Cytopathology & Histopathology

Biography

Biography: Gayane Badalian-Very

Abstract

Personalized medicine (PM) is an evolving field of medicine in which treatments are tailored to the individual patient. Targeted therapies used in PM have narrow range of efficacy and consequently only a specific group of patients benefit from each inhibitor. Determining the susceptible group is of outmost important both from clinical and economic (payers) perspectives. To learn which patients would benefit from a particular drug therapy or, conversely, which patients should not receive the medication, the Food and Drug Administration works with drug and device manufacturers that are developing certain tests called companion diagnostics (CDx). These refer to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. The CDx is used to identify who would benefit from the treatment and sometimes to determine if there are patients who not only would not benefit, but could be harmed by use of a certain drug for treatment of their disease. The companion diagnostic is essential to the safe and effective use of the drug. They go together. The molecular diagnostics field plays a vital part in PM / CDx and has greatly expanded over the past twenty years; expanding by more than 20% annually compared to most other laboratory procedures. Companion diagnostics is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. Because the companion diagnostic test is designed to be paired with a specific drug, the development of both products requires close collaboration between experts in both regulatory device center, which evaluates the test to determine whether it may be cleared or approved, and regulatory drug center, which evaluates the drug to determine whether it may be approved. Many payers are eager to support CDx tests that enable clear decision making with proven clinical utility. However, unlike medical devices and drugs, there is no clear or standardized method of preparing evidence of clinical utility, establishing coverage, or setting a reimbursement rate for a CDx test. Instead, coverage and reimbursement is set on a case-by-case basis whereby payers determine what is best for their beneficiaries in terms of improving their quality of life and treatment outcomes with opportunities to reduce medical costs. In the face of rapidly evolving technology and absence of a clear road map for decision making, there is a payer dilemma: how to quickly evaluate, cover, and pay adequately for CDx tests that provide a clear benefit to patients and the insurer, while ruling out those tests that are of no benefit.