NEW YORK (GenomeWeb) – Switzerland's mandatory health insurance (OKP) will reimburse noninvasive prenatal trisomy screening for certain high-risk pregnancies starting July 15, the Swiss Federal Department of Home Affairs (EDI) said today.
OKP will pay for NIPT if standard first trimester screening — a combination of biochemical blood tests and nuchal translucency analysis — indicates a risk higher than 1:1000 for fetal trisomies 21, 18, or 13.
A positive or inconclusive NIPT should be followed up by invasive diagnostic testing — amniocentesis or chorionic villus sampling — because of the possibility of false-positive NIPT results, EDI said in a fact sheet describing the testing process.
All prenatal testing, including first trimester screening and NIPT, will require pretest counseling by qualified doctors and informed consent from patients.
According to projections by EDI, following coverage of NIPT, the number of invasive diagnostic prenatal tests in Switzerland is expected to drop from more than 3,000 to several hundred per year, resulting in fewer miscarriages, which it said occur in about 1 percent of invasive procedures.
EDI said the country's mandatory health insurance had already covered amniocentesis and chorionic villus sampling. As of July 15, it will also cover the cost of conventional first trimester screening and, in case of increased risk, NIPT.
According to an updated list of tests covered by Swiss mandatory health insurance that was published today — the so-called "list of analyses" — insurance will reimburse NIPT at a rate of CHF950 ($1,000). Only tests included in the list are eligible for reimbursement.
For NIPT, the list specifies a "noninvasive prenatal test of free fetal DNA from maternal blood via high-throughput sequencing, only for trisomies 21, 18, and 13 together," suggesting that NIPT employing other technologies — for example Roche's latest Ariosa Harmony test, which runs on a microarray platform — may not be covered.
The list also stipulates that fetal fraction needs to be included in the lab report, a requirement that a number of NIPT providers currently do not fulfill. In addition, if work associated with the analysis is split between several parties, all steps of the analysis must be performed in Switzerland.
According to LifeCodexx, a company based in Constance, Germany that offers the noninvasive prenatal PrenaTest, this is the first time NIPT is generally covered by a national health insurance system.
"We are very pleased that the PrenaTest is now available to many affected women in Switzerland," said LifeCodexx CEO Michael Lutz in a statement. "This was a very important goal," he said, adding that his company applied for coverage of its test by Switzerland's OKP at the end of 2013.
Earlier this year, LifeCodexx struck an agreement with private Swiss health insurance firm Helsana for coverage of the PrenaTest. Overall, LifeCodexx has run 5,000 PrenaTests for Swiss patients to date.
A LifeCodexx spokesperson told GenomeWeb that the PrenaTest, if required by OKP rules, will be performed by the Center of Laboratory Medicine Dr. Risch, which is based in Switzerland.