Stakeholders across healthcare are beginning to weigh the benefits and challenges digital therapeutics could bring to their businesses, and pharma is no exception.
During an afternoon roundtable session held Wednesday at BIO 2018 in Boston, a panel of digital medicine and pharmaceutical representatives discussed the impact that these novel medicines has had, and could have, on drugmakers, regulators, and those prescribing the medications.
“[Digital medicine is] important for purposes of adherence and compliance, and I think it’s important for gathering data to negotiate agreements with payers,” Don Jones, chief digital officer at the Scripps Translational Science Institute, said during the session. “But where I think it really is important … is to create a flywheel iteration process to continue to recreate the product; essentially, to be able to do what the rest of the world does in consumer electronics and other industries, which is to create version 1.1, 1.2, 1.3. … And then from insights you can gain from the data you’re getting back in, get insights into filing new claims with the FDA [and] you essentially can reinvent the product. And the opportunities there are obviously huge — bigger than compliance opportunities.”
Digital therapeutics — defined in this case by Jones as just about anything that combines software, hardware, and, usually, molecules for health outcomes — are beginning to receive recognition outside of their earliest advocates. But it’s not just the approval of a few high-profile therapies such as Pear Therapeutics’ reSET and Proteus Digital Health/Otsuka Pharmaceutical’s Abilify MyCite; several providers, payers, and drugmakers are recognizing the benefits of packaging their more traditional treatments alongside a wider connected or sensor-driven service. These implementations may not yet be the norm, but according to Canary Health’s President and CEO Adam Kaufman, they’re already leading to serious changes in the wider strategies of pharmaceutical companies.
“What is happening in some settings — and the one that we do the most work in, diabetes — is that’s now transforming business models,” he said. “So I think if the business models now reimburse around engagement, around outcomes, it’s not sufficient to just have the treatment, you have to wrap complete service around it. That is happening differently by product category as well as disease state, and some diseases are farther along. … I think in drug classes where there’s the 15th drug in whatever, there’s going to be a push by the manufacturers on one hand and the payers on the other to have a full service, a full solution, and that will ultimately transfer over.”
Jones noted that interest in digital medicines is high among pharma executives with whom he’s spoken, and that resistance within the sector to digital change primarily comes from those below the top rung of the corporate ladder.
“I see a great deal of enthusiasm at the C-suite. The gap, if I see it, is in the mid-tier down, and it kind of comes down to ‘my job, my performance, my bonus’ all being tied with making sure a product moves down its various steps — if I have to make it more complicated by thinking of more things, that just gets in the way,” Jones explained. “Most of the better C-suites are now stepping back and saying ‘what are the platforms I need to have in place in order to be successful as a digital pharmaceutical company across many drugs?’ Those are really good questions.”
While it’s easy to point to regulatory forces as a potential impediment to digital adoption, members of the panel were generally warm to the FDA’s ongoing work to classify the new treatments. Otsuka Phamaceuticals' Senior Director of Global Clinical Development Timothy Peters-Strickland in particular was full of praise for the agency that was “finding a path” during its hands-on appraisal of Abilify MyCite.
“Since our approval and even before our approval, the landscape is starting to change,” he said. “We’ve had, I think, around 15 interactions with the FDA just around this product … and we’ve had more FDA meetings face-to-face than we’ve ever had before with any of our other products. They’ve been engaged, I think they wanted a path forward as much as we did.”
Instead, the panel most often pointed to complications and additional processes introduced by the products themselves as potential barriers to their greater adoption within pharma and wider healthcare. Chief among these were siloed services, products that complicate or increase physician or staff workflows, and wider technologic complications arising from a lack of industry-wide data standards.
“The companies that are addressing this particular issue … come from the services, consulting, device manufacturing, and software industries. They don’t come from pharma, and they’re thinking about it from the perspective of telecommunications,” Jones said. “[Pharma] really has to be a Switzerland that sits in the middle — it could potentially be a consortium of lots of pharma companies that get behind it, but it can’t be one company. So, what I’m beginning to see are very large entities that have lots of experience [with telecommunications network creation] beginning to step up to this plate and offer solutions. They’re all early, but there’s a couple choices now.”