Out-Law News | 20 Apr 2022 | 4:00 pm | 2 min. read
Two new drugs will soon be the first antibiotics to be made available for NHS England as part of a “Netflix-style” subscription payment model developed by the National Institute for Health and Care Excellence (NICE).
It comes after NICE published draft guidance estimating the value of cefiderocol and ceftazidime-avibactam to the NHS last week. Both drugs will only be used to treat patients with severe drug-resistant infections who would otherwise have limited or no other treatment options.
The new subscription-style payment model, backed by NHS England, NHS Improvement and the Department of Health and Social Care (DHSC), has been designed to try and address the lack of new antimicrobials being developed and the growing threat posed by antimicrobial resistance (AMR). In 2020, only 41 new antimicrobials were being tested in clinical trials compared with about 1,800 immuno-oncology drugs.
AMR develops when the pathogens that cause infection evolve to make antibiotics and other antimicrobial drugs less effective or stop them from working altogether. The World Health Organisation highlighted AMR as one of the 13 urgent health challenges of the current decade, and in January 2019, the UK government published plans to contain and control AMR by 2040.
This NICE model is the first of its kind and the hope is that NHS England’s experience will feed into work at an international level and better incentivise companies to develop new antimicrobials
Helen Cline, life sciences and health regulation expert at Pinsent Masons, said that developing new antimicrobials under current reimbursement and payment models was “not attractive to investors” because “most pricing and reimbursement arrangements for medicines work on the basis of payers and developers agreeing a price per pill.”
“Policies designed to prevent antimicrobial resistance dictate that use of antibiotics has to be limited to ensure the drugs retain long term social value, meaning the volume of sales can be low and the price-per-pill model limits return on investment for developers,” Cline said.
NICE’s subscription model is intended to incentivise the development of new antimicrobials by ensuring a fixed annual fee is paid to the company regardless of how many prescriptions are issued. The public body said that, while it usually values a drug based largely on the health benefits it provides for patients, the public health benefits of antimicrobials were far more extensive. It said that effective antibiotics were essential for ensuring that chemotherapy and other medical procedures go ahead and provided a range of treatment options to reduce the risk of resistance developing as existing antimicrobials become less effective.
Because of this, the NICE draft guidance on cefiderocol and ceftazidime–avibactam estimates their benefits to the health of the overall population in England. The draft guidance will inform commercial discussions between NHS England, NHS Improvement and pharmaceutical companies to agree payment levels in subscription-style contracts.
Cline said: “Antimicrobial resistance is one of the biggest threats to human and animal health today, and no one country can solve the problem alone. The ‘Netflix-style’ national subscription model being championed by the NICE and NHS England for the purchase of these first two candidates will delink the pre-agreed payments from volumes. Instead, payments, which have yet to be agreed, will be linked to delivery of product when needed.”
“This NICE model is the first of its kind and the hope is that NHS England’s experience will feed into work at an international level and provide financial certainty to both payers and developers, and better incentivise companies to develop new antimicrobials. Experience with this type of subscription model could also have value in other therapeutic areas such as cell and gene therapies, which is an exciting prospect for the years ahead,” Cline said.
25 Jan 2019