In September 2019, AMCP convened a multidisciplinary stakeholder forum to examine systems and processes that will support the adoption and utilization of digital therapeutics, an emerging class of therapeutic interventions that poses many questions for the health care system. The forum included health care leaders in academia, health plans, integrated delivery systems, digital therapeutics manufacturers and industry leaders, pharmaceutical manufacturers, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations.
During a media briefing that took place in conjunction with the AMCP eLearning Days, a panel spoke about the use of digital therapeutics in managed care and highlighted findings from the forum. The panel included: Susan A. Cantrell, RPh, CAE, CEO of AMCP; Joseph Honcz, RPh, MBA, principal at Consulting 4i; Jeff Abraham, vice president of market access and trade at Akili Interactive; Yuri Maricich, MD, chief medical officer of Pear Therapeutics; and Mark Bini, chief patient experience officer at Express Scripts.
The following questions from members prompted the forum: Are digital therapeutics better suited for the pharmacy or medical benefit? How will effectiveness be determined? What type of evidence needs to be evaluated when deciding whether to use digital therapeutics?
Four domains were discussed at the forum:
- Can we definite it?
- Where does it fit?
- What is the evidence?
- What kind of value does it drive?
The group developed the following definition of digital therapeutics: Software that delivers a clinical mechanism of action, either alone or in combination with other standard-of-care treatments to improve outcomes.
At the forum, various benefit coverage options were discussed. While some participants suggested that the unique features of digital therapeutics could be best addressed by a novel digital benefit, others argued that creating an additional benefit would result in further health care system fragmentation. Some digital therapeutics might be more appropriate for the medical benefit, while others might be better aligned with the pharmacy benefit, so the group decided that the mechanism of action, mode of access, and potential outcomes help define where it should fit, instead of pushing it one way or another.
The forum participants noted that digital therapeutics should be evaluated using clinical evidence, and they must meet strict quality, security, and usability standards. Randomized, controlled trials are still the gold standard, according to the forum, but this may be a challenge for this type of therapeutic, so a more pragmatic trial may be necessary.
Digital therapeutics offer a great point of access to patients and can help to generate a lot of data to track outcomes. The group decided that value can be measured for these digital therapeutics and that value-based contracting is the forefront of how to value these digital therapeutics.
During the briefing, Mr. Abraham noted that the COVID-19 pandemic has really shed a light on the use of telemedicine and how this technology can and likely will be incorporated into practice in the future. “These products provide an opportunity to provide care to people in these unique situations and [as we] face new challenges,” he said.
Dr. Maricich talked about how Pear Therapeutics has a prescription digital therapeutic for addiction management that helps give people access to a treatment modality for which no pharmacotherapy is approved. These types of treatments broaden access to treatment options that are available any time of day and at any geographic region. He said they have observed patient engagement and patient willingness and interest to continue digital therapeutic treatment. He also noted that education of clinicians and patients is an important component of this treatment. Implementation, however, can be a challenge for digital therapeutics. “Most patients know how to swallow a pill,” he said, “but software is different. We’ve had to create models to help implement these therapeutics.”
Mr. Bini discussed how Express Scripts created the industry’s first digital health benefit, which evaluates digital health solutions through the lens of clinical effectiveness and usability and negotiates value in return for clients. They took a medication formulary and applied it to digital health, including solutions that span diabetes, pulmonary conditions, cardiovascular conditions, and behavioral health, with plans to expand to women’s health, oncology, inflammatory conditions, and musculoskeletal conditions. “It’s been quite a journey, and it hasn’t been perfect,” he said. “We’ve started to identify the unmet need in digital health.”
As the world of therapeutics is evolving, AMCP got involved to help demystify this area and address some barriers to use to help ensure that patients can benefit from these new tools. Many digital therapeutic offerings fall into conditions where conventional tools sometimes fall short and in diseases that cause a significant burden to society where there are limited solutions to help patients. “To have another tool in the toolbox is very attractive, and AMCP wants to be part of the solution in helping members evaluate digital therapeutics, where they fit into therapy, and what is the logical payment pathway,” said Ms. Cantrell.
Media briefing. AMCP eLearning Days, April 20-24.