13/06/2019 | BlogPost
During Healthware Labs’ journey of the last five years working with pharma in designing, building, and launching Digital Therapeutic solutions, and partnering with digital health startups to "up" their offerings to DTx status, one tiny issue of critical importance always comes up.
While the focus of many of these efforts is on clinical validity or technology wizardry being brought to life, at the end of the day if there is no clear path to reimbursment, the entire effort may be for naught.
Trying to figure out if, how, and by whom your new DTx solution will be paid for is the stuff that keeps most of us DTxers up at night, dreaming up B2B2C2SellTheAnonData2Third-Parties monetization schemes that somehow will keep our investors and sponsors convinced to keep funding our otherwise great digital therapeutic solutions.
This financial insomnia all changed quite drastically with the overnight news that Big Health, a SF based company and their insomnia treatment app Sleepio partnered with CVS Health to be included in the formulary of approved drugs that can be reimbursed by the health benefits programs they administer for insurance companies and big employers.
The important part of this bit of news (besides the reimbursability itself) is that there was no need to create a new category criteria for Sleepio to be included, but it was simply listed as another drug, so that insurance companies and employers benefit centers will be able to add Sleepio to the list of solutions they reimburse, and check patients’ eligibility, using the same systems and processes used for drugs.
Digital therapeutic solutions such as Sleepio, with clinical validity and studies to back their efficacies, have yet to gain widespread traction due specifically to the lack of rehimbursability options that benefit traditional drug based therapies, so this is a very significant first step, at least in the US.
In Europe the picture is still hazy, and fragmented from country to country, and the opportunity of having one’s DTx solution automatically covered across many insurance companies and payor benefit systems is a pipe dream at best. There are a few exceptions such as UK’s NHS offering certain apps of approved solutions (Sleepio is one of them), or some of Germany's private insurers covering some DTx solutions such as Tinnitracks, or in France where DTx solutions can try to gain coverage by the France health system, but only if they are able to integrate as part of a tele consultation solution (with doctors becoming de-facto DTx gate-keepers in France’s model).
One other thing to also keep in mind if you are a large company or startup working on DTx solutions, is that you are in for the long haul. This type of “success”story does not happen overnight. Sleepio’s founders Colin Espie and Peter Hames launched their company in 2012, already achieved clinical validation in clinical trial the same year, and received positive comments in both The Lancet and Nature journals in 2013 (which is the same year they were included as a launch app in the NHS-approved health apps library), and this inclusion in CVS Health’s partnership happened 6 years after the fact. It is however through the success stories of companies like Sleepio that the road to a truly Digital Health Future is being paved and becoming shorter by the day, and we could not be prouder here at Healthware Labs to be part of this fantastic journey.