The growing prevalence of ultrahigh-cost drugs under development is prompting health systems nationwide to rethink strategies around access, financial management and workforce preparedness.
These therapies, including cell and gene treatments, present certain financial and logistical hurdles that require special planning and collaboration.
A Dec. 9 forecast published in the American Journal of Health-System Pharmacy, highlighted the urgent need for pharmacies to develop sustainable financial models and strategic plans to address reimbursement complexities and ensure access as some ultrahigh-cost drugs can cost over $1 million per patient.
Currently, the most expensive drug in the U.S. is Lenmeldy, a $4.25 million gene therapy the FDA approved March 18, 2024 for children with a rare genetic disease.
Becker’s spoke with Susan Mashni, PharmD, senior vice president and chief pharmacy officer at New York City-based Mount Sinai Health System; Ross Thompson, vice president and chief pharmacy officer at Durham, N.C.-based UNC Health and Melanie Massiah-White, vice president and chief pharmacy officer at Fairfax, Va.-based Inova Health about how they are preparing for these therapies.
Financial challenges and reimbursement strategies
With the high cost of these drug therapies, health systems have needed to strike a balance with financial sustainability and maintaining patient access.
Dr. Mashni highlighted the critical role of Mount Sinai in securing agreements with pharmaceutical manufacturers and payers to reduce financial risks.
“We work more closely with our strategy partners and our finance partners about what kind of risk we’re willing to take and how we can work with pharmaceutical manufacturers directly to come up with different ways that we can do different financial arrangements, as well as with the payers,” she said.
At UNC Health, Mr. Thompson shared the role that payer engagement has for the health system. “Specific to cell and gene therapies, we realize our need to proactively work directly with our payors to understand coverage policies and our rate of reimbursement for providing these treatments,” he said.
Mr. Thompson also emphasized that with a growing number of patients requiring the treatments, the health system will likely feel cash flow challenges with the timing between when they acquire the treatment and receive reimbursements for administering the ultrahigh-cost drugs.
Managing insurance with patient access
To ensure coverage and reimbursement for some high-cost therapies, health systems are developing strategies to help patients better access these medications.
For Inova Health, Dr. Massiah-White explained that insurance companies often will require prior authorization for high-cost medications, which could delay patient access to essential treatments. “Beyond that, our goal is to minimize out-of-pocket patient expenses wherever possible,” she said. “We strive to leverage manufacturer assistance programs, copay cards and more to ensure patient access.”
She also said that the health system’s pharmacy patient assistance team secured over $9 million in free medications for uninsured and underinsured patients in 2024.
Mount Sinai follows a patient centric approach to ensure whether a patient would be “fit” for a high-cost therapy.
“Our first step is determining whether or not the patient is a suitable candidate for the therapy, followed by securing access as we would for other specialty medicines,” said Dr. Mashni.
UNC Health has two teams, a pharmacy revenue integrity team and a managed care team who work in collaboration with one another to approach insurance companies with a full view or perspective on plan policies.
“The coordination between these two teams ensures we approach insurance companies with a full perspective on plan policies and what it will cost to provide the service so we can then ensure our rate of reimbursement is sufficient to cover our costs. This team also tracks the individual claims through to final payment,” Mr. Thompson said.
Storage considerations and training
Ultrahigh-cost drugs often can require specialized storage and handling procedures, which means there has been a greater need for health systems to implement training for the therapies.
Dr. Mashni explained that Mount Sinai is continually reevaluating all drugs the health system is administering and prepping, especially as many new potentially hazardous drugs enter the market.
“We work with manufacturers, and then we work internally with our teams. We have team members that have accreditations from [the American Society of Health-System Pharmacists] and other places around sterile compounding and hazardous compounding, ” she said. “We also have a technician training program where we make certain that all of our staff, not only our firm assistant techs, but also even our nurses, are trained appropriately.”
To address challenges, Inova Health has a [pharmacy and therapeutics] formulary review process that focuses on evidence-based decision making for both medication safety and handling. Ms. Massiah-White said the health system also has a pharmacy service center that ensures their facilities are well equipped for supply chain complexities.
Mr. Thompson added that certain ultrahigh-cost drugs can require handling protocols similar to those of a laboratory or bloodbank, which can increase logistical complexity. However, he said the team at UNC Health has been committed to learning new procedures and mastering new techniques to deliver therapies and maintain access.
“It is important that our teammates have the knowledge and the tools they need to perform this important work and we are dedicated to ensuring these teammates have the time and training individual manufacturers provide before offering a new therapy to our patients,” he said.
