NEW YORK (360Dx) – German authorities plan to decide in August 2019 about reimbursement by the country’s statutory health insurance system for noninvasive prenatal diagnostic testing for fetal trisomy risk, according to an update announced on Thursday.
Last August, the Federal Joint Committee (G-BA), a stakeholder committee representing doctors, hospitals, and health insurance funds in Germany, decided to evaluate NIPT for assessing the risk of fetal trisomies 13, 18, and 21 in high-risk pregnancies, comparing it to invasive methods, such as amniocentesis and chorionic villus sampling, that are already covered by public insurance. However, it did not provide a timeline or details of the process.
This week, the G-BA outlined the steps of the evaluation and said that it plans to make a decision in August of 2019. Specifically, the committee commissioned the Institute for Quality and Efficiency in Healthcare (IQWiG), an independent contractor for the Federal Ministry of Health and the G-BA, to evaluate the evidence available for NIPT and to put together information for patients who may receive such testing in the future.
In addition, the G-BA asked stakeholders and industry professionals to provide input on NIPT via a questionnaire, which they can submit within the next month. The committee also said that it will ask the German Ethics Council and the Genetic Diagnostics Committee — expert committees that advise the government — for their assessments.
The G-BA pointed out in its announcement that the information for patients should emphasize that pregnant women have the right to decline prenatal diagnostics. It also clarified that although IQWiG was asked to gather the patient information at this time, this does not imply that the G-BA’s decision on NIPT will go a certain way, but merely ensures that the information will be available at the time the decision is made.
A spokesperson for LifeCodexx, the first NIPT provider in Germany, said via email that the company highly appreciates the process moving forward and that it plans to fill out the questionnaire.
According to the timeline, IQWiG will submit preliminary results for the evidence report in October, and the final report in April 2018. It will deliver the information for patients in the second quarter of 2019. Based on the report and the input from stakeholders, the G-BA plans to make its later that summer.