Mobile apps for IBS? Indegene partners with metaMe to launch digital ‘gut-directed hypnotherapy’ therapy – Endpoints News

What if instead of taking a pill or injection, you could download an app to help relieve the pain of irritable bowel syndrome?

That’s what the gut-directed hypnotherapy behind metaMe’s Regulora digital prescription therapy aims to do. The digital app guides users through 7 sessions over 12 weeks of virtual psychological interventions. It’s not an unproven science – in-person cognitive behavioral therapies, hypnotherapy, and mindfulness-based therapies have been shown to be effective in treating IBS and IBD.

But will this efficiency translate into digital therapeutics? With FDA clearance and study data, along with marketing partner Indegene, metaMe is looking to see when the app will launch in Q3.

As a co-marketing partner, Indegene not only works on payer coverage, as well as healthcare provider outreach and consumer marketing readiness for Regulora, but also bases its payment on results. Indegene and metaMe’s co-commercialization model means that the former’s efforts in digital IBS therapy will be rewarded based on its success.

Outcome-based models are increasingly common in pharmaceutical drug marketing – where a drugmaker’s payment depends on the effectiveness of the treatment – ​​but they are less common in commercialization and marketing.

Marut Setia

“We work with a lot of start-ups, if you will, and we work with them on a model that suits them better, with risks and rewards shared with Indegene,” said Marut Setia, SVP of Medical Technology for Indegene. “…We’re moving away from a traditional channel where you say ‘I did 5 campaigns for you, so you owe me $500,000.’ It’s not the same anymore. The question is how many leads are you able to generate, how many impressions did we get for you, how many sales and how many influencers?”

With Regulora FDA-approved and prescription-ready at launch, Indegene is focusing on payers first, followed by training HCPs. Prescription-based digital therapies are most common in the mental health, addiction, and pain management categories, but there aren’t many in IBS. The Digital Therapeutics Alliance lists 20 examples of digital therapies on its website, but none treat IBS. There are a few others, including Mahana Therapeutics’ Parallel app licensed in 2020.

Setia said Regulora has proven data to back up its effectiveness, so “now it’s all about communication and getting that evidence to the doubters through the right channels.”

Healthcare professionals and eventual patient marketing will be based on education – explaining the new concept of using digital therapy for IBS and, especially for healthcare professionals, showing clinical evidence and targeting and prioritizing the right clinicians.

Patient education will include discussions with advocacy groups about the issues and defining the benefits, Setia said.

The development of digital therapeutics or DTx is accelerating, in part thanks to the Covid-19 pandemic. A recent study in PLOS found 63 already approved, but 150 FDA-regulated DTxes are awaiting clinical trial results this year.

Still, education, as the market grows, will be needed. While most American adults rated digital health tools as convenient, safe and accurate, about a third also found them difficult to use, scary or confusing, according to a Morning Call survey last year.

Casey J. Nelson