Out-Law News | 03 Nov 2017 | 2:16 pm | 3 min. read
Approximately five "breakthrough" products each year will be supported through the new Accelerated Access Pathway (AAP), the Department of Health (DoH) said.
Outline plans on how the AAP would work were detailed by the DoH in its response to the Accelerated Access Review (AAR) (18-page / 2.82MB PDF) which it commissioned in 2014 in a bid to pinpoint how innovative new treatments and digital technologies could be deployed in the NHS more quickly. The final report from the AAR was published in October last year.
Of the new pathway, the DoH said: "This will be a new route to market that will streamline regulatory and market access decisions; getting those innovations that we believe will be truly transformative to patients more quickly. We will make the process from bench to bedside quicker, cheaper, and easier for innovators and the NHS. The government’s ambition is to bring forward by up to four years patient access to these selected, highly beneficial and affordable, innovations."
The commercial terms on which the various products selected for participation in the AAP will need to be "cost neutral" to the NHS, the government said.
"Across this basket of products, 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," the DoH said. "Medicines, medical technologies, diagnostics, and digital products at any stage will be eligible to benefit from the AAP, including repurposed medicines where a new indication is found for an existing product. 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. 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," it said.
Catherine Drew, expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com, said the new AAP offers great potential to revolutionise health care, but said there are cost challenges to overcome.
"New technologies are helping businesses in the pharmaceuticals market and wider life sciences sector to develop innovative new products and services," Drew said. "There is a potential, through greater collaboration, for the benefits of these new treatments and technologies to be delivered to NHS patients far sooner than is the case currently. The government's commitment to a new AAP is a welcome step towards achieving this."
"There will, however, be commercial challenges to address. Currently, life sciences companies can face a challenge in gaining widespread use of their innovations in England, because they fail to convince NICE that the benefits on offer are sufficiently great to merit setting aside cost constraints the NHS is under. These cost constraints are not going to disappear in the near future, so the challenge for businesses seeking to participate in the AAP will be in reaching an agreement that is commercially viable for the NHS whilst being commensurate to the level of investment they have put in to developing the breakthrough treatments," she said.
In its report, the government said that it plans to improve "commercial capability in NHS England" to enable it to strike "win:win commercial deals" with industry for fast-tracking medicines through the AAP.
To help encourage industry participation in the pathway, the government said it also intends to streamline the process that pharmaceutical companies must go through currently to win approval for new medicines to be introduced in the NHS. In future, the companies will have to "begin only one dialogue for each medicine", it said.
Decisions on which products will be selected for fast-tracking through the AAP will be taken by a cross-sector group known as the Accelerated Access Collaborative (AAC), the government said.
The group will include representatives from the government, NHS England, NHS Improvement, the National Institute for Health and Care Excellence (NICE), The Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health Research (NIHR) as well as representatives for patients, industry and clinicians. The AAC will be chaired by Sir Andrew Witty, former chief executive of GlaxoSmithKline.
"As the new fast track pathway will benefit only a few products every year one would hope that in practice it will not be restricted to certain disease areas and includes emerging advanced therapy innovations such as gene therapies," said expert in life sciences Helen Cline of Pinsent Masons. "The proposals are a central part of the government’s strategy to make the UK the market of choice for developing and launching new innovative products."
The Early Access to Medicines Scheme (EAMS) already exists in the UK to fast-track new drugs on the market. The DoH said that drugs companies that engage with EAMS will not be barred from participating in the AAP.
The DoH said: "We agree that more can and should be done to accelerate access to market; we recognise that the current commercial arrangements and pathways can be unnecessarily complex. We agree that we need a better understanding of unwarranted variation in uptake, and a system that maximises the appropriate use of innovative products. The recommendations will, of course, need to be delivered within the budgetary envelope set by the government for the NHS."