PrenaTest® one step closer to statutory reimbursement in Germany
The Federal Joint Committee starts procedure for method validation of non-invasive prenatal tests
Constance, August 19, 2016, Germany – PrenaTest®, Europe´s first non-invasive molecular genetic prenatal diagnostic test (NIPT) for the determination of the most common chromosomal disorders in unborn children, is likely to be reimbursed within the near future by statutory health insurances in Germany.
Today, the Federal Joint Committee of Germany (G-BA) has approved the start of a validation procedure (“Bewertungsverfahren”) for NIPT for determination of fetal trisomies 13, 18 and 21 for risk pregnancies. The validation procedure will evaluate how non-invasive molecular genetic tests such as PrenaTest® could improve pregnancy care, in particular compared to invasive methods such as amniocentesis.
The application for this procedure was handed in jointly by the Federal Joint Committee together with the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung) and the National Association of Statutory Health Insurance Funds (GKV Spitzenverband). It is primarily based on the original application by LifeCodexx in 2013 to seek reimbursement on a trial period through a novel reimbursement scheme (“Erprobungsregelung”) which received an initial positive vote in April 2014.
„We are delighted about the decision today and expect the validation procedure to clearly demonstrate the usefulness of non-invasive prenatal tests as part of pregnancy care” said Dr. Wera Hofmann, Chief Scientific Officer of LifeCodexx. “These methods are foreseen to strongly reduce the risk of procedure related fetal losses associated with invasive testing which are reported to occur with a frequency between 0.5-1%.
„Since introduction of the PrenaTest® in August 2012 the number of amniocentesis has more than halved in our genetic lab “ added PD Dr. Markus Stumm, Human geneticist at the Center for Prenatal Diagnostics and Human Genetics Kudamm-199 in Berlin (Germany). “NIPT has also demonstrated a higher accuracy compared to first trimester screening (FTS) for determination of fetal trisomies 13, 18 and 21.
„The decision by the Federal Joint Committee of Germany highlights again LifeCodexx role as pioneer given its initial application to consider NIPT for statutory reimbursement on a trial period three years ago” commented Dr. Michael Lutz, CEO of LifeCodexx. “Assuming a positive outcome of the validation procedure more than 70 million lives insured in Germany through the statutory health insurance system could benefit from NIPT within the next 36 months.”
To date, PrenaTest® has been paid for by many private and statutory health insurance programs in Germany on an individual case basis. In Switzerland, NIPT is reimbursed through statutory health insurances since summer 2015 under certain conditions. This decision was in kind driven by LifeCodexx initiative and request in 2013. PrenaTest® has been developed and performed in Germany in strict conformity with the highest quality standards as per the European Directive on In-vitro Diagnostic Medical Devices.
About LifeCodexx AG
Headquartered in Konstanz (Germany), LifeCodexx AG has been developing innovative and clinically validated non-invasive diagnostic tests based on the newest molecular analytical methods since 2010. With the PrenaTest®, Europe’s first non-invasive prenatal test (NIPT) for the determination of the most common chromosomal disorders in unborn children, launched in 2012, LifeCodexx AG has been changing prenatal diagnostics considerably. The test is performed within Germany in strict conformity with the highest quality standards as per the European Directive on In-vitro Diagnostic Medical Devices.
Dr. Michael Lutz
Phone +49 (0) 7531 97 69 460