EDITOR'S PAGE
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During the past couple of months, various proposals and programs specifically intended to support the development of personalized medicine have been coming out of Washington. In April, Senator Barack Obama (D–IL) reintroduced the Genomics and Personalized Medicine Act of 2007, which proposes to increase funding for genomics research. At the end of March, the Department of Health and Human Services (HHS) launched its Personalized Healthcare Initiative (see Trends & Perspectives, page 14), which intends to support fundamental developments in the areas of genetic medicine and healthcare information technology.
Obama and HHS have shown they realize the great potential of personalized medicine to improve the quality of healthcare. Both the Obama bill and the HHS program are trying to build systems for implementing the many facets of personalized medicine, including the development of diagnostic tests that clinicians would use to predict the likely outcomes of drug therapies. However, a major point that they fail to address is how such tests are going to be paid for.
Indeed, one of the biggest hurdles for personalized medicine will be gaining adequate reimbursement that would give patients access to tests for selecting the proper type and dosage of medication for their conditions. Greg Downing, director for the HHS initiative told IVD Technology that reimbursement for such tests is an important issue that will need to be addressed. However, HHS is still in the early stages of dealing with this issue, and its primary focus is developing evidence that demonstrates the utility of such tests in clinical populations.
There have been some signs of hope regarding reimbursement for tests that help physicians determine the right medication for their patients. Last year, California’s Medicare insurance carrier agreed to provide reimbursement coverage for the Oncotype DX test by Genomic Health Inc. (Redwood City, CA). This test quantifies the likelihood of breast cancer recurrence and predicts chemotherapy response for early-stage breast cancer patients. Since then, even though this test costs nearly $3500, private insurers Aetna and Kaiser have also decided to reimburse this test.
Nonetheless, such reimbursement is still more the exception than the rule. One of the major challenges is that since pharmacogenomic tests have not been around long enough to establish a proven track record, insurance companies are hesitant to provide reimbursement for such expensive tests. Insurers are also skeptical about paying to test people who are not already sick.
In order to make the case for reimbursement for tests that would help clinicians better select treatments for their patients based on their individual needs, the IVD industry should continue to work with industry associations to fight for greater reimbursement for all IVDs. The industry should also offer to share information regarding the utility of pharmacogenomic testing with HHS. In the future, personalized medicine could be an area of significant growth for the IVD industry. But until reimbursement for pharmacogenomic testing is established, personalized medicine will face an uphill struggle.
