Spurred by significant investments, the digital therapeutics space has emerged into a fast-growing global market that is poised to reach more than $14.5 billion by 2028.
Over the last five years, the U.S. Food and Drug Administration (FDA) has cleared more than 35 digital therapeutics across a number of therapeutic categories. Digital therapeutics – which diverge from other digital health tools, in part, because they are intended to prevent, manage, or treat a medical condition and must be cleared or certified by regulatory bodies to support claims of risk and efficacy – offer the potential to provide alternative, evidence-based treatment options for patients.
While the DTx market has gained significant momentum over the last half-decade, DTx developers continue to face challenges, particularly related to coverage, payer acceptance and provider use. The existing barriers have prevented more widespread adoption of products – particularly prescription digital therapeutics (PDTs), which are FDA-cleared software-based treatments required to be prescribed by clinicians. Most major commercial payers have declined to cover them and the majority of public coverage for PDTs is via one-off contracts with state Medicaid plans.
“Insurance coverage is absolutely critical,” Ben Lewis, co-founder and CEO of Limbix, a digital therapeutics solution for adolescent mental health, told Fierce Healthcare in October.
Evolving coverage trends
However, the coverage landscape for PDTs appears to be gaining traction. In April, the Centers for Medicare and Medicaid Services (CMS) introduced a level II Healthcare Common Procedure Coding System (HCPCS) billing code for prescription digital behavioral therapy. Meanwhile, if passed, the Access to Prescription Digital Therapeutics Act of 2022 – a bill introduced earlier this year – would add PDTs to the list of services and products eligible for coverage under Medicare and Medicaid and would direct CMS to establish payment methodologies and product-specific HCPCS codes. This bill would potentially make it easier for commercial payers to process payments for PDTs.
In October, Highmark confirmed its plans to pay medical claims for PDTs cleared by the FDA when prescribed by a licensed healthcare professional within the appropriate medical specialty and used within its approved indications. Now, at least 17 Blue Cross Blue Shield insurers offer at least one PDT as a standard pharmacy or medical benefit for some members.
The coverage decisions are consistent with key findings from research led by members of AmerisourceBergen’s Consulting team which showed payers anticipated more PDT would receive coverage in the next 18 months. Additional AmerisourceBergen-led research, which was also presented at AMCP Nexus, revealed the majority of payers surveyed said they were more likely to cover a PDT compared to non-prescription DTx, in part, because of the requirement for clinical evidence and regulatory oversight, said Alex Kilgore, PharmD, manager of US Market Access Strategy on AmerisourceBergen’s Consulting team.
“Most coverage decisions are highly product-specific and are often dealt with on a case-by-case basis. As the DTx market continues to mature and more standardized review pathways are established, I anticipate payers will develop more individualized product policies,” Kilgore said. Despite the recent coverage decisions, Kilgore noted there is a significant demand among payers for proof of long-term benefit as well as more consistent evidence generation for PDT – specifically, head-to-head comparisons, prospective randomized controlled trials (RCT) and real-world evidence.
Addressing challenges across provider workstream, patient journey
Kilgore is also on the AmerisourceBergen team leading the development of DTx Connect, a cloud-based, fully integrated ordering, dispensing and fulfillment platform that aims to facilitate patient access to physician ordered DTx and diagnostics. AmerisourceBergen recently announced plans to launch DTx Connect, which seamlessly integrates with electronic medical records (EMRs), enabling physicians to easily access and order DTx products through their e-prescribing workflow and subsequently monitor patient fulfillment.
Addressing barriers across the provider workstream and patient journey is critical to advance the industry and unlock the potential value DTx products can offer. Physicians report that prescribing DTx is more difficult than prescribing traditional therapies and cite a number of challenges related to DTx, such as reimbursement, patient fulfillment, ongoing support and a lack of interoperability of DTx within EMRs or current prescribing workflows.
DTx Connect aims to address some of those challenges through a variety of features, such as e-prescribing through EMRs and efficient dispense and fulfillment, said Micaela Brandau, vice president of Global Products and Solutions at AmerisourceBergen. For example, after a physician orders a product, DTx Connect delivers a welcome message on behalf of the care team via text or within the patient portal. Patients will also receive messaging to support enrollment and initiation of PDT or non-prescription DTx treatment and access educational materials. The platform can also provide physicians with patient status alerts, including notifications for patient fulfillment.
Several digital health companies, including Mahana Therapeutics and Videra Health, plan to pilot the platform. AmerisourceBergen is also engaged in conversations with health systems to pilot the platform.
“Our goal with DTx Connect is to make prescribing and fulfillment a seamless part of the care process and help patients start and stay on physician-ordered digital therapeutics,” said Brandau, who recently served on a panel at DTx East 2022. “DTx Connect also strengthens the support we can offer to DTx developers across the commercialization journey, which already includes market access consulting and patient support services. Through our collective capabilities, we’re uniquely positioned to help developers at each stage of the product lifecycle—from working alongside them to bring products to market and scale distribution to delivering provider and patient support services to advance access.”
To learn more about the support AmerisourceBergen offers to DTx developers and healthcare providers, including DTx Connect, check out: https://www.amerisourcebergen.com/manufacturer-solutions/digital-therapeutics