Before the pandemic hit, Akili Interactive was well into the process of applying for FDA clearance for its first product. The company had just completed a randomized trial of Endeavor, a video game meant to improve attention in children with ADHD.

Last week, the FDA temporarily waived requirements around digital health tools to get them into the hands of more patients. On Thursday, Akili released its product to the public based on the FDA’s emergency guidance.

The company is still actively pursuing 510(k) clearance for Endeavor, but plans to temporarily offer it to the public at no cost, said Jeff Abraham, vice president of market access and trade for Akili.

“There are a lot of kids that are receiving behavioral health or even medications, and they’re in a really challenging environment now,” Abraham said during a panel hosted by the Academy of Managed Care Pharmacy. “We took that very seriously to get our product out as fast as we could in about a week.”

The Covid-19 pandemic has created a new environment for digital health, as patients quarantined at home become more comfortable receiving care through a screen. But companies will still face many of the same challenges as they did before, namely prescribing and reimbursement of their therapeutics, Abraham said.

“The conversations we’ve had have shifted since the beginning of Covid,” he said. “There’s a sense of urgency today in accessing and providing some sort of care and doing whatever we can to help.”

But the hurdles of coverage reimbursement remain, Abraham said. They just look different.

“I think those are still going to be there, and it’s going to be different in how we define value, because the care pathways are changing,” he said.

 

Implementation during a pandemic

Dr. Yuri Maricich, CMO of Pear Therapeutics, explained what that process looks like for his company. Pear is a well-established player in the digital therapeutics space, with three FDA-cleared products for addiction treatment and insomnia, all of which are prescribed by a physician.

The company has seen tens of thousands of patients using its products and coming back to refill their prescriptions. For the latter to happen, the company has had to create models to make its product fit into physician workflows.

“Most patients know how to swallow a pill and most clinicians know how to prescribe one. There doesn’t need to be a lot of implementation work there. Software is different. It does require extra effort,” Maricich said. “In the pandemic, we’ve seen an enormous transition into virtual care. … That implementation model is different when it’s virtual versus when it’s face-to-face.”

On top of that, many payers still have differing attitudes toward digital health. Some still have lots of questions about how they would implement these products, including how they would think about cybersecurity and what they need in terms of clinical evidence. Others already have a set criteria for what they need, making for a straightforward conversation, Maricich said.

Express Scripts is an example of the latter. The PBM launched the first digital health formulary last year, with its first group of preferred products including Livongo, Pear, Propeller Health, Livongo and Welldoc. Express Scripts Chief Patient Experience Officer Mark Bini said the company plans to expand into women’s health, oncology, inflammatory conditions and musculoskeletal conditions as it adds more companies to the formulary.

Express Scripts picks which digital health products to include based on their clinical effectiveness and usability. Clients can pick which tools they want to include in their plan from the formulary, instead of sorting through the thousands of apps that are currently on the market.

Bini said the new formulary had been well-received by Express Scripts’ clients.

“We see digital health space as sea-change for pharmacy and role that pharmacist will play in this space,” he said. “We can augment care to an order of magnitude that is immeasurable.

Depending on how the pandemic continues, digital health companies may yet have another role to play. Academy of Managed Care Pharmacy CEO Susan Cantrell said the organization had been hosting conversations with members about the challenges they’re facing in caring for patients during the pandemic.

At first, those were centered on supply chain challenges. Now, Cantrell said she had been hearing more concerns about patients with chronic conditions who don’t have access to their doctor right now.

“The longer the current situation lasts, we’ll continue to see more and more creative thinking about how you deliver care to a patient who has uncontrolled hypertension or type 2 diabetes during this time and their front line caregiver is not available,” Cantrell said. “There’s more anxiety about making sure that when we do get back to whatever normal looks like, that patients with chronic conditions haven’t suffered serious health setbacks during this time. This underscores the need for the use of technology —  including digital therapeutics — now more than ever.”

Photo credit: elenabs, Getty Images



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