The UK government has backed the creation of an “accelerated access pathway” (AAP) under which a handful of selected breakthrough innovations – medical devices, diagnostics, drugs and digital products – could reach patients up to four years earlier than under standard assessment procedures.
The new pathway, to be introduced in April 2018, is expected to shorten the overall time to market for certain “transformative” new products, mainly by allowing cost-effectiveness evaluations to be carried out in tandem with the regulatory approval process. It will also offer companies early price negotiations and the potential for “flexible and confidential commercial arrangements.”
Candidate products will be selected by a new “Accelerated Access Collaborative” chaired by former GlaxoSmithKline chief executive Sir Andrew Witty and comprising representatives of national regulatory and evaluation bodies, with input from industry, patients and clinicians. The AAC will be set up by the end of the year and the first products to enter the new pathway are expected to be identified from April 2018.
The government makes clear, though, that a commitment to faster access to what will no doubt be expensive new products must be balanced against the financial sustainability of the National Health Service. The new pathway, it says, must be “cost neutral” for the health service and “must deliver improved value to the taxpayer.” To this end, a new strategic commercial unit will be established within NHS England to negotiate what the government calls “cost-effective deals.”
The proposals are contained in the government’s long-awaited response to the Accelerated Access Review (AAR), an independent report produced in October 2016 by Professor Sir John Bell and supported by the Wellcome Trust. In its response, the government broadly supports the proposals outlined in the AAR, which looked at ways of speeding up access to innovative new health technologies.
Health minister Lord O’Shaughnessy said the new arrangements would not only benefit patients but would “guarantee future collaboration between the life sciences sector and the NHS post-Brexit – benefiting the British economy and creating jobs.”
Life science companies have been pushing for mechanisms to shorten times to market for innovative products and strengthen the life sciences sector, particularly as uncertainty mounts over the UK’s relationship with the EU after Brexit in March 2019.
It’s no surprise then that industry has broadly welcomed the announcement – albeit with some caveats about the need for high-level political leadership and NHS commitment to make the project succeed.
“Providing greater central alignment through the Accelerated Access Collaborative is an important step to speed innovations through the varied support programs” – ABHI CEO Peter Ellingworth
The Association of British Healthcare Industries welcomed the government’s response, saying the move would “significantly speed up the time taken for patients to access lifesaving MedTech.”
ABHI CEO Peter Ellingworth said the association was “pleased to see key MedTech recommendations reflected” in the response. “Delivering a consistent set of national, regional and local routes to market will support the diverse nature of the MedTech sector and help ensure that NHS patients have improved access to new technologies. Providing greater central alignment through the Accelerated Access Collaborative is an important step to speed innovations through the varied support programs.”
Steve Bates, CEO of the BioIndustry Association, said the government’s response to AAR was “a key piece in the jigsaw of UK government life science policy that will set the environment for our sector in the lead up to Brexit and beyond. It fits between the publication of the Life Sciences Industrial Strategy in the summer and ahead of both an anticipated Sector Deal and the outcome of the Treasury-led Patient Capital Review later in the year.”
Bates pointed out, though, that “no strategy can succeed without a corresponding plan of action. Polling undertaken by the BIA earlier this year showed that 82% of NHS staff were unaware of either the Accelerated Access Review or the proceeding government strategy Innovation, Health and Wealth.”
Moreover, he said, while the government refers to numerous other initiatives such as NHS Test Beds and the Innovation Scorecard, BIA polling “reveals that only 5% of NHS staff are aware of these two programmes. If the Review’s ambition for innovation is to truly take hold then it requires both NHS buy-in and top-level government leadership.”
On the academic research side, Professor Paul Workman, chief executive of the Institute of Cancer Research, welcomed the new pathway, noting that while the number of treatments and technologies that secured a breakthrough designation “could be quite small,” this was “a genuine opportunity” to accelerate access to real innovations.
The Accelerated Access Pathway
The core of the initiative is the new accelerated access pathway, which is intended to align and coordinate regulatory, reimbursement, evaluation and NHS diffusion processes for breakthrough innovations. “We will make the process from bench to bedside quicker, cheaper, and easier for innovators and the NHS,” the government says.
Its aim is to “bring forward by up to four years patient access to these selected, highly beneficial and affordable, innovations.” As well as drugs, devices, diagnostics and digital products, these could include “repurposed medicines where a new indication is found for an existing product.”
The government expects around five innovations a year to gain breakthrough designation and go onto the new pathway, but stresses the need to avoid any extra costs to the NHS. Any products placed on the AAP “that are cost additive will need to be offset by products that deliver cost savings, beyond those already factored into NHS plans,” it says. “Efforts will be focused on those products that will deliver the greatest benefit to patients and improve value for money.”
Each breakthrough product will benefit from “bespoke case management, which will coordinate across partners to streamline the journey,” according to the government. “In return for these commercial benefits, we expect industry to come forward with a cost proposition that delivers additional value for patients and the NHS beyond that achieved under the current system, and is affordable.”
To spur collaboration between companies and the NHS when negotiating commercial agreements, the government says that a new strategic commercial unit is to be established in NHS England to give it “enhanced commercial capability” by April 2018. There is “clear demand” from innovators for win-win commercial deals and the new function will be able to develop these types of arrangement.
In parallel, the commercial liaison team at NICE will support commercial engagement between companies and NHS England, “creating a smooth interface for companies throughout the appraisals process.”
The government in its response does not go into great detail about the criteria a product will have to meet to merit “transformative” (or breakthrough) designation, saying only that “a new transformative designation should be applied to those innovations with the potential for greatest impact.”
The AAR itself defined such innovations as “the most strategically important products with the potential to deliver significant benefits in cost or outcomes,” and suggested criteria such as significant improvement to patient-relevant outcomes, improved affordability, unmet need, strategic importance to the NHS, alignment with NHS priorities, and clear and measurable outcomes.
An important component of the new scheme will be the early identification of what is coming through company pipelines. The new pathway will offer horizon scanning for new technologies to identify a subset of potential breakthrough products that could benefit from the AAP, the government says, adding that this will be a “key capability required for a forward-looking NHS that can articulate its priorities to industry, and prepare to deliver against those priorities.”
It notes that the PharmaScan database currently enables horizon scanning for pharmaceutical products, and that NHS England is currently building on these capabilities to create a parallel system suitable for medical technologies. In addition, the recently established National Institute for Health Research Innovation Observatory is now using data analytics to “explore trends in health innovation across drugs, medical technologies, diagnostic tools and healthcare services.”
Accelerated Access Collaborative
The job of selecting candidates for the new pathway will fall to the new AAC, which will comprise representatives of the NIHR, NICE, the Medicines and Healthcare products Regulatory Agency (MHRA), NHS England, NHS Improvement and the government.
Input to the AAC will be sought from industry and patient groups that have “sufficient breadth of experience and independence to allow them to inform AAC discussions on the different technology types and conditions those technologies might benefit.” Further details will be published on the membership of the AAC, which the government expects to be in place in late 2017.
The government stresses the importance of understanding and evaluating the impact of the new pathway over time. In line with the AAR’s recommendation, it says, “we believe that the AAC should be responsible for measuring and evaluating the impact of our accelerated access programme and assessing the industry response to it. The views of the AAC will be informed by parties across the system, who will be represented in the group.”