As our understanding of the human genome deepens, genetic testing technologies have grown rapidly. The NIH Genetic Testing Registry, launched in February 2012, now includes more than 19,000 tests for 4,500 conditions and 3,000 genes, and new discoveries are being made every week. As a 2013 review in the journal Personalized Medicine illustrated, genetic testing is one of the fastest growing segments of the laboratory market, and is expected to rise from $1.5 billion in 2010 to $4 billion in 2015.
While there is a great deal of excitement about genetic technologies, in some cases the technology precedes the clinical evidence and utility. Health insurers and providers are challenged to keep up with these rapidly evolving technologies to ensure that high-quality, high-value care is being delivered to members.
The right genetic test in the right individual can be of great benefit — for example, identifying a medication that's more likely to be effective for the patient or uncovering a higher risk of developing a particular disease, such as breast cancer, and aiding the patient and physician in developing a rigorous early detection and prevention plan. But unnecessary tests — where the science can't support the accuracy of test, the person seeking a test isn't a good candidate for the testing, or the test isn't useful in guiding treatment, management, or prevention of a disease — can cause a great deal of stress for the member, spur further unnecessary (invasive and costly) testing, and drain healthcare resources that could be better utilized.
Given the complexity in the field of genetic testing and the rapidly changing landscape, it is challenging for clinicians to stay abreast of developments and be informed about current consensus guidelines for these tests. At Harvard Pilgrim, we believe there's an opportunity to support our members and provider partners by evaluating common genetic tests and offering a point of view on the validity, clinical utility, and appropriate use of these tests.
This fall, Harvard Pilgrim is establishing a clinical medical policy on BRCA genetic testing, which identifies the presence of a BRCA1 or BRCA2 genetic mutation that can substantially increase the risk of breast and ovarian cancer. Since BRCA testing has been available for more than 10 years, Harvard Pilgrim was able to draw on a solid base of clinical evidence and consensus recommendations to develop this comprehensive policy. Additionally, in the last year BRCA testing has been in the media spotlight, with celebrities such as Angelina Jolie discussing the decision to be tested, which may leave some members wondering whether BRCA testing is right for them, too.
In the coming year, we will be evaluating other genetic tests and expect to introduce additional clinical guidelines. You can rest assured that, as with our BRCA policy, these clinical guidelines will be supported by strong clinical evidence, and aimed at ensuring that our members receive high-quality, appropriate clinical care.