Digital healthcare companies seeking FDA approval must weigh access versus income


Companies in the growing digital healthcare space are increasingly weighing in on Food and Drug Administration approval for their products, a strategy aimed at differentiating them from competitors as they seek to convince insurers and employers to cover their own. offers.

Companies such as Biofourmis, Akili Interactive and Pear Therapeutics offer software systems for specific diseases. Patients need prescriptions from suppliers to use the products. Insurance coverage for these products and services could allow these companies to reach more patients – and get paid more for them.

As this $ 9 billion industry matures, taxpayers will have to look beyond FDA approval when evaluating the effectiveness of these tools, and digital healthcare companies will have to make decisions about whether to submit products to them. the FDA based on what is best for its own business models, said Drs. Torous, director of the digital psychology division at Beth Israel Deaconess Medical Center at Harvard University.

The prescription requirement that accompanies Food and Drug Administration (FDA) approval limits patient access by limiting what type of medical providers can use these digital products to treat patients, Torous said. For example, Pear Therapeutics offers an app for people with opioid use disorder, but patients can only access it with a prescription from a doctor who has the authority to prescribe treatments, such as a psychiatrist. But psychologists and other licensed medical professionals carefully treat patients with substance use disorders.

“As this space becomes more crowded and applications that perform all similar functions seek to separate, there may be a market advantage for FDA approval,” said Torous, who also chairs the Health IT Committee. the American Psychiatric Association. “But it’s unclear if they have more evidence, or if they provide more effectiveness and more value at this point.”

Some apps are supported by clinical trials, Tourous said. Big Health has developed a tool to treat insomnia and anxiety, and 30 peer-reviewed studies support its effectiveness, he said. This research shows that the Big Health utility produces strong clinical results at a lower cost than traditional mental health treatments, and without the use of drugs. The San Francisco-based company has reached 12 million patients through contracts with employers like Comcast.

Big Health did not seek FDA approval even though it followed the agency’s regulations anyway, CEO Peter Hames said. The company believes that requiring prescriptions directly contradicts the goal of digital health, which is to improve access and address supplier shortages.

“I don’t understand the logic of prescribing them as necessary since it radically reduces access to a time when we should be striving to increase access to evidence-based digital solutions, rather than just copying and pasting the Big Pharma’s old way of doing things, ”Hames said.

The FDA approved the first digital therapeutic tool in 2017 when it canceled Pear Therapeutics ’opiate app. Pear Therapeutics has since entered public markets through a $ 4 billion special-purpose acquisition company, or SPAC. The company plans to spend that capital to develop a series of 14 applications aimed at conditions ranging from anxiety to irritable bowel syndrome. So far the FDA has approved three Pear Therapy apps. Two are for opiate use disorder, one of which is used in conjunction with medication, and one app that uses cognitive behavioral therapy to calm chronic insomnia.


Prescriptions for these products are legally necessary because the company puts them on sale as treatments for diseases, said Dr. Yuri Maricich, marketing director of Pear Therapeutics. FDA reviews of digital healthcare products are critical because patients rely on them for treatment and because these patients share personal information with app developers, he said.

But FDA approval does not necessarily mean a safer product. Pear Therapeutics may have collected and shared data on opioid users with third parties, according to a recent report by the Opioid Policy Institute. This has raised questions about the company’s privacy and security practices and could represent violations of federal law, the report’s authors concluded.

Pear Therapeutics has a strict post-marketing surveillance program that monitors all complaints and reports made by the FDA, said Maricich, who also said he had not read the Opioid Policy Institute report.

“For companies that don’t want to go to the FDA, what are they worried about?” Marcich said. “If they really have the data and the data shows that they are safe and effective, and that they have done the quality work to show that it is reliable, why should they be shy about taking that to the FDA?”

As more payers consider covering the software, further research is needed on its effectiveness, particularly because its potential to enrich access to drug-free care is so great, said David Whitrap, vice president of communication and dissemination to the Institute for Clinical and Economic Review (ICER).

Pear Therapeutics ’opioid app offers a short-term value at the current price of $ 1,200, ICER concluded last year. There were no randomized trial data showing that the product worked, Whitrap said.

FDA approval alone is not enough to justify insurance coverage for these apps, Whitrap said. Instead, choosing to look for the agency’s bond is more of a marketing and sales decision, he said.

“A big part of that depends on how the company wants to market the product,” Whitrap said. “Is it something they want to sell to consumers, or do they want to seek an insurance refund for it? Is there a price point beyond what a typical consumer is willing or able to pay? If those answers are yes, then an FDA-approved smart business decision for the company to be prosecuted. “

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