Trailblazer WellDoc To Sell First Mobile Prescription Therapy
(ED: This is the first case of the prediction of Dr. Topol, Dean of Digital, writing a prescription for a program, which beats Happtique’s intentions)
WellDoc, which sells a type 2 diabetes management program on a mobile device, scored another milestone yesterday. It launchedBlueStar, a prescription version of its Diabetes Manager program which received clearance from the Food and Drug Administration in 2010. Like any medical device, WellDoc had to demonstrate that its device is safe and effective. BlueStar is the first disease therapy to be prescribed through an app, where a combination of algorithms and drugs could alter the way medicine is practiced in the future.
“This is the first effective use of a mobile health application where there’s a positive feedback loop; the technology learns from what the patient is doing, and patients can then improve their self-care,” says Jerome Fischer, an endocrinologist at the Diabetes & Glandular Disease Clinic in San Antonio, Texas.
It is also the first to be eligible for reimbursement. Self-insured companies, such as Ford, Rite Aid, and DexCom, a glucose monitoring company, have signed up to offer BlueStar as part of their pharmacy benefit plans.
WellDoc targets specifically type 2 diabetes, a disease that afflicts more than 8% of the U.S. population, and is growing unabated. Increasingly, the medical community recognizes that drugs are not enough, and that intervention in the form of personal health coaches, even algorithmic ones, are needed to educate patients and keep them engaged.
Still, keeping patients motivated and changing lifestyle behavior are some of the thorniest issues in disease management. “There’s no app or health coach that’s going to help, if someone doesn’t want help,” says Lyle Berkowitz, a primary care physician who works with diabetes patients at Northwestern Memorial Hospital. In 2011, the New England Journal of Medicine published disappointing results of a Medicare trial of 242,417 diabetes and heart failure patients on eight disease management programs, using nurse-based call centers. They didn’t reduce hospitalization, or save money. Some of the reasons: nurses often intervened late since calls were pre-scheduled; and there was no relationship between the health coach and the patient’s primary care provider which could facilitate changes in a treatment plan.
The burgeoning mobile health industry has shown scant evidence its tools improve clinical outcomes, but WellDoc has published results of a year-long randomized clinical trial to prove that its product works. (It caught the attention of National Institutes of Health director Francis Collins who featured it on his blog). Delivery of immediate feedback in response to a patient’s blood sugar levels through the automated mobile coach, combined with quarterly reports to a primary care doctor led to a mean decline of 1.9% in average blood sugar levels over the previous three months. Those levels dropped 0.7% in patients receiving usual care.
WellDoc now has to do what any drug company does: knock on doctors’ doors. The company plans to build a small salesforce, and perhaps partner later with a pharmaceutical company. It will start calling on primary care doctors, and endocrinologists in Detroit, Ford’s headquarters, and other areas such as San Antonio, Texas. It plans to launch nationwide by the end of the year. “We have to drive our own path,” says Chris Bergstrom, WellDoc’s chief strategy and commercial officer.
BlueStar has richer features than WellDoc’s first product Diabetes Manager. Patients still input their blood sugar level, get alerts if it’s high or low, and chart it over several months to detect trends. If patients are struggling with low blood sugar, it suggests drinking half a cup of apple juice, or eating 3 to 5 hard candies. But, Diabetes Manager didn’t provide feedback on medication dosage or intake, more personalized coaching, or recommendations to doctors–all of which have the potential to boost medication adherence.
It works like this: like a drug, a doctor prescribes BlueStar for one month (refills can also be prescribed) to supplement any medication. A pharmacy gets the prescription, adjudicates the claim, then forwards it to WellDoc. The company dispatches a trainer who helps the patient download BlueStar on a smartphone or laptop, and walks them through. Using a trainer is an expensive proposition, but WellDoc says it’s a trial. “This is so new, we want to learn what the right experience is,” says Bergstrom.
BlueStar calculates the insulin dose a patient should take based on the physician’s medication regimen, taking into account blood sugar levels, and the number of carbohydrates a patient consumes at a meal. If needed, WellDoc sends the doctor a report recommending evidence-based protocols for changing the patient’s treatment regimen.
All this was new territory for pharmacies and the National Council for Prescription Drug Programs which maintains standards for exchanging pharmacy data. “Their reaction was ‘you’re like a drug, but you’re not; you’re like a device, but you’re not,’” says Bergstrom. “They realized this is where the future is going,” adds Anand Iyer, WellDoc’s president.
WellDoc says pricing will vary with each health plan, since it is based on negotiations with pharmacy benefits managers, such as Caremark, Express Scripts ESRX -0.66%, and OptumRx, but will cost one-third to half the price of branded diabetes drugs, which run $200 to $300 a month.