Molecular Testing in NSCLC and Cost

John Fox, MD, MHA: There is a lot of angst about the cost and appropriate use of molecular diagnostic testing in cancer treatment. Let me first say that our goal is to get the patient on a therapy that is most effective for that patient. And molecular diagnostics and IHC (immunohistochemistry) testing allow us to identify which therapies are unlikely to work. I would say that any time we give a patient a therapy that’s unlikely to work, that’s a waste. It’s a waste of a potential opportunity to improve their outcome, and it’s a waste of resources. I’d also say that this angst about the cost of testing, put in context, should almost be forgotten. The cost of these therapies that we’re prescribing may be $10,000; $15,000; or $20,000 dollars a month, and that’s if it’s monotherapy. In combination, it could be significantly more.

So, the cost of the molecular diagnostic testing to identify which therapy is most appropriate for a patient is a good investment, in my mind. In non—small cell lung cancer, we have EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) mutation testing. ROS (proto-oncogene tyrosine-protein kinase) testing can also help identify, for a patient, which therapy they would be most likely to respond to.

The question of whether or not we should do broader molecular diagnostic testing is addressed in the NCCN Guidelines. In fact, they say the patient should have broad genetic testing to not only identify which therapies are approved for which they’d be eligible, but also to identify patients who might be eligible for a clinical trial. In our frame of reference, being involved in a clinical trial is a good thing for patients. It helps reduce their out-of-pocket costs, it reduces our costs, and in Medicare (for example, in the Medicare Advantage Plans), in patients on an approved Medicare trial, all those costs revert to your original Medicare. So, I think there are good clinical reasons and good financial reasons for a health plan to cover the costs of those tests to determine whether or not a patient is eligible.

For example, there’s the National Cancer Institute-MATCH Trial and the TAPUR Trial. Our plan pays for molecular diagnostic testing for patients to determine if they’re eligible for a trial because we believe that if we’re willing to pay for the research, we need to pay for the testing to determine whether or not they’re eligible for that research.

In the formulary approval process and in setting up the parameters for approving the drug, we often include molecular diagnostic tests or companion diagnostic tests as a prerequisite for getting the drug (if the clinical trials indicate that a patient is more likely to respond with a specific molecular mutation or require that as part of the prior authorization process to ensure that the patients are appropriate for that therapy). Again, if they’re getting the therapy and they’re unlikely to respond to it, it only exposes them to the side effects and the cost, without any clinical benefit.

It’s ironic, though: if a provider wants to prescribe a drug that has a companion diagnostic, we’ll make sure that they have that test in order to get the drug. But the converse is not true. If a provider wants to prescribe a different drug, we don’t ask the question, “Have you had EGFR, ALK, or ROS testing?” But I think in the next few years, that’s going to be standard—that we require every patient be tested so that we know (regardless of whether or not they’re getting a platinum-based therapy or an immunotherapy or an EGFR-focused therapy) that that’s the most appropriate option for that patient and is consistent with the guidelines.

The interesting question is, what do you do, as a health plan, if a patient has molecular diagnostic testing and IHC testing and is an appropriate candidate for both immunotherapy and say, for example, EGFR tests or EGFR therapy? In that circumstance, we’ll revert to the guidelines. And the guidelines, today, don’t address that question as to if you are appropriate for different targeted therapies. So, that would be left to the discretion of the physician and what they think is best—the best balance of outcomes and toxicities.