Hansa Biopharma Announces Positive Reimbursement in Spain for Idefirix as Desensitization Treatment for Patients in Kidney Transplantation

Hansa Biopharma, a pioneer in enzyme technology for rare immunological conditions, has announced that the Spanish Minister of Health (Ministerio de Sanidad) has granted access and reimbursement to Idefirix, the company’s first-in-class treatment, for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. The positive reimbursement decision follows the conditional approval granted by EMA in August 2020.

Søren Tulstrup, President and CEO, Hansa Biopharma said, “At Hansa, our mission is to develop innovative treatments and bring them to patients with the highest unmet medical needs, contributing to equitable access to care for those living with rare immunological conditions. The reimbursement approval of Idefirix in Spain is another important step in this direction, as it now allows highly sensitized patients to be desensitized using Idefirix, enabling a potentially lifesaving kidney transplant.”

Of almost 4000 patients registered on the waiting list for a kidney transplant in Spain at the end of 20212, up to one in five (20%)3 are classified as highly sensitized. More than 3000 kidney transplantations are performed each year in Spain, with approximately 90% of the transplanted organs coming from deceased donors.

With the reimbursement decision in Spain, Idefirix® is now available, among others, in the five most populated countries in Western Europe: Germany, France, UK, Italy, and Spain, which account for around two-thirds of all kidney transplants from deceased donor performed in the continent. Across Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.

“This is a great news for highly sensitized patients in Spain who struggle to find a compatible organ,” says Dr Oriol Bestard, Chair of Nephrology and Kidney Transplantation at Vall d’Hebron University Hospital in Barcelona, and treating physician of the first patient who received Idefirix in the context of the Hansa post-authorization efficacy study (PAES) in Europe. “Many highly sensitized patients are still disadvantaged and in urgent need of more personalized and innovative desensitization options that can enable incompatible kidney transplantation. Having treated (the first) Idefirix® -enabled kidney transplant patients as part of Hansa’s PAES study, I now know first-hand this innovative treatment has the potential to alter the lives of those highly sensitized patients with the highest unmet medical need.”