The UK government has published the findings of the independent Accelerated Access Review (AAR) that it commissioned almost 2 years ago. The objective for the review was to make 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 report makes recommendations which would enable patients to benefit from innovative medicines, medical technologies, diagnostics and digital products, improving efficiency and patient outcomes.
Of most interest to those of us working in the regulatory arena, it proposes the creation of a new Accelerated Access Partnership to help simplify and speed the process for getting the most promising new treatments and diagnostics safely from preclinical development to clinical use. Via this new partnership, which should span NHS England, NHS Improvement, NICE and the MHRA, innovators would have access to “joined-up help with clinical development, regulation and assessment of cost effectiveness”.
According to commentary in the Pharma Times, this could potentially bring forward patient access to drugs by up to four years if a scientific opinion from the Early Access to Medicines Scheme is used (saving 12-18 months) and there is no delay at the NICE appraisal stage (which takes around two years) or during the process for NHS commissioning and adoption (which takes two years or more).
Elsewhere, recommendations cover: improved horizon scanning for innovative new products, systematic prioritisation of the best innovations in the pipeline; better data on the impact of technologies on patient outcomes and uptake; local support for the spread of innovation and stronger incentives for local NHS organisations to use and spread the benefits of innovation.
Chief Executive of the ABPI, Mike Thompson, said “The Accelerated Access Review is an important foundation for building a Life Sciences Industrial Strategy and opens the door to greater collaboration between innovators, patients and the NHS to make the UK a world leader in researching, developing and using new treatments and technologies.
If we work together to deliver the necessary step-change in getting innovative medicines to British patients we then could see growth in research and development, manufacturing and employment in a post Brexit UK. Turning this into reality now relies on a positive government response to the Review, and a clear implementation plan.”
The government said it will now consider the proposals “and respond more fully in due course, mindful of the need to ensure affordability”.
Click here to access the full report.