Leo Gordon, MD: Our patients have mostly been treated as inpatients. They usually stay in the hospital anywhere from 7 to 14 days. Again, with the clinical trials we’ve been seeing these patients frequently—on day 8 and 15. They have a PET [positron emission tomography] scan on day 29. We insist that our patients stay within a certain distance of the center; in the Chicago area we have them stay within an hour of the hospital, which could be only a mile away.
We also instruct these patients to go to the emergency department if they become sick or develop unexpected problems. They’re going to be identified as patients who’ve just had CAR T cells, and the local emergency department will know to be in touch with investigators from our center to manage potential toxicities. These requirements are certainly designated for the commercial setting as well.
Nilanjan Ghosh, MD, PhD: The financial component of this is important for 2 reasons. The first is, it takes time to figure out the financial component because we do not have much experience with this. CAR T-cell therapy for B-cell lymphoma has only been commercially available for a year now; we’re learning. The financial consultants who deal with billing and reimbursement procedures are learning this too. The insurance companies are learning about this, but because this is relapsed/refractory aggressive B-cell lymphoma, there’s already a lag time between seeing a patient and giving the treatment. There’s an extra delay from the financial aspect due to financial clearance, which makes it more of a logistics challenge. These situations should be handled by specialists who can expedite the process knowing how needy these patients are.
The second part of it is the regulatory component. This is viewed as gene therapy. One of the guidelines from the FDA is to be able to follow these patients for up to 15 years.
The next part of this is reporting. Long-term outcomes are very important for us and therefore, the Center for International Blood and Marrow Transplant Research has partnered with Novartis and Kite Pharma to collect and analyze this data. These can be reported over time. Finally, patients’ outcomes and events should be reported by MedWatch to the FDA so they can also receive reports from the centers.
Transcript Edited for Clarity