NICE recommends use of Hansa Biopharma’s Idefirix (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

Hansa Biopharma, “Hansa” 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.

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. 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.

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. Risk factors for becoming highly sensitized include previous transplantation, blood transfusion and pregnancy. 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. 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.

“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.”

Long-term dialysis places a significant burden on both patients and healthcare systems, reducing health-related quality of life and increasing the risk of mortality and hospitalization.

“We are thrilled that NICE has recommended Idefirix as the first licensed therapy for highly sensitized kidney patients. These patients have serious disease burden and unmet needs and this recommendation is a significant milestone for them”, says Søren Tulstrup, President and CEO, Hansa Biopharma. “For Hansa, this recommendation is also encouraging as we continue to pursue our vision: A world where patients with rare immunologic diseases can lead long and healthy lives”.

Hansa will work with national health service commissioners in England, Wales and Northern Ireland to support the implementation of the service in line with the NICE’s recommendations.