Otsuka American Pharmaceutical is tracking payer practices and attitudes about digital therapeutics with a series of four surveys.
A survey of 110 payer decision-makers shows grow digital therapeutics for heart-related conditions and diabetes, a shift away from ad-hoc methods of evaluation of the therapeutics and an openness to conducting pilot programs with manufacturers.
The survey also found that alternative payment model and value-based contracting are extremely important to many payers as they make coverage decisions. Alternative payment models were rated as “extremely important” to coverage decisions by 65% of the respondents.
It wasn’t easy for products to gain coverage. The survey found that payers added just 21% of evaluated products to their formularies in 2022.
The survey is one of four that Otsuka American Pharmaceutical is conducting to gain insights into payer perspectives on digital therapeutics, especially prescription digital therapeutics (PDTs). The company, which was identified as the sponsor to the respondents, conducted a survey in late 2021 to collect baseline data on payer views of digital therapeutics. That survey found that payers recognized the value of digital therapeutics but also lack of clarity about FDA authorization and variability in how they are viewed. The second survey, which comprised 20 questions, captured 2022 perspectives and experience. The largest percentage (42%, or 46 out of 110) of respondents were decisionmakers at pharmacy benefit managers. The remainder worked for integrated delivery networks (35%, or 38 out of 110), national health plan (14%, 15 out of 110) and regional plans (10%, or 11 out of 110).
The survey found that payers understanding of the difference between digital and prescription digital therapeutics had improved since the 2021 baseline and that 71% of the payer decisionmakers said they were very clear on the difference. A slightly larger percentage (77%) were categorized as having clarity on FDA authorization of software as a medical device, the category that prescription digital therapeutics come under at the FDA.
The survey found that the time that the respondents devoted 12% of their working hours to digital therapeutics and that 73% of the respondents evaluated between 10 and 15 digital therapeutics in 2022. When categorizing digital therapeutics by the conditions they treated, the survey found that coverage increased the most in 2022 for digital therapeutics addressing diabetes and heart-related conditions while coverage for products for gastroenterological, musculoskeletal and oncological conditions decreased. The survey also showed that methods that decisionmaker respondents have become from formal. The baseline survey showed that 25% of the evaluations were ad hoc and done without a framework. The survey covering 2022 found that just 5% of the evaluations were done on an ad hoc basis and that 26% used a framework that had been developed externally.
The importance of pilot projects and real-world evidence to payers was evident in the survey results. Almost two-thirds (63%) of the respondents’ organizations were prepared to partner with digital manufacturers on PDT pilot program and 28% had a pilot-to-coverage pathway. Moreover, all the respondents said that patient real-world evidence from those pilots were important to informing coverage decision and more than 75% of the respondents consider the experience derived from a pilot program as very or extremely important factor in their coverage decision-making.
The survey also showed how important FDA authorization is to payers, with 69% of the respondents indicating that FDA approval or clearance was required for coverage and 63% indicated that inclusion in treatment guidelines was
The survey also suggests that manufacturers of PDT will need to be prepared to negotiate alternative payment models and value-based contracts with payers. The baseline survey showed only 15% indicated that alternative payment models were of extreme importance to coverage decisions. The 2022 results showed that that percentage had more than quadrupled and reached 65%. The interest in value-based contracts and alternative payment models may be due, in part, to the inherent capabilities of many digital therapeutics to collect information on patients.