By Angela Maas
The FDA has approved nearly 10 therapies for acute myeloid leukemia (AML) over the past couple of years. Because most of them target a specific biomarker, it’s critical that people diagnosed with the condition undergo genetic testing to determine whether they fall into a particular patient subgroup.
“Prior to two years ago, we had no new drugs for over a decade, and now we have eight new drugs approved in just the last two years, so the whole field has changed,” said Daniel J. DeAngelo, M.D., Ph.D., chief, division of leukemia, institute physician, professor of medicine, Harvard Medical School, in an interview published on the website obroncology.com.
Many of the newer drugs are oral formulations, which, “in general, are easier to administer,” points out Mesfin Tegenu, R.Ph., president of PerformRx, LLC. “Rather than having to go into a hospital or clinic for treatment, a patient can simply take a medication orally for their condition.”
Payers utilize a variety of management tactics with AML therapies. “Payers often require prior authorization of these therapies due to safety, concern for off-label usage and cost,” says Tegenu. A variety of drugs are used off-label for certain patient populations, he notes.
Asked if AML is a condition suited for value-based contracting, Tegenu asserts that “all therapies associated with high cost should have some kind of value-based payment models to make drug manufacturers an integral part of the health care delivery system. We plan to initiate this discussion with all leading pharmaceutical companies.”
According to Winston Wong, Pharm.D., president of W-Squared Group., the newer drugs would be better candidates for such deals due to AML’s heterogenicity and the fact that “the treatment foundation is still conventional chemotherapy, which for the most part is available as a generic.”