Hansa Biopharma, “Hansa”, pioneer in enzyme technology for rare immunological conditions, announces the recommendation by the National Institute for Health and Care Excellence (NICE) for its first-in-class treatment Idefirix in the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. NICE considers Idefirix to be a clinically and cost-effective treatment.
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The recommendation marks an important milestone for patients in England, Wales and Northern Ireland, as appropriate specialized transplant centres will be able to use Idefirix® to enable transplantation for highly sensitized patients, currently highly unlikely to receive a lifesaving compatible kidney transplant. The Medicines and Healthcare products Regulatory Agency’s (MHRA) granted conditional approval of imlifidase from the European Commission conditional approval in August 2020.2 The NICE recommendation builds upon this approval by considering the cost-effectiveness of Idefirix® in addition to its clinical efficacy and the significant unmet need of the patient population it treats.1
Kidney transplant candidates are classified as highly sensitized if they have pre-formed antibodies against available donors known as human leukocyte antigens (HLA). These antibodies can carry the risk of causing damage to the transplanted kidney and potentially lead to rejection.3 Risk factors for becoming highly sensitized include previous transplantation, blood transfusion and pregnancy.4 Finding a match for these patients can be particularly difficult, meaning they spend a longer average time on transplant waiting lists, and therefore have an increased risk of dying while waiting for a suitable donor.5,6 The annual average number of kidney transplants in the U.K. over the last five years are 2,400 from deceased donors and 926 from living donors.7
“A lack of effective desensitization approaches has meant that until now, people who are classed as highly sensitized kidney patients in England have struggled to find a donor match, and have often had no alternative but to remain on long-term dialysis with a very poor quality of life,” says Dr Adnan Sharif, trustee at Kidney Research UK. “We welcome this decision, which will allow new opportunities for certain highly sensitized patients to qualify for a life-altering transplant, and gain freedom from dialysis. Decision making around who has access to the treatment is key, and the lifespan of the transplanted kidneys will need to be carefully monitored.”