NICE perspective on Avita - risks?, page-2

NICE is a bit like our TGA or the FDA, its part of the UK's health system, it makes recommendations on medical drugs and devices to be used by the public health system (NHS) in the UK, particularly important for reimbursement payment from the NHS.

In 2014 they reviewed ReCell for inclusion in their reimbursement program (like our PBS), you can read their judgement here - https://www.nice.org.uk/guidance/mtg21/evidence/review-decision-february-2018-pdf-4780198765
Essentially they did not recommend ReCell for reimbursement because of the lack of evidence of it being better than SoC in 2014. ReCell did not have any meaningful randomised clinical trials, only case studies to encourage use by surgeons. This is the reason why for more than 15 years, ReCell has had limited use.

After googling, it looks like NICE will be reviewing ReCell again in August this year, it will be interesting what their take on it is this time because of having a PMA FDA approval and the so called independent economic model.