Cell and gene therapies have exploded in the last 15 years, offering new avenues for treating cancer and rare diseases. But these advanced therapeutics come with high costs and clinical complexities, making it essential for all stakeholders to be actively involved in their procurement, management, and delivery.
Ultra-high-cost drugs “don’t follow normal channels. You can’t just hit a button,” said Anthony Boyd, senior director of pharmacy, oncology, and infusion services at the Ohio-based Cleveland Clinic.
In High-Stakes Operations: A Deeper Dive Into Ultra-High-Cost Drug Management, presented Dec. 10 at the ASHP Midyear Clinical Meeting & Exhibition, Boyd and his colleagues shared lessons learned from their health systems.
Key players in the planning and administering of ultra-high-cost drugs — which can range from $500,000 to several million dollars per treatment — include a hospital or health system’s chief medical officer, chief financial officer, entire pharmacy department, primary care providers, and representatives from the scheduling, referral, informatics, and legal teams.
The most important person at the table, the Midyear presenters emphasized, is the patient receiving the therapy. In addition to facing a life-threatening health condition, they may need to travel great distances for treatment and require inpatient admission for steps such as cell collection.
“There’s quite a bit of work to make sure that the patient’s being cared for and getting what they need. All of these stakeholders need to be involved from the very beginning, whether you’re aware of the timing of the patient case or not,” said Venessa Goodnow, assistant vice president and chief pharmacy officer at Jackson Health System in Miami, Florida.
Boyd and Goodnow shared some operational best practices for managing ultra-high-cost drugs to ensure a positive patient experience and care outcome while promoting financial stewardship:
- Assign a dedicated interdisciplinary team to oversee the institution’s ultra-high-cost drug program, possibly as a subcommittee of the Pharmacy and Therapeutics (P&T) committee. “There’s no right or wrong way. It’s just whatever works best for your organization,” Goodnow said.
- Build out electronic health records (EHRs) to account for complex dosing, to ensure both medication safety and accuracy of billing and coding.
- Clearly define the roles and responsibilities of the pharmacy, cell and gene therapy, and cellular laboratory teams who must work closely together to deliver care.
- Collect data about important steps, decision-makers, and timelines for each patient case. This information can help you set reasonable expectations, avoid treatment delays, and inform revenue cycle management in the future.
- Be prepared to hone your contract language and review processes. Cell and gene therapies are typically sourced directly from a manufacturer under single-case agreements, even when a hospital or health system has an existing partnership with that company.
- Become familiar with the payer reimbursement structure for each agent, which can differ from other buy-and-bill products and is often outcomes-based.
Planning ahead will become even more critical as cell and gene therapy options expand, Boyd noted. Thousands of therapies are in the pipeline, and non-oncology disease states are a growing area. “It’s going to continue to get more targeted. So the question is, how do we continue to adapt and evolve and develop infrastructure that will allow us to be successful?” he posed. “It’s not something you can build overnight.”
Each health system can design policies and processes that suit the scope of their ultra-high-cost therapy practice — and this is an opportunity for pharmacists to lead.
“Try to be as proactive as possible,” Goodnow encouraged Midyear attendees. “Even if you don’t have a patient right now, go ahead and get that committee structure together so when that referral comes in, you’ve already got the team assembled.”
She added, “The more and more patients you care for, the more you learn.”
To learn more about how pharmacists are identifying and managing challenges with the integration of ultra-high-cost medications into patient care, review the 2024 report and infographic from ASHP’s Pharmacy Executive Leadership Alliance® initiative.
