By Allison Proffitt
September 14, 2017 | Diagnostics is a tricky space right now, says Charles Mathews, Vice President of Boston Healthcare. He spends lot of his time focusing on reimbursement and at last month’s Next Generation Dx Summit in Washington, D.C., he outlined for me some paths around our current payment and reimbursement hurdles.
“If you force payers to set the evidence bar, they’ll set it so high,” Mathews said. Unnecessarily high, he argues. Payers don’t really know the science behind each test, and how they should differ.
When developing companion diagnostics, companies must think about reimbursement from the beginning. We should focus on the type of evidence we need to get payers on board, he said. “We need to come up with our own rating system, and give it to payers.”
The goal should not be a single evidence bar, Mathews says, but rather a curve. For example, a study on colorectal cancer, a disease that accounts for 8% of all new cancer cases, should provide more evidence than a test for Huntington’s Disease, which effects 3 to 7 per 100,000 people of European ancestry.
The framework Mathews describes can’t be built by a single group, but he does believe that harmonization is possible. It shouldn’t be up to payers to determine value, and he doesn’t think pharma should have sole responsibility either. “That’s a fox-watching-the-henhouse problem,” he joked.
He believes the diagnostics industry must define for itself what good looks like.
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Highlights:
00:30 defining “good” for novel diagnostic tests
00:53 various types of diagnostics and needed evidence standards
01:17 the problem with a randomized controlled trial
01:35 defining a new evidence standard