Happify Health is launching its first prescription digital therapeutic (PDTx), called Ensemble, which will focus on treating Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD). 

Unlike Happify’s other products, Ensemble has to be prescribed by a clinician. Patients are able to use the smartphone or computer in order to tap into the therapeutic. The PDTx is focused on helping patients build new skills and habits to manage their condition by using cognitive behavioral therapy (CBT), mindfulness and other techniques delivered through sequenced modules. 

"Ensemble has been designed as a single treatment that targets underlying processes that are common to both MDD and GAD. Decades of research have established that psychological interventions, including those included within Ensemble, are helpful for both disorders,” Dr. Murray Zucker, Chief Medical Officer at Happify Health, said in a statement.

“Additionally, our digital AI coach, Anna, has been trained by a team of clinicians,  psychotherapists, content creators, writers, data scientists, and research psychologists to  provide human alliance and connection, as well as a tailored experience designed to increase  engagement for patients."

According to the company, the tool is meant to be used in conjunction with other mental care resources and isn’t a substitute for medications. 

While this is the company's first prescription product, Happify has been focused on the mental health space for years. 

“So in the last eight years, that's been our focus as we move forward from a direct-consumer to an employer health-plan market, and now towards more pharmaceutically oriented products,” Chris Wasden, head of DTx at Happify Health, told MobiHealthNews.

“We've realized that we had to move the claims of our products towards those of an FDA regulated product, which would be to treat a specific diagnosed condition, and those diagnosed conditions that we treat are major depressive disorder and generalized anxiety disorder.”

As of today, the product does not have FDA clearance, however, the company does plan to seek a 510(K) clearance in the future. The product is able to launch thanks to an FDA guidance issued in April of 2020 that lets digital health companies targeting eight psychiatric disorders, which include anxiety and depression, go to market without clearance. Wasden noted that the agency renewed this decision a few days ago. 

“Actually, they issued the renewal of that guidance, and we decided to do this, taking advantage of the guidance as a real-world evidence study. So all the patients who had good access to our product will be enrolled in a real-world evidence study,” Wasden said.

“The data that we collect from that study is what we will use for the FDA finally to get clearance for the product under the 510(K) clearance pathway and also with the existing product code that the FDA's given for CBT for psychiatric disorders.”

The FDA has certain expectations from a prescription digital therapeutic that it may not have from a direct-to-consumer product. 

“There's a number of important differences. So one has to do with dosing. We really don't have a firm dosing regimen with our existing products. It's really up to the patient to use it as often as they want to do it in any order that they want,” he said. “They can abandon doing some activities and choose the other activities. They could do the same activity multiple times from an FDA-cleared product.

"The FDA expects a lot more structure, discipline and order in the way that the interventions are delivered. And so we've had to go back and look at how we would change the experience of the patient so that it's still engaging, but do it in such a way that it meets those FDA requirements.”

Wasden said the other difference between this product and previous ones is that it includes instruments correlated with ones already used clinically, including the PHQ9 and the GAD7, used to measure depression and anxiety, respectively. 

The company has also begun to integrate this tool into a physician’s workflow for diagnosing and prescribing. Wasden noted that the physicians the company is initially working with will have the product integrated into their EHR. 

As for the reimbursement question, currently, the company is offering the product free to patients because they are launching it as an investigative device to gather data for an FDA submission. 

“However, moving forward, after we get FDA clearance, we would seek to get reimbursement for the product. We've been doing interviews with payers for many years now. As you may be aware, some of the largest payers in the United States are already our customers with some of our other products,” Wasden said. 

WHY IT MATTERS 

Anxiety and depression are both common conditions in the U.S. According to the CDC, one in six adults will have depression at some point in their lives. Additionally, the CDC reports that in 2019, 15% of adults in the US reported experiencing symptoms of anxiety in the past two weeks. 

Depression and anxiety rates have soared amidst the COVID-19 pandemic. A Kaiser Family Foundation survey found that more than 40% of U.S. adults reported symptoms of anxiety or depressive disorder during the COVID-19 pandemic, compared with just 11% in the months prior to the outbreak.

THE LARGER TREND 

Happify Health has been around since 2012 and specializes in creating digital self-guided health programs. In March the company closed a $73 million Series D funding round. While the company got its start in the mental health space, it has also rolled out products for heart health and psoriasis. 

The company has also worked in the pharma space before. In 2019, the life science giant Sanofi inked a deal with Happify focused on treating multiple sclerosis symptoms, in particular anxiety and depression. 

Happify Health isn’t the only digital therapeutic on the market. Pear Therapeutics landed a de novo clearance for its PDTx focused on substance abuse called reSET in 2017. Since then, the company has released several other products, including one focused on opioid abuse disorder and another for chronic insomnia.