There’s a piece of advice I’ve used many times over the past 20 years, and when it comes to Pharma and digital medicine, once again it rings true. I used to go to a magic shop on Carson Street in Pittsburgh when I spent a summer in the area during high school. My friends and I would watch the shop employees go through a few tricks a couple times a week. It was cheap entertainment. But one card trick, in particular, caught my eye and I coughed up the ten bucks to buy it.
When he made the secret to the illusion was clear to me, I couldn’t believe it. The underlying “magic” was so simple, yet the shop owner later told us it was one of their best sellers. Then he dispensed a bit of wisdom. “Which looks better,” he asked, “a magic trick which looks great but is hard to do, or a magic trick which looks great but is easy to do?”
There’s no question that drug development has gotten difficult over the past 10 years. More trials. Longer trials. More patients. Greater regulatory scrutiny. Leaner candidate production from the research labs. The clip of innovation has leveled off. Yet, substantial healthcare improvement opportunities exist.
When we talk with physicians, the one clear message is the need to help patients sustain healthy behaviors. This includes everything from medication adherence, proper diet, appropriate levels of activity, to biometric tracking and continued engagement with health care providers. Sound familiar?
With Apple enjoying five years of success since it introduced its App store, digital health apps have been a part of the scene since its start. Individually, each of these apps usually addresses one or at most two aspects of effective disease management. But only a handful do so in a coordinated manner which has been backed by clinical evidence. In short, while it may be trendy to talk about prescribing apps, it’s also inaccurate.
Apps as Medicine
Apps are not medicine. Or at least that was valid until WellDoc announced that their BlueStar product would be available via prescription. How is this possible? It’s not a difficult magic trick by any stretch. WellDoc started with well-established outcome measures for type II diabetes. Then they built an integrated system (with a mobile app interface) to facilitate and simplify the many aspects of effective type II diabetes management. Then they conducted a clinical trial to show their system was effective — and they only needed a few hundred patients.
Next they did something revolutionary. WellDoc approached the FDA about marketing their app and integrated system as a medical device. Going through this process (510k approval) enables WellDoc to market medical claims about their product. This enables them to market their product as being safe and effective. Finally, WellDoc has gotten insurers (payers) to agree to reimburse for their product. They are starting small here. They are beginning with large corporations who self-insure like Ford and RiteAid and marketing specifically to their employees and their health care providers.
The last piece of the puzzle? It’s boots on the ground. The time-honored tradition of sales reps knocking on physicians’ doors to educate them about BlueStar. If you are in Pharma and reading this, I hope it sounds familiar. This is exactly the approach our industry has been taking to develop medications and bring them to patients. WellDoc followed the same playbook. Only they didn’t develop a pill — they’ve developed digital medicine.
Digital Apps and Pharma
Apps which support marketing programs are nothing new to Pharma. They are now part of the launch plan canon and practically a requirement for any chronic condition app. But thus far, these apps have been little more than agency developed marketing glitz. To my knowledge, no pharmaceutical company has studied if companion app usage has improved/enhanced overall outcome measures relative to just taking the medication alone. But they should.
There are reasons to proceed with caution (which I’ll review in a separate blog post). However, there are far more compelling reasons for Pharma to move ahead in developing digital medicine.
First, if nothing else, they will gain valuable data and insights into patient behavior. Insights which could help them understand patient subgrouping or assist them in designing better clinical trials.
Secondly, medication adherence will likely be a component of any effective healthy disease management regimen. Indirect revenue from prescription continuation is a grail Pharma is working hard to try and grasp. Mobile apps provide a viable approach to help meet this goal.
Lastly (and most compelling), Pharma can generate a novel revenue stream by selling companion “medical devices” (aka digital medicine, mobile medical apps) with their medications. While WellDoc has not made their reimbursement financials public, anecdotal reports suggest they are receiving $50-$100 per patient per month for the use of their system.
As Pharma goes after increasingly complex targets in an environment which is becoming more competitive and costly, the industry needs to return to a focus on improving human health. They need to cease insisting that pills are the only way path to wellness. The simple things help. The real magic won’t just be healthier patients, it could mean revitalizing the industry.