Do P&T Committees Need Help With Cell and Gene Therapy? | AMCP 2024

Expensive cell and gene therapies are fast becoming a feature in U.S. healthcare, not the rare exception. The tried-and-true ways of pharmacy and therapeutics (P&T) committees may not be suited to dealing with therapies that cost millions of dollars and may require special handling. At least that is what pharmacists and others at the UC Davis Health health system in Sacramento, California, discovered. They set up an emerging therapies committee to better handle some of the high-stakes intricacies of cell and gene therapies.

Jenny Craven, Pharm.D., is in the new role of senior emerging therapies pharmacist and leading the effort. Craven and Sarah Bajorek, Pharm.D., MBA, assistant chief pharmacy officer, ambulatory care, at UC Davis Health, spoke about the health system’s new emerging therapies committee Tuesday at the annual meeting of the Academy of Managed Care Pharmacy in New Orleans. They were interviewed by Managed Healthcare Executive prior to the meeting.

Craven said the committee has 15 to 20 members, a group that includes pharmacists, clinicians, an ethicist and executives and managers from the business departments of the health system. When a drug is being “onboarded,” a workgroup is created to oversee the details of the process. The committee and the workgroup structure has been “successful in terms of efficiency and speed and getting the drugs on board a little bit easier than when we didn’t have the right people in the room,” says Craven.

Some of those “right people” are from the health system’s contracting team that works on getting letters of agreement or single-case agreements in place so the health system can be sure the insurer will cover the cost of the drug.

“We’ve seen is that when we are able to establish these agreements, which are outside of regular contracting, we’re able to get that analysis done relatively quickly. It is not an afterthought,” Craven said.

Craven and Bajorek said the UC Davis’ processes and the emerging therapies committee was part of the reason that a patient was treated at the health system with Elevidys (delandistrogene moxeparvovec), the first gene therapy for Duchene muscular dystrophy, 43 days after the treatment was approved by the FDA.

It also helped that UC Davis was test site for the clinical trials of Elevidys, Bajorek noted. The COVID-19 pandemic also factored in. “One of the benefits of COVID is that we got really good at dealing with ultra-low temperature freezers and processes with that” she said.

Elevidys is a single-dose treatment that is infused intravenously. To prepare for the infusion, UC Davis did a mock run of the drug’s administration that involved rehearsing the transfer of the drug from where it is stored to the pediatric infusion center. “The nerves are higher, obviously, when it’s a real medication, but the team did a great job, and I think that having that [mock run] was really helpful,” Bajorek said.

The unexpected does happen, though. “Once we had our first drug, there were challenges with the barcode scanning of the product,” said Bajorek. “So we contacted our IT person. They were able fix it, resolve it, in less than 10 minutes. So having those connections and knowing who to contact is necessary.”