Expert Q&A: Managing Ultra-High-Cost and Gene-Based Therapies in Health Systems

In an interview with Pharmacy Times, Anthony Boyd, PharmD, BCPS, senior director of pharmacy, oncology, and infusion services at Cleveland Clinic, discusses the complex, multidisciplinary infrastructure required to manage ultra-high-cost, gene-based therapies within health systems. He emphasizes the importance of clearly defined roles, closed-loop communication, and early engagement with stakeholders, including pharmacy and clinical teams, payers, and electronic health record (EHR) specialists. Boyd highlights proactive strategies such as weekly cross-functional meetings, dedicated pharmacy teams, and early EHR build planning to mitigate operational risks. As these therapies expand beyond hematology-oncology, he stresses the need for scalable clinical, operational, and payer-focused frameworks to ensure patient access while minimizing risk.

Pharmacy Times: Please introduce yourself and explain your current role.

Anthony Boyd, PharmD, BCPS: My name is Anthony Boyd. I’m a senior pharmacy director here at the clinic supporting our oncology and infusion service lines. I help oversee our campuses in both Ohio and Florida, [and] help provide a number of these services within our international markets as well.

Pharmacy Times: Who are the essential stakeholders involved in managing an ultra-high-cost therapy, and how must roles and responsibilities be clearly defined to avoid delays or errors in care?

Boyd: It’s a really good question. We recently did a presentation on this at [ASHP] Midyear—Vanessa and I did a presentation at Midyear. In general, there are a lot of stakeholders involved within the health system, as well as within the pharmacy department alone. Taking a step back and zooming out, there are a number of folks at the C-suite level who are typically involved in management and understanding these therapies, including the chief pharmacy officer, chief financial officer, and chief medical officer.

There are obviously physicians and care providers directly caring for these patients. Given the high cost, looping in the managed care team is critical, including the prior authorization team. Often, these therapies are managed in conjunction [with] the pharmacy and the cell lab in terms of product handling, so extreme coordination between those groups is required.

Within the pharmacy group, there are various pharmacy leaders, clinical pharmacists providing direct patient care, and those responsible for procurement and supply chain, as well as those responsible for EHR build, because it is very complex. The number of stakeholders involved is incredibly extensive, but all of them are needed for the infrastructure. From a direct patient care standpoint, we also have specialists and patient nurse navigators who help guide the patient through the care journey.

We’ve really tried to map out the different steps in the process and make sure there is clear ownership of who is handling each step. We also have a caregiver on our team who has helped map out what the ordering process looks like, the mechanism for communication for those orders, and how we close the loop. Closed-loop communication is incredibly key throughout these processes, and we’ve created an internal SOP [standard operating procedure] to help define many of these roles.

Pharmacy Times: From referral to administration, what are the most vulnerable points in the procurement process for ultra-high-cost drugs, and where do you see systems most commonly break down?

Boyd: It’s a really good question. I would say closed-loop communication is an incredibly important tool here. Within our organization, it’s often the clinical team or the nurse care coordinator who is interacting directly with the patient and helping them through the steps of the journey, including working in various manufacturer portals to get these drugs prepared. They do a lot of the direct interfacing with the patient.

However, there needs to be a warm handoff to the pharmacy team to know when to order the drug, when to ensure it arrives at the right time, and to account for any clinical delays. Once administration occurs, it’s also important to make sure the financial pieces are closed out. We do a lot of that warm handoff communication via email, which works well, and we have multiple redundancies built in to ensure coverage when staff are out.

The vulnerabilities really lie in the handoff communication. With these patients, things can change clinically; there may be manufacturer-level delays, and there are many opportunities for timelines to shift. Making sure there is clear communication and having dedicated pharmacy stakeholders who review these cases regularly helps ensure we understand the full clinical picture and can close the loop from referral to administration.

Pharmacy Times: How can pharmacy leaders identify and mitigate operational failure points—such as prior authorization, payer alignment, or product logistics—before they affect patient access?

Boyd: One unique thing we developed within our organization is a weekly meeting that includes administrators, clinical teams, payer teams, and pharmacy stakeholders responsible for ordering and procurement. These groups meet weekly to assess patient cases and ensure alignment, which helps mitigate issues in real time rather than relying solely on email communication. That weekly structure has worked really well.

When thinking about the future-state pipeline and administrative burden associated with these therapies, the question becomes how we continue to grow efficiently. We now have a dedicated team responsible for ordering these agents, whereas historically this was something I managed as part of my role, among others. Establishing a dedicated pharmacy team has been a huge help.

Pharmacy Times: What EMR build components are critical for safely and efficiently managing ultra-high-cost therapies, and what mistakes do organizations often make when designing these workflows?

Boyd: Early engagement with the EHR team is critical, especially as these therapies come to market. One strategy we’ve used is engaging the manufacturer early, reviewing their EHR build guides, and meeting with our EHR team to map everything out. These therapies are complex, with multiple cell components, charge placement considerations, pediatric vs adult dosing schemas, and in some cases multiple days of therapy. All of that must be built safely into the EHR.

Early engagement has been key for us. We haven’t encountered too many mistakes because of this proactive approach, but we’ve learned lessons along the way. Phoning colleagues to see how other organizations are building these therapies into their EHRs has also been helpful, particularly [as] many of us are on shared health record systems. There is also an opportunity for manufacturers to provide strong, standardized EHR build guides for complex therapies to help streamline implementation when new products launch.

Pharmacy Times: As more ultra-high-cost and gene-based therapies enter the market, how should health systems evolve their operational infrastructure to scale without increasing risk?

Boyd: I think about this in a few buckets. One is ensuring there is sufficient clinical infrastructure to support these patient populations. Historically, many of these therapies have been concentrated in hematology-oncology, but we’re entering a world where they will expand across additional disease states and patient populations. Having conversations now about where patients will be treated, referral pathways, and ownership within disease-state teams is critical.

For multisite organizations, another challenge is taking expertise from certain sites and deploying it across others as demand grows and more locations begin administering these therapies. On the payer side, scalability is also a concern. These therapies are administratively intensive, and engaging payer teams now to plan for future landscapes and efficiencies will be essential.

Ultimately, ongoing collaboration, sharing expertise across disease states, and learning from one another, such as through Midyear discussions, will help pharmacy teams and clinicians successfully navigate this evolving frontier.