Prescription digital therapeutics firm MetaMe Health, gearing up to launch its app for IBS-related abdominal pain later this year, has tapped consultancy Indegene to assist with market access and other aspects of the rollout.

Dubbed Regulora, the prescription app was cleared by the U.S. Food and Drug Administration late last year to deliver behavioral therapy based on gut-directed hypnotherapy (GDH). The treatment will be available to adults with irritable bowel syndrome, via their doctor or GI specialist. Initially the launch will focus on securing payer coverage.

“We’ve started to have direct, one-on-one conversations with payers but won’t ramp that up until the middle of Q2 of this year,” said MetaMe CEO Tim Rudolphi. 

Indegene’s market-access group, MME, will craft value messaging and determine the payers to target. The messaging will focus on how Regulora can reduce treatment cost and widen access to treatment, according to Indegene SVP Marut Setia. 

IBS afflicts some 30 million U.S. patients, the company says, about half of whom are already being treated for associated pain. According to one estimate, treatment costs range between $1.7 billion and $10 billion per year.

Rudolphi, who spent the early part of his career in big pharma, said he doesn’t anticipate Regulora will have significant reimbursement coverage until at least six months post-launch. “But no one launches a product in the healthcare ecosystem with immediate reimbursement,” he noted. “There’s some education needed that this type of uptake is really quite standard, even with prescription drugs today.”

All the same, digital therapeutics face an unusually steep uphill climb on that front. While pharmacy benefit managers ExpressScripts and CVS Caremark each have “digital formularies” that list digital health products, commercial payers have not begun uptake of digital therapeutics (DTx) en masse. And Medicare has yet to develop guidance for DTx reimbursement.

“It’s been difficult,” Rudolphi acknowledged, adding that market research the firm has conducted suggests payers are open to covering Regulora. “It’s going to be a challenge.”

Other elements of the launch effort involve educating HCPs on clinical evidence and patients on the need for diagnosis. MetaMe also plans to set up a digital health clinic providing patients the opportunity to connect via telehealth. During it, they can confirm their diagnosis and, if Regulora is an appropriate choice, have a prescription written and initiate treatment. 

A third element is outreach to prescribers, especially those whom Indegene deems potential early adopters based on its HCP profiling. The launch will take “a largely digital-first approach,” Setia said. “We do expect to put some boots on the ground, but it will be very selective.”

While the exact cause of IBS is unknown, a mind-body connection has been suggested in the medical literature. The American College of Gastroenterology recommends use of GDH in its IBS treatment guidelines. 

The pivotal study MetaMe submitted as part of its 510(k) application showed the efficacy of GDH administered by app. Sixty-eight percent of patients said they were satisfied with the treatment, while 87% said they’d recommend it to someone else.MetaMe has raised a total of $6.1 million to bring its DTx to market, according to Crunchbase. It most recently secured $2.2 million from a bridge round led by Hyde Park Angels.