SALT LAKE CITY — Can “digital medicine” help a child with ADHD? Or a senior with dementia? Most people think of medicine as a pill or a foul-tasting liquid. But a company in California says it also can be a video game.
Akili Interactive Labs, with offices in San Francisco and Boston, has petitioned the Food and Drug Administration for permission to market a video game that would be prescribed for children with ADHD. The company cites clinical trials that showed children who played the game had improved attention and inhibitory control. Its website talks about the promise of “digital medicine.”
“In our experience, caregivers of children with ADHD have shown great interest in the prospect of a non-drug product that can help improve their child’s attention. While there are always skeptics, we’ve received tremendous enthusiasm from families at the prospect of our product,” said Julie DiCarlo, Akili’s senior vice president for communications.
The FDA has not said when it will rule on Akili’s request, which has been pending since 2018. But the growing number of what are known as “digital therapies,” combined with research on the health benefits of exercise and other nonpharmaceutical treatments of disease, is prompting some doctors to prescribe things that don’t come in a bottle. Chief among them are health apps, or “prescription digital therapeutics” such as those developed by Pear Therapeutics that provide cognitive behavioral therapy and other help for people struggling with drug and alcohol addiction.
These and other untraditional prescriptions come with a question: Should health insurance companies have to pay for them?
In Canada, doctors who believe their patients’ conditions can be improved with movement can write a “Prescription to Get Active” that gives the patient a free gym membership. In New York, people can get treatment for depression by reading specially curated books through “bibliotherapy.” A primary care doctor in Oakland, California, is prescribing time in nature for families. And video games and apps designed to stimulate the brain are said to show promise not only in treatment of ADHD and autism, but also dementia.
Health insurance doesn’t just pay for drugs; it also can cover medical equipment such as canes and hospital beds when prescribed by a doctor. Could video games, healthy meals and gym memberships be part of your coverage in the future?
‘Are you ready to play your medicine?’
The game developed by Akili Interactive is played on a tablet and is designed to stimulate specific neural networks. “It sends players through landscapes like a molten lava river and an icy winter snowscape, rewarding them with stars and points as they finish tasks,” Rebecca Robbins explained in STAT.
The Akili website asks visitors “Are you ready to play your medicine?” and the company says its products cause physiological changes in the brain and could also help people with major depressive disorder, autism spectrum disorder and multiple sclerosis. The game devised to help ADHD, called AKL-T01 at this stage of development, stimulates the prefrontal cortex, which plays a key role in cognitive function, the company says.
The FDA has never before allowed the marketing of a video game for treatment of ADHD and would not comment on Akili’s filing, which is not public information. And while FDA approval doesn’t open the door to insurance coverage, it would be virtually impossible to achieve without it, analysts say.
“Health insurance providers rely on data and evidence, including FDA approval, to understand what tools, treatments, and technologies best improve patient health and protect patient safety. So coverage will depend on the data and evidence available to ensure patients are getting the most effective treatment tailored to them,” said Cathryn Donaldson, communications director for America’s Health Insurance Plans, in an email.
Katherine Hempstead, senior policy adviser at the Robert Wood Johnson Foundation, the nation’s largest philanthropic organization devoted to public health, noted that Boston-based Pear Therapeutics has received FDA approval for its digital products for people with opioid use disorder and other types of addiction, including alcohol. But that approval did not appear to open any floodgates for other companies.
“There is a pathway for these digital apps to get into insurance benefits and be covered services, and that’s highly sought after, but I also think it’s hard. There are a huge number of these apps, and I think they have a difficult path to getting that status,” Hempstead said.
Christopher Guiffre, Pear Therapeutics’ chief financial officer and chief operating officer, said his company is the first to have FDA approval for what people in the industry called PDTs — prescription digital therapeutics. They may seem like apps, Guiffre said, but they’re software that treat disease, which is why his company believes it’s important to have a term that distinguishes their products from health and wellness apps that count calories or track worrisome moles on skin.
Pear’s PDTs, which the FDA approved in 2017 and 2018, are not yet broadly covered by insurance, although company officials have had more than 70 meetings with insurance company officials and are hopeful about the results. “I think you’re going to see coverage decisions for Pear this year,” Guiffre said. “I don’t know exactly how many, I don’t know exactly which ones or exactly what terms, but it’s noncontroversial to say that Pear will pave the path for other companies like Akili.”
“Those products that get FDA labels, that are meant to be prescribed and used under the supervision of a doctor and treat serious disease — those products will have insurance, and we will show that in 2020,” he added.
However, Caitlin Donovan, senior director of public relations for the National Patient Advocate Foundation in Washington, D.C., said that even with FDA approval, there are already things that many people think should be covered by health insurance but aren’t.
“Insurance in general never seems to cover anything it should, and they don’t have to cover anything outside of essential health benefits,” she said. “Think about things right now that aren’t covered, like hearing aids and certain types of vision care.”
And because states have different regulations, some parents who have babies that are allergic to breastmilk can get formula covered through insurance; others can’t. (Utah is among states that don’t require infant formula to be covered.)
Conversely, insurers have come around on coverage of treatments that were once considered unconventional, such as chiropractic care for lower back pain. So it’s conceivable that digital therapies could one day be covered, too.
“I think it’s reasonable to think that insurers should cover anything that has been peer-reviewed to be effective treatment for a condition, particularly if it’s as effective, or more effective, than existing treatments,” Donovan said.
Good v. bad screen time
Tyler Page of Minneapolis, the author of “Raised on Ritalin,” was diagnosed with ADHD as a child. Now 43, he says he’s not yet convinced of the value of video games to help the condition.
“The bright side is there isn’t really any worry of harm with a video game, where there might be with medications. Video games aren’t typically very expensive and are within the reach of most families, so it seems like the fight for FDA approval is for them to get into the insurance system where they stand to make more money than they might selling on their own,” he said.
Of course, regardless of whether insurance covers it, some parents might balk at any medical treatment that puts their children in front of a screen, given widespread alarm about what constant screen use is doing to young Americans. That’s something the team at Akili has thought about, too, and DiCarlo said that the company’s products automatically cut off “treatment” after 30 minutes of use.
“We are aligned with the American Academy of Pediatrics in its policy on media use in school-age children and adolescents and support the AAP policy statement that distinguishes between ‘good’ and ‘bad’ screen time. We believe that our investigational products would fall into the category of having important positive effects as defined by AAP,” DiCarlo said.
There’s still the question of whether expanded benefits would ultimately cost consumers who are already struggling to pay premiums, which have risen steeply over the past decade.
According to the Kaiser Family Foundation, a family of four with large employer coverage spent $4,706 on their share of health premiums and $3,020 on deductibles, copayments and coinsurance in 2018, for a total of $7,726, the analysis finds.
That was up from $2,838 in premiums and $1,779 in cost sharing in 2008, for a combined cost of $4,617, the foundation said.
“It’s an interesting issue. I think there’s a school of thought that would say if you want to make something cost a lot more than it needs to then put it under an insurance benefit,” Hempstead said.
