Balancing Innovation, Access, and Affordability in Oncology: Scott Soefje, PharmD, MBA, BCOP

As oncology spending increases, questions around value, access, and sustainability are becoming increasingly important for both payer and provider organizations. In this interview, Scott Soefje, PharmD, MBA, BCOP, director of pharmacy cancer care at Mayo Clinic, examines the key cost drivers shaping today’s cancer care landscape—from accelerated drug approvals and rising prices to administrative burdens like prior authorization.

Soefje also discusses the growing role of pharmacists, technology, and comparative efficacy data in improving adherence, reducing financial toxicity, and ensuring that innovation in immunotherapy delivers meaningful value without compromising patient outcomes.

This interview has been lightly edited for clarity.

AJMC: Which cost drivers in oncology are most urgent for payers and provider organizations to address, and where do you see the greatest opportunity to reduce financial toxicity without compromising outcomes?

Soefje: I think the biggest problem in oncology right now is how fast the costs are rising without clear evidence of benefits, and I think it's a combination of a couple of things. One is that so many drugs are approved through accelerated approval right now that we don't always have those final outcomes that we need, but the prices continue to go up. It's kind of hard to look at this and say, “Is this the right drug? Is this the cost-effective drug that we need?” What's going to have to happen is that payers, providers, and I think even patients are going to have to start demanding that cost-effectiveness data. Is drug A better than drug B? Is drug A better and more cost-effective than drug C? I think we've kind of lost some of those comparative studies because of how fast we're approving drugs, how rapidly things are coming out, and it's a “what the market will bear” kind of mentality for setting the price. And those 2 things don't go well together. I'm concerned as a health care provider—I've been in this for a while, but what I'm kind of concerned about is, if we as health care don't get costs and outcomes under control, are we going to end up with a European-style health care system where someone tells us what the price of the drug is and what drugs we can use in certain situations? Most providers in the US don't want that kind of system, but the system is going to break if we don't figure out some way to stop it.

AJMC: Prior authorizations continue to be a major pain point in oncology. What evidence-based or policy-driven approaches have you found most effective in streamlining access while maintaining appropriate utilization?

Soefje: The best way is we need providers and payers to sit down in a room and talk to each other. We have to stop seeing each other as the enemy. We have to start talking about, “Look, we will stay on NCCN guidelines,” or whatever the guideline processes are, and say, “As long as it's an NCCN-approved protocol, I don't have to do prior authorization”—or some system like that. I know at Mayo Clinic, we've had some success in negotiating with some payers, and we've gotten some payers where we don't have to do prior authorizations if it's FDA approved or NCCN guidelines. Now, we always run the risk of it being denied on the back end because we didn't code it right or it's not documented correctly, and they don't see it that way. But it's taken away some of those prior authorizations.

I also think too many providers are starting to see prior authorizations as a crutch to ensure that the payer is going to pay for the drug. The question I have when we start acting like that is, you should know whether the payer is going to pay for the drug if you're following the guidelines and the pathways and all those other things. How do we get together as a group and say, “Look, you're approving 85% of our prior authorizations anyway. Why do we need to go through this extra step?” There was a Health Affairs publication a few years ago that showed that there's about $93 billion a year to the United States health care system for all of the control mechanisms payers are putting into place—prior authorization, step edits, and all that kind of stuff, because of the personnel that's been required to hire to do all of this work. What's a big portion of it? We need to get rid of that.

AJMC: With oncology increasingly shifting to oral and outpatient settings, where do you see the largest gaps in ensuring adherence, monitoring, and affordability for patients outside the infusion center?

Soefje: It's an interesting world. Before, if someone got intravenous therapy, we knew they were compliant. We knew they were adherent, because they came in and got it, and if they didn't show up, then we could pick up phone and go, “Hey, what's going on?” Now, we give them a prescription, and they go off and get it filled. We know from literature that a certain percentage of those never get it filled. We also know from literature that a certain percentage are rationing their medications because of cost. As I keep teaching my residents, the most expensive drug is the one that doesn't work, if you look at it from a cost-effectiveness perspective. So, how do we make sure patients are taking the meds, etc.? I think it's a great role for pharmacists to get involved in. You see more organizations starting oral chemotherapy monitoring programs, or they're getting their clinic-based pharmacists involved with oral chemotherapy adherence. Specialty pharmacies are getting involved with this. It is a way for us to pick up the phone and go, “Have you taken your medication today?”

I also think technology is going to get involved. I have seen the prototype of the tablet with the microchip that when that chip hits the stomach acid, it sends a signal to the app on the phone that sends it to the provider that says the patient took the medicine today. Whether it ever comes to fruition, I don't know. But what are those kinds of technology type things that we can do to help people take their meds? And then this kind of leads back into the very first question: a lot of this is due to cost, and how do we get the cost down? And how do we get the cost so that it's affordable and people don't have to ration their meds, don't have to decide between meds or food today, and they can continue to take it? We're headed to a world, particularly in cancer, that we're turning this into a chronic disease. And there are some patients whose cancer will be under control as long as they're taking their medicine. It becomes very important to be adherent to that kind of medicine, and that means it must be affordable, it must be easy to take, and there must be a way to manage side effects. I firmly believe pharmacy has got a huge foot in the door right there for managing patients on the oral therapies and making sure they work. We're doing some studies here looking at to see whether pharmacists that are managing some of our oral meds have better outcomes than when they didn't manage the meds. In the hypertension world and the diabetes world, it is clear that with pharmacists involved, patients are better. So, when will it become a time that it is considered substandard care if you don't have a pharmacist involved in the care? That's where I'd like to see us get at some point.

AJMC: Immunotherapies now represent a major share of cancer spending. How can health systems and payers better evaluate value—not just cost—when determining access to these treatments across different cancer types?

Soefje: It kind of depends on how you define immunotherapy, right? If we're talking PD-1 inhibitors, there's a lot of questions I have about those. Do we really need so many of them? At what point in time does the FDA say, “If we're going to approve your drug, you have to compare your drug to one of the other PD-1 inhibitors that's the standard of care.” I think that's a problem right now, and we need to get to that. At what point in time do we also say, when some of these drugs are in the same class of drugs, “Hey, all these drugs are the same. We're going to bid them. You give us your best price, and that's the one we're going to use in our system.” I think the problem right now is—like with the PD-1s—they all have niche indications, and so they're not comparable right now. We're going to have to figure out ways to get through some of this.

When you think about some of the other immunotherapies and we start talking about bispecific drugs and CAR [chimeric antigen receptor] T-cell drugs, now you’ve got high costs, and you're going to have to show the value. We have a lot of questions in those areas, like multiple myeloma, where you have CAR T, bispecifics, and bone marrow transplantation, how do you sequence this? Are we looking at $5 million or $6 million in the course of a lifetime to treat this disease? What we really need is—and it sounds like I'm a broken record here—but we need to come back to is this cost-effective? And how do we show that it's cost-effective and that this one is the best one to start with? And then then we go to this one, and then do we go to that one? And when do we stop? That's the other problem: when do we stop?

Particularly with immunotherapy, because we're just at the very beginning of the immunotherapy world, it's going to continue to grow. I saw a study recently that said there's something like 4000 gene therapy and cellular therapy products in the pipeline from preclinical all the way to phase 3. Well, if half of those make the market, what's this going to look like? Even if a quarter of them make it the market, it's going to be a huge number. Managing the cost around them is something that we're really going to have to focus on. And when we talk about costs, I like to talk about value. Value, by definition, is outcomes over cost. I think a lot of times when we talk about maximizing value, what we do is we ask how we’re going to lower the cost and we forget about asking how we maximize that outcome. So how do we prove that these drugs are the best drugs to use, and when should we use them?

I also think everybody's going to have to start talking about when we should stop. The problem is, is we all have that patient who was on the eighth or ninth or 10th line of therapy that got a response, and everybody's afraid to stop because they're afraid that this is that patient that's going to do the same thing. It all adds up to the cost, and it hurts the value over time.