Hansa Biopharma and German Association of Primary Payers Agree on Reimbursement Pricing of Idefirix® (imlifidase) as Desensitization Therapy for Highly Sensitized Kidney Transplant Patients

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

LUND, Sweden, March 15, 2022 /PRNewswire/ — Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), the pioneer of enzyme technology for rare immunological diseases, today announces that it has reached an agreement to reimburse Idefirix in Germany with the National Association of Statutory Health Insurance Funds, GKV-Spitzenverband (GKV-SV) March 15. The reimbursement agreement covers the entire statutory health insurance system and is also adopted by private health insurers in Germany.

This completes, within the planned 12-month time frame, the AMNOG (Medicines Market Reorganization Act) process for Idefirix® in Germany.

In addition, German hospitals can receive additional funding for the final reimbursement price on the basis of a positive decision (status NUB 1) as communicated in January by the InEK Institute for the Hospital Remuneration System.1 For Idefirix®,12 hospitals applied for NUB status in October 2021 which entitles them to extrabudgetary funds for the agreed reimbursement price.

Approximately 2,000 kidney transplants are performed each year in Germanymore than 75% of which were transplanted from deceased donors.2.3 There are more than 11,000 patients on the waiting list for kidney transplants in Germany.2.3

“We are very pleased to have entered into this agreement with GKV-SV. At Hansa, our commitment is to significantly improve the lives of highly sensitized patients in Germany waiting for a potentially life-saving kidney transplant,” says Søren Tulstrup, President and CEO, Hansa Biopharma. “Highly sensitized kidney patients 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 healthcare systems and is associated with reduced 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 Germanypricing and market access procedures have now been completed in Sweden and the Netherlands as well as on an individual hospital basis in Finland and Greecewhile early access, including full funding, was achieved in France end of February. Market access procedures are underway in 10 countries, including the largest markets in the Europe.

This is information that Hansa Biopharma AB is required to make public under the EU Market Abuse Regulation. The information has been submitted for publication, through the contact person listed below, to 3:25 p.m. CET to March 15, 2022.

For more information:

Klaus Sindahl, Head of Investor Relations
M: +46 (0) 709 298 269
E: [email protected]

Katja Margell, Corporate Communications Manager
M: +46 (0) 768 198 326
E: [email protected]

Notes to Editors

About imlifidase

Imlifidase is an enzyme derived from bacteria Streptococcus pyogenes and has the ability to specifically target and cleave (or break) all classes of immunoglobulin G (IgG) antibodies.7

IgG antibodies targeted specifically to the transplanted kidney are known as preformed human leukocyte antigens (HLA) or donor-specific antibodies (DSA).8 Highly sensitized patients have high levels of these preformed antibodies which can bind to the donor organ and damage the graft.9 Once they are inactivated with imlifidase, there is a window of opportunity for the transplant to take place. As the body begins to renew depleted antibodies, the patient will receive immunosuppressive therapy to reduce the risk of organ rejection.

The efficacy and safety of imlifidase as a pre-transplant therapy to reduce donor-specific IgG has been studied in four open-label, single-arm, six-month Phase 2 clinical trials.6, 8,11,12

Hansa is currently collecting further clinical evidence and will submit additional efficacy and safety data based on an observational follow-up study and a post-approval efficacy study. Imlifidase has been reviewed under the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) programme, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. processing.13

Imlifidase obtained conditional European Marketing Authorization from the EMA in August 2020 for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive cross-test against an available deceased donor. Use of imlifidase should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.13 Conditional approval allows the Agency to recommend a medicine for marketing authorization in cases where the benefit of a medicine being immediately available to patients outweighs the risk that all the data will not be available. not yet available.

About kidney failure

Kidney failure can progress to kidney failure or end-stage renal disease (ESRD), identified when a patient’s kidney function is less than 15%.14 ESRD represents a significant health burden, affecting nearly 2.5 million patients worldwide.11 A kidney transplant is the treatment of choice for suitable patients with ESRD, as it provides improved survival and quality of life compared to long-term dialysis. There are around 80,000 kidney patients on transplant waiting lists across the European Union.15

Full product information can be accessed via the initial Summary of Product Characteristics found here.

About Hansa Biopharma

Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company with a mission to develop and commercialize innovative, life-saving and life-changing treatments for patients with rare immunological diseases. Hansa has developed a first-in-class anti-immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program based on the company’s proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, auto -immunes, gene therapy and cancer. Hansa Biopharma is based in Lund, Swedenand operates in Europe and in the United States. The Company is listed on Nasdaq Stockholm under the symbol HNSA. Learn more at https://hansabiopharma.com.

The references

1. InEK Datenportal, InEK GmbH (g-drg.de)

2. DSO-Jahresbericht 2020.pdf

3. DSO-Jahresbericht 2019.pdf

4. Lonze BE, et al. Anne Surg 2018; 268(3):488-496

5. Kuppachi S, et al. Transpl Int 2020; 33(3):251-259

6. Lorant T, et al. Am J Registry 2018;18(11):2752-2762

7. Hansa. Idefirix® Summary of Product Characteristics

8. Jordan SC, et al. N English J med 2017; 377(5):442-453

9. Eurostam report (A Europe-Europe-wide strategy to improve transplantation of highly sensitized patients based on acceptable HLA incompatibilities.) Available at https://cordis.europa.eu/project/id/305385/reporting . Last accessed April 2021

10. Lorant T, et al. Am J Registry 2018;18(11):2752-2762

11. Jordan SC, et al. Transplantation October 21, 2020 – online volume first issue

12. Winstedt L, et al. PLoS One 2015 ; 10(7): e0132011

13. European Medicines Agency. Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last accessed May 2021

14. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure. Last access May 2021

15. Transplantation Newsletter 2020. pp 58-60

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Andrew B. Reiter