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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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1 Recommendations

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1 Recommendations

1.1 Imlifidase is not recommended, within its marketing authorisation, for adults who are waiting for a kidney transplant from a deceased donor, who are highly sensitised with human leukocyte antigens (HLA) and have a positive crossmatch with the donor.

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

The clinical evidence was limited and had a short follow up. There is a lack of long-term evidence to show the benefits of imlifidase. However, studies suggest that imlifidase gives a short timeframe to do a transplant for people who are highly sensitised with HLA. Using imlifidase might substantially increase the time from a kidney being donated to the transplant taking place. This could increase the risk of donor kidneys becoming unusable, which has not been accounted for in the model.

Kidneys are a scarce resource and there is a moral and ethical obligation to ensure that transplants are given 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. These people might now have improved access to a suitable matched kidney without imlifidase.

The cost-effectiveness estimates are likely to be higher than what NICE normally considers an acceptable use of NHS resources. There is also substantial uncertainty because of the challenges in how imlifidase could be integrated into the existing transplant process. Imlifidase is therefore not recommended.