1 Recommendations

1.1 Imlifidase is recommended as a desensitisation treatment option for adults who:

  • are waiting for a kidney transplant from a deceased donor

  • are highly sensitised to human leukocyte antigens (HLA)

  • have a positive crossmatch with the donor and are unlikely to have a transplant under the available kidney allocation system (including prioritisation programmes for highly sensitised people).

    It is recommended only if:

  • a maximum of 1 dose is given

  • it is given in a specialist centre with experience of treating high sensitisation to HLA

  • the company provides imlifidase according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with imlifidase that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Many people with kidney disease may be on dialysis while they wait for a kidney transplant. This can have a substantial negative effect on health and quality of life. People can be highly sensitised usually because they have previously had a transfusion with a blood product, had a transplant or been pregnant, and they may have to wait several years for a suitable kidney. Some people on the waiting list may never have an offer of a donor kidney or may become too unwell to have a transplant. Imlifidase temporarily removes a substantial proportion of a person's antibodies, including those against HLA, so that a transplant can be done. It allows a donor kidney to be used that might otherwise not be a suitable match.

The best available clinical evidence is limited and short term. Studies suggest that imlifidase gives a short period of time to do a transplant for people who are highly sensitised to HLA. Using imlifidase might increase the time from a kidney being donated to the transplant taking place.

Kidneys are a scarce resource, and the UK Kidney Offering Scheme is responsible for ensuring that transplants are allocated in an equitable way. The changes to the UK Kidney Offering Scheme in 2019 have improved access for people who are highly sensitised to HLA. But there is still an unmet need for these people. People with certain protected characteristics (those from Black, Asian or minority ethnic family backgrounds and women who have been pregnant) have an increased chance of becoming highly sensitised and so would be the main groups to benefit from imlifidase.

The cost-effectiveness estimates are within the range that NICE usually considers an acceptable use of NHS resources. There is substantial uncertainty about the estimates, but this uncertainty needs to be balanced against the benefits of more equitable access to transplants. Also, integrating imlifidase into the existing transplant process will be challenging. So, it is recommended, but it is essential that only 1 dose per person is used, in centres with experience of treating high sensitisation to HLA. This will help to minimise the time from a kidney being donated to the transplant taking place.

  • National Institute for Health and Care Excellence (NICE)