Illumina, Harvard Pilgrim Partner on NGS-Based Average-Risk NIPT

Illumina will partner with Harvard Pilgrim Health Care to offer non-invasive prenatal testing (NIPT) to women with average-risk pregnancies based on next-generation sequencing (NGS), under a value-based contract whose value was not disclosed.

The partners said their agreement was designed to provide open market access to, and reimbursement of, NGS-based NIPT, noting that many payers limit NIPT coverage to pregnant women 35 years of age or older, who are deemed to be at higher risk.

Harvard Pilgrim has agreed to add pregnant women under the age of 35 to those eligible for the test.  While the cost of NIPT is expected to be offset by reduced expenditures on other screening modalities, Illumina has committed to cover any potential increased costs in order to ensure affordability, Harvard Pilgrim said today in a separate statement.

Illumina’s contract with Harvard Pilgrim is intended to generate data that will demonstrate to payers and employers the clinical and economic value of NIPT for detecting aneuploidy births.

The partnership also includes a two-year study within Harvard Pilgrim’s population designed to assess the total costs and clinical outcomes of NIPT versus traditional screening practices. Harvard Pilgrim is a not-for-profit health services company that provides insurance coverage to more than 3 million customers in New England and beyond.

“We are thrilled to partner with Harvard Pilgrim on the first ever value-based contract of its kind involving NGS-based assays,” Ammar Qadan, Illumina VP, global market access, said yesterday in the company’s statement. “We expect this study to demonstrate the value of NIPT for average-risk pregnancies and to help accelerate the adoption and reimbursement of NIPT.”

Tina Amirkiai, an Illumina spokeswoman, told Clinical OMICs the agreement isn’t limited to just Illumina NIPT tests. NIPT. Payers typically resist directing the testing to a single test provider when establishing coverage for a test. Under the partnership, providers offering tests for Harvard Pilgrim patients will get paid for tests ordered for average-risk pregnancies.

“With this agreement, we are working to enable the entire marketplace for NIPT,” Amirkiai said.

Illumina's tests include NIPT offerings. Last year Illumina launched in Europe the VeriSeq NIPT Solution, an in vitro diagnostic test intended for labs to use in-house as a sequencing-based screening test for the detection of fetal aneuploidies from maternal peripheral whole blood samples in pregnant women of at least 10 weeks gestation. VeriSeq NIPT provides information regarding aneuploidy status for chromosomes: 21, 18, 13, X, and Y.

Illumina also offers the Verifi and Verifi Plus prenatal tests, which require samples to be sent to Illumina's CLIA lab for processing. Verifi and Verifi Plus are also  designed to safely and noninvasively screen for the most common chromosomal aneuploidies as early as 10 weeks into a patient’s pregnancy, using a single maternal blood draw.

Verifi screens for common chromosomal conditions that include trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome). Additional screening is available for sex chromosome aneuploidies and select microdeletions in singleton pregnancies. In twin pregnancies, screening for aneuploidy in chromosomes 21, 18, and 13 and the option to screen for the absence of the Y chromosome is also available.

Verifi Plus includes the same testing as Verifi plus additional options that include:

• Expanded autosomal trisomy testing (all chromosomes)
• Sex chromosome aneuploidies: Monosomy X (MX; Turner syndrome); XXX (Triple X); XXY (Klinefelter syndrome); and XYY (Jacobs syndrome)
• Microdeletion syndromes: 1p36 deletion; 4p- (Wolf-Hirschhorn syndrome); 5p- (cri-du-chat syndrome); 15q11 (Prader-Willi syndrome/Angelman syndrome); 22q11 deletion (DiGeorge)

Results are reported in approximately 3–5 days after the sample is received—though time to report may vary depending on demand, Illumina said.

While Harvard Pilgrim is a pioneer in value-based healthcare programs, those efforts have been directed at broadening access to pharmaceuticals. The agreement with Illumina marks the nonprofit’s first ever value-based contract for an NGS-based screening test.

“Through this partnership with Illumina, Harvard Pilgrim is furthering its quality agenda by making this test available to pregnant women of average risk and can do so in a way that limits the extent to which this expansion might increase overall healthcare costs,” added Harvard Pilgrim CMO Michael S. Sherman. “We hope that it will provide a model for balancing access and affordability for advances in personalized medicine.”