Hansa Biopharma recently announced a recommendation by the Scottish Medicines Consortium (SMC) for its “first-in-class” treatment Idefirix (imlifidase) in the desensitisation of highly sensitised adult patients prior to receiving a kidney transplant from a deceased donor.
The SMC considers Idefirix to be a clinically effective and cost-effective treatment, and recognises the significant unmet need of the licensed patient population it treats, as per a Hansa press release.
The recommendation marks an “important milestone” for patients in Scotland, the release adds, as specialised transplant centres will be able to use Idefirix to enable transplantation for highly sensitised patients who are currently highly unlikely to receive a lifesaving compatible kidney transplant.
Kidney transplant candidates are classified as highly sensitised if they have a broad and intense range of pre-formed antibodies against almost all donor organs. These anti-bodies are known as human leukocyte antigens (HLAs). Finding a match for these patients can be particularly difficult, leading to a longer average time on transplant waiting lists and an increased risk of the patient dying while waiting for a suitable donor, the Hansa release continues, and the approval of Idefirix offers a new option to these highly sensitised patients in need of transplant to increase the chances of successful matching with a deceased donor organ.
“A lack of effective desensitisation approaches has meant that, until now, people who are classed as highly sensitised kidney patients 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,” said Adnan Sharif (Queen Elizabeth Hospital, Birmingham, UK), who is also a trustee of Kidney Research UK. “It is fantastic to see that the SMC has followed the direction of England and Wales to offer certain highly sensitised patients the opportunity of a life-altering transplant. The decision-making around who has access to the treatment is key, and the lifespan of the transplanted kidneys will need to be carefully monitored. But, success could see many patients gain freedom from gruelling dialysis treatments.”
Hansa will work closely with Scottish health boards to support the implementation of the service in line with the SMC’s recommendations.
Last month, alongside its partner Medison Pharma, Hansa also announced that the Polish Ministry of Health had agreed to include Idefirix on its reimbursement list for desensitisation of highly sensitised patients prior to kidney transplantation. Based on the decision to grant reimbursement, Idefirix became fully financed and available to patients who qualify for a newly established drug programme run by multiple transplant centres in Poland as of 1 September 2022.