Cerus Corporation (NASDAQ:CERS) announced today that the Institute for the Hospital Remuneration System (Institut für das Entgeltsystem im Krankenhaus, or InEK) in Germany will include pathogen-inactivated platelets for national reimbursement starting January 1, 2018. Pathogen-inactivated platelets will be reimbursed through ZE (Zusatzentgelte) codes 164 and 165 and cover both platelet collection methods currently in use in Germany, apheresis and whole blood derived buffy coat platelets. The INTERCEPT Blood System is the only pathogen inactivation system currently approved in Germany for treatment of platelets.
The national reimbursement codes for pathogen-inactivated platelets allow German hospitals to recoup the costs of INTERCEPT platelets at a premium price over untreated platelet units. With approximately 575,000 platelets produced each year in Germany, the German market is the largest in Europe. Four German Red Cross blood services manufacture approximately 45% of the platelets used each year. In total, there are approximately 60 blood banks and self-collecting university hospitals in Germany.
“InEK’s decision to provide national reimbursement for pathogen-inactivated platelets is a pivotal public health policy change that could improve patient access to platelets with a reduced risk of transfusion transmitted infection,” commented William ‘Obi’ Greenman, Cerus’ president and chief executive officer.
German blood and blood products are regulated by the Paul Ehrlich Institute (PEI), the Federal Institute for Vaccines and Biomedicines. PEI requires blood centers to submit marketing authorization applications (MAAs) in order to manufacture and distribute blood products, including INTERCEPT platelets. The review period for new MAAs can be up to 12 months following submission.
“Cerus’ German team is prepared to work with blood centers and hospitals to educate clinicians about this new reimbursed treatment option, and support the local marketing authorizations necessary to make INTERCEPT more broadly available within the market,” continued Greenman.
In addition to enabling access to platelets with a reduced risk of disease transmission, reimbursement is also expected to improve access to increased shelf life for platelets. In 2008, the German National Blood Advisory Committee (Arbeitskreis Blut, or AK Blut) advised the German Ministry of Health that the shelf life of conventional platelet components should be shortened to four days to reduce the incidence of life-threatening septic transfusion reactions arising from potential bacterial contamination. Only pathogen-inactivated platelets, such as those treated with the INTERCEPT Blood System may be stored for five days, without additional interventions to reduce the risk of sepsis. The option to extend shelf life from four to five days is estimated to reduce platelet wastage rates by as much as 15-20%.
Reimbursement rates for 2018 are published on the InEK website at:
http://www.g-drg.de/inek_site_en/G-DRG-System_2018/Fallpauschalen-Katalog/Fallpauschalen-Katalog_2018
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Red Blood Cell system is in clinical development. See http://www.cerus.com for information about Cerus.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements regarding the expected impact of national reimbursement on patient access to INTERCEPT platelets and the impact of INTERCEPT platelets on platelet wastage rates. These forward-looking statements are based upon Cerus’ current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization, implementation and use of the INTERCEPT Blood System, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, filed with the SEC on August 4, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
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