Imlifidase (also known as Idefirix and made by Hansa Biopharma) has been recommended for people who are waiting for a kidney transplant and who are highly sensitised to human leukocyte antigens (HLAs) to prevent the body rejecting the donor organ.
The company estimates there are over 100 people eligible for imlifidase in England and Wales.
HLAs are a type of molecule in the body which play an important role in the immune systems response to foreign substances.
People who are highly sensitive to HLAs have a greater risk of their kidney transplant being rejected due to the immune system’s response to the surgery.
This can happen in people who have had previous blood transfusions, and blood type and pregnancy are some of the risk factors that can increase the chances of developing an HLA sensitisation. This means some people from Black, Asian or minority ethnic family backgrounds, and people who have been pregnant, would be more likely to be highly sensitised.
Imlifidase is an enzyme given before a kidney transplant in order to prevent the immune system from rejecting the donated kidney. It works by breaking down a type of antibody called immunoglobulin G (IgG) which helps protect the body against foreign or harmful substances.
Clinical trial evidence based on 3-year follow-up data showed imlifidase was effective for highly sensitised people needing kidney transplants.
Helen Knight, interim director of medicines evaluation in the NICE Centre for Health Technology Evaluation, said: “People who are highly sensitised to HLAs can often be waiting a long time for a kidney transplant They are often on dialysis, and this can have a significant impact on their quality of life.
“Imlifidase gives people a greater chance of having a successful kidney transplant and a better quality of life in future. We know that some people from ethnic minority backgrounds and people who have been pregnant are more likely to be highly sensitised to HLA’s because they are more likely to have a specific blood type or from changes to the immune system which occur during pregnancy. This treatment gives hope for some groups of people that they will not be left behind and can receive similarly positive outcomes should they have a kidney transplant.”
Sajid Javid, Secretary of State for Health and Social Care, said: “This is fantastic news and will give people waiting for a kidney transplant renewed hope of a successful outcome.
“I have no doubt Imlifidase will make a positive and lasting difference to their quality of life, and I welcome NICE’s recommendation that it should be offered as a treatment option to eligible adults.
"This will particularly benefit people from ethnic minority backgrounds and those who have been pregnant, helping to level up health disparities and ensure everyone can live longer and happier lives."
Today’s recommendations say that imlifidase should be offered as a treatment option to adults who have a positive cross match with the donor and are unlikely to have a transplant under the available kidney allocation system.