More on Pharmacy Best Practices (Oct. 2006): Pharmacogenomics

Insurers are evaluating the costs and benefits of generic testing to determine their level of commitment to the emerging medical discipline.

SelectHealth, based in Salt Lake City, Utah, has a genetic testing committee to help determine which tests are covered and how best to use the results.

"We use the ACEE model to help guide us in the scientific evaluation of genetic tests. ACEE takes its name from four components of evaluation-analytic validity, clinical validity, clinical utility and ethical, legal and social implications," says Roy Gandolfi, MD, SelectHealth's associate medical director. "We try to educate our physicians to optimize the interpretation of genetic tests and to keep in mind that we are looking at the whole person. Our decisions are not just 'yes' or 'no' propositions."

"At Blue Cross of California, we don't want to waste medications on those patients who cannot benefit from them," adds Jeff Kamil, MD, chief medical officer for the Thousand Oaks, Calif.-based insurer. "We cover screenings when there is a family history of a disease or the likelihood of identifying something relevant to the prognosis of a condition. It is not a cost issue but rather, what is right for the patient."

Monogram Biosciences, in south San Francisco, is in the business of ensuring that the right person receives the right medicine at the right time. A developer of molecular diagnostics for HIV and cancer, Monogram aligns patients and medications to improve health and avoid expensive, ineffective therapies.

The company has created phenotype and genotype resistance tests to help physicians select the drugs that will provide the greatest benefit to an individual and the longest term benefit. Genotypic resistance testing looks for mutations in the genetic code of HIV that would be associated with resistance to specific antiretroviral drugs, while phenotypic resistance testing looks at the ability of HIV to replicate in the presence of a drug.

"Every therapy will fail over time," says Alf Merriweather, chief financial officer for Monogram. "With more choices and screenings to find the right drug, HIV is no longer a death sentence as it was 15 years ago, but more like a chronic disease."

Monogram also has developed its eTag technology, which identifies the proteins and protein combinations on which the drugs being tested react, providing information on a patient's chances of responding favorably.

"Managed care organizations want clinical data; they don't want to pay for drugs that only work 10% of the time. However, when a drug has a high probability of effectiveness, they are willing to cover it," Merriweather says.

The next step is gene therapy, which for the first time in the history of treating cancer, has succeeded in shrinking and even eradicating large, metastatic tumors. However, the therapy only worked in two out of 17 patients. The study was reported in a recent issue of Science, and is one example of inserting genes into a patient's cells to compensate for an inherited genetic defect, allowing the body to fight a disease on its own without drugs.