FDA-Cleared Digital Therapeutics
| Product | Indication | Evidence | Cost |
|---|---|---|---|
| Somryst | Chronic insomnia | FDA-cleared; RCT evidence | $900 per course |
| reSET-O | Opioid use disorder | FDA-cleared; RCT evidence | $1,000 per course |
| Freespira | PTSD; panic disorder | FDA-cleared; RCT evidence | $1,500 per course |
| Endeavor | ADHD (pediatric) | FDA-cleared; RCT evidence | $450/month |
DTx vs. Drug Therapy
Digital therapeutics can replace or supplement traditional drug therapy for certain conditions. Somryst (CBT-I for insomnia) is as effective as sleep medications — but without the side effects or dependency risk. reSET-O (for opioid use disorder) improves outcomes when combined with medication-assisted treatment. Digital therapeutics are typically less expensive than drug therapy and have fewer side effects.
Coverage Strategy
IQ Insight
Covering FDA-cleared digital therapeutics is an emerging pharmacy benefit design strategy. Digital therapeutics that are as effective as drug therapy — but less expensive and with fewer side effects — are high-value benefits. Consider covering FDA-cleared digital therapeutics for conditions where they are evidence-based alternatives to drug therapy.