Illumina, San Diego, has signed a value-based contract with Harvard Pilgrim Health Care, Wellesley, Mass, a not-for-profit health services company that provides insurance coverage to approximately 1.2 million people in Connecticut, Maine, Massachusetts, and New Hampshire. The goal of the agreement is to accelerate patient access to and reimbursement for next-generation sequencing (NGS) for noninvasive prenatal testing (NIPT).

Many payors limit NIPT coverage to pregnant women of advanced maternal age (35 years of age or older), while NIPT for women with average-risk pregnancies (under 35 years) remains uncovered by many major insurance companies. As part of its contract with Illumina, Harvard Pilgrim will provide open market access to NIPT for average-risk pregnancies, permitting more pregnant women to take advantage of NIPT technology.

The agreement marks Harvard Pilgrim’s first-ever value-based contract for the use of NGS.

“Harvard Pilgrim is thrilled to have reached this first-of-its-kind agreement with Illumina, which allows us to expand patient access to NIPT,” says Michael S. Sherman, chief medical officer of Harvard Pilgrim Health Care. “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.”

The collaboration also includes a 2-year study in the Harvard Pilgrim population that will assess the total costs and clinical outcomes of NIPT versus traditional screening practices. The study will seek to accumulate the real-world data needed by payors and employers to demonstrate the clinical and economic value of NIPT for detecting aneuploidy births (babies with genetic anomalies).

“We are thrilled to partner with Harvard Pilgrim on the first-ever value-based contract of its kind involving NGS-based assays,” says Ammar Qadan, vice president of global market access at Illumina. “We expect this study to demonstrate the value of NIPT for average-risk pregnancies and to help accelerate the adoption and reimbursement of NIPT.”

“While we have entered into innovative outcomes-based agreements for pharmaceuticals, this is the first agreement we have done for an NGS-based screening test,” says Sherman. “We hope that it will provide a model for balancing access and affordability for advances in personalized medicine.”