The Lynx Group

The Role of Molecular Diagnostics in Cancer Treatment

July 2011, Vol 2, No 4

Philadelphia, PA—The field of oncology stands to benefit greatly from molecular diagnostic trends, according to Jane F. Barlow, MD, MPH, MBA, Vice President, Clinical Innovation, Medco Health Solutions, who offered a pharmacy benefit manager’s (PBM) perspective of the role of diagnostics, including the use of companion tests in drug development. These companion tests will represent another potential expenditure and coverage decision for PBM companies.

Currently, more than 800 tests are available for tumor profiling on solid tumors, Dr Barlow said, and another 100 tests are available for hematologic malignancies. In addition, 22 inherited cancer syndromes can now be tested for, and an additional 10 risk profiling and cancer screening tests are available. The entire molecular diagnostics area is boasting double-digit growth at a rate of 35% yearly (Figure 1).


This is huge compared with other types of  diagnostics, which are experiencing single-digit growth. Yet about 20% of the molecular-based tests are believed
to be inappropriate, said Dr Barlow. “With the range of oncology tests on the market, we’re measuring clinical utility—evidence of utility (eg, BRCA for inherited breast cancer) versus evidence still being developed (eg, Oncotype DX for colon cancer),” she says (Figure 2).


Drug Companion Tests on the Rise
There are more drugs in development for cancer than for any other clinical area, according to Dr Barlow, who points to 900 drugs in some stage of development, many of which are oral oncolytics. Many pharmaceutical companies are using diagnostics as part of their regimen for evaluating the drugs. In the current oncology drug pipe - line, an estimated 12% to 50% of drugs are considered to be “personalized medicine.” A whopping 80% of companies have strategic partnerships related to personalized medicine, she said. It is expected that by 2025, 10% to 20% of all new drugs will be labeled with a companion test, in particular cancer drugs, according to April 2010 data from Kalorama Information.

Dr Barlow discussed 9 pipeline drugs that have partnerships to develop companion diagnostics. The US Food and Drug Administration (FDA) is helping drive the push, she said.

“Last year for the first time, the FDA didn’t approve a leukemia drug for which, during the clinical trials, the pharma company had not performed companion testing to identify those who would benefit from the drug. When the company brought the drug to approval, the companion test or diagnostics hadn’t been developed for commercial use. FDA sent it back and said get the testing developed so that when the drug is approved it can be used in the appropriate people,” she said. “This is the first time that this occurred at FDA. It really heralds where we’re headed in the future with diagnostics.”

What It Means for Health Plans
Adding value to diagnostics in oncology requires the alignment of various aspects of care (Figure 3). At Medco, there is a specialty treatment management protocol, which is soft coverage management or support. “When we see drugs that come to play being dispensed through Medco or elsewhere, we have questions we ask to be sure testing is being done. We work with patients and with providers to ensure that the right person is getting the right drug; if testing is indicated, then testing is done. We’ve merged from our client population into one umbrella focus. It’s one oncology focus so we can pull orals, injectables, everything together,” she said.

Drug Companion Tests on the Rise

Medco also works to facilitate discussions with providers so that providers make the call regarding testing. Yet, there is inherent difficulty in managing these tests, whether on the health plan side or pharmacy side, because it’s hard to know whether people have had tests.

Education’s Influence
“When we think about driving value-based diagnostics in cancer care, we recognize that it’s a multifaceted program,” Dr Barlow said. “It’s not just about access to testing. We do realize there’s also a huge role for education.”

She notes that in 2008, Medco, along with the American Medical Associ ation (AMA), sent a fax survey to all AMA physicians on pharmacogenomics and received about 10,000 responses.

“What was surprising even to us— 98% of providers recognized that diagnostics plays a role in choosing the drug and dose of drug. But only 10% said that they knew enough to put it to use in practice. There’s a huge gap,” she said. “With rapid development of new tests, that education gap likely will remain. There’s a role for policy and how plans think about what they’re going to cover and not cover. Then there’s a role for management, whether through a prior authorization process or friendlier management.”

Dr Barlow points to a “tremendous” role for diagnostics in disease treatment, especially via the new companion tests. Yet, there must be recognition that every new test is something additional to cover.

“We have to figure out if we’re going to spend the same amount or more for this type of testing. We have to use that money wisely,” she added.


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