The pharmacy as an app store?
That’s a reality now after the Food and Drug Administration cleared WellDoc, a 100-person health care technology firm based in Baltimore, to sell a prescription-only smartphone app for diabetes patients.
Not only that, but a few major national employers — including Ford Motor Co. and RiteAid — have already agreed to reimburse employees who use the app through their prescription benefit plans. Patients will take the physician’s prescription to a pharmacist, who adjudicates the claim and notifies WellDoc. WellDoc then dispatches a staffer to meet with the patient to install the app and offer training.
The app, called BlueStar, provides real-time suggestions to patients with type 2 diabetes about how to maintain their glucose levels — what to eat or when — and when they should test their glucose levels. Available on a smartphone, tablet or computer, it periodically sends patient data to their physician via an automatic e-mail or fax.
A few times a day, patients input as much or as little information as they choose about their medication, glucose level and food consumption.
“They might come in and say, ‘My glucose level is 70 [miligrams per deciliter of blood], and I’m about to eat 30 grams of carbs. I’m at a restaurant, and I’m feeling tired today,’ ” said Chris Bergstrom, the company’s chief strategy officer.
The app might then suggest the patient eat a certain amount of carbs before testing glucose again in a certain number of minutes, and might send a suggestion to the patient’s physician about adjusting medication levels.
Relative to other diseases, type 2 diabetes is “fairly dynamic and changes throughout the patient’s journey,” Bergstrom explained, so it’s common for patients’ medication regimens to change, requiring more frequent monitoring of a treatment’s efficacy. The app “really just off-loads that analysis that a doctor might otherwise have to do” at the beginning of a patient’s visit.
Because the app makes medical suggestions to doctors — though never directly to patients, Bergstrom emphasized — it falls under FDA purview.
The FDA’s regulations on mobile apps are evolving. According to a draft guidance issued in 2011, the administration regulates apps which “input patient-specific information and — using formulae or processing algorithms — output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.”
It can be challenging to develop policies which protect public health while promoting innovation, said Bakul Patel, a senior adviser for the FDA’s Center for Devices and Radiological Health.
“There are many advantages to mobile medical applications, and they can contribute to healthier lifestyles and better medical care. But, as with any medical device, they carry a certain amount of risk, and FDA’s job is to assure the safety and effectiveness of medical devices,” he wrote in an e-mail.
The cost of FDA compliance adds million of dollars to his company’s costs each year, Bergstrom said. This includes adding more processes to handle employee training, product development, operations and marketing as a result of maintaining FDA quality standards. These costs are in addition to FDA filing fees, legal fees and the full-time quality assurance staff WellDoc hired.
But what was more difficult than FDA compliance, Bergstrom said, was securing patient reimbursement for BlueStar. After gaining FDA approval, WellDoc staff established a licensed relationship with pharmacies all over the country, and worked with individual pharmacy benefits managers at insurance companies to accept the product. They also regularly peddle the solution to physicians.
“We go to a physician’s office as a pharmaceutical company would. We describe to the physician the new product ... We explain how it fits into generally helping them in their practice, with cost, quality and satisfaction outcomes measures, and how it helps the patient adhere to the physician’s orders,” Bergstrom said, noting that ultimately, it’s up to the physicians whether they want to prescribe BlueStar.
The business is still new. Until it’s profitable, “we’re going to invest ahead of revenue for a while to grow the company and get it deployed,” Bergstrom said.