Oral Oncolytics: A Look Ahead

Bruce A. Feinberg, DO: In the remaining time, I’d like to look at the future [of oral oncolytics]. In 5 years, as we see with 25% to 35% of the pipeline being oral, where do we see orals becoming [used]? We’re going to have the value-based care and the clinical pathways. We’ve got the shift in terms of risk being borne more and more at the delivery level—whether by the provider in the community or the hospital. What role will that insurance company play in that process?

Bruce J. Gould, MD: Well, I would say the cool thing in my career, and this is one of the reasons I became an oncologist, was I wanted to see incurable cancers become at least chronic diseases, if not cured. Clearly, the first steps to understanding that is to understand what makes a cancer cell a cancer cell.

Now that we’ve done a good job of starting to understand the pathways, the work is in developing targets to hit the appropriate driver mutations. In all likelihood, based on what we know now, we’re going to need at least one, if not more than one, expensive drug—whether it’s an oral oncolytic, immunotherapy, a combination of [drugs], or [an expensive drug that] is used in sequential therapy. As we know more and can do more, the cost of care is going to continue to skyrocket, and trying to control that spend is going to be a major challenge.

Bruce A. Feinberg, DO: As a community provider, does community medicine survive this in order to manage that kind of cost? Does it portend the end of community care and a shift to large institutional settings where they can [bear the risk] for these very high-cost treatments? How do you see that weathering of the storm for community oncology, given that vision?

Bruce J. Gould, MD: First of all, I always say private practices are not insurance companies, so we can only take a limited amount of risk. How these costs are ultimately managed, I think, has yet to be determined. But, clearly, there is a role for the oncologists in that management. He or she (or the persons on the front lines who are having the face-to-face discussion with the patients), understand the patient’s disease, comorbidities, and wishes.

So, again, I think the incentive for that physician is to do the right thing, but yet the cost-effective thing. I think that’s where we’re moving with these new risk-sharing models and value-based care models: from the private payers, as well as the oncology care model from the Centers for Medicare & Medicaid Services.

John L. Fox, MD, MHA: For the last decade or more, we’ve been doing experiments to see what works. Medicare and the Center for Medicare & Medicaid Innovation is doing their oncology care model to see whether or not holding providers more accountable for cost and outcomes reduces the total cost of care. Ironically, I don’t think we’re going to reduce the total cost of care through drugs, necessarily. I think, [instead], it’s using molecular diagnostics to drive out ways by not putting people on drugs that weren’t likely to be effective in the first place. It’s choosing agents that have equal efficacy but at a different cost.

Even more importantly, it’s driving out waste from [preventable] emergency room visits and hospitalizations, and providing [unnecessary] care at the end of life that patients wouldn’t have wanted had they known their options, as well as [offering] better hospice and palliative care. I think the future looks bright for driving out waste because everyone could agree that there is waste that exists in the system. I’m just not sure that it’s going to be from drugs. But at the end of the day, we’re looking for partnerships with practices, systems, and even with manufacturers around how we can improve oncology care and oncology care delivery. In fact, with manufacturers, we’re looking for partnerships where manufacturers take accountability for the outcomes of their drugs.

Manufacturers of devices, drugs, and diagnostics don’t bear any accountability for their outcomes. Should we be looking in that arena for partnerships where manufacturers are willing to take accountability for outcomes? In the oral space, it works very well because they don’t have the same Medicaid best pricing that you have in the infusible space.

Bruce A. Feinberg, DO: You could see that. Give that first 14-day split fill and [put it] on the manufacturer—and only if they then refill.

John L. Fox, MD, MHA: Yeah, I would agree. Some manufacturers have done that, but that’s not really a health outcome or a clinical outcome. That’s just [asking], did they have toxicities, or was there some other reason they didn’t fill the medication? I think we’re looking more at, “Did you achieve the results upon which your approval was based?”

Bruce A. Feinberg, DO: That gets harder because then you have to come to some consensus over what is reasonable.

John L. Fox, MD, MHA: I don’t disagree. This is hard work.

Bruce J. Gould, MD: How you measure it and how you report it is going to be very challenging.

John L. Fox, MD, MHA: Well, I think our ability to measure outcomes has improved.

Bruce A. Feinberg, DO: It’s both how to measure and when to measure, right?

John L. Fox, MD, MHA: And the interval between. How long are you willing to wait to measure an outcome?

Bruce J. Gould, MD: Trying to distinguish between a drug effect and the biology of a disease can be tricky sometimes.

John L. Fox, MD, MHA: I’m at risk for that today. I’m at 100% risk for that today, regardless of whether it’s the drug or the biology. The manufacturers need to have some skin in the game in that space.

Bruce A. Feinberg, DO: Great. On behalf of our panel, we thank you for joining us and we hope you found this program informative.