Patient Cost, Convenience Important Considerations When Reviewing Formulary Approvals in Oncology: Q&A With Andrea Iannucci, PharmD, BCOP

Andrea Iannucci, PharmD, BCOP, assistant chief pharmacist at UC Davis Health, spoke with The American Journal of Managed Care® (AJMC®) about the accessibility of new formulary drugs in oncology and innovative ways that UC Davis has implemented supportive care for patients with cancer.

This transcript has been lightly edited for clarity.

AJMC: How are you evaluating the clinical and economic implications of newly approved cancer-directed therapies before integrating them into your institutions further?

Iannucci: We have a pretty robust formulary review process for our oncology drugs. We operate as a subcommittee of our pharmacy and therapeutics committee, and we really try to take a very proactive approach to being ready to review a new drug as quickly as possible after approval. We'll work with our providers to get an assessment of what their interest is in a new product, and then we'll do our due diligence to do an assessment of the product to determine what is the overall value. I think first and foremost, the thing that's most important is, what is the evidence that supports the efficacy of the agent? What is this agent going to offer that we don't already have to offer patients? Is there an advantage therapeutically? Is there an advantage due to patient convenience, like a subcutaneous formulation vs a few hour long infusion? Is it better tolerated?

And then, of course, you have to consider the costs associated with the drugs. Some of our thought process will also make an assessment of what the review and FDA approval is. Was this an accelerated approval? What are the conditions for that product to meet or achieve full FDA approval? We have seen a number of oncology drugs achieve initial accelerated approval and then come off the market later due to toxicities or ineffectiveness. It's really important that you consider all of those different things.

But ultimately, it's difficult in this era where there's several oncology drugs, sometimes that are approved every month, and sometimes they really offer an advantage or fill a niche that no other drug has been able to fill, or that they're going to fulfill an unmet need. Just because they're expensive doesn't mean that it's not right to use them, but we also need to make sure that they're safe for patients. We try to incorporate all of those things, plus the interests of our providers and the patients that we have in terms of do we have patients that meet the population of patients for whom the drug was studied and approved.

In general, we're going to adhere to—especially for newly approved drugs and absolutely for a drug that was approved under accelerated pathways—the FDA approved indications so that we can limit unauthorized use of the agent. But that's the overall process that that we will look at. Then, depending on what the agent is and whether there are safety issues, we may also do some additional follow up.

AJMC: What innovative strategies have you implemented to optimize supportive care, such as managing chemotherapy-induced toxicity or improving adherence to prophylactic regimens?

Iannucci: There are some practical, logistical things that I think are not novel here, but I think the best thing that we do in this era of technology is we build everything into a treatment plan. All of the supportive care that goes along with whatever regimen or single agent that a patient is going to get, we're going to build that into our treatment plan, so that our treatment plans are helping guide our providers to prescribe medications with best practice, supportive care medications included. We'll do an assessment of what is the emetogenic potential of a regimen, and make sure that we have antiemetics that are optimized to meet the needs of the patient to try to ensure that their best chance for success with those regimens but other supportive meds as well, whether it be growth factor or other symptom management components. That's 1 of the key things that, I think, helps drive that.

And then I think that what we've done, and in many of our areas, to really continue to optimize that from beyond just the initial, "This is what everyone's going to get," is really to incorporate some pharmacist assessment, to work with the providers to tailor the regimen for subsequent cycles of treatment to ensure that we're optimizing supportive medications as the patient has demonstrated their ability to tolerate or not tolerate the therapy. The way we accomplish that is different in different settings. With our patients that are on oral chemotherapy. We have pharmacists in the clinic that really focus on oversight of assessment of those patients for toxicities, making sure that they have access to the meds, making sure that they understand how to use the supportive meds, and that they are using the supportive meds if they're having side effects.

Then they also operate under a collaborative practice agreement so that they, alongside with the provider, can make adjustments to supportive meds to help ensure that those patients are able to get the therapy that they need. In our infusion areas, the pharmacists do similar work. They review the patient's experience between cycles of infusion-based therapies and work with the provider to make adjustments that are tailored to meet that patient's needs. Those are some of the, I think, the key things that that we've implemented.

AJMC: What are the most pressing clinical and operational challenges in delivering CAR T-cell and other cellular therapies for hematology?

Iannucci: There are a lot. One big challenge is just the cost of those therapies, but also the toxicities associated with those therapies. It's a big commitment for the patient as well as the institution to provide that kind of treatment for patients. There are a lot of different ways that you can do it, but some of the things that can make the process take a little bit longer is making sure that we have the right authorization for the patient, because these therapies are so expensive, and the reimbursement sometimes you're going to barely cover the costs associated with the treatment and the care of the patient with what you get reimbursed. Constantly monitoring that and making sure that you have things set up so that you can proceed with giving the therapy in a sustainable way and offering it to patients in a sustainable way.

Initially, when CAR T products came out, I was honestly a little bit skeptical. They seemed to, in my opinion, not bring as much value as I thought they would have for the dollar amount that you pay for them. but as we've gained more and more experience and we're looking at using them earlier into therapy, I see that they have a hugely important role in extending life for patients, especially with lymphomas and multiple myeloma, as they've moved up earlier into therapy. I think that the reimbursement issue is significant because it could be a deal breaker if there's no way for the patient to pay for those medications. Fortunately, even the manufacturers have some assistance programs and things like that. But that's one of the biggest logistical issues.

And then there's a lot of other issues as well. Where are you going to give it? Some institutions, including our own right now, are primarily administering those on the inpatient unit, so the patients are staying in for the duration of time before they're deemed safe enough to go. Usually that's going to be anywhere from 10 days to 2 weeks, but sometimes it could be extended. We would love to be able to begin to move our patients into the ambulatory setting, and we're working on that. We're doing our lymph depleting chemotherapy in the ambulatory setting now, but I think that both for patient convenience and to help lower costs associated with the whole process, if we could do more of that in the ambulatory setting would be ideal. But we also need the infrastructure to be able to support those patients, to make sure that they're being assessed every day and that they have access to emergency care as quickly as they need it, because of some of the toxicities of those.

Then I think some of the other challenges that we see with those is we've got so many new oncology drugs that are coming into this space of CAR T and other cell therapies, like bispecific agents that have very similar indications, and learning where those fall in therapy in comparison to CAR T. Should you give a bispecific before CAR T, or is that something that you should reserve for after CAR T? Where are you going to get the biggest benefit from these therapies? I think we're continuing to learn what the best, sequence is for these types of agents. But I feel like what we're beginning to see is that earlier use of car T is where we're seeing some of the best outcomes.

AJMC: Can you share examples of process improvements or technology adoption that have significantly reduced delays or improved care coordination for oncology patients?

Iannucci: Some of the things that we are working on in our health system right now are trying to centralize our authorization process for all of our infusion locations. I've talked about authorization a lot, and it, unfortunately, is an important component of what we do, because these therapies are so high cost, and we don't want patients to be handed a bill that they weren't expecting for some uncovered, expensive therapy. It is the reality of how we function. We have to make sure that we have authorization for the treatment that we want to administer, but however we can streamline that process and minimize the delays in care for our patients, I think is going to improve that. By having a centralized team to do that authorization work, they're really the subject matter experts for this type of therapy, these infusion-based therapies. They know who to talk to, they know the right lingo to use, and the authorization times as we've moved to the centralized model have actually decreased over time. I think that is providing a benefit to our patients for sure.

Then some other things that we're looking into—and we're doing some work with a new population health group at the cancer center—is, where are we using resources that we could be doing more preventive things or acting more quickly. One of the things that we're looking at is more urgent access to infusion treatment. We have patients that might have complications from cancer-directed therapy and have to go into the emergency room for antinausea meds or hydration, electrolyte replacements, and things like that. What we don't want is for the prior authorization process to become a barrier to care. But it had been a barrier to care in that we couldn't schedule patients for infusion appointments without validating that we had the authorization process. We've been working on, over the last several months, a process to escalate infusion appointments for these urgent type scenarios, where we could do a retroactive authorization instead of a prior authorization, knowing that these are therapies that will really make a difference to the patient that could prevent them from having to the emergency room, or even an unnecessary hospital admission, if we could provide support for them more efficiently in the infusion setting.

Then something that the cancer center in general has done is they actually have an urgent care at home process, which has also helped improve things immensely for our patients, for symptom management, because we do provide a lot of regional care. The Sacramento area is a large region, and with traffic in the area, could take you 30 to 45 minutes, or even longer, to get in. But having resources that some of this care could be brought out to you at your home has been really valuable and also very convenient for patients.