Late one Friday afternoon, Biologics by McKesson received an urgent call from an emergency room physician in rural Texas. One of his patients had received a toxic dose of fluorouracil (5-FU), a common colorectal cancer treatment.
5-FU toxicity is a serious, life-threatening condition. The most severe side effects include seizure, coma, heart attack, and severe nausea, vomiting and diarrhea1.
The patient needed treatment with Vistogard, the only antidote approved to treat 5-FU toxicity, within 24 hours. With immediate Vistogard treatment, he had a 96% chance of survival. In historical 5-FU toxicity cases using standard supportive care measures that did not include Vistogard, 84% of patients died2.
If Biologics couldn't get Houston Methodist the antidote in time, the patient would need to be sent to the University of Texas MD Anderson Cancer Center—an advanced academic center located within Texas Medical Center, which includes 60 institutions—for more advanced care. Doctors anticipated a five-day, inpatient stay.
Working well into Friday night, Biologics and the patient's pharmacy benefit manager (PBM), got Vistogard delivered to the hospital the following morning–and the patient went home that afternoon.
How did Biologics and the PBM get the antidote delivered so quickly? Why did the PBM issue approved use of a new drug not recognized in its system? Here's how the story unfolded, and how their actions benefited both the patient and the payer.
Priority #1: Get approval to dispense.
By the time Houston Methodist contacted Biologics—the exclusive specialty pharmacy provider for Vistogard—it was the end of the business day for the Cary, North Carolina-based company. Biologics pharmacist and senior director of pharmacy operations, Gregory D. Wolfe, PharmD, BCOP, and vice president of market access, Paula Bickley, worked overtime to identify the patient's insurer and PBM.
"It took a number of calls for us to be able to provide the information our PBM contacts needed to elevate our stat request," says Bickley. "It wasn't until about nine o'clock on Friday night that we actually had an agreement and an official authorization approval to dispense."
Priority #2: Deliver therapy.
With an approval to dispense Vistogard to the patient, Biologics had to get the drug from North Carolina to suburban Texas overnight. Biologics hired a courier to deliver the drug to a FedEx location in Raleigh-Durham. A second courier delivered the drug to the patient’s local hospital's inpatient pharmacy.
"It can be difficult to get a hospital to accept and take custody of a therapy on a weekend," says Bickley. "The courier needed to communicate directly with the pharmacy, so the pharmacy could alert the clinical support team on staff and make sure they prepared and administered the therapy appropriately, which they did."
Why the PBM green-lighted Vistogard
Vistogard received FDA approval in December 2015. As a relatively new drug, it was still making its way into PBM and payer systems when the emergency occurred. Biologics also wasn't yet authorized to dispense Vistogard under its contract with the PBM.
In addition to administrative hurdles, authorizing Vistogard would mean a considerable prescription drug expense for the payer. The average cost for a 20-dose course of treatment is about $80,000. Medicare currently pays up to 50% reimbursement in a hospital setting3.
The parties involved considered all factors when approving therapy, both financial and clinical. Without the antidote, the patient would need to be transported and admitted to MD Anderson Cancer Center, an internationally recognized cancer care hospital. "Even though the cost of the drug could be considered significant, when compared to a five-day stay in an academic center; well, there is no comparison," says Bickley.
After lengthy conversations on a Friday night, the decision makers understood the importance of getting the patient the antidote he needed, rather than risk a hospital stay and possibly a lost life. The decision alleviated an emergency situation and decreased overall costs for the payer – while ensuring the patient was treated in the best way possible and close to home.
The benefits of the specialty pharmacy-PBM relationship
"Although the PBM had to report out a significant pharmaceutical event for this patient, they understood that by doing so, they eliminated some medical spend on behalf of the plan," says Bickley. "In other cases, when payers contract pharmacy benefits to a third party, there's a lack of visibility between medical and pharmacy costs. When that happens, it's really a missed opportunity to increase value."
According to a report from sPCMA, a division of the Pharmaceutical Care Management Association, the specialty pharmacy-PBM partnership has the ability to increase medication adherence rates, reduce hospitalizations and lower patient medical costs. Close communication with patients to help them manage complex diseases and drug treatments can halve the number of readmissions, the report states4.
"PBMs and payers are clearly starting to understand that as the use of oral, treat-at-home, therapeutic alternatives increases, they need to be ahead of that curve," says Bickley. "They're beginning to understand the payoff of aligning their benefits with broad access to these therapies."
Getting life-saving treatment to this patient in less than 24 hours is one of many examples of the value and importance of collaboration between specialty pharmacies and PBMs. It shows that when specialty pharmacies and PBMs cultivate their relationship, they can work efficiently to help patients when emergencies strike.
What's the real happy ending to this story? The quality of life and health for this patient increased exponentially.
As Bickley notes, "Being able to procure approval to dispense a therapeutic antidote that allowed the patient to go home the next day is a real testament to the clinical effectiveness of the medicine and the collaboration involved."
- Ma WW, Saif MW, El-Rayes, BF et al (2017), Emergency Use of Uridine Triacetate for the Prevention and Treatment of Life-Threatening 5-Fluorouracil and Capecitabine Toxicity. Cancer 123(2):345-356
- "Medicare Program; Hospital inpatient prospective payment systems for acute care hospitals…" The Federal Register, A Rule by the Centers for Medicare and Medicaid Services, August 14, 2017.
- "PBM Specialty Pharmacies Improve Patient Outcomes and Reduce Costs." sPCMA, 2017.