Houston, TX—With the onslaught of drugs that will target genetic subsets of patients, companion diagnostic testing will become vitally important, said Jane F. Barlow, MD, MPH, MBA, Vice President of Clinical Innovation, Medco Health Solutions (now Express Scripts), New York, who spoke on personalized medicine during the 2012 Annual Conference of the Association for Value-Based Cancer Care.
“The whole area of pharmacogenomics testing is very important for safety, but also to ensure that the right drug, or at least not the wrong drug, is given to an individual patient,” she said (Figure).
More than 700 oncology drugs are currently in the pipeline, according to the PharmaLive.com special report Drugs in Development: from Pipeline to Market (July 2011). This is 3 to 7 times higher than drugs for other conditions.
Drug development is increasingly partnering with diagnostics. A recent survey of pharmaceutical companies found that 12% to 50% of current clinical pipelines involve personalized medicine, 80% of companies have strategic partnerships related to personalized medicine, and 50% of drug trials collect DNA samples from trial participants (http://csdd.tufts.edu/reports/description/impact_reports). By 2024, it is expected that up to 20% of all new drugs (especially cancer drugs) will be labeled with a companion test (Kalorama Information’s Worldwide Market for Cancer Diagnostics, 4th ed; July 2010).
“This has not come about at the speed initially anticipated, but once in development, we need to be prepared for how to think about using these tests,” Dr Barlow said.
“Today, all coverage programs are triggered by the drug. In the future, this may be based more on disease state,” Dr Barlow predicted. “As we look at this field, we are realizing we need to take an approach that may be different in the future."
Vital to this is more information matching tumor specifics to the patient’s characteristics, which will guide treatment decisions and companion diagnostics. She predicted that a companion diagnostic test for a drug will foster “seamless coverage criteria for the whole course of treatment.”
Currently, Dr Barlow added, pharmacy benefits managers lack “visibility” of the whole swatch of the oncology drug landscape, because many are intravenous products and are reimbursed under medical benefits. “But we think about this as a whole, in terms of designing programs,” she said, and in terms of “the different levers that can be pulled to manage appropriate utilization.”
Medco’s main “levers,” she said, are pharmacogenomic testing, pharmacy drug utilization review programs, specialty therapy management protocols, and prior authorization criteria.
The pharmacogenomic testing program aims to ensure appropriate drug use, and it is paid for entirely by plan sponsors (typically, employers). The process is that opportunities for diagnostic testing are identified for the physician, the physician is told the test will be covered by the patient’s health plan, and if the physician wants to order the test, the patient is contacted and can agree to the test or decline it.
“On average, 50% of physicians say yes, and 50% of patients say yes,” Dr Barlow reported. “We just facilitate the test.”
The drug utilization program stores patients’ genetic test results, which allows them to be reviewed when future treatments are prescribed. The drug utilization review would show, for example, that a patient may be a poor CYP2D6 metabolizer and thus needs drug dose adjustments. The specialty therapy management program applies primarily to high-priced drugs and focuses on patient support.
With the increase in oral drugs, the prior authorization criteria “lever” has become an important component of pharmacy benefits management. Although some sponsors require testing before paying for a drug, in less rigid cases, a drug may be covered in the absence of test results; however, the pharmacist can take the opportunity to educate providers about pharmacogenomic testing, she said.
A look at a few common but expensive drugs that are linked to biomarkers illustrates how healthcare dollars can be used wisely or can be misspent (Table). “A fair proportion of the population may not benefit from these drugs,” Dr Barlow emphasized, “and in these cases, you spend many dollars on a course of treatment that basically has no value for the patient. That is why we are interested in diagnostic testing and, as pharmacy benefits managers, we feel that it is important to create these programs.”
