Hansa Biopharma AB, “Hansa” today announced that its first-in-class treatment Idefirix® (imlifidase) has been granted early access post marketing authorization (Autorisation d’accès précoce) in France by French HAS (Haute Autorité de Santé) for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified in the Marketing Authorization received from the European Medicines Agency (EMA).1,2
The aim of early access programs in France is to accelerate access to innovative medicines before (AP1) or after (AP2) marketing authorization (and before completion of the full P&R process), as in the case of Idefirix® when all the following conditions stipulated in article L.5121-12 of the French Public Health Code (CSP) are met:
• There is no appropriate treatment available on the market;
• The initiation of the treatment cannot be deferred;
• The efficacy and safety of the medicinal product are strongly presumed based on the results of clinical trials; and
• The medicinal product is presumed to be innovative, notably compared with a clinically relevant comparator.
The approval of this early access program for Idefirix® is valid for a year from the date of decision, funded through the National Security System, and is effective across kidney transplant centers in France. The authorization has been granted based on Hansa’s dossier submitted in December 2021, which rendered a positive opinion of the Transparency Commission. Full details of the early access program can be found at the HAS website.
Approximately 3,600 kidney transplantations are carried out annually in France, with more than 80% transplanted from deceased donors.3 According to the Agence de Biomédecine, in 2020 hyperimmune patients represented 11.1% of kidney transplant recipients, while the proportion of hyperimmune patients on the active renal transplant waiting list was 23.7%.
“Kidney patients with high levels of HLA antibodies have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis,” says Søren Tulstrup, President and CEO, Hansa Biopharma. “Delivering Idefirix® as a new therapy option for highly sensitized kidney patients in France demonstrates our commitment to improving the lives of patients with rare immunological conditions.”
Long-term dialysis can place a significant burden on patients and on healthcare systems and is associated with a reduction in health-related quality of life and increased risk of mortality and hospitalization.4-6
Commercial launch and market access efforts for Idefirix® in Europe continue to progress. Pricing and reimbursement processes have been completed in Sweden and the Netherlands, as well as on an individual hospital basis in Finland and Greece. Market access procedures are ongoing in 14 countries including Germany, France, Italy and the United Kingdom (U.K.). A Health Technology Assessment (HTA) dossier for Spain was submitted in January 2022, which completed HTA filings in all of the five largest markets in Europe.