In October 2016, the final report on the Accelerated Access Review (AAR) of innovative medicines and medical technologies was published, putting forward a series of recommendations on how to speed up access to innovative drugs, devices, diagnostics and digital products to National Health Service (NHS) patients. The report was independently chaired, and has been generally welcomed by industry. Recognising that the current system needs to be re-designed to allow for potential benefits and better opportunities for the NHS, patients and innovators, the proposals aim to secure better, cheaper and faster adoption of innovation through establishing streamlined mechanisms for prioritising emerging technologies, designing new pathways to accelerate approvals, speeding up adoption, evaluating technologies more efficiently and aligning national organisations to transform the NHS’s ability to adopt the right innovations rapidly. The report describes the pathway to market for both strategically important innovations and those with more incremental benefits.
The AAR was first launched by the government in March 2015, with the aim of making the UK “the fastest place in the world for the design, development and widespread adoption of medical innovations and stimulate new investment, jobs and economic growth to support the NHS”. The final report has identified opportunities for acceleration throughout the approval and adoption process and has recommended “a process for identifying and pulling transformative innovations into the NHS quickly, using the range of emerging regulatory pathways”. It also notes the importance of generating patient data and proposes a much more streamlined approach to reimbursement for innovators, both through conditional licensing and through a new mechanism for pricing individual products using a range of new pricing tools.
The specific recommendations include:
- The NHS should develop enhanced horizon scanning and clarify its needs to innovators.
- A new transformative designation should be applied to those innovations with potential for greatest impact.
- Patient involvement in horizon scanning and prioritisation, continuing along the whole innovation pathway.
- An Accelerated Access Pathway (AAP) for strategically important, transformative products should align and coordinate regulatory, reimbursement, evaluation and diffusion processes to bring these transformative products to patients more quickly; three annexes to the report set out AAPs for medicinal products, medical technologies/diagnostics and digital products.
- A new strategic commercial unit should be established in NHS England.
- The AAP should be suitable for medical technologies, diagnostics and digital products as well as medicines and emerging forms of treatment.
- A single set of clear national and local routes to get medical technologies, diagnostics, pharmaceuticals and digital products to patients.
- National routes to market should be streamlined and clarified; regional and local routes to market should be enhanced to operate consistently across the NHS.
- The route for digital products should build on the Paperless 2020 simplified app assessment process.
- Digital infrastructure should enable the system to capture information on the use of innovations and associated outcomes.
- The process of assessing emerging technologies should be made fit for the future.
- A range of incentives should support the local uptake and spread of innovation, enabling collaboration and with greater capacity and capability for change.
- Improved accountability and transparency around uptake of innovation should be supported by NICE.
- An Accelerated Access Partnership should align national bodies around accelerating innovation.
Key to implementing all these recommendations will be collaboration and early dialogue between the NHS and innovators, as will collaboration between the NHS, patients and innovators in providing the data needed to make decisions about the real benefits of innovation. The NHS should see benefits in the shape of a more cost-effective and informed but dynamic system, patients should gain earlier access to new treatments and innovators should find that some of the challenges of the UK market (such as the slow track to reimbursement and low prices without generating wider diffusion and volumes) are addressed. Development of appropriate payment systems will be crucial.
The recommended new approach aims to not only benefit patients by providing faster access to new treatments, but also to improve the international competitiveness of the UK’s pharmaceutical and medical technologies industry in the run up to Brexit and beyond. Whilst welcoming the proposals, industry groups note that effective implementation will be crucial, and this will need proper resources. The report anticipates that patients, clinicians and industry will all recognise the benefits of the proposed new model and work hard to make it work, and notes that NHS England and NHS Improvement will, as key stakeholders, need to be fully engaged.
Many other EU countries, as well as the European Medicines Agency, have also proposed or introduced schemes to speed up patient access to innovative treatments, especially where there is an unmet medical need, reflecting the general desire for faster, more flexible regulatory systems to keep pace with medical and technological developments.