Influence of Biomarkers in Immunotherapy Treatment Decisions




Steven Peskin, MD, MBA, FACP: [In regard to coverage of companion diagnostics], if there’s a specific explicit companion diagnostic associated with a targeted therapy or immunotherapy, that companion diagnostic would be covered in conjunction with the assumption that it’s going to be used to decide whether or not to use a particular demonstrated effective immunotherapy, or targeted therapy, or precision therapy. Those would be covered.

It gets a bit greyer [in the] area where there is a broad range of biomarkers that have implications in certain cancers. We’re not sure, yet, what the implications are for therapy, so we’re continuing to very vigorously study those kinds of issues by working with some of our key thought creators (thought leaders) that are helping us to make decisions about the use of biomarkers or the coverage of biomarkers as it relates to oncology care.

There are certain therapies that are known to work very well in select patients but to be of no clinical utility or clinical value in other patients. Again, there are going to be grey areas where the particular immunotherapy is demonstrated to be extremely effective in a certain cohort with a certain biomarker (KRAS or others) but might also be, perhaps, less effective [in other cohorts]. Then, we clearly have situations where it’s ineffective, and maybe even counterproductive. In that sense, we would look for the test to be done prior to the initiation of certain therapies.

[When it comes to] early identification of nonresponders, that is, again, very much aspirational. We’re working with certain clinical partners on more rapid elucidation of nonresponders, using data analytics to more quickly and effectively identify nonresponders, so that we can move on, and, with our clinical organizations, get that patient (perhaps) into a clinical trial or into using another therapy that might be effective in that situation. Or if the situation is such that there are no good alternatives, then we are looking at palliative care as opposed to treatment for that type of care. So, looking for nonresponders is something we are very much working collaboratively with our oncology clinical partners on.
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