The company says the therapeutic will fill an unmet need with a 12-week treatment for irritable bowel syndrome.
The more than 30 million Americans with irritable bowel syndrome (IBS) may soon have access to an established form of treatment in an entirely new way of delivery.
MetaMe Health, the maker of digital prescription therapies. recently announced a partnership with Indegene to commercialize a new digital therapy to treat abdominal pain associated with IBS. The smartphone app has already received FDA clearance.
Tim Rudolphi, MBA, Managing Director of metaMe, said Managed Healthcare Executive® that IBS is well suited for this new type of therapy due to the large patient population.
“IBS is a condition with significant unmet needs for both patients and providers, which insurers (payors) understand,” he said. “Additionally, current drug therapies to treat IBS have side effects that limit use and are expensive.”
MetaMe’s prescription therapy is called Regulora. It is the first digital treatment to receive FDA clearance for abdominal pain associated with IBS. Patients prescribed therapy are encouraged to download an app and use it to self-administer gut-directed hypnotherapy, an established form of treatment that until now has been administered in person by specialist therapists, the company said.
A 2015 review article published in Food & Therapeutic Pharmacology found a wide range of response rates for gut-directed hypnotherapy, from 24% to 73% in published studies. However, it found that 4 out of 5 studies of long-term use of the therapy found the benefits to be long-lasting.
“Research shows that symptoms (of IBS) are mediated by a dysregulation of sensory signaling and motility between the brain and the gut,” Rudolphi explained. “The bidirectional pathway of the nervous system between the brain and gut is a major contributor to IBS hypersensitivity and abdominal pain.”
Gut-led hypnotherapy is designed to address the “miscommunication” between the brain and the gut, he said, resulting in reduced pain, normalized visceral sensation and decreased colon contractions. . It is also designed to soothe negative thoughts related to IBS.
Rudolphi said the process for prescribing Regulora will be much like the process for any other prescription, except the pharmacy will dispense an access code, rather than a bottle of pills.
“The doctor writes the prescription and sends it to the pharmacy,” he said. “The pharmacy will decide with the insurance, collect the payment and issue the access code. This code will unlock the app for the prescribed period of time,” he said.
In the case of Regulora, a standard course of treatment will be 12 weeks. The Regulora app is downloadable from the Android and Apple app stores, but he said patients won’t be able to access it without a valid, unexpired passcode.
While the idea of smartphone-based therapy is convenient for patients, the newness of the therapeutic class also creates obstacles, like helping doctors understand the therapy and the technology behind it, and then convincing them to prescribe it.
MetaMe’s partnership with Indegene is designed to help remove these barriers. Under the multi-year agreement, Indegene will leverage its commercialization model for physician and patient education efforts. Indegene also uses machine learning and artificial intelligence to help identify potential patients. In its press release announcing the partnership, MetaMe said the partnership would allow it to focus on developing therapies, while Indegene paves the way for commercialization.
Rudophi said he expects the product to launch later this year. When it does, he said it will likely be paid for with a one-time fee for the entire 12 weeks of therapy. He said he’s optimistic that payers will see the value in this new kind of treatment option.
“Payers have been very receptive to this new processing option during preliminary conversations,” he said.