New and innovative drugs that are deemed strategically important and “transformative” to patient care could be made available up to four years earlier than the present system allows if proposals from an independent review are given the go-ahead.
According to the final report by the UK government-commissioned Accelerated Access Review, which was published on 24 October 2016, products likely to be given transformative status would be those — typically at phase III clinical trial stage — that could deliver “a step change” in costs or clinical outcomes.
“The transformative designation should signal, within the UK and internationally, a product’s strategic importance to the NHS. It should be reserved for the small number of products that have the potential to provide significant benefits in either patient outcomes or NHS costs,” the report says.
Products defined as transformative would have a bespoke development plan drawn up by a new Accelerated Access Partnership — a “light touch” umbrella group bringing together existing national organisations such as NHS England, the National Institute for Health and Care Excellence (NICE), England’s health technology assessment body, and the Medicines and Healthcare products Regulatory Agency, which regulates medicines and medical devices in the UK.
“Transformative” products would also be given an early evaluation by NICE, the report says, while at the same time, a new commercial unit (set up by NHS England) would begin discussing the potential pricing of the product with the product’s manufacturers.
Although only between five and ten products per year are expected to be given this new status, the accelerated access pathway is described as a “key plank” of the review’s recommendations.
The report says: “The accelerated access pathway should allow products with a transformative designation to meet regulatory requirements, agree commercial arrangements, receive revenue and achieve market access as quickly as possible. We expect that this could bring forward reimbursed access by up to four years in some cases.”
Launching the report, chair of the review Sir Hugh Taylor describes the plan as “ambitious” but says it will “prepare the health system for an exciting era in medical innovation”.
“We’ve listened to the views of the NHS, patients, clinicians, the life sciences industries and academia – and it is clear we need to act now to make the most of the tidal wave of new drugs and technologies that are being developed,” he says.
Lord Prior, minister for NHS productivity, says the report provides “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 the thriving life science industry and use innovation to improve patient outcomes and tackle the financial pressures on the NHS”.
The report was welcomed by the Association of the British Pharmaceutical Industry (ABPI), whose chief executive officer Mike Thompson described it as an “important foundation” for building a national life sciences strategy.
“[It] 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 … and a clear implementation plan.”
Another of the report’s recommendations — to provide funding for small and medium-sized businesses and not-for-profit organisations that have products granted a positive scientific opinion as part of the government’s Early Access to Medicines Scheme (EAMS) — was welcomed by the Bio Industry Association (BIA).
Under the current system, companies have to provide the medicine free of charge to the NHS until it receives a positive recommendation from NICE. This has been a barrier for many small biotech companies.
Steve Bates, chief executive of the BIA, says: “To ensure the funded EAMS becomes a reality, we now need to see a rapid response from the government to fulfil these recommendations followed by a timely implementation from NHS England.
“It is essential that the UK system is seen as globally competitive.”
The Accelerated Access Review was commissioned by the government in November 2014 with a remit to speed up NHS patient access to innovative drugs with a specific focus on drug regulation, reimbursement and uptake.