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
Thanks for reading. You can find previous posts in the Employer Coverage archive
Please “like” and suggest this newsletter to friends and colleagues. Thanks!
Tomorrow: GLP-1 drugs NOT associated with increased risk of thyroid cancer in large medical record database