Today NICE published their Advice on “AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas”. This formal external review and publication is a significant step in getting AMBLor® adopted into clinical care pathways in the UK. It follows on from AMLo’s NICE AdviSeMe prize for AMBLor® in 2018.
The MiB reviewed studies in 1,025 people with early stage non-ulcerated melanoma and showed that “AMBLor can identify low risk of disease progression in non-ulcerated Stage 1 and 2 melanomas. It is not suitable for identifying high risk melanomas.”
In the Resource consequences section [PDF, p14] the advice notes:
“A budget impact assessment by the company suggests that AMBLor could be cost saving when compared with standard care. Cost savings may range from £2 (stage 1A) to £245 (stage 2A) per person, with average savings of £175 per person.”
The cost savings are based on future changes to current NG14 Guidelines on the management of people with melanoma, by relieving those at reduced risk from higher levels of follow-up and interventions.
NICE also noted that the supporting studies most reported in abstracts or posters and of a retrospective design, were also, “well-designed retrospective studies using prospective sampling from existing diagnostic specimens. Pathologists were blinded to patient outcomes when scoring slides with AMBLor, and data of clinical outcomes was only provided from sites once scoring was completed.” AMLo considers the designs of these studies to be of particularly high quality and adhering to REMARK standards but nevertheless an interventional prospective study will be commenced in 2022 to further cement the role of AMBLor as a valuable prognostic in melanoma pathways and demonstrate resource impact.
The comments by independent experts and patient support groups was gratifying to read. In particular the contribution by The British Skin Foundation:
“AMBLor is a new technology that has the potential to benefit patients and healthcare providers. It could assist with determining appropriate treatment paths for people with melanoma. AMBLor offers a notable change in prognostic tests for melanoma. It may lessen the worries of patients and could save the health service time and resources that can be used elsewhere.
“Communication and advice on new technologies like AMBLor are important to raise awareness among healthcare providers and the public. Without this, there may be unequal access to novel technologies in different locations.”
Finally AMBLor is still awaiting its UK CA mark. This is expected in Q3 2022 after which time it will be available to the NHS and private healthcare providers. In the meanwhile a UKAS-accredited Referral Service at Newcastle-upon-Tyne Hospitals Trust, utilising the same biomarkers—AMBRA1 and loricrin—is available.. It is likely that patients would need to pay for this service.