What if instead of taking a pill or injection, you could download an app to help ease the pain of irritable bowel syndrome?
That’s what the gut-directed hypnotherapy behind metaMe’s Regulora prescription digital therapeutic aims to do. The digital app guides users through 7 sessions over 12 weeks of virtual psychological interventions. It’s not unproven science — in-person cognitive-behavioral therapies, hypnotherapy and mindfulness-based therapies have proven effective in treating IBS and IBD.
But will that effectiveness translate to a digital therapeutic? With FDA authorization and study data, along with go-to-market partner Indegene, metaMe is looking to find out when the app launches in the third quarter.
As co-commercialization partner, Indegene is not only working on payer coverage, along with outreach to healthcare providers and prepping Regulora marketing for consumers but also basing its payment on outcomes. Indegene and metaMe’s co-commercialization model means the former’s efforts for the IBS digital therapeutic will be compensated based on its success.
Outcome-based models are becoming more common in pharma drug commercialization — when a drugmaker’s payout is dependent on the effectiveness of the treatment – but it’s less common in commercialization and marketing.
“We work a whole lot of young companies, if you will, and we work with them on a model that is more suitable for them, with risks and rewards shared with Indegene,” Marut Setia, SVP of medical technology for Indegene, said. “…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 prescribers?”
With Regulora FDA-cleared and ready for physician prescribing at launch, Indegene is focusing first on payers followed by HCP education. Prescription digital therapeutics are more common in mental health, substance abuse and pain management categories, but there aren’t many in IBS. The Digital Therapeutics Alliance lists 20 example digital therapeutics on its website, but none that treat IBS. There are a few others though including Mahana Therapeutics’ Parallel app authorized in 2020.
Setia said Regulora has the proven data to back its effectiveness, so “now it’s a question of communication and taking that evidence to the skeptics through the right channels.”
HCP and eventual patient marketing will be based on education – explaining the newer concept of using digital therapeutics for IBS and, specifically for HCPs, showing clinical evidence and targeting and prioritizing the right clinicians.
Patient education will include talking to advocacy groups addressing questions and defining the benefits, Setia said.
Development of digital therapeutics or DTx is accelerating, thanks in part to the Covid-19 pandemic. A recent study in PLOS found 63 already approved, but a whopping 150 FDA-regulated DTx are expecting clinical trial results this year.
Still, education, as the market develops, will be necessary. While most US adults gave positive marks to digital health tools as convenient, safe and accurate, about one-third also found them difficult to use, scary or confusing, according to a Morning Call survey last year.