Abstract
Chris Anderson, Editor in Chief
Diagnostics manufacturers will tell you that one of the big challenges is predicting whether—and how much—insurers will pay for new tests developed and brought to market. To date, both labs and test makers have faced widely varying policies and payment rates from private and public insurers for the provision of molecular testing. In this is not tenable for continued advances in precision medicine, in tailoring treatments to each patient's unique molecular make up.
But this may be changing. This issue, staff editor Alex Philippidis examines the Parallel Review Program that allowed the FoundationOne CDx test to win concurrent marketing approval from the FDA and a proposed National Coverage Decision (NCD) from CMS. This action bridges the gap between an FDA approval that a test reproducibly and accurately diagnoses a disease and whether the provision of the test provides an economic benefit in determining how healthcare is delivered.
It also may mark the official coming out party, if you will, of next-generation sequencing as a tool for broadly reimbursed molecular testing. According to a CMS spokesperson, should FoundationOne CDx gain a final NCD, expected early this year, four additional NGS-based tests would also qualify for coverage: Thermo Fisher Scientific's Oncomine Dx Target Test (which in December, won a similar NCD); Foundation Medicine's FoundationFocus CDxBRCA; Illumina's Praxis Extended RAS Panel; and Memorial Sloan Kettering Cancer Center's MSK-IMPACT panel.
There are two important developments here to note. First, the Parallel Review Program shines new light on an approval pathway that has existed in the shadows for six years and could serve as a method to bring diagnostic tools to the clinic. Second, it highlights the FDA's evolving view of NGS-based tests that portends a growing number of approvals in the coming years.
That is not to say theses development were not viewed with consternation in some quarters. Notably, those who run molecular pathology labs in hospitals and academic medical centers worry they might lose out on getting insurance coverage for in-house laboratory-developed tests (LDTs) if reimbursement for testing is tied directly to an FDA approval. It's yet another plot twist in the ongoing debate surrounding LDTs and one that doesn't seem to have a resolution on the horizon.
But leaving aside the LDT debate, it's clear the FoundationOne approval and proposed NCD is a step in the right direction. And if the test is successful in the marketplace, the sleepy Parallel Review Program that rightly marries both clinical validity with clinical utility, can expect to get more interest from diagnostic developers.