When Baltimore, Maryland-based WellDoc announced its newest mobile health offering BlueStar this week, the big news was the fact that a "mobile integrated therapy" -- as the company refers to its offerings -- could be prescribed to patients via existing Rx channels and would be paid for by some private health plans.
MobiHealthNews caught up with WellDoc's Chief Strategy and Commercial Officer Chris Bergstrom and the company's President and COO Anand Iyer to learn more about how WellDoc secured reimbursement from private payers and got its BlueStar product recognized by the appropriate prescription compendiums and standards body, as well as how the company plans to get BlueStar onto physicians' prescription pads and into patients' hands.
"Others talk about prescribing apps [with platforms] like Happtique," Bergstrom said, "what they really mean is recommending mobile apps, not adjudicating them at pharmacies and in compliance with state laws and FDA regulations. We are adjudicating this product through a pharmacy, which I don't think a mobile health product has ever done before. We had to go through the [National Council for Prescription Drug Programs], which is the standard body that governs all the pricing, processes and standards for drugs. [We also] have to change the process for adjudicating at a pharmacy, because obviously this is not the same as a bottle of pills."
WellDoc had to work closely with the National Council for Prescription Drug Programs and comb through its bylaws to show that its mobile health offering should be treated with the same regard as a prescription drug. Bergstrom said when the company approached the various compendium and listing services for prescription medications, it ended up being a lot easier filling our the description fields for BlueStar than those groups anticipated. BlueStar has "indicated use" spelled out in its FDA 510(k) clearance, just like a medication or any other prescription only medical device.
"We don't have coverage with [Centers for Medicare and Medicaid] yet but we also haven't tried to get it yet," Bergstrom said. "We deliberately started with the private insurance companies first, and we might be tackling Medicaid second and then [Medicare] third. There was some strategy to that thinking, but it was also a matter of bandwidth, and just following wherever the water is flowing fastest and the easiest."
WellDoc's team believes that innovative and potentially disruptive products can still leverage a lot of the systems in place in healthcare today.
"To me it has never been rocket science," Bergstrom said. "Everything we are doing is something that each of us has done before [elsewhere]. Doing them with a really unique product, just required a little more effort, if you will," he said. "For prescribing [digital] products there is no need to reinvent the wheel, there's just a need to fit these novel products into the existing wheel."
BlueStar is, in effect, the prescription only version of WellDoc's diabetes management system that has secured three FDA clearances over the course of the past three years. As noted in the 510(k) clearance document, the Rx version of the offering has clinical decision support tools for care providers who prescribe the program to their patients. BlueStar also offers dynamic and adaptive feedback to patients, whereas previous products like WellDoc's DiabetesManager had a sizeable but ultimately limited bucket of static responses that it provides patients based on their entries.
"[Unlike DiabetesManager BlueStar includes] clinical decision support and [it] advises the doctor with: 'This is where the patient was', 'This is what has changed', 'This is what the evidence suggests you should do' but 'Do what you think is right'," Iyer explained.
WellDoc's next step is to create a salesforce that will employ the gamut of traditional physician marketing tactics to get the word out that BlueStar exists among primary care providers and endocrinologists.
When physicians do prescribe BlueStar to a patient, instead of handing an Rx to them and instructing them to head to the nearest Walgreens, the doctor faxes a prescription to WellDoc. The company says this is similar to the process for how insulin pumps are prescribed and some specialty drugs, too. WellDoc aims to capture some unique information about the patient and the medications they are taking as part of that faxed Rx, it then has a pharmacy in the state where the prescription came from dispense and adjudicate it. Following that, WellDoc sets up a face-to-face training session with the patient where they learn how to use BlueStar and also provide the company with more information to help tailor the program to meet their needs.
"We are literally going to have to be knocking on the doors of over 40,000 primary care physicians and endocrinologists," Bergstrom said. "We'll be at all the diabetes trade shows, doing scientific sessions, working with the opinion and thought leaders who influence others in the field... Once we do a baseline of doctor marketing, let's say about a year, we will then layer on top of that direct to consumer marketing, perhaps even television commercials, so that patients can then go into their doctor's office and say: 'Hey I heard about this thing called BlueStar. I thought it might be right for me. Can we talk about it?'"
While WellDoc isn't officially disclosing the price of BlueStar, the company said its "pricing structure is significantly less than other prescription products" for diabetes management and "less than the -- say -- $300 a month a lot of the drug therapies cost."
So, how did WellDoc become the first to get to this watershed announcement of a prescribable, reimbursable mobile health product? Bergstrom and Iyer suggested a number of reasons, but two main ones were the team they have in place and the fact that they have always relied on angel investors instead of venture capital firms.
"If you want to do all these things that WellDoc has done, find angels, no VC has the patience," Iyer told MobiHealthNews while summarizing comments an investor at a recent digital health event made on the subject. "Can you imagine us going to a VC in the early days of 2005 or 2006?"
"When you have an angel, they really believe in the vision," Bergstrom said. "They're not hung up on: 'When do I get my 3x return?' They are patient and -- until they think the vision is fundamentally flawed -- they are going to be supportive."
WellDoc expects others in mobile health will also get their clinically-validated, FDA-cleared offerings onto prescription pads, and the company believes leveraging the existing infrastructure is -- for now, anyway -- the best way to go.
"To the extent that your disruptive innovation can disrupt the outcome -- both the numerator health and the denominator cost -- but not the workflow of the process to get those outcomes -- then you win," Iyer said.
"As obvious as it is, that's a huge learning."