Clinical Progress and Coverage Policies in Immuno-Oncology - Episode 9
Antoni Ribas, MD, PhD: Clinical pathways could give guidance to practitioners on what is appropriate, or not, to use in a certain indication. I know the companies that set up clinical pathways put a lot of effort into having a fair assessment of the field and seeing what may be beneficial for a patient, as well as cost-effective. The data keep changing quickly, and one of those assessments takes a period of time. I think, by now, whatever assessment was done with PD-1 blocking antibodies needs to take into account that the great majority of the patients who respond up front will continue to respond, at least in melanoma.
Patients not requiring additional treatments is the biggest saving for this class of therapies. If the patients have a lower risk of having complications due to progressive cancer, they do not have to go into the hospital because of toxicities, they do not have to go into a hospital because the tumor is growing, given an emergency—all of that should be incorporated. And it may not be seen by the initial readout of the randomized trials or the pivotal trials that led to the approvals. So, I would argue that the clinical pathways, which are based on taking raw numbers from pivotal clinical trials, may underestimate the benefit of agents that are associated with long-term, long-lasting responses for patients that have a metastatic cancer, for whom the normal course would be to get worse over time. And now, it’s been changed and reversed.
I think clinical pathways can guide practitioners that are not that used to a specific cancer to make sense of the data and say, “Ha, I think this is the best treatment for my patient.” I’m a medical oncologist who dedicates all of my time to melanoma. It’s logical that I’ll be going to the scientific meeting sessions on melanoma, and I’ll be reading the papers, and I’ll be looking for the latest abstracts. I’ll be thinking, in this situation, “What may be the best option for a patient?” I would not expect that a colleague of mine in the community who sees 20 times more lung cancer than melanoma would have the same time to dedicate to melanoma and come up with their own conclusions. So, I think clinical pathways do help in that situation, as do the recommendations from different organizations that try to say, “We’ve looked at the evidence. We think that this is the best option.”
The issue is that the recommendations are based on the evidence that was available at that date, whenever they did that recommendation. Evidence changes over time, so I hope it’s that evidence is taken in the context of any new information that may become available.