How the UK’s Accelerated Access Review aims to guide medical innovations to their destination
Published in October, the UK's Accelerated Access Review set out a series of recommendations for streamlining the access process, aiming to cover not just new drugs, but also medical devices, diagnostics and digital tools.
Underlying the plans is the hope that the time it takes for patients to have access to the latest innovations could be cut by up to four years. But as the political manoeuvring accelerates this year in the run-up to the start of Brexit negotiations, where does that leave the review?
It's still a priority was the answer from Dr Luisa Stewart, deputy director at the government's Office for Life Sciences, which has a foot in both the business and health camps at Whitehall. “Accelerated Access will be a key component of the life sciences industrial strategy sector deal,” she told the Westminster Forum's Assessing Priorities for NICE seminar last month.
That new industrial strategy (see p7) hands a prominent role to life sciences, naming it as the first of 10 strategic pillars that will be leant upon to support the government's planned model of seeking 'sector deals'. The strategy itself, published just last month, won warm words from the country's pharma and biotech trade associations, though they also hope it will just be a starting point and can have a wider impact.
Dr Stewart told the seminar there was a clear case of need for the Review. “Although we have, in the UK, a proud reputation of being at the forefront of innovation, we're not always good at seeing that through in terms of ensuring all patients access it. We will need to do that, both for the benefits of our patients and our economy, and also for the NHS and helping it deliver [on] the challenges it [faces].” Chief among these are the Five Year Forward View, the wide-ranging NHS strategic plan published in October 2014. Underpinning it is a need for the health service to make significant efficiency savings.
The Accelerated Access Review was launched in November 2014 by the then-minister for life sciences George Freeman and chaired by Sir Hugh Taylor, a former civil servant at the Department of Health and currently chair of Guy's and St Thomas' NHS Foundation Trust.
The independent review's final report emerged in October 2016, with potential implications for treatment access for a number of conditions, with myeloma, melanoma and dementia highlighted in the publication.
Chief among its 18 recommendations was the proposal for a new Accelerated Access Pathway that would offer 'strategically important, transformative products' a faster route to national implementation. This pathway would better align the current regulatory, reimbursement, evaluation and diffusion processes, and provide companies with tailored support in navigating the new, simplified system.
“The idea behind this,” Dr Stewart explained, “is that we would identify a small number of strategically important products, those that had the most capacity to deliver transformative change to patients, and that public bodies would cooperate to help get those through the pathway quicker.” The intention is for it act as a 'lit runway' for nominated products to 'land and be taken up by the NHS', she said.
But there will be trade-offs to be made. “We would expect a negotiation between the innovators and the NHS to ensure that we get better value for money. You will get longer on the market within patent, but for that we would expect a lower price for the NHS.” This makes it sound like the price cuts mandated by current Patient Access Schemes that pharma companies agree with the Department of Health with input from NICE.
Furthermore, the Review is looking for more than just pharma innovation, with medical devices, diagnostics and digital health also falling within its remit, and there 'innovation' has its limits. Currently the pathway is likely to be open to between five and 10 products a year, Dr Stewart said.
Speaking at The Economist's War on Cancer conference in December, George Freeman - chair of the prime minister's Policy Board since July last year - said: “The real challenge for the AAR is some 'early wins'. There is a consensus now in industry and charities and NHS leadership that this is possible, that we can leverage how NHS procurement and research happen to strike bold new deals in acceleration and better value. The key is to pick the right winners… the AAR team are looking for innovative products that hit the sweet-spot.”
Meanwhile, speaking in October when the Review was published, NHS England chief executive Simon Stevens pledged that the new service would be “increasingly open to agreeing innovative win/win product-specific reimbursement models” for greater patient access.
Ultimately the government says the Review's recommendatiosn have the potential to cut four years from the process, through a funded Early Access to Medicines Scheme (EAMS) alongside more speedy technology appraisal and NHS commissioning.
The review suggests greater investment could be attracted via the creation of a new Strategic Commercial Unit to open up a commercial dialogue with innovators. The unit would consider flexible pricing models and design risk-sharing arrangements between the NHS and the innovator with a view to rapid uptake for better outcomes. Incentivised innovation collaboration schemes with streamlined access routes could translate this investment to a local level, supported by a single digital platform as part of the NHS's Paperless 2020 project.
You will get longer on the market, but we would expect a lower price for the NHS
The UK's cost-effectiveness watchdog NICE will have an important part in these changes, but may itself be expected to change. “Within this… NICE plays an absolutely critical role,” Dr Stewart said. “The Review was very supportive of NICE and its evolution to date, and the need for it to continually evolve. The Review talks about lighter touch processes for products where there is clear evidence of efficiency, it will need to support the new commercial process.”
Also speaking at the Westminster Forum seminar last month was NICE's deputy chief executive and director of health and social care Professor Gillian Leng. She noted that engaging with the government on the new Life Sciences Strategy (see p7) and the Accelerated Access Review were among NICE's top priorities for the health system.
“We've always had close engagement with life sciences and with the industry, our role is to provide an objective independent assessment, but we are aware of the pressures on industry and on life sciences,” she added.
However, the complexity of the UK's health service brings major difficulties, in and of itself. “We might always want to get things right to the person or the patient in front of us, but to get a system right that doesn't overspend, that doesn't underspend, is a huge challenge,” Leng said. “It is always in a state of flux, there are always new technologies and treatments coming into that system - it's not a closed box.”
A strong basis
Responding to the Review's publication last year the health secretary said in a statement: “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 our thriving life sciences industry and use innovation to improve patient outcomes in the context of the financial pressures on the NHS. It will be important to implement this report in a way that is affordable for the NHS. The Government will now consider the proposals in detail with our partners and will provide a fuller response in due course.”
As a timeline 'in due course' is an ambiguous one. Dr Stewart was keen to point that the UK's ruling Conservative Party's 2015 election manifesto included a commitment to implement the review's conclusions. But she also noted the government has yet to formally respond to the Review, saying only: “We are considering the recommendations and also working on what goes into the life sciences industrial strategy. This is not about us not wanting to implement [it], we are exceedingly supportive, but this is about us working out precisely how and what our priorities are.”
She added: There will be further announcements in due course.”