Clinical OMICS

MAY-JUN 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com May/June 2018 Clinical OMICs 25 locations that will inform deci- sions on therapy selection. "We'll see a very signifi- cant increase in the number of applications to the FDA, whether it be clearance or approval, in order to ensure coverage for these types of tests," Spetzler noted. "Cer- tainly, that's our intention and plan. We've engaged with the FDA already, and I believe that other providers will do the same thing." AdvaMedDx, a division of the Advanced Medical Tech- nology Association representing diagnostics manufacturers, is "very hopeful and encouraged about the final NCD and its potential for expanding coverage for these types of tests to patients with advanced cancer," Executive Director Susan Van Meter said. "We're certainly seeing positive movement in the direction of ensuring patient access, but this is really the beginning." CMS' focus on tying NGS test coverage to therapy selec- tion means that diagnostics companies whose tests could show significant value, but are not companion diagnostics, will likely struggle with how their tests fit into coverage under Medicare. Mathews said ClearView Healthcare Part- ners is working with one such developer seeking to market a cancer–recurrence monitor- ing assay. "The good news is, now it's not exclusively prohib- ited by the policy. But now we're back to, how can you convince the local MAC that there's value in that partic- ular application of sequenc- ing?" said Mathews, whose firm has offices in Newton, MA; New York; and San Francisco. "In general, having this pathway is better than not having this pathway, but it leaves open questions about how to bring forward assays that are not specifically focused on therapy selection or in oncology specifically." Whatever ways those are resolved, Mathews added, "the final NCD has now established a recognizable and repeat- able pathway for others that are interested in this space. That is really exciting for those of us that work in the space, because one issue people have had is the big overhang from investors all the way down through innovators, who have been saying, 'If we went and did this, and we built this big product, would anybody ever pay for it?' Now, there's a very clear pathway saying, 'If it fits the criteria of the policy, if we are able to get not an FDA approval but now clearance for it, then Medicare at least will pay for it.'" line with the Medicare NCD. "I think there is a chain of events in which it will be more widely used in Medicare patients, and that puts pressure on commercial payers, and people say, 'Wait! Because I'm 63 years old, I don't get this, but if I'm 65, I do? It doesn't make any sense,'" said Charles Mathews, principal with ClearView Healthcare Partners. Near-term, roughly half of respondents indicated they would not change their commercial coverage from current policies. "Payers have been of two minds. They do see potential value in NGS diagnostics but their whole world has been framed by clinical utility. 'Show me that this product is actually improving care, and then I will pay for it,'" Mathews said. The final NCD, Mathews noted, combined policy considerations with the desire of CMS and FDA to be viewed as promoting in- novation and being more adaptable to a changing landscape for technology and clinical care. That dynamic, he added, evoked CMS' 2014 coverage approval for Exact Sciences' Cologuard multi- target stool DNA test for colorectal cancer in asymptomatic, aver- age risk beneficiaries ages 50–85. He said payers also face unresolved implementation challeng- es of coding for the new tests, and paying for related tests. Will payers have to pay different rates for, say, FoundationOne CDx and the FoundationOne comprehensive genomic profile? Should CMS assign a single value to a suite of tests, and risk discouraging developers from bringing additional assays through the regula- tory process? David Spetzler, Ph.D., president and CSO of Caris Life Sciences predicts private payers will mi- grate in significant numbers to- ward panel codes. "As the number of individual markers that have well defined and kind-of unassailable clinical utility increases, they will simpli- fy their policy to include panels," Spetzler said. "It will probably take six months to a year for them to get there, but I think they will." n Charles Mathews, principal, ClearView Healthcare Partners Thermo Fisher made a splash with FDA approval last year with its On- comine Dx Target Test. Now it plans to expand use of the test beyond NSCLC and to market the test overseas.

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