Digital Therapeutics Emerge Into Uncertain Regulatory, Payment Landscape

Although the idea of smartphones as personal health devices has become common among the general public, the integration of that idea into the formal regulatory and payment structure remains very much a work in progress.

One potential milestone could be on the horizon. Congress is considering legislation called the Access to Prescription Digital Therapeutics Act of 2022, a bipartisan bill that would establish benefit categories for certain digital therapeutics so that they could be reimbursed by Medicare, Medicaid and other public payers. Versions of the bill were introduced in both the House and Senate in March.Proponents, including the Digital Therapeutics Alliance, an industry trade group, argue it would bring much-needed clarity and legitimacy to digital therapeutics.

In the meantime, developers of prescription digital therapeutics continue to press forward. In March, the prescription digital therapeutics maker metaMe Health announced a partnership with Indegene to commercialize a new digital therapeutic to treat abdominal pain associated with irritable bowel syndrome (IBS). The smartphone app received clearance from the FDA in late 2021.

Tim Rudolphi

Tim Rudolphi, MBA, metaMe’s chief executive officer, told Managed Healthcare Executive® that their digital therapeutic, Regulora, would have the effect of expanding access to a type of drug-free therapy for IBS-related pain. He says symptoms of IBS are mediated by a dysregulation of sensory and motility signaling between the brain and gut, leading to hypersensitivity and gut pain. Regulora administers gut-directed hypnotherapy (GDH), which aims to resolve the brain-gut “miscommunication” and thereby alleviate symptoms.

“GDH has been shown to produce positive outcomes for those living with IBS, but has previously been inconvenient for many patients, as it has required in-person visits with trained therapists,” he explains. “With Regulora, patients can access treatment privately from anywhere at any time, empowering them to improve their quality of life without hassle or fear of stigma.”

Though the app makes therapy administration simpler, the company is now focused on making sure that obtaining the app is equally streamlined. Rudolphi says if all goes according to plan, the process should look much the same as obtaining a bottle of pills from the pharmacy.

“The physician writes the prescription and sends it off to the pharmacy,” he says. “The pharmacy will adjudicate with insurance, collect payment, and issue the access code.”

That access code will allow the patient to unlock the app, which patients can download from the Apple and Android app stores. The access code will work for the duration of the prescribed course of treatment, which, according to Rudolphi, is generally expected to be 12 weeks. He notes the intention is for payers to pay a one-time fee for the entire course of treatment.

Under metaMe’s multiyear deal with Indegene, the latter will use its commercialization model to conduct outreach to both physicians and patients. Indegene says it will use machine learning and artificial intelligence to identify potential patients.

Regulators’ embrace

Still, the success of products like Regulora will depend on more than patients and physicians. Digital therapeutics makers will also need to convince regulators to embrace the technology and payers to pay for it.

Andy Molnar, chief executive officer of the Digital Therapeutics Alliance, says laws such as the Access to Prescription Digital Therapeutics Act of 2022 are an important early step in that process. “The need for a benefit category and proper coding will allow for patients and providers to own their care,” Molnar said in a press release.

For his part, Rudolphi is optimistic that payers will cover Regulora. He says his company plans to launch the product later in 2022.