National Health Service patients in the UK could get quicker access to innovative therapies via a new route for approval in the country.

The product of close collaboration between the UK's National Institute for Health and Care Excellence (NICE), drug regulators, the NHS and equivalent organisation in Scotland, the new Innovative Licensing and Access Pathway (ILAP) aims to accelerate the journey between clinical trials and patient access to new medications.

The scheme will co-ordinate work by the Medicines and Healthcare products Regulatory Agency (MHRA), NICE, the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I) to support and advise companies launching their medicines in the UK.

Under the initiative, the MHRA and NICE will work together to advise companies on clinical trial design, with the aim of ensuring optimal data is generated for regulatory approval and health technology appraisal. NICE's Scientific Advice and Office for Market Access services will also contribute to supporting products in the ILAP.

“NICE has a central role in ensuring flexible and swift access to innovative medicines for patients in England and supporting the life sciences sector to launch their products here,” said Gillian Leng, chief executive of NICE. “Partnering with the MHRA and others to build this frictionless pathway to the timely availability of cost-effective medicines is one of the ways NICE is delivering benefits for patients, the NHS and life sciences industry.”

“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible,” said Lord Bethell, minister for Innovation.

Shionogi’s novel antibiotic Fetcroja (cefiderocol) has been selected by NICE and the National NHSE&I to be included in a pilot subscription reimbursement model designed to fuel the development of new weapons in the fight against antimicrobial resistance.

Under the model, pharma companies will be paid upfront for access to their antibiotic product, based on its value to the NHS as opposed to how much is used, in the hope that this will encourage new research and development in the area.

Last year it was announced that two drugs proven to be both safe and effective will be selected to undergo health technology assessment by NICE throughout 2021 using adapted methods for antimicrobials, which will then be used to decide the level of the subscription payment from April next year.

Fetcroja was approved in Europe in April 2020 for treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options, including infections caused by carbapenem-resistant Enterobacterales and non-fermenting species such as P. aeruginosa, A. baumannii and S. maltophilia.

“We are delighted that NICE and NHSE&I have recognised the important role of Shionogi and our novel antibiotic, cefiderocol, in the fight against antimicrobial resistance,” said Mark Hill, global head of market access, Shionogi. “Our bid was assessed according to a rigorous selection process, including novelty, activity against the most difficult to treat pathogens and serious infection, surety of supply and antimicrobial stewardship, and our company and our medicine met all these criteria.”

Antimicrobial resistance (AMR) is a major global health threat, with 700,000 deaths globally and 5,000 deaths in the UK caused each year by an infection with multidrug-resistant bacteria.