AMCP Nexus 2021: What’s Promising, What’s Problematic About Prescription Digital Therapeutics

A panel discussion on prescription digital therapeutics identified them as a sweet spot for value-based agreements and collection of real-world evidence. But should they be paid for through the pharmacy benefit? And is there enough evidence available for payers and PBMs to make sound coverage and formulary decisions? For answers, stay tuned.

There are only six currently on the market and eight in late-stage development, but prescription digital therapeutics (PDT) could usher in an era of value-based contracts, easier collection of real-world evidence and greater access to care, according to members of a panel on PDTs at the AMCP Nexus 2021 meeting in Denver.

The panelists also discussed possible pitfalls and sticking points for the new therapies, including whether they should be paid for on the pharmaceutical or medical benefit and the lack of standards for supporting evidence that would help payers organize PDTs into formulary tiers.

Pear Therapeutics in Boston, a leading PDT developer that has three therapies on the market, sponsored the Tuesday afternoon session. Yuri Maricich, M.D., MBA, chief medical officer and head of development at Pear and one of the panelists, expressed confidence that patients will use PDTs. “Patients do everything on their mobile devices. They expect they should get treatment on their mobile devices.”

There are thousands of health-related apps that are on the market without FDA approval. The handful PDTs may have some of the same feature and capabilities as a sophisticated app, but they has been approved by the FDA in a category of a medical device that requires safety and efficacy evidence from a randomized trial.

Patrick Gleason, Pharm.D., BCPS, FCCP, FAMCP, assistant vice president, health outcomes, at Prime Therapeutics, a PBM owned by Blues plans, and Robert O’Brien, vice president, specialty, at Real Endpoints, a market access consulting firm, were on the panel with Maricich. John Fox, a consultant and president of Foxworthy Healthcare Consulting, was the moderator.

Pear and Prime announced in September that they had into entered into a value-based agreement for two of Pears PDTs, reSET, for substance use disorders, and reSET-O, for opioid use disorder. Both the PDTs provide cognitive behavioral therapy but have safety warnings that they should not be used as standalone therapies. Pear and Prime are not disclosing the financial details of their agreement but have announced that some of Prime’s payments for PDTs will hinge on the hospital inpatient stays and total healthcare costs of the patients who are prescribed the PDTs and the physician engagement of the physicians who prescribe it. Prime is making the PDTs and the value-based agreement available to its member Blues plans but it will be up to the individual plans whether they want to put the PDTs on their formularies.

Gleason talked about the advantages of value-based agreements during the AMCP Nexus 2021 session. How value-based agreements with commercial payers affects a drug’s Medicaid best price has been a sticking point with value-based agreements for drugs but devices are not subject to the best-price rules. “This is the space I finally want to be in,” Gleason. “With drugs you are just so limited on your ability to do value-based contracting because of Medicaid best price.”

Gleason also said that the value-based agreements for drugs are complicated and expensive for PBMs and payers because the burden of keeping track of whether a drug is meeting the agreed-upon outcomes falls on them. “In this case, it is the manufacturer that is going to do the reporting,” Gleason said. “The payer can audit if they are concerned about that the information that is being provided back and fulfillment of the terms of the contract. But it is a lot less of a burden on the payer in value-based contract as result of the way the data is being collected.”

O’Brien also expressed enthusiasm about the data that the PDTs will generate: “What excites me about this whole space is that the real-world data is going to be flowing much more readily in this space than what we have traditionally seen with drugs or biologics.”

O’Brien said later, “I think this (PDTs) is the door, the window, that will allow all of us to have a much more readily accessible flow of data on the real patient experience.” Maricich also spoke about the ability to check on use of PDTs on a routine basis, and the information generated by the PDTs could bring about alignment between value and payment because of the easy access to a wealth of data.

Maricich, whose company also has a PDT for insomnia called Somryst, said the reason the PDTs have been developed for mental and behavioral health is the enormous need and the shortage of treatments. “There is no drug for autism,” he commented. “Thankfully, there is a PDT in development for that.”

Whether PDTs should be seen as druglike and paid for under the pharmacy benefit or as an extension of medical treatment and paid for under the medical benefit is an open question. Gleason made a spirited case for them being paid for on the pharmacy benefit because the coding is specific and would allow payers and PBMs to keep better track of the prescriptions.

Gleason also spoke about payers and PBMs needing more evidence to evaluate PDTs if they are to make coverage and formulary decisions. He referenced an Institute for Clinical and Economic Review report that listed seven possible categories for assessing PDTs: durability of benefit, impact on healthcare utilization, impact on clinician productivity, usability and accessibility for the patient, security, generalizability to diverse population, and scalability.