Digital therapeutics have proven efficacy in treating patients with behavioral health conditions, but a host of challenges are preventing their widespread adoption across the health care industry, according to speakers at AMCP Nexus 2021.

Presenters discussed how the pandemic has changed the digital therapeutics landscape, how these technologies can improve patient outcomes, and what regulatory changes are currently being implemented or on the horizon for payers.

The COVID-19 pandemic created a “new normal” in which the health care landscape has seen an increased demand for digital solutions, such as wearable sensors and telehealth visits, said Marc Weiss, MBA, director of marketing and digital medicine, Otsuka America Pharmaceutical, Inc.

Strategic considerations for digital health products differ from traditional pharmacotherapy in several ways, Mr Weiss said, including:

• increased speed of discovery and development of digital products;
• maturing regulatory frameworks in an evolving marketplace;
• variations in level of evidence required to progress through clinical trials (as opposed to standardized levels of evidence for pharmacotherapy);
• limited analogs for commercialization of digital health products (as opposed to analogs by therapeutic area, route of administration, or mechanism of action);
• multiple commercial models with unknown long-term viability;
• unclear benefit categorization;
• pricing under pressure due to undefined reimbursement processes; and
• multiple strategies to secure reimbursement, with some payers resisting coverage of novel digital therapeutics.

“We don’t have all the information that we need to make the decisions that we can easily make on the pharmacology side. That presents challenges,” Mr Weiss said.

Regarding partnerships between digital therapeutics manufacturers and payers, Mr Weiss said that although there is a desire to partner, “There are some tough conversations to take place. Multiple strategies and approaches are needed between the developers of these treatments and those that are going to wind up paying for them.”

Molly Burich, MS, senior director of reimbursement and policy, Otsuka America Pharmaceutical, Inc, discussed some of the policy shifts taking place in the wake of the expanding market, including federal legislation geared toward making a new benefit category for digital therapeutics in the Centers for Medicare & Medicaid Services (CMS).

The bill, which has bipartisan and bicameral sponsors, would create a coding and payment paradigm for prescription digital therapeutics in Medicare to ensure reimbursement.

“Policymakers are excited about what digital solutions could mean for patients,” Ms Burich said.

Ms Burich also noted that CMS included five new remote therapeutic monitoring codes in the CY2022 proposed physician fee schedule rule, which could be applied to prescription digital therapeutics if they are finalized. A final rule is anticipated to come in early November.

“This really shows a good evolution on the part of CMS,” Burich said. “There’s an acknowledgment that these technologies are here in some cases or will continue to come, and we have to come up with a reimbursement paradigm for the physician.”

Additionally, the US Food and Drug Administration (FDA) has established the Digital Health Center of Excellence, a committee designed to offer regulatory support during the FDA’s review of digital therapeutics as manufacturers seek market authorization. The FDA is also holding a workshop on artificial intelligence and machine-learning devices to increase transparency surrounding digital therapeutics.

“Overall, we’re going to continue to see some movement in the space,” Ms Burich said. “CMS taking action is going to be a good catalyst for other payers to consider these solutions as well.”

Prescription digital therapeutics combined with standards of care have shown greater efficacy vs placebo in clinical trials of patients with a variety of mental health conditions, including attention deficit hyperactivity disorder, opioid use disorder, and schizophrenia, said Kaan Tunceli, PhD, senior director and head of value evidence strategy in central nervous system and digital therapeutics, Global Value and Real-World Evidence, Otsuka Pharmaceutical Development & Commercialization, Inc.

Beyond improving patient outcomes, the addition of digital therapeutics to the standard of care improved QALYs and reduced costs, Dr Tunceli said. He added that digital therapeutics also alleviate capacity constraints in mental health care and improve provider decision-making through real-time data.