Helen Clinea life science and health regulatory expert at Pinsent Masons, said developing new antimicrobials under current reimbursement and payment models was “not attractive to investors” because “most Drug pricing and reimbursement works on the basis of payers and developers agreeing on a price per pill.”
“Policies designed to prevent antimicrobial resistance dictate that the use of antibiotics must be limited to ensure that the drugs retain long-term social value, which means that sales volume may be low and the pattern of price per pill limits the return on investment for developers,” Celine says.
NICE’s subscription model aims to encourage the development of new antimicrobials by ensuring that a fixed annual fee is paid to the company, regardless of the number of prescriptions dispensed. The public body said that while it generally values a drug largely on the health benefits it provides to patients, the public health benefits of antimicrobials are much broader. He said effective antibiotics were essential to ensure chemotherapy and other medical procedures go smoothly and provided a range of treatment options to reduce the risk of resistance developing as existing antimicrobials become less effective.
For this reason, the NICE draft guidelines on cefiderocol and ceftazidime-avibactam estimate their health benefits for the general population in England. The draft guidelines will inform commercial discussions between NHS England, NHS Improvement and pharmaceutical companies to agree payment levels in subscription-type contracts.
Cline said, “Antimicrobial resistance is one of the greatest threats to human and animal health today, and no country can solve the problem alone. The national “Netflix-like” subscription model championed by NICE and NHS England for the purchase of these first two candidates will decouple pre-agreed payments from volumes. Instead, payments, which have yet to be agreed, will be tied to product delivery when needed. »
“This NICE model is the first of its kind and the hope is that the experience of NHS England will feed into work internationally and provide financial certainty for payers and developers, and better incentivize 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 years to come,” said Cline.