by Amy M. Miller, Ph.D., PMC Executive Vice President

Personalized medicine challenges all aspects of health care, from the way discoveries are made to how they are regulated, covered, paid for and delivered in the clinic.

Since the mapping of the human genome 13 years ago, we have seen many efforts to alter, update and improve these processes to accommodate personalized medicines, innovative and novel diagnostic tests, and new approaches to care.  Excitement is palpable throughout the world, and personalized medicine’s proponents are no longer being accused of hyping a future that does not exist.

FDA’s new drug approvals demonstrate that about one in four new drugs (28 percent) are now targeted, a ratio likely to remain the same or increase in coming years.  As tech company NextGxDx’s count of genetic tests shows, there has also been an explosion of personalized medicine diagnostic tests on the market. Encouraged by the incredibly fast work of the National Institutes of Health (NIH) and FDA, U.S. policymakers in both chambers of the Republican-controlled Congress and the Democratic-controlled White House have expressed enthusiasm for the field’s potential.

Yet, some groups question the value of these advances.

Take non-small cell lung cancer (NSCLC) for example. This disease exemplifies how a personalized approach can provide more for patients than the standard of care. Over a few short years, several new drugs and diagnostic tests for NSCLC have come to market, changing the trajectory of treatment for the disease. The first-generation ALK-targeted drug, for example, did not cross the blood-brain barrier; the second-generation therapy does. Diagnostics for NSCLC began with one-mutation tests, moved to panel tests for multiple mutations and are now moving into the realm of next-generation sequencing tests that reveal an even more comprehensive array of valuable information about the tumor. Thanks to immuno-oncology, we now have a new class of drugs to fight the disease.

Based on discoveries in clinical medicine, FDA regularly updates labels to move drugs from the second or third line to the front-line when paired with a diagnostic test. Teams of practitioners are learning about these new tools and putting them into practice.

The Institute for Clinical and Economic Review (ICER), which has released its evaluation of two classes of NSCLC drugs, may not share my excitement about these recent advances. The organization’s value assessment process has, by design or perhaps inadvertently, no mechanism for capturing the value of targeted medicines, since its model is built on population averages.

We strongly encourage advocates for personalized medicine to engage the organization and, as a first step, suggest that ICER evolve, like so much of the health care system already has, by treating personalized medicines and companion diagnostics differently than traditional therapeutics.

Comments on ICER’s draft evidence report are due September 16, 2016.