NEW YORK (GenomeWeb) – Germany's publicly funded health insurance system plans to cover noninvasive prenatal testing (NIPT) for trisomies 21, 13, and 18 for particular high-risk pregnancies only, according to a draft decision published today.
The document, authored by the Federal Joint Committee (G-BA), which makes coverage decisions for Germany's government-funded health insurance, contains proposed changes to guidelines that govern which pre- and perinatal services are covered by public health insurance. Invasive genetic testing, including chorionic villus sampling and amniocentesis, is already covered for certain indications under these guidelines.
"This is explicitly about the application of [NIPT] in pregnancies with particular risks," with the goal to replace, as far as possible, tests associated with significant risks to the unborn child, said G-BA Chairman Josef Hecken in a statement. "This is not meant to be about screening in all pregnant women."
According to the draft document, NIPT should only be used in women with a particular risk or to investigate abnormalities in individual cases. A statistical increase in risk, such as due to maternal age, is not considered sufficient to warrant NIPT.
The goal is to offer NIPT in order to reduce invasive testing, although NIPT reports will recommend to follow up on positive results with an invasive test.
Also, only NIPTs with demonstrated high quality will be covered. Tests need to have been evaluated in prospective diagnostic cohort studies, published in peer-reviewed journals, and have shown a sensitivity of 99.13 percent and a specificity of 99.95 percent for trisomy 21, a specificity of 99.97 percent for trisomy 13, and a specificity of 99.94 percent for trisomy 18.
In addition, physicians counseling patients on NIPT must be qualified under Germany's Genetic Diagnostics Act and according to guidelines from the Genetic Diagnostics Commission (GEKO). Resources to be used for counseling patients are currently under development.
Finally, patient representatives on the G-BA have suggested to make NIPT only available from 12 weeks of gestation. In addition, they have recommended that patient counseling should include resources that offer information about living with trisomy, for example, from families with affected children.
A number of stakeholders, including the German Medical Association, two German associations of midwives, scientific societies, test manufacturers, the German Ethics Council, and GEKO now have six weeks to comment on the proposal in writing, which will be followed by an oral hearing to discuss open questions.
G-BA plans to make a final decision in August of this year, which it anticipates will go into effect in the fall of 2020 after information for counseling patients has been gathered, and pending approval by the Federal Ministry of Health.