The UK government’s efforts to accelerate the approval of important new medicinal therapies will be headed by Sir Andrew Witty, the former chief executive of GlaxoSmithKline.
Witty has been chosen to chair the Accelerated Access Collaborative (AAC), an organisation that will have the responsibility to coordinate the various government bodies that will decided which new treatments should be selected for the Government’s new Accelerated Access Pathway (AAP), due to come into effect next April.
Products that enter the AAP will get a ‘breakthrough’ designation, giving a package of support that will allow firms to accelerate clinical development and get a fast-track route through the NHS’ approval process, which the Department of Health says could mean they reach the market up to four years earlier.
Despite the innovation happening here, our uptake in the NHS can be too slow, said Health Minister Lord O’Shaughnessy. “[These] new measures will not only benefit patients by improving how quickly and easily we can get innovative products from the lab to the bedside, but will guarantee future collaboration between the life sciences sector and the NHS post-Brexit – benefiting the British economy and creating jobs”.
Meanwhile, the UK’s National Institute for Health and Care Excellence (NICE) has been chosen to run the AAC office which it says will make decisions on “which medicines and technologies should be granted access to the pathway, drawing on advice from patients, clinicians and industry, and providing a single point of access for innovators”.
The AAC is expected to be in place in late 2017 and first products will be identified from April 2018. The government is anticipating that around five products a year will go through the AAP process, and expects these to be cost-neutral to the NHS, which means that any products placed on the AAP that are cost additive will need to be offset by products that deliver cost savings.
Witty will serve as the independent chair of the group, working with representatives from other stakeholders to communicate the most-pressing NHS needs to technology developers and identify potentially breakthrough products, with the AAC serving as a go-between for patient groups, healthcare professionals, regulators and the industry.
“Patients, scientists and the UK economy will all benefit from the positive steps outlined by the government,” he said, adding: “The opportunity to ensure the NHS gets rapid access to cost effective breakthrough technologies is vitally important, and I’m delighted to help lead the effort to deliver this.”
Last October, the independent Accelerated Access Review (AAR) led by Sir High Taylor set out a series of recommendations for streamlining the access process for new drugs, medical devices, diagnostics and digital tools. The government has now published its response to the review, endorsing its findings and setting out its plans to meet the recommendations.
In July, it kicked off the AAR implementation with a scheme to make £86m available to smaller firms developing and testing new technologies in the NHS.
“It is critical that we take the opportunity to create a catalyst for change in the access landscape,” says the government response document. “We agree that more can and should be done to accelerate access to market [and] we recognise that the current commercial arrangements and pathways can be unnecessarily complex.”
“Each breakthrough product will benefit from bespoke case management, which will coordinate across partners to streamline the journey,” it pledges, whilst asserting that “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”.