AJMC Panel Sees Advantages in FDA Regulation of Molecular Diagnostic Tests for Cancer Care

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The American Journal of Managed Care convened a discussion of 2 leading clinicians and 2 medical directors for leading payers, all of whom saw some merit in FDA's plans to bring oversight to the diagnostic testing market. The strongest advocate for greater FDA oversight was Daniel F. Hayes, MD, clinical director of the Breast Oncology Program at the University of Michigan, who will be a future president of the American Society of Clinical Oncology.

FOR IMMEDIATE RELEASEFebruary 27, 2015AJMC Panel Sees Advantages in FDA Regulation of Molecular Diagnostic Tests for Cancer Care

The clinical director of the Breast Oncology Program at the University of Michigan sees great promise in the FDA’s plans to regulate molecular diagnostic testing in cancer care, and called on third-party payers to support bringing rigor to the field by reimbursing those tests that pass regulatory muster.

With great candor, Daniel F. Hayes, MD, described the “caveat emptor” climate that exists in the current testing market, and he had high praise for the responsible approach that FDA has taken thus far. “There’s a great deal of concern that this will squash innovation and dampen down new test development,” he said, explaining that he feels oversight will have the “opposite” effect.

Dr Hayes, recently elected the 2016-2017 president of the American Society of Clinical Oncology (ASCO), noted he was speaking in his own capacity and not on ASCO’s behalf. However, ASCO President Peter P. Yu, MD, presented a letter supporting FDA’s action to a Congressional subcommittee in January. (For more coverage, click here.)

The discussion also featured Francisco J. Esteva, MD, PhD, professor of medicine, director of breast medical oncology, and associate director of clinical investigation, Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center; John L. Fox, MD, MHA, associate vice president, medical affairs, Priority Health; and Bryan Loy, MD, MBA, vice president oncology, laboratory and personalized medicine, Humana. Surabhi Dangi-Garimelli, PhD, managing editor of Evidence-Based Oncology, one of The Ameican Journal of Managed Care’s indexed publications, moderated the discussion. You can access this essential installment in the AJMCtv series that brings together perspectives of payers and providers by clicking here.

This wide-ranging discussion covers the role of genetic counselors, the shortcomings of research on current laboratory developed tests, and even the role of laboratory marketing in driving patient demand for tests—much of which is currently beyond FDA purview.


No one on the panel opposed FDA regulation of molecular testing in cancer care, but it was not seen as a panacea, either. Panelists described oversight as just one element in bringing greater accountability and value for patients. The effort will demand work by physicians and groups like ASCO and the National Comprehensive Cancer Network (NCCN) to create better guidelines, to educate oncologists in field, and to manage patient expectations about testing. Dr Hayes pointed to ASCO’s forthcoming CancerLinQ as a tool to educate oncologists and bring more standardization in care.

Viewpoint of Payers on Diagnostics

Dr Loy said he is most optimistic about collaboration among payers, medical oncologists, and the testing laboratories. He hopes this will lead to measurement systems across large populations, which will allow both payers and patients to answer the question, “Are we really getting the value we thought we were getting?” Such measurement should apply not only to future tests, but also to tests being used now, he said.

Dr Fox described the difference between predictive tests, which tell the patient, providers, and payers whether or not a given cancer therapy will work for a patient, and prognostic diagnostic tests, which seek to guide the course of care by a physician--and for which prospective studies are often lacking. He and Dr Loy agreed that studies showing an association between a test result and an outcome didn’t always prove how physicians would behave in the real world. As Dr Loy said, that second item is what drives costs, and thus, is what payers need to know.

Sometimes, Dr Loy said, “Having the study doesn’t necessarily mean that we’re going to get the value out of those tests as a payer. … Having a good test in the wrong hands, or if the information never gets utilized, there is not value for us.”

As Dr Esteva noted, new genomic next-generation sequencing studies that have arrived in recent years are not based on clinical outcomes, which was not the case with earlier diagnostic tests. “Outcomes in a particular relevant patient population used to be and should be our most important factor, but I’m not sure that’s what’s happening today,” he said.

More Assistance in Guidelines Needed

Reimbursement for diagnostic tests has been a major issue in the industry, both with commercial insurers and with CMS. Alongside these disputes have been complaints that robust ASCO and NCCN guidelines do not exist for diagnostics. As Dr Esteva and Dr Hayes noted, however, in some measure these challenges exist because of a lack of evidence.

However, Dr Esteva said, there have been cases in which physicians embrace diagnostic tests that prove their value, both in analytical and clinical utility, but NCCN guidelines do not keep up with what is happening in clinical practice. Dr Fox acknowledged this is a problem, because his health plan will cover tests based on NCCN guidelines, but “if it’s not there yet, what do we do?” Ultimately, Dr Fox was more concerned that physicians might not embrace diagnostic tests—and might not order them, thus preventing patients from receiving the benefit of targeted therapies or avoiding unnecessary treatment. All four panelists sounded hopeful about the prospects for diagnostic testing in cancer care, despite the many regulatory, reimbursement, and education issues that must be resolved.

About the Journals

The American Journal of Managed Care (AJMC) celebrates its 20th year in 2015 as the leading peer-reviewed journal dedicated to issues in managed care. Other titles in the franchise include The American Journal of Pharmacy Benefits, which provides pharmacy and formulary decision-makers with information to improve the efficiency and health outcomes in managing pharmaceutical care, and The American Journal of Accountable Care, which publishes research and commentary on new healthcare delivery models facilitated by the 2010 Affordable Care Act. AJMC’s news publications, the Evidence-Based series, bring together stakeholder views from payers, providers, policymakers and pharmaceutical leaders in oncology and diabetes management. To order reprints of articles appearing in AJMC publications, please call (609) 716-7777, x 131.

CONTACT: Nicole Beagin (609) 716-7777 x 131