Coverage decisions about prescription digital therapeutics may take payers out of their comfort zones and require new processes and subject matter experts, according to members of a panel at the AMCP annual meeting. But P&T committees are likely to still be central to the process.
Digital therapeutics are going to take payers evaluating them for coverage into some uncharted territory. But members of panel on evaluating prescription digital therapeutics (PDTs) at the annual meeting of the Academy of Managed Care Pharmacy also said some familiar thinking and processes could be called upon.
With some adaption, evaluation of PDTs lend themselves to the pharmacy and therapeutics (P&T) committee structure and process that payers have, said Joseph A. Albright, Pharm.D., director, commercial pharmacy programs, BlueCross BlueShield of North Carolina.
“It sounds like a ‘duh” thing, but for us, it really wasn’t,” Albright said during the session on Wednesday. “We were looking at this as more of a one-off solution.”
Albright and his fellow panelists, Sam Sui, Pharm.D., utilization management clinical pharmacist for Fallon Health, a health insurer in Worcester, Massachusetts, and Terry Cothran, D.Ph., senior pharmacy director of the Oklahoma Health Care Authority, said they saw a need to bring additional expertise into the review process but they said it was too soon to consider additional hiring. “There are too many balls in the air right now,” said Albright.
Although they didn’t mention the company or its PDT by name during the session, the early experience that Albright, Sui and Cothran described was with a Pear Therapeutics PDT. The Boston-based company is struggling financially and announced on March 17 that it was exploring “strategic alternatives to maximize shareholder value” including acquisition, divestiture of assets or licensing.
Sui mentioned that the PDT “actually had very low utilization” in an accountable care organization in western Massachusetts where it was thought it might be higher because of the prevalence of opioid use disorder in that part of the state. Sui said Fallon is in the process of working with the leaders in that health system and individual clinics on why they are not prescribing the PDT.
Cothran referenced low uptake: “As you might imagine prescriber engagement took awhile to uptick, so it was slow at the beginning of the year and it progressed as we got toward the end of the year.” Cothran said that there is a “positive trend” in costing savings from the PDT, but more complete results will be available after midsummer. The Oklahoma Medicaid program made an upfront payment for the PDT with eye toward seeing lower costs for hospitalization and emergency departments among those who use it. “The idea was the savings we see there will equal or exceed the initial upfront investment,” said Cothran.
Albright said that employers were still considering whether to offer the PDT in their coverage so he didn’t have any information on uptake. Despite Pear’s apparent struggles, Albright said that the efforts to set up a review process for PDT was not a dead end because there are other PDTs.
The three panelists agreed that PDTs should be paid for through the pharmacy benefit because it was simpler, and that they would be easier to track that way. But they also spoke about the contrast between the well-worn and well-understood path of FDA approval of drugs with all of its alerts and databases and the lack of familiarity with FDA clearance and authorization of PDTs.
“We need to create a new workflow for digital therapeutics so it is not just a ‘hey look over here, a manufacturer has shot us an email.’ We need to create a process so each one is reviewed fairly,” said Albright, who mentioned that he has team that is going through a backlog of PDTs.
Albright said there was a need to bring in new subject matter experts into the review process for PDTs. He said that cognitive behavioral therapy was the therapeutic alternative to the PDT that the North Carolina Blue plan covered. There is a psychiatrist on the P&T committee, but the PDT raised questions about how does it fit into the organization’s overall strategy for behavioral health. As a result, the review process involved conferring with leaders in the organization’s behavioral department.
“To be honest, it can be seen as an extender or even somewhat of a competitor to cognitive behavioral therapy,” said Albright, “so we wanted to make sure that we were hitting the right bases, crossing t’s and dotting i’s, so that we weren’t setting something where providers might be opposed to it.”