As Fentanyl Deaths In Youth Rise, Will Digital Health Solutions Find Quicker Adaptation?

It was a beautiful sunny day with white clouds in the sky as families gathered in a church in Kent, Connecticut. There was a lingering sadness in the air, as people greeted each other to memorialize the death of a loved young man. Alec was vibrant and full of life, an incredible hockey player, a loving brother and adored son but had lost the battle of many years to opioids at the young age of 26. Sadly this was not a rare event in this small town- the funeral director that over saw this noted that this was the 9^th young man who had died in a matter of a few months in this town.

In 2022, there were over 100,000 deaths due to the opioid crisis around the country and this epidemic transcends race, gender, socioeconomic strata and education. One of the mainstays of treatment, cognitive behavioral therapy is essential for recovery. This key modality, also used for many other mental health illnesses such as depression and anxiety, helps to catalyze behavior change and is essential for long term management. However, access to traditional cognitive behavioral therapy is limited as it is expensive, often not covered by insurance, and there are simply not enough mental health professionals for all of the people in need during the current mental health crisis. And along with access issues, opioid use disorder is more deadly than ever due to the infiltration of synthetic high grade fentanyl that is widespread in the US.

How can we solve the access issues? Innovative solutions to solve this are urgently needed. Harnessing the power of digital innovation to provide software based behavioral therapy that is evidence based and FDA approved seems like an incredible solution. Pear Therapeutics, who filed for bankruptcy last week, was a pioneer for those with OUD in need, and hoped to offer this much needed behavioral therapy that could be administered on a person’s smartphone. These programs were designed with access in mind and these apps, reSET and reset-O were intended to help address substance use disorder and opioid use disorder.

Not only was Pear able to show scientific evidence that this worked via clinical trials, but they also sustained FDA authorization that established these apps as safe and effective. But while regulatory approval secured market access, the evidence needed to convince payors to support pricing and reimbursement decisions for digital therapeutic products was a real challenge and remains so, for digital health companies. Pivoting and navigation around barriers were to no avail for Pear Therapeutics, and they ultimately filed for bankruptcy.

From a health need point of view, deaths via fentanyl increase in some states by 800% and the mental health crisis continues to grow as does the lack of access, especially for those with disparities including the rural areas of the US. How can we speed up the adaption of innovation to solve for some of the biggest problems that we face as a society- equitable access? How can we ensure that the promise of digital innovation can actually overcome the barriers of our complex and often broken health system?

“It is going to require a multi-stakeholder outlook to be effective,” said Jennifer Goldsack, CEO of the Digital Medicine Society (DiMe). “A solid regulatory strategy is essential, but not sufficient. Digital health product developers must develop evidence not just to satisfy the needs of regulators, but also payers, prescribing clinicians, and patients themselves. These … may well be too much for an innovative company to define alone, underscoring the importance of even the most innovative companies coming to the table to ensure a viable market for their products.”

Unfortunately, while the need for innovative therapies continues to increase, so too does the uncertainty facing many digital therapeutics and other health tech companies in the wake of Pear’s announcement. And that is truly disappointing, especially for the families who continue to face crisis and difficulties with access to treatment that could help save lives.

Cammie Wolf Rice, Founder of the Christopher Wolf Crusade, and a parent who lost her son Christopher to this crisis, made an urgent appeal: ‘The vast majority of those who have a substance use problem are not treated,… Access to therapy must be improved.’

As innovation continues to increasingly offer evidence based solutions to close gaps for equity and access, we must also lay down the groundwork to rapidly adapt. This is what our youth and families urgently need. Let’s find a way to create behavior health solutions that we can universally utilize , so that our kids and society have a better chance for healthy and full lives.