This article was first published on Lexis®PSL Life Sciences on 8 December 2017. Click for a free trial of Lexis®PSL.

Rachel Bradley, senior associate in Penningtons Manches’ commercial, IP and IT team, and Katie Gordon, senior knowledge lawyer, explain the key points of the Accelerated Access Review (AAR) and consider the Government’s response, from the perspective of the life sciences sector.

Original news

Government rolls out project for ‘breakthrough treatments’ to reach patients faster, LNB News 03/11/2017 The Department of Health and Department for Business, Energy and Industrial Strategy have published a joint response to the Accelerated Access Review (AAR), which proposed solutions on how the Government could aim to improve patient access to breakthrough technologies and treatments. The Government’s response to this review includes a proposal to allocate £86 million in funding to support innovators and the NHS in overcoming barriers, including an accelerated access pathway (AAP) to bring breakthrough products, technologies and treatments to market and to patients as quickly as possible.

What is the background to and the aim of the AAR?

The AAR is an independent review commissioned by the UK Government to consider ways to speed up access for NHS patients to:

  • innovative drugs
  • devices
  • diagnostics
  • digital products

The review was launched in November 2014 by George Freeman MP, the then minister for life sciences, as the ‘Innovative Medicines and Medtech Review’ and later renamed as the ‘AAR’. The AAR began work in March 2015 and was led by Sir Hugh Taylor, the chair of Guy’s and St Thomas’ NHS Foundation Trust, with support from the Government’s Office for Life Sciences, the Welcome Trust and an external advisory group chaired by Professor Sir John Bell (Regius Professor of Medicine at the University of Oxford). The AAR sought views from over 600 people and organisations (including, among others, clinicians, NHS commissioners and patients groups) and published its final report in October 2016.

What are the main recommendations of the AAR report which was published in October 2016? Which recommendations are of particular interest to the life sciences sector?

The review makes a total of 18 recommendations aimed at improving access to and uptake of medical innovations, some of which develop on initiatives set out in the government report entitled ‘Innovation, Health and Wealth’ published in 2011. The main recommendations in the AAR report are as follows:

  • development by the NHS of an enhanced ‘horizon scanning’ process to help identify those innovations that have the most potential to deliver improved outcomes or efficiencies and give them a ‘transformative designation’ to act as a trigger for such innovations to enter an accelerated pathway to patients and receive additional support to navigate the market and to reach patients;
  • creation of an accelerated access pathway (AAP) for strategically important, transformative products (including medical technologies, diagnostics and digital products as well as medicines and emerging forms of treatment) that would be supported by a new strategic commercial unit established in NHS England;
  • a single set of clear, streamlined and consistent national and local routes to get medical technologies, diagnostics, pharmaceuticals and digital products to patients;
  • digital infrastructure to enable the system to capture information on the use of innovations and associated outcomes;
  • a range of incentives, increased accountability and transparency, local infrastructure and clinical leadership to support the uptake and spread of innovation within the NHS;
  • establishment of an accelerated access partnership to coordinate key national bodies around the principle of accelerating innovations and providing a single point of access for innovators.

The review’s headline announcement of a new AAP to speed up and simplify the process for getting selected innovative products from pre-clinical development to patients is of particular interest to the life sciences sector. As is the review’s recommendation that products participating in the early access to medicines scheme should receive funding prior to National Institute for Health and Care Excellence (NICE) assessment, with such funding focused on strategically important products manufactured by small and medium-sized enterprises (SMEs) and not-for-profit organisations. Also of interest is the recommendation for the establishment of a new strategic commercial unit to facilitate commercial dialogue to create flexible arrangements with innovators working on new products so as to secure faster access to the NHS market.

How does the Government’s response address the AAR recommendations, in particular those relevant to the life sciences sector?

The Government accepted the recommendations of the AAR in its response published in November 2017 and set out plans to introduce the new AAP. The response also includes plans to set up a new accelerated access collaborative (AAC) chaired by Sir Andrew Witty (the former CEO of GlaxoSmithKline) that will make decisions on which products should be granted access to the accelerated access pathway. In addition, the response confirmed £86 million in Government funding to support innovators and the NHS in overcoming barriers to getting new, innovative technologies to patients quickly. It also notes the Government’s intention to improve NHS England’s commercial capacity and capability to deliver deals that achieve better value for the NHS and innovators.

What are the accelerated access pathway and the AAC and when will they become operational? What are the advantages of these initiatives for patients, the NHS and life sciences businesses?

The AAP will be introduced in April 2018 and will be a new route to market that aims to streamline regulatory, reimbursement, evaluation and diffusion processes so to get strategically important, cost effective products into the NHS as rapidly as possible. The new pathway aims to deliver faster access through features such as:

  • streamlining the pathway from market authorisation through to patient use
  • generation of real-world evidence in addition to clinical trials data
  • early price negotiation and the potential for flexible and confidential commercial arrangements

The AAP will complement existing schemes, such as NICE’s fast track appraisal process and it will be possible for pharmaceutical products to participate in the early access to medicines scheme (EAMS) while on the AAP. The pathway is intended to be cost-neutral or cost saving and it is anticipated that around five products a year will receive breakthrough product designation and go onto the new pathway, subject to satisfactory commercial negotiation. Analysis carried out for the AAR suggests that the AAP will bring forward patient access by up to four years where an EAMS scientific opinion is used and where there are no delays in the technological appraisal or in NHS commissioning and adoption.

Selecting the products for the AAP will be done by the national organisations responsible for regulating, evaluating and delivering new innovations to patients (National Institute for Health Research, Medicines and Healthcare products Regulatory Agency, NICE, NHS England, NHS Improvement and Government) with input from independent representatives for patients, industry and clinicians. This group will be referred to as the AAC and will be headed by an independent chair who will be accountable to ministers and, as mentioned above, will be Sir Andrew Witty in the first instance. It is envisaged that the AAC will identify its first products from April 2018. In addition, the AAC will be responsible for monitoring and measuring the impact of the accelerated access programme and on assessing the industry response to it. It will be for the AAC, in discussion with partners, to determine success criteria, but the expectation is that it will consider indicators such as:

  • the level of industry interest in the AAP
  • speed of product progression through the AAP
  • improved health and quality outcomes
  • increased affordability of new technologies and products
  • improved value for money
  • increased impact of academic health science networks (AHSNs)
  • SMEs getting products to patients more quickly and easily

It is proposed that the initiatives could speed up access for NHS patients to new innovative treatments by up to four years and enable the NHS to gain early access to cost effective innovations. The fact that the initiatives aim not only to speed up reimbursement and adoption but also foster greater collaboration between innovators and the NHS has been welcomed by many in the life sciences industry. Commenting on the review ABHI CEO Peter Elllingworth stated: “Delivering a consistent set of national, regional and local routes to market will support the diverse nature of the MedTech sector and help ensure that NHS patients have improved access to new technologies. Providing greater central alignment through the Accelerated Access Collaborative is an important step to speed innovations through the varied support programs.”

Dr Richard Torbett, executive director of commercial policy at the ABPI, said in his comments on the Government’s response to the AAR: “The Government’s commitment to speeding up access to the most innovative medicines and treatments is very much welcome. This should benefit thousands of NHS patients as well as delivering significant long-term savings for the health service if appropriate investment in these transformative therapies is made available.”

The Institute for Cancer Research (ICR), in its comment on the Government’s response, welcomes the announcement and, although the number of treatments and technologies that end up getting ‘breakthrough’ designation could be quite small, the ICR notes that this is a genuine opportunity to accelerate access to some real innovations.

Do the initiatives outlined in the Government’s response to the AAR also respond to some of the Life Sciences Industrial Strategy’s proposals?

Yes, one of the key recommendations of the Life Sciences Industrial Strategy (LSIS) led by Sir John Bell was adopting the AAR to secure faster patient access to innovative new treatments and technologies. The recommendations set out in the LSIS are now being used to work towards a sector deal to be negotiated by government, industry and others. In its response to the AAR the Government notes its support for Sir John’s view that its commitment to the AAR’s implementation represents a key step in the sector deal. The Government’s response further notes that ‘in turn we look to industry to develop innovations and technologies that not only deliver better outcomes for patients, but do so with improved value for money’.

However, as the BioIndustry Association (BIA) notes in its comment on the Government’s response to the AAR of 3 November 2017, for the AAR to have a real impact, and to really speed up access to patients to innovative medicines, it will be important to have buy-in from both the NHS as well as industry and currently there is little or no awareness of the AAR, or other initiatives that are already in place among staff in the NHS. The BIA stands ready to work closely alongside government and NHS leadership to take the important agenda forward.

In addition to what has been explained on the AAP and AAC, what are the next implementation steps?

Other implementation steps set out in the Government’s response to the AAR include:

  • development by NHS England of a horizon scanning database for medical technologies to run in parallel with PharmaScan, which enables horizon scanning of pharmaceutical products;
  • NHS Innovation Accelerator is expected to announce its third cohort of innovators in early 2018
  • Digital Health Technology Catalyst to support SME led projects to develop the evidence base required to launch their products in the NHS with phase one projects selected in January to March 2017;
  • extension of the Test Bed Programme launched in January 2017 for a further two years;
  • new ‘innovation exchanges’ to be established to encourage greater collaboration between 15 AHSNs, innovators, clinicians and patients to help them navigate the system - the intention is that the innovation exchanges will increase AHSN capacity and capability to assess the local value of new technology and promote diffusion of innovative technologies;
  • £6 million pathway transformation fund to help NHS organisations integrate new technologies into everyday practices and help overcome practical obstacles such as training staff on how to use new technologies;
  • Innovation and Technology Payment (ITP), which builds on the innovation and technology tariff, is expected to go live in April 2018 - the ITP aims to support the NHS in adopting innovative medical devices, digital platforms and technologies, in a faster and a more systematic way. Innovative products or technologies will be selected for the ITP through a competitive process and then NHS England will identify ways of supporting adoption across the NHS, for example through introducing a reimbursement for usage or centrally procuring items