Pharma-created therapeutics have developed beyond pills from a doctor’s office to include apps, virtual reality and video games for anxiety, heart failure, diabetes and more. These prescription software programs, known as digital therapeutics, comprise a growing global market that could hit $13 billion by 2026. This projected growth is being spurred by the numerous advantages of using a personalized and low-risk approach that doesn’t require as many healthcare interventions amid an acute shortage of providers.
So why aren’t more doctors prescribing them?
Some may hesitate to embrace an unfamiliar option or may be stymied by the lack of infrastructure to support prescriptions. But experts say the biggest issue is money.
“Reimbursement is the biggest barrier that we’re facing right now,” said Jessica Hauflaire, COO of the Digital Therapeutics Alliance. Medicare and most commercial insurance companies won’t cover most digital therapeutics, even for FDA-regulated prescription technology, validated to ensure it delivers on its medical claims.
Pharma joins the digital fray
Digital therapeutics companies are now looking to change that by making a financial case to payers, proving the technologies are worth the investment. To that end, Curavit, a virtual CRO, is tracking digital therapeutic interventions and outcomes in clinical trials using Health Economics Outcomes Research. MedRhythms, a company focused on creating neurotherapeutics, is working with Curavit to gather information in a trial for its digital therapeutic MR-001, which aims to help patients regain walking ability following a stroke.
“With the low risk and availability and scalability of digital therapeutic products, I see it becoming the first course of treatment.”
COO, Digital Therapeutics Alliance
Data collection will examine whether people stick with the treatment, which uses rhythmic cues to help normalize physical movements, how long treatment effects last, and its potential economic value. Ultimately, Owen McCarthy, president and co-founder of MedRhythms said this information could help prompt changes to the field.
“Three changes that would impact broad access for digital therapeutics: creating clear reimbursement pathways, integrating education about digital therapeutics into medical school curriculum, and continued work on improving workflows for prescribing/dispensing of digital therapeutic products,” McCarthy said.
Pharma’s approach to digital therapeutics
While payers hesitate to embrace digital therapeutics, many pharma companies already see their value.
“We're working with a lot of big pharmaceutical companies that are partnered with a digital therapeutic company and I think it's a win, win,” said Joel Morse, CEO and co-founder of Curavit. “The pharmaceutical companies have resources, and they invest in a tremendous amount of R&D. The digital therapeutics companies have a tremendous amount of innovation, and a lot to bring to the table.”
Some notable partnerships include a venture between Boehringer-Ingelheim and Click Therapeutics on a digital therapeutic for schizophrenia, and a partnership between Sanofi and Happify Health to create a mental health treatment for people with multiple sclerosis. AstraZeneca also developed a digital therapeutic to monitor symptoms in people with breast cancer to gauge treatment response.
Digital therapeutics also have the potential to improve treatment for chronic health conditions, said Hauflaire.
“They are personalized to the individuals. They provide data and insight, 100 data points a minute, which is something that traditional medicines and med devices cannot do,” she said. “It's well positioned to provide data to individuals and to their provider systems. They’re also low risk, especially when you have a person with a chronic condition, it’s about stacking medications. A digital product does not interfere with those chemicals or biologics in their system.”
France, Belgium, and South Korea, are already working to put this digital therapeutic infrastructure in place and experts hope that the U.S. will follow suit, said Hauflaire. A bill called Access to Prescription Digital Therapeutics Act of 2023, which would expand Medicare coverage to include prescription digital therapeutics, is working its way through Congress.
“But with any piece of legislation it’s very, very slow,” she said.
If advocates successfully make their case, digital therapeutics could become another broadly used tool to improve patient care.
“With the low risk and availability and scalability of digital therapeutic products, I see it becoming the first course of treatment,” Hauflaire said. This technology could also help spur progress toward the holy grail: value-based care.
“With the data provided by digital products we can get there much faster,” Hauflaire said.