NEW YORK (GenomeWeb) – Noninvasive prenatal testing for fetal trisomy risk may become reimbursable by Germany's statutory health insurance within the next few years, following a decision of a committee last week to conduct an evaluation of the method for high-risk pregnancies.
Several NIPT providers in Germany said they are hopeful the evaluation, which could take up to three years, will lead to a positive reimbursement decision and the inclusion of NIPT in the catalog of covered medical services, called EBM. This will likely result in a boost in testing volumes, they said, even if coverage remains restricted to pregnancies with increased risk of fetal trisomies.
Such risk can be defined in several ways, such as the mother's age, family history, previous affected pregnancies, and results of prenatal screening tests. An estimated 20 percent of pregnant women in Germany are 35 years or older at the birth of their first child.
In the meantime, competition between clinical laboratories offering NIPT in Germany is mounting, with several labs cutting their prices over the past year and another provider, Amedes, launching a low-cost test last month.
At the moment, women in Germany wanting to receive an NIPT — often to avoid an invasive procedure that comes with a small risk of miscarriage — usually pay for it out of pocket, though private and statutory health insurance have covered the tests on a case-by-case basis. The tests are offered through doctors' offices and are provided by private laboratories that currently charge between €250 ($280) and €650 ($730).
Last week, the Federal Joint Committee (G-BA), a stakeholder committee representing doctors, hospitals, and health insurance funds that decides which drugs, tests, and medical services are reimbursable by Germany's statutory health insurance, said it had decided to assess the method of noninvasive prenatal molecular diagnostic testing for determining the risk of fetal trisomies 13, 18, and 21 in the context of high-risk pregnancies. More than 70 million individuals in Germany are insured through the statutory healthcare system.
The aim of the evaluation, the G-BA said, is to study whether and how noninvasive prenatal molecular genetic tests could be utilized in the same context as invasive methods, such as chorionic villus sampling and amniocentesis, which are already covered for high-risk pregnancies.
With its decision to assess NIPT under a process called "methods evaluation" (Methodenbewertung), the G-BA is shortcutting the path toward reimbursement. In 2014, in response to an application from NIPT provider LifeCodexx, the committee had originally decided to conduct a clinical study under a process called "Erprobungsregelung" first, followed by an evaluation of the technology.
According to Michael Lutz, CEO of LifeCodexx — the first company to introduce NIPT in Germany in 2012 — the original plan was to analyze 7,000 clinical samples between 2015 and the end of 2016, and only then to start the methods evaluation process that kicked off last week. In the face of evidence from several high-quality studies involving thousands of women, the G-BA apparently decided to forego such a study, shaving at least a year off the decision process.
For its evaluation, the G-BA said, it plans to obtain input from professional societies as well as other organizations, such as the German Ethics Council, an independent government-instituted committee that weighs in on ethical and societal implications of research and development, in particular in the life sciences.
Several testing laboratories in Germany welcomed the G-BA's decision to evaluate NIPT for health insurance coverage, though they said it is unclear yet which women might eventually be eligible for coverage — this depends on whether the G-BA will define at-risk pregnancies based on age or other risk factors, or on the results of a first-trimester screen — and what the reimbursement level will be.
"We are delighted about the decision today and expect the validation procedure to clearly demonstrate the usefulness of noninvasive prenatal tests as part of pregnancy care," LifeCodexx CSO Wera Hofmann said in a statement last week.
Lutz told GenomeWeb that he definitely expects the NIPT market to increase once the test becomes part of the reimbursement catalog. "How much, I don't know," he said. A few years ago, about 50,000 invasive prenatal tests were performed annually in Germany, he added, of which an estimated half have already been replaced by NIPT, so there is "still some room to grow."
In addition, he expects uptake of NIPT in the first-trimester screening market, which he said consists of about 250,000 to 300,000 screens per year. First-trimester screening tests for chromosomal abnormalities, which often combine a biochemical blood test with a nuchal translucency scan, are currently not covered by Germany's health insurance, and introducing NIPT in this market would require a low price, he said.
Cenata, a company based in Tübingen that provides Roche's Harmony test, said in a statement that the G-BA's decision "provides hope that these highly specific and sensitive testing methods will in the future be available to any patient meeting the indications who wishes to receive it, irrespective of income."
According to Dirk Biskup, Cenata's managing director, the benefit testing laboratories will derive from insurance coverage will largely depend on the reimbursement level, which is still unknown.
In the meantime, while NIPT largely remains a self-paid test, prices continue to plummet and competition within Germany is mounting.
Last month, for example, Amedes, a network of 60 clinical laboratories and practices in Germany and Belgium, started offering its Fetalis test to doctors and their patients at a price of €249. Like Cenata's test, Fetalis, which will officially launch in early September, uses Roche's Ariosa Harmony test technology.
Amedes initially offered Natera's Panorama test but decided to implement Roche's technology as an in-house test instead "because we do not want to be dependent on other laboratories' technology," Christoph Keck, a medical director for sales and marketing at Amedes, told GenomeWeb. Fetalis, which tests for fetal trisomies 13, 18, and 21 as well as monosomy X, is performed in the company's prenatal laboratories in Essen and Hannover, according to the firm.
Cenata last month lowered the price for its full-range Harmony test, which assesses trisomies 21, 18, 13,sex chromosomal abnormalties, and fetal sex, to €399 from €450, and it launched a test option that only looks for trisomy 21 for €333. Â
LifeCodexx, meantime, now offers the full version of its PrenaTest, which covers trisomies 21, 18, 13, sex chromosomal abnormalities, and fetal sex for €499 instead of €660 a year ago, and a trisomy-21-only version for €349, down from €440 last year.Â
In a proposal from July requesting the methods evaluation, several G-BA members explained in more detail how NIPT might be integrated into prenatal care in Germany and under what circumstances it might become a covered service.
NIPT is already well known among both gynecologists and patients, they wrote, and having to pay for the test out of pocket "represents a not-insignificant financial burden for women and couples," warranting a closer look at the technology.
The use of noninvasive prenatal diagnostics in high-risk pregnancies to assess the risk of triosomies 13, 18, and 21 could be justified if the results are accurate enough to replace invasive testing for these indications, they wrote, so the overall number of invasive tests could be reduced. However, positive NIPT results should be followed up with an invasive test.
What needs to be studied, they added, is whether NIPT should be offered as a contingent test after first semester screening finds an elevated risk. In any case, they said, it should be restricted to high-risk pregnancies of women who prefer NIPT to an invasive test.
The evaluation should also assess whether NIPT, compared to invasive tests, can deliver reliable results earlier during pregnancy and without a risk of miscarriage. Though no therapies are available for most chromosomal alterations, they wrote, knowing about such defects earlier could help parents prepare better for the birth of a sick child. Also, women weighing the option of terminating their pregnancy may be able to do so at an earlier stage.
Reimbursement of NIPT under certain conditions will definitely result in additional costs, they wrote, but these will be counteracted by a decline in costs for invasive tests and their complications. Total healthcare costs resulting from the implementation of noninvasive prenatal testing as a reimbursable service, they concluded, will mostly depend on which group of high-risk pregnancies the test will be offered to, an aspect the evaluation should study.
Healthcare systems in other countries, including the Netherlands, France, Belgium, the UK, Austria, Switzerland, and certain states or provinces of the US and Canada, the authors noted, have discussed implementing NIPT in different ways, but none of these countries have advocated NIPT as a primary screen for all pregnant women. Usually, they wrote, NIPT is used after first- or second-trimester screening for trisomy risk, and in case of a positive result, invasive diagnostic testing is recommended.
In their evaluation of NIPT, the authors wrote, G-BA members should consider existing fears about an expansion of indications for prenatal diagnostics and the "potential danger of selective prevention of pregnancies, in particular with fetal trisomy 21." It is important, they wrote, to provide expecting parents with support for an informed decision based on available genetic knowledge.