The United Kingdom (UK) government has published the final version of its long-awaited Accelerated Access Review (AAR), an independent report evaluating strategies to facilitate rapid patient access to new medicines and healthcare technologies.
Implications | The Accelerated Access Review (AAR), an independent advisory report commissioned by the UK government and produced in partnership with the Wellcome Trust, sets out 18 recommendations intended to expedite the adoption of novel medical treatments in the UK. In particular, it proposes a new partnership between UK healthcare bodies to streamline processes and bring forward patient access to new drugs by up to four years. It also calls for more flexibility in UK drug pricing, creation of a new National Health Service (NHS) strategic commercial unit, and disinvestment in outdated products and services. |
Outlook | The report has the declared aim of making the UK "a world leader in healthcare innovation, with an NHS that embraces the new drugs and technologies that patients need". Its long-awaited publication, postponed from last spring, has been welcomed by pharma industry representatives as being supportive of research and development, and enhanced collaboration between the industry and the NHS. The UK government has indicated that the report provides a strong basis for adapting healthcare policies and the attracting investment, while being "mindful of the need to ensure affordability". A full government response to the proposals in the report is expected in due course. |
The United Kingdom's long-awaited Accelerated Access Review (AAR) was published on 24 October 2016. This is an independent report, commissioned by the UK government in collaboration with the Wellcome Trust, in consultation with the National Health Service (NHS), patients, clinicians, the pharma industry, and academia, and chaired by Sir Hugh Taylor. The overall aim of the report is to "accelerate access for NHS patients to innovative medicines, medical technologies, diagnostics and digital products, making our country the best place in the world to design, develop and deploy these innovations". It also reflects a major government manifesto commitment to increase the use of innovative new medicines for NHS patients.
An interim report was published in October 2015, with details of key themes arising from consultation with stakeholders (see United Kingdom: 6 November 2015: UK's Accelerated Access Review interim report puts forward proposals to accelerate access to innovative drugs and technologies). These themes have since been explored by the review team, and a list of 18 key recommendations has been drawn up, covering the entire development spectrum from early research, preclinical and clinical trials through regulation to cost-effectiveness appraisals, pricing, and routine commissioning for NHS patients.
The full report may be accessed here.
The recommendations are:
1. The NHS should develop an enhanced horizon-scanning process and clarify its needs to innovators.
2. A new "transformative designation" should be applied to innovations with potential for greatest impact.
3. Patients should be involved in horizon scanning and prioritisation throughout the whole innovation pathway.
4. An Accelerated Access Pathway is set out in the report, for strategically important and transformative products. This should be a streamlined route aligning expedited regulatory, reimbursement, evaluation, and adoption processes to facilitate the most rapid patient access.
5. NHS England should establish a new strategic commercial unit.
6. Apart from new drugs and treatments, the Accelerated Access Pathway should also be applicable to medical technologies, diagnostics, and digital products.
7. A single set of clear national and local routes should be established, to enable patient access to new medicines, treatments, technologies, and diagnostics.
8. National regulatory routes to market are in need of streamlining and clarification.
9. Many products will benefit from regional and local routes to market, and this process should be enhanced for consistent operation across the NHS.
10. The route for digital products should build on the Paperless 2020 simplified app assessment process.
11. The digital infrastructure should enable the system to capture information on the use of innovations and associated outcomes.
12. The assessment process for emerging technologies should be "evolved so that it is fit for the future".
13. A range of incentives should be established to support local uptake and spread of innovation, enabling collaboration, and with greater capacity and capability for change.
14. Academic health science networks (AHSNs), tertiary academic teaching hospitals, and NHS clinical leaders should drive and support evaluation and adoption of innovative products.
15. The UK's health technology appraisal (HTA) body, the National Institute for Health and Care Excellence (NICE), should support improved accountability and transparency around uptake of innovation.
16. An Accelerated Access Partnership (AAP) should be formed, aligning national healthcare bodies with the aim of accelerating innovation.
17. The new AAP should be established immediately.
18. The AAP and clinicians should take the lead in implementing the recommendations of the AAR.
The Accelerated Access Pathway
The report cites a scenario where patient access to strategically important novel drugs may be brought forward by up to four years. This would be theoretically feasible if the treatment is eligible for the early access to medicines scheme (EAMS) (saving 12–18 months) and there is no delay at the NICE cost-effectiveness appraisal stage (around two years) or during the process for NHS commissioning and adoption (which takes two years or more). Streamlining could be achieved via shortened clinical development, concurrent regulatory and HTA processes, pre-approval reimbursement with flexible pricing and a conditional entry period, and incentives for adoption, support, and uptake of the new treatment at the commissioning stage. The report cites lessons learned in the rapid response to the Ebola virus outbreak and strategies for overcoming regulatory challenges in the treatment of dementia. The Accelerated Access Pathway is intended to fit seamlessly with existing early access and breakthrough medicine schemes for pharmaceutical products, with time taken out of the process by better alignment of regulation and cost-effectiveness evaluation.
NICE evaluations
While stating from the outset that "this review is extremely supportive of NICE as a global leader in health economic evaluation and evidence-based guidance", the report makes strong recommendations that NICE must now evolve and adapt its methods and process to ensure that they are "fit for purpose". In particular, it recommends that NICE should support NHS England in agreeing commercial arrangements for strategically important products, and that its appraisal processes should support acceleration, allowing products with sound evidence of increased efficiency to undergo a lighter-touch process. In fact, regarding the latter point, NICE has very recently published proposals to achieve exactly this, now at the consultation stage (see United Kingdom: 14 October 2016: NICE proposes fast-tracking for most cost-effective treatments and new budget impact threshold).
A more controversial suggestion following on from the above is that "NICE should consider recovering the costs of their assessments". A previous leak of this information was not received favourably by the pharma industry, citing difficulties for smaller pharma companies and challenges for the industry in accessing the UK market, particularly for rarer indications (see United Kingdom; 6 October 2106: UK NICE proposes GBP282,000 flat fee to assess new drugs – report).
The Accelerated Access Partnership
The report proposes that a new partnership, the AAP, be set up with immediate effect, including representatives from NHS England, NHS Improvement, NICE, and the national Medicine and Healthcare Products Regulatory Agency (MHRA). The AAP is intended as a "light-touch umbrella organisation" to allow innovators to access "joined-up help" for clinical development, regulation, and cost-effectiveness assessment. Its activities should include horizon scanning for and prioritisation of strategically important products, design of selection criteria and processes for assigning a transformative designation, and clarifying the priorities of the healthcare system to innovators for an improved investment focus in research. The AAP would also oversee the Accelerated Access Pathway, assist innovators during the process, provide guidance to market, and facilitate affordable commercial arrangements.
The report recommends that the AAP be set up immediately so that the collective leadership can be effective in 2016–17 and that the AAP takes the lead in implementing the recommendations of the AAR.
Outlook and implications
The long-awaited publication of this report, originally scheduled for early spring, has received a positive response from the pharma industry and public healthcare sector alike. Its ambitious and far-reaching plans, broken down into the 18 key recommendations, have also received a cautious welcome from the government. Parliamentary Under-Secretary of State for Health Lord Prior has stressed that the report "provides us with a strong basis to make the right decisions about how the health system can be adapted to meet the challenges of the future, attract inward investment, grow its thriving life science industry and use innovation to improve patient outcomes". Tellingly, he touches on the issue of stretched NHS resources in stressing that patients should be able to access the most cost-effective new innovations "in a way that is affordable and sustainable", and that the AAR should be seen as "part of the solution to that efficiency challenge, rather than adding to it".
The chief executive of the Association of the British Pharmaceutical Industry (ABPI) has given a positive endorsement to the report, describing it as an important foundation for building a Life Sciences Industrial Strategy with the government, and welcoming the opportunity to encourage collaborations between innovators, patients, and the NHS. He also sees it as a key step in the direction of significant "growth in research and development, manufacturing, and employment in a post-Brexit UK". However, the onus is now on the government to respond and produce a clear implementation plan.
The government has stated that it will consider the proposals in the report and "respond more fully in due course, mindful of the need to ensure affordability".