NEW YORK – Germany's publicly funded health insurance plans to pay for noninvasive prenatal testing for fetal trisomies under limited circumstances, likely starting at the end of next year.
According to a final decision made today by the Federal Joint Committee (G-BA), the authority that makes coverage decisions for Germany's government-funded health insurance, NIPT for trisomies 21, 18, or 13 will be covered in "justified individual cases" and after counseling by a doctor that uses information for patients provided by the insurance.
Specifically, NIPT will be covered if a fetal trisomy is suspected in the course of regular prenatal care and this constitutes an "unacceptable burden" for the pregnant woman.
The goal is to avoid invasive testing like amniocentesis or chorionic villus sampling (CVS), which results in miscarriage in 0.5 to 1 percent of cases, according to a statement from G-BA. Invasive testing will only be used to confirm a positive NIPT finding.
By limiting insurance coverage of NIPT to very limited circumstances, the decision ensures that "NIPT is not used for ethically untenable 'screening' but can only be applied under certain conditions," said Josef Hecken, G-BA's chairman, in a statement.
In an open letter to members of Germany's federal parliament, Hecken justified the G-BA's coverage decision despite potential future parliamentary debates about ethical questions surrounding the use of NIPT, arguing that future legislation can always amend the current decision. "It seems unjustifiable to deny affected pregnant women this lower-risk test methodology," he wrote, adding that "the tests are approved and available in Germany."
Coverage of NIPT is pending approval by the German Federal Ministry of Health, as well as the development of information for insurance holders, which is expected to be completed at the end of 2020.
In addition, only tests for which high quality has been demonstrated in published studies will be covered. This requires a sensitivity of at least 97 percent and specificity of at least 99 percent for trisomy 21, and a specificity of at least 99 percent for trisomy 13 and trisomy 18.
The G-BA's decision follows a three-year process that included an evaluation of NIPT as a testing method. Earlier this year, the committee had published a draft decision that had proposed to cover NIPT for high-risk pregnancies.
For the final decision, G-BA said it considered comments from 30 stakeholders.
NIPT has been widely available in Germany since 2012, usually on a self-pay basis, which is not going to be affected by the new insurance coverage decision.
Several laboratories in Germany provide NIPT, including Eurofins LifeCodexx, which offers a qPCR-based test, and Cenata, which offers Roche's microarray-based Ariosa Harmony test.
Dirk Biskup, managing director of Cenata, said his company appreciates the reimbursement decision, in particular the test quality requirements. "This will exclude tests that are offered today that are lacking any clinical studies or scientific publications," he said.
"In hindsight, the decision of the G-BA is a very smart compromise taking into account the discussion Germany had on the ethical aspects of NIPT," Biskup said, adding that the final version was somewhat unexpected by industry insiders. "To the best of my knowledge, the experts were assuming that NIPT would be covered either for all pregnant woman or only for pregnant woman with a certain well-defined risk," he said.