Clinical OMICS

JAN-FEB 2019

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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Page 14 of 51 January/February 2019 Clinical OMICs 13 Fortunately, as healthcare undergoes its transition to a value-based model, and as more doctors learn about the benefits of using an FDA-approved test, there is reason for optimism among diagnostic developers. Priming Payers Aside from the money provided by a diagnostic compa- ny's pharma partner in a drug-companion diagnostic co-development project, the most important stakeholders for a CDx developer are the healthcare payers, both public and private. One problem CDxes often face is being lumped in with other tests, often LDTs, under the same CPT code. The result is a test developer being reimbursed at a significantly lower rate that doesn't recognize the accuracy, specificity and reproducibility of their FDA-approved test. This was the case recently for MolecularMD, the devel- oper of the MRDx BCR-ABL companion diagnostic for chronic myeloid leukemia (CML) patients in the chronic phase being treated with Tasigna from Novartis. The test measures molecular response to treatment in patients to iden- tify those who can stop taking the drug and receive ongoing monitoring of treatment-free remission (TFR). The initial reimbursement decision from the Centers for Medicare & Medicaid Services (CMS) for MRDx was sig- nificantly less than half of what the company was hoping for. A contributing factor was there are two other BCR-ABL tests avaialable that are broadly used at large reference labs for the diagnosis and management of patients with both chronic and acute myeloid leukemia. According to Fritz Eibel, chief marketing officer for Molec- ularMD, after more than a month of intense consultation, the company convinced CMS officials that MRDx was able to test the molecular response of patients at a deeper level and was purpose-built to test for TFR, unlike the other tests available. As a result, the test is now reimbursed at $505, two-and-a-half times the initial rate proposed by CMS. "We think private payers will key off this decision and it will help us with reimbursements from them," said Eibel. "But MRDx is labor intensive, so it is also help- ful that laboratories running the test can now, at the very least, break even." Steve Anderson, chief scientific officer at Covance, a sub- sidiary of diagnostics testing company LabCorp, added that (continued on next page) AlexLMX / iStock / Getty Images

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