FDA breakthrough device will pay you not to consume alcohol

DynamiCare Health have received FDA Breakthrough Device Designation in the U.S. for their prescription digital therapeutic (PDT), which treats alcohol use disorder (AUD). The solution, “DCH-002”, comprises an app, breathalyser and debit card. It also incorporates cognitive behavioural therapy (CBT) to help address underlying drivers for alcohol dependency. Users also earn a financial award if they receive a negative result from a random breath test. 

Why it’s Notable:

• The WHO estimates that overall, 5.1% of the global burden of disease and injury is attributable to alcohol. In the U.S. alone, the National Institute for Alcohol Abuse and Alcoholism (NIAAA) found that between 2019 and 2020, alcohol-associated liver disease deaths increased 22.4%, with the largest affected group being those aged 25 - 44. In 2021, alcohol misuse cost the U.S. $249B. Further, a 2021 study found that increased drinking spurred on by the pandemic alone will lead to an estimated 8K additional deaths from alcohol-related liver disease, >18K cases of liver failure, and 1K cases of liver cancer by 2040.

• Alcohol dependency is multi-faceted but for many affected, stress and mental health are significant contributing factors and access to appropriate supports such as therapy and coaching are critical to recovery. With over 150 million U.S. citizens currently living in federal-designated mental health professional shortage areas, more accessible solutions are going to be required to support those in need.

Industry Implications: 

• Offering financial incentives to drive patient outcomes is an interesting model that is sure to raise a few eyebrows. A rise in addiction clinics using this approach has led to probes in the U.S. due to concerns that they may be breaching a federal anti-kickback statute. However, clinics have argued that they are exempt as it is service users, and not clinicians, who are being rewarded.

• Further, this model of motivating patients through reward, which is termed “Contingency Management”  has been proven to be effective across addiction areas which are notoriously difficult to treat and cause significant cultural, social and economic burdens on both a local and national level.  

• DynamiCare have demonstrated verified abstinence rates twice as high as controls. Many chronic conditions beyond addiction have significant lifestyle related drivers. We all know that certain activities, such as poor dietary balance or sleep scheduling, can affect our health profoundly, yet the majority of us continue on in these habits. Moving beyond merely informing people of the consequences of their choices or lifestyles into more active motivation for habit-breaking may be worth exploring in other relevant areas.

If you, or anyone close to you, has been affected by alcohol dependency issues, please seek support through websites such as drinkaware.ie, or speak with a licensed medical professional.