Hansa Biopharma completes the AMNOG reimbursement process for Idefirix® inGermany Hansa andNational 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
This completes, within the foreseen 12 month timeline, the AMNOG (Medicines Market Reorganization Act) process for Idefirix® in
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
Roughly 2,000 kidney transplantations are carried out annually in
"We are very pleased to have reached this agreement with GKV-SV. At
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
This is information that
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For more information:
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
M: +46 (0) 768 198 326
E: katja.margell@hansabiopharma.com
Notes to editors
About imlifidase
Imlifidase is an enzyme derived from the bacterium 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 at the transplanted kidney are known as preformed Human Leukocyte Antigens (HLAs) or donor-specific antibodies (DSAs).8 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.9 Once they are inactivated with imlifidase, there is a window of opportunity for the transplant to take place. By the time the body starts renewing the depleted antibodies, the patient will be receiving immunosuppressive therapy to reduce the risk of organ rejection.
The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials.6, 8,11,12
Imlifidase was granted conditional European Marketing Authorization from the EMA in
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.14 ESRD poses 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 because it offers improved survival and quality of life benefits compared to long-term dialysis. There are approximately 80,000 kidney patients on transplant waiting lists across the
Full product information can be accessed via the initial Summary of Product Characteristics found here.
About
References
- InEK Datenportal,
InEK GmbH (g-drg.de) - DSO-Jahresbericht 2020.pdf
- DSO-Jahresbericht 2019.pdf
- Lonze BE, et al. Ann Surg 2018; 268(3):488-496
- Kuppachi S, et al. Transpl Int 2020; 33(3):251-259
- Lorant T, et al. Am J Transplant 2018;18(11):2752-2762
Hansa . Idefirix® Summary of Product Characteristics- Jordan SC, et al. N Engl J Med 2017; 377(5):442-453
-
Eurostam Report (A
Europe -wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at https://cordis.europa.eu/project/id/305385/reporting. Last accessedApril 2021 - Lorant T, et al. Am J Transplant 2018;18(11):2752-2762
-
Jordan SC, et al. Transplantation
October 21, 2020 - volume online first issue - Winstedt L, et al. PLoS One 2015; 10(7): e0132011
European Medicines Agency . Available at: https://www.ema.europa.eu/en/news/new-treatment-enable-kidney-transplant-highly-sensitised-patients. Last accessedMay 2021 NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure. Last accessedMay 2021 - Newsletter Transplant 2020. pp 58-60
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-and-german-payer-head-association-agree-on-reimbursement-price-for-idefirix---imlifi,c3525416
https://mb.cision.com/Main/1219/3525416/1548738.pdf
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