Evaluation of prescription digital therapeutics

November 15, 2023

This month’s Health Affairs has a review of the research data used to demonstrate efficacy of prescription digital therapeutics. Prescription digital therapeutics are software that is used for a medical purpose, such as software to help care for diabetes, irritable bowel syndrome, substance use disorder, post-traumatic stress syndrome, and a variety of other clinical problems. There are many advantages to using digital therapeutics. They should not cause adverse effects like pharmaceutical products, and they might even have a positive placebo effect. Some analysts suggested that the digital therapeutics market would be over $22 billion by 2031.

Companies pioneering digital therapeutics have had a rough year. Pear Therapeutics, which had raised over $400 million from investors, offered programs to treat substance use disorder, opioid use disorder and insomnia. Pear went bankrupt this spring and was liquidated for just $6 million.

The Food and Drug Administration (FDA) has approved 20 digital therapeutics (for 22 indications from 18 different companies). The researchers in Health Affairs found that:

• Only two of the digital therapeutics had been evaluated in a randomized, double-blind trial

• Two thirds of the clinical studies were performed after the digital therapeutic was marketed and had less rigorous evaluation standards.

• More than half of the studies didn’t report on participant race and 80% didn’t report on ethnicity, making it difficult to know if the study was applicable to any given population.

• A third of the trials required English proficiency.

Implications for employers:

• Digital therapeutics could offer promising solutions to difficult clinical problems and should not cause adverse effects like allergic reactions or bad side effects like some drug therapy.

• The field of digital therapeutics remains young, and likely needs more standardization of evaluations.

• Employers can check with their medical and pharmacy benefits to determine if members have access to digital therapeutics that require prescription.

• Employers seeking to deploy digital therapeutics should be sure that clinical trials were performed on a relevant population and should evaluate results critically.

• Employers can look into the viability of digital therapeutics vendors or purchase solutions through carriers or pharmacy benefit managers to protect them from vendor financial failures.

Illustration by Dall-E

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