC can’t trump NHSE though, because the Government response states that “[the AAC] will not disrupt existing statutory accountabilities for managing the NHS budget.” Sir Andrew Witty, ex-Chief Executive of GSK, has already agreed to chair the AAC. The AAC should be up and running and identifying the first transformative innovations by April 2018.

The job for the AAC is not just in selecting transformative innovations, but also to evaluate impact of the AAP. The AAC will decide it’s own success criteria, although the Government makes some suggestions for what it might want to look at, including: level of industry interest in AAP, speed of AAP, improved health and quality outcomes, increased affordability and value for money of innovations, increased impact of other parts of the innovation landscape including the Academic Health Science Networks (AHSNs) – their job is to link with industry on a more local level in the NHS-as well as small and medium sized enterprises (SMEs) getting products to patients faster and more easily. The trouble with this approach is that the success of the AAP is likely to be a function of the choice of innovations to go through it: a decision that rests with the AAC itself.

Specifically for pharmaceuticals, there will be a transfer of responsibilities for Patient Access Schemes (PAS) from the Department of Health (DH) to NHSE. PAS are an important tool; companies can offer confidential discounts to the NHS as part of a NICE appraisal to help secure NICE approval. Transferring responsibilities for PAS to NHSE further boosts NHSE’s influence, as they already took on responsibilities previously under the Commercial Medicines Unit (CMU) from the DH.

It’s often in the methods and processes to determine and achieve value for money-and affordability–that can add time to access new medicines. It’s not always easy to show, nor agreed by all, that an innovation is value for money and affordable. Not only can NICE, or other commissioners, take their time to appraise an innovation, but if parties can’t agree or need to negotiate a lower price, the time from launch to actual use can be long. The Government’s response to the AAR won’t address many longstanding issues. Does that signal that these issues aren’t a priority for Government?  Perhaps they will be addressed as the Government and industry begin the process of negotiating a new Pharmaceutical Price Regulation Scheme (PPRS) for 2019 onwards, a scheme that has seen a widening in scope over time, to include access and not just pricing.

Table 1

Leela Barham is an independent health economist and policy expert. You access her website here and contact her at leels@btinternet.com