Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: [Dr Mullangi,] I’ll go to you and talk a little bit about practices in terms of payers and health systems. From my experience, when you don’t have an FDA approval, you often have to fight tooth and nail to get something approved by deeming your patient clinically ineligible for that certain drug. There also may not be data to support the utility, depending on what we’re going to hear later today. How has your experience been with these CDK [cyclin-dependent kinase] 4/6 [inhibitors]? Your experience is probably going to come from the metastatic setting, but how are health systems and payers handling these medications?

Samyukta Mullangi, MD, MBA: I’ll speak a little bit about the pathway program that [Dr Andersen] has mentioned. Cancer is expensive. Everyone knows that. About 3% of people live with cancer. They account for over 10% of health care expenditures. Breast cancer, in particular, outpaces every other malignancy in terms of overall cost burden. And I think that’s driven a lot by the incidence and prevalence of breast cancer, as well as the fact that our therapies are very expensive. Clinical pathway programs are often a tool that has been developed over the last few years and is increasingly used by both payers and providers to try to standardize drug prescribing and limit any kind of inappropriate use. Obviously, the cost of therapies is driven by price. It’s also driven by utilization. Looking at cancer, it feels like the elephant in the room. The biggest contributor here is the price, which we don’t have an influence on as individual oncologists, but there are different levers there to try to handle that. The Inflation Reduction Act [of 2022] now has drug price negotiation provisions, so maybe we’ll see the movement of prices over the next few years. But in terms of inappropriate utilization, I think pathways have been developed to try to standardize that and try to limit any kind of excesses to the extent that they exist. But provider-led pathways and payer-led pathways can differ greatly. I think what [Dr Andersen] described as a provider-led pathway, it’s integrated directly into the medical record. It’s a helpful real-time decision support tool. Payer-led pathways, which are a little bit more common, can differ in terms of how expansive they are [in terms of] what drugs do they include and the degree of focus on cost as a factor in determining inclusion or exclusion on the pathway. Also, their placement on workflow because they’re oftentimes not there as a real-time decision support tool. Sometimes they’re just something that a physician has to be aware of in the ether. And then later when they’re submitting prior authorization paperwork, [they] recognize that what they had recommended to a patient was or wasn’t on the pathway. Some payers, Elevance Health, [for example], will pay physicians a fairly large amount of money, like $350 per patient per month, if they prescribe a pathway-compliant regimen. And that’s nothing to sneeze at. We’ll talk about this later in this discussion, but CMS’s [Centers for Medicare & Medicaid Services’] upcoming enhancing oncology model only pays practices $70 per patient per month. That’s a big difference, 5 times as big. Payers are very interested in trying to ensure that physicians are prescribing pathway-led regimens, but there are limitations to the pathway programs in general. They’re not exhaustive. They don’t incorporate considerations for radiation oncology, surgery, diagnostics, symptom management, or supportive care, and are hyper-focused on anticancer drug therapy prescribing. They are only developed for common cancers with some evidence.They’re generally rare cancers or cancers with missing data or are left out it. They tend to also focus on areas where there is a high degree of variance in real-world prescribing patterns. Right before this panel discussion, I looked up a pathway provider that many national payers use. And I noticed that the adjuvant abemaciclib indication wasn’t even present on it. That’s not to say that physicians can’t prescribe it, or that it wouldn’t be on the pathway, it’s just that it hasn’t been addressed. It’s not been codified in the same way that maybe a provider-led pathway may have been more attuned to and trying to update more frequently.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: Yeah, I’ve looked intensively in this whole pathway space. And as you said, there’s a lot of variability, and even the vendors of the pathways forget the payer side from the health system side, and the variability and source of data that these pathways collect in terms of making treatment recommendations. Sometimes it’s solely NCCN [the National Comprehensive Cancer Network], sometimes it’s an FDA approval, and it does become challenging. You tend to see this variability across practices. [Dr Andersen], I know you walked us through the use of pathways and you select all these factors and characteristics, but let’s say you want to go off pathway. What does that process look like? And how is pathway adherence evaluated or looked at? Is it something that you have to adhere to? Can you tailor it to the patient preference? I could speak a little for our practice, but I’d be interested to hear from you.

Jay Andersen, MD: Great questions. I would say the off-pathway algorithm may vary from practice to practice in our network. In my practice, if you want to go off pathway, you click on what you want and you have to describe why, with rationale. In our particular practice, it then goes to our practice P&T [pharmacy and therapeutics] committee and they have, I think, 48 hours to respond, yes or no. And in our practice, if they say no, you can’t give it. Other practices are not as restrictive. In general, our thought is you should be 80% or more compliant. So the nod is, we should have deviations. If you’re never deviating, maybe you’re not really an up-to-date, forward-thinking practitioner, because there are reasons to deviate. So, that’s how our system works.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: Are cisplatin shortages a reason to deviate?

Jay Andersen, MD: As a matter of fact, just before I mentioned I’m on the pathway, that came up in an email yesterday: are we going to modify our pathway based on that? I have yet to hear an answer back. I don’t know that we routinely, historically have done that, but maybe there’s a reason to favor curative settings vs not. But those are other issues.

Heather McArthur, MD: Can I ask a question? How quickly do those pathways get updated? We mentioned ribociclib in first-line metastatic data that were presented, and I went home and changed my practice and started prescribing ribociclib. How quick is your pathway’s response to that, and how do you incorporate that into your practice?

Jay Andersen, MD: We meet monthly. Usually there’s a general agenda; [for instance,] breast [cancer] has certain months of the year for annual updates, but if there’s a hot topic, we can add it to the agenda. We can be very nimble. On our pathways, NCCN representatives are on the call, and our philosophy is [that] we can be narrower than NCCN, not broader. We use their template as a general template, but then we may tailor [treatment], which we do in a lot of cases, more so. To that question, we still have all 3 agents listed on our pathway, like on NCCN. We have no restrictions at the moment. But as the OS [overall survival] data with [ribociclib] have evolved, that has come up for conversation. We don’t have a final answer on that yet, but I think clinicians are using that data individually.

Heather McArthur, MD: Interesting.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I have seen within the network, we were using the same pathway. I have seen updates happen as quickly as a month timeframe in terms of practice changes, like significant practice impacts. And I have seen in other disease states where it’s…been 6 months since the data have been out, but we have yet to make a significant shift because the therapeutics are equivalent. But [it] could be that there is some type of financial component to it where you’re trying to negotiate contracts on prices, and this is really where you bring in these different things that go into a pathway that lead to some of the limitations we’re seeing.

Transcript edited for clarity.