In addition, there is often a crossover design in which patients receive 1 formulation followed by the other on 2 different tracks. That way, patients can report on quality of life, how they feel the treatment went, and whether they had any unusual AEs.
With AEs specifically, these studies compare effects as perceived by the patient, as well as certain measurable AEs such as allergic reactions or injection site pain. Those are usually well described in FDA publications. If there is no meaningful difference in AEs and the PK levels are the same, we assume that the drug will work in the same manner.
From a safety and tolerability standpoint, what administration-related AEs should multidisciplinary teams look out for when transitioning patients to a subcutaneous regimen?
When converting from IV to subcutaneous administration, the obvious questions are these: Are there injection site reactions? Are allergic reactions common with the subcutaneous formulation vs the IV formulation? Are there any reactions to compounds or medications that are included in subcutaneous formulations but not in IV formulations?
Again, those are usually outlined in crossover studies, and the formulations are required to be equivalent for FDA approval.
How are you incorporating patient convenience and treatment burden into shared decision-making, and what patient-reported metrics or lifestyle considerations tip the decision toward subcutaneous care?
The main advantage of subcutaneous over IV administration is the time spent in the treatment area. Some IV formulations may take 6 to 8 hours to deliver, whereas the subcutaneous version may take only a few minutes. There is clearly a win from the patient side, and most patients would rather take the subcutaneous version than a prolonged IV infusion.
When the choice is between a 60-minute infusion and a subcutaneous injection, the time saved is not that big. With IV administration, you still have to go through the trouble of having an IV started or a port accessed before administration.
If the clinic is giving a lot of subcutaneous injections, you may have to create a special place in the infusion suite for subcutaneous injections only. In fact, we did that ourselves when we designed a new building for our clinic. We created an area just for subcutaneous injections that is a little more private and off to the side, so people do not have to expose their abdomen to everybody.
What potential do you see for expanding subcutaneous care into community satellites or even home-based models, and how significantly could this reduce travel burden and time in the clinic for patients?
The main advantage of subcutaneous over IV administration is reduced time at the clinic. Say patients have a 60-minute travel time and a 30-minute process to get the subcutaneous injection and head back home. The time they save might be an entire afternoon or an entire morning. They can get back to work for a day or half a day instead of spending the whole day on the process of an IV infusion.
Home administration is a little trickier for patients receiving cancer treatments. It would have to be a very well-educated patient with extra support to ensure that the injection is given properly. With some older wearable delivery systems, we had injection failures in which the device became dislodged. Patients were getting an important rescue medicine to protect their blood from AEs. They would remove the device, all the medicine would be running down their arm, and they would be back the next day getting a regular shot.
It can be done, but we like to know that we gave the injection the correct way ourselves rather than send people home with it. You could find patients for whom home administration might be advantageous, though.
From a practice management and health system perspective, where is subcutaneous administration delivering the most immediate operational impact, and what administrative or reimbursement hurdles still need to be addressed?
As part of our process for evaluating who will receive IV vs subcutaneous administration, we have a pharmacy division that evaluates the cost impact to the patient. That division helps guide decisions on who will receive the subcutaneous formulation and who will not. We want to make sure we are not producing a financial burden for patients in exchange for that convenience.
The operational impact is being able to move people through the delivery process more quickly. Theoretically, if half your drugs were given subcutaneously as opposed to as 2-hour IV infusions, you could have a smaller footprint in a treatment area and save costs on personnel and labor.
As subcutaneous delivery continues to advance across oncology specialties, where do you see its greatest long-term potential, and what critical questions or clinical gaps remain for future real-world evidence to answer?
The technology is well proven. It has been around for at least a decade, and there are probably [several] different medications that used to be given intravenously and are now given through subcutaneous injections. The technology is well established.
I am not sure what limits the technology places on giving medications subcutaneously, or which medications are good candidates and which are not. I know that in other areas, particularly rheumatology, a lot of medicines are given subcutaneously. Subcutaneous delivery will expand as the need arises and as people develop newer protein- or antibody-based treatments.
