2:58 PM
 | 
Mar 02, 2018
 |  BioCentury  |  Strategy

De-risking risk reduction

What Illumina hopes to accomplish with the first-ever value-based diagnostics deal

Slow and inconsistent reimbursement practices coupled with a lack of data on health or economic outcomes at launch often slows uptake of new, high-priced molecular diagnostics and sequencing-based tests.

A first-of-its kind deal between Illumina Inc. and Harvard Pilgrim Health Care Inc. is intended to generate data to support broad reimbursement by multiple payers for non-invasive prenatal tests made by multiple testing companies.

Illumina’s stake in the non-invasive prenatal test (NIPT) market extends beyond its own Verifi genomic sequencing kits, which detect chromosomal abnormalities. That’s because many other NIPTs run on Illumina’s next-generation sequencing (NGS) platforms including the MiSeqDx and NextSeq 550Dx.

Illumina derives the bulk of its revenues from its sequencing instruments and assays and reagents that are purchased to use on the platforms. For 2017, the biotech reported $2.8 billion in revenue, with $1.8 billion (64%) from consumables and $515 million (19%) from instruments.

The company believes use of NGS tests in all pregnant women, not just those whose pregnancies are considered high risk, could reduce costs and improve outcomes for both mothers and babies.

But absent evidence to support those or other benefits to the healthcare system, “it really ends up as a cost-plus type of a business model,” said Ammar Qadan, VP of global market access at Illumina.

On Feb. 1, Illumina and Harvard Pilgrim announced two separate collaborations for NIPTs designed to align the tests’ reimbursement with their value.

“I think it’s innovative and can drive thinking in other areas.”

Michael Sherman, Harvard Pilgrim

The first is a risk-sharing deal that will test Illumina’s hypothesis about the ability of NGS tests to lower costs.

Harvard Pilgrim, a regional payer covering over 3 million lives in New England, will reimburse the cost of NIPTs for all pregnancies. The partners will track total screening costs for low- and average-risk pregnancies, including NIPTs, serum based tests, ultrasound and invasive follow-up tests.

If after one year the total screeing costs are higher than the historical costs Harvard Pilgrim has incurred for low- and average-risk pregnancies, where NIPT was not used, Illumina must make up the difference. If the costs are lower, Harvard Pilgrim gets to keep the savings.

Screening for high-risk pregnancies is not part...

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