Hansa Biopharma and German payer head association agree on reimbursement price for Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

Hansa Biopharma and German payer head association agree on reimbursement price for Idefirix^® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

• Hansa Biopharma completes the AMNOG reimbursement process for Idefirix^® in Germany
• Hansa and National Association of Statutory Health Insurance Funds (GKV-SV) agree on reimbursement price
• German hospitals can receive extra funding for the final reimbursement price based on a positive NUB status 1 decision

Lund, Sweden, March 15, 2022. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), the pioneer in enzyme technology for rare immunological conditions, today announces having reached an agreement on the reimbursement for Idefirix in Germany with the National Association of Statutory Health Insurance Funds, GKV-Spitzenverband (GKV-SV) effective March 15. The agreement for reimbursement covers the entire statutory health insurance system and is also adopted by private health insurances in Germany.

This completes, within the foreseen 12 month timeline, the AMNOG (Medicines Market Reorganization Act) process for Idefirix^® in Germany.  

Additionally, German hospitals can receive extra funding for the final reimbursement price based on a positive decision (NUB status 1) as communicated in January by the InEK- institute for the hospital remuneration system.¹ For Idefirix^®,12 hospitals applied for the NUB status in October 2021 which entitles them to extra budgetary funds for the agreed reimbursement price.

Roughly 2,000 kidney transplantations are carried out annually in Germany, with more than 75% transplanted from deceased donors.^2,3 There are more than 11,000 patients on waitlist for a kidney transplantation in Germany.^2,3

“We are very pleased to have reached this agreement with GKV-SV. At Hansa, our commitment is to significantly improve the lives of highly sensitized patients in Germany who are waiting for a potentially life-saving kidney transplant,” says Søren Tulstrup, President and CEO, Hansa Biopharma. “Highly sensitized kidney patients 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.”

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, hospitalizations and additional costs.^4-6

Commercial launch and market access procedures for Idefirix^® in Europe continue to progress according to plan. Beyond the new agreement in Germany, pricing and market access procedures have now been completed in Sweden and the Netherlands as well as on an individual hospital basis in Finland and Greece, while early access including full funding was secured in France end of February. Market access procedures are ongoing in 10 countries, including the largest markets in Europe.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out below, at 15:25 CET on March 15, 2022.