Aligning Stakeholders in Oncology’s Evolving Drug Distribution Landscape

A guest expert from Asembia 2025 explores how reimagining limited drug distribution models in oncology can eliminate care fragmentation, enhance patient outcomes, and foster stronger collaboration among providers, pharmacies, payers, and manufacturers.

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Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, FAPO: My name is Kirollos Hanna. I'm a pharmacist by training. I am the director of pharmacy with a private community oncology practice in the Twin Cities, Minnesota Oncology. We are part of the larger US oncology network, which spans the US in terms of community oncology practices. Prior to my role here, I was a clinical pharmacist on the inpatient side at Mayo Clinic. I'm currently an assistant professor at the Mayo Clinic College of Medicine. Following my clinical career with Mayo Clinic, I did spend about 6 years with the M Health Fairview brand in a clinical role as well as a manager role prior to moving into overseeing pharmacy services for our private practice. 

Please share a brief overview of the presentation you participated in at Asembia 2025. 

Dr Hanna: At Asembia 2025, I was fortunate to be part of a panel with Mike Reff, Desi Kotis, as well as Jill Fitch from BeOne and Frank Scimeca from Florida Cancer Specialists. This was a really great panel titled "Beyond Limits: Rethinking Drug Distribution to Drive Patient-Centered Care”. The aim of our panel was to bring together multiple stakeholders from academic oncology, from a pharmaceutical partner, an organization [called] NCODA (Network for Collaborative Oncology Development & Advancement), as well as myself from private practice, and Frank. The goal was to spend a little bit of time talking about the limited distribution network of oral oncolytic medications. 

When you look at the limited distribution network—and how we defined limited distribution 5, 6, 7 years ago and where limited distribution sits today—there have been a lot of changes and a lot of variabilities. At the end of the day, the core and center of limited distribution models is to ensure that we're providing the best patient care for the patients that we treat within our cancer centers, whether we're talking on the academic side or whether we're talking about the community oncology site. We delved pretty in-depth in terms of what it means to have a limited distribution network, what value that actually brings to patients. When we are not part of that limited distribution network, we also highlighted the fragmentation that we see when prescriptions are going out of health systems and going to, for example, pharmacy benefit manager (PBM)-owned pharmacies. We talked about the limitations as they relate to the monitoring of these patients, increased wastage to the overall health care system. We also talked about how the continuity of care is best reflected when we do see medications staying within a limited distribution model. Not only did we get that—one of the extremely valuable areas that we also got insight was from our pharma partner being part of this panel, and they were able to also demonstrate that when they partner by providing access to certain oral oncolytics to academic community pharmacies, as well as specialty pharmacies, everyone wins, not just from a patient-centric perspective. Pharma is able to get pretty robust data that demonstrate dose intensity, longer time on therapy, quicker interventions. All of these things were the goal of the panel. We highlighted a couple of new terms as they relate to specialty pharmacy. 

As I mentioned, the limited distribution definition has drastically changed over time. We talked about the various types of models—what it means to have a closed distribution network, meaning you have a very highly restricted network where the manufacturer works to designate control of where the medication has access. We also talked about the oncology-optimized limited distribution network. We understand sometimes just one particular entity may not have access, but we talked about what it means to have that encoder preferred model overall in terms of the limited distribution model. Then, we talked about PBM-influenced distribution models, where they limit it to just the handful of PBM distributors, and then the open distribution network, which has been aligned with more of that fragmented care that I've briefly highlighted. 

How have Limited Drug Distribution (LDD) models changed the landscape of oncology patient care, and what challenges do they present to practices and patients alike? 

Dr Hanna: When we look at drugs that are available under a limited distribution model, the extreme value that we see is that cancer centers can timely assess their patients and timely provide the medication to their patients without having to jump through multiple hoops of coordinating the care of an oral oncolytic prescription, for example, through the various distribution channels that we see. When you think of the “buy and bill” side—that book of business—a patient comes and sees a provider, they get their labs checked, they go over to the infusion center to receive their care. In 99% of cancer centers, that is the standard model. When you look at the oral oncology model, however, it's important to highlight that oral oncology probably makes up about 30% to 35% of our book of business. When we look at that particular model, these patients are still coming in to see a provider, getting their labs checked. In an ideal world, they should be able to get their oral oncolytic prescription directly from the pharmacy—the medically integrated pharmacy that is within that particular institution—on their way out. That's going to be reflective of dose modifications, dose changes, but we also know that these patients have been assessed in an appropriate manner as it relates to the cycle length of their chemotherapy. 

But when you look at the open network models—and when we're limited and required to send prescriptions externally—we have to take multiple other factors into consideration. We're going to have to work ahead of time, maybe prematurely assess or evaluate our patients or prematurely send a prescription into an external pharmacy that has to call the patient and doesn't have access to the electronic medical record, things like the patient's labs, things like EKGs that may be pertinent, and any progress notes or any assessments that may have impacted that patient. They then have to coordinate that prescription, getting mailed out to the patient, getting it to the patient and [getting] the patient started. As you can see, that specific model requires hurdles to jump through and can lead to various issues, such as wastage. Again, in the event that that patient needs a dose modification or a dose change or a dose delay. That's really where the value of limited distribution comes in. 

What does successful collaboration between oncology practices, specialty pharmacies, manufacturers, and payers look like in today’s environment? 

Dr Hanna: I think when we look at collaboration between the key stakeholders at play here, it’s very, very important for us to work together to ensure that we build out a model with the patient in mind. A patient-centric model is the key to success. There are multiple factors, and I completely understand that there's a business that we must run, all of us, whether you're on the pharma side, on the payer side, or on the dispensing pharmacy health care system side. However, when we look at the cost of care—when we look at dose modifications, dose wastage in safety events that have occurred—they have significantly impacted the overall cost of care as well as just wastage. When we look at the models where we have limited distribution, it does truly bring a lot of cost avoidance to the overall model. Good collaboration is health systems and community oncology practices working closely with pharma partners to help them understand some of these clinical benefits of having a limited distribution model, continuing to stress that point, and demonstrating and providing data that align with patients being on treatment, quicker intervention, timely assessment of symptoms, and timely intervention around any type of adverse event and symptom management that may occur. By being able to do that, we can demonstrate value back to the pharmaceutical partner. 

In contrast, when we look at the pharmaceutical partner, great collaboration is that pharmaceutical partner working with these independent merit-based incentive payment systems (MIPS) or our specialty pharmacies that can be part of this limited distribution model or this optimized limited distribution model. Giving us access to their therapeutics, trying not to have this open network. Because when we end up having this open network, often times when we look at the payer,[and] the payer is setting forth certain mandates that require us to send those prescriptions out to an external pharmacy that may not have access to all these resources that we have that can help support our patients. All of that has to work hand in hand. 

It's also going to be important, I think, for health systems and private practices that have MIPS that we're able to demonstrate to the payer the value that we can bring by filling for their particular patient population. Not only is it important to represent that data to pharma, but it's also important to have that relationship with the payer as well. Because if we can demonstrate cost saving and cost avoidance to payers, that's also going to be very attractive versus having these mandates of certain prescriptions going through PBMs and external pharmacies outside of the particular health system. There is a lot of value there, but it does require—whether you look at it as a triangle or whether you look at it as a box—multiple stakeholders that should be held accountable in terms of data reporting and transparency. [This will] ensure that, at the end of it all, we want to make that patient the center of it all, while understanding there are great economics that are driving many of these factors. But it's still very, very important that, if we look at that patient, we can demonstrate that value and that we can have successful partnerships. 

What policy or regulatory shifts would best support equitable access to life-saving oncology medications under LDD frameworks? 

Dr Hanna: I think when we look at [this] from a policy perspective or a legislative regard, we've seen this in the past 1 to 3 years or so—the government coming in and taking a closer look at historically and still currently various unregulated PBM practices. The Federal Trade Commission (FTC) has put out a report around some of the things that have been going on with PBM practices in terms of some of the economic drivers, and the various things that have been going into that book of business, and I think it's going to be important for us to continue asking these questions. The overall health care spend has continued to rise. We have a lot of exciting moving parts within the overall system, things like the Inflation Reduction Act, which is looking at containing costs and controlling costs. But I still think we always have to look at the bigger picture in terms of where there are gaps in the overall system. 

From a legislative perspective, having better control over some of the payer abilities to mandate health systems and MIPS to not have access to care. Because of these prescriptions going out—and these PBMS owning their pharmacies or owning their specialty pharmacies—they're sending it in-house to themselves. When you think about that overall model it really has provided significant fragmentation, as I've mentioned. I think any type of regulatory processes around that would be of great value, but it also just can't come from the push for this or from community oncology or Integrated Delivery Network (IDN-owned specialty pharmacies in making this push, we need that partnership also from pharmaceutical manufacturers. That was, again, going back to our Asembia panel, where we found great value by partnering with one of our pharma partners. Continuing to stress that message, I think, will help move the needle forward.