Patient support for digital therapeutics: Do's and don'ts for designing your program

Digital therapeutics are generating a lot of buzz in healthcare — and for good reasons. These innovative treatments combine the proof of concept advanced by consumer applications with the health outcomes of today's leading specialty therapies. The biggest differences, of course, are the potential for improved access to these therapies and efficacy without side effects.

"The idea that you could have the option of a digital therapeutic that is showing efficacy for autoimmune types of disease states is remarkable, as is the idea of being able to get relief from the symptoms without some of the adverse effects that may be associated with traditional pharmaceutical therapies," says Myra Reinhardt, Vice President of Product Innovation and Analytics at Lash Group. "I'm really intrigued by the science behind it and where we can go in terms of what digital therapies can deliver." Some digital therapeutics may even be available without a prescription or offered as employer-sponsored benefits.

With so much promise, it's no surprise that health-focused developers would be eager to bring new digital therapeutics to market. If you're one of these innovators, don't let a murky coverage landscape or a patient support program that can't keep pace hold your product back. Keep these do's and don'ts in mind as you commercialize your digital therapeutic.

DON'T create prescriber hurdles
In addition to ensuring digital therapeutics maintain security and privacy for patients, the experience of getting a patient to enroll in and use a digital therapeutic should be seamless for the physician — whether they're prescribing it or not. Consider investing in provider education in addition to direct-to-consumer marketing. Additionally, evaluate the potential for field support if there's a need to connect providers with patient access programs or a desire to increase provider awareness of reimbursement options.

When using a telemedicine or self-pay approach to enroll patients in the therapy, develop a strategy for communicating with the patient's primary care physician so that there's continuity in care.

DO rely on qualified partners for coverage and reimbursement expertise
The digital therapeutics in market to date have seen little consistency in terms of how they are covered. For a while at least, that will continue to be the case as payers consider adding digital products to a plan's formulary through formulary exception request processes and their standard reimbursement setups — sometimes determining in real-time whether they're going to cover under the pharmacy benefit or the medical benefit.

The companies that will be more successful are those that invest in an access strategy that includes pre-launch communications and pre-approval information exchange with payers.

"A strong reimbursement support model and a deep understanding of both medical and pharmacy coverage and how to navigate novel products are going to be key," adds Colleen Cummins, Product Director at Lash Group. "These are going to be very unique for the next several years. There's not a clear roadmap to copy from a product that came to market similarly just a month or two ago. You're going to need a partner who can support and understand how to navigate the more complex side of reimbursement."

DON'T accept just tech support
As you seek out patient support partners for your digital therapeutic, look for an organization that can meet tech timelines while speaking pharma's language. That means they'll learn your app inside and out while leveraging decades of experience supporting patient access to life-changing therapies. “Instead of just supporting the technology itself, expect a patient support partner to bring you knowledge of reimbursement models, patient access challenges, and how to adapt support programs,” explains Ashlee Burr, Director of New Business Development at Lash Group.

But remember, this is a new space. While very few patient services companies have launched numerous digital therapies, the best partners will have experience launching novel therapies across innovative categories and can bring that expertise and flexibility to bear for your groundbreaking product.

DO evolve your outreach
For patient support programs, communication with patients over the past few decades has largely been conducted by postal mail or phone. In the last five years, patient support partners have incorporated texting, interactive voice response (IVR) options, and in-app communications to improve engagement and make communication more convenient. Now, the digital therapeutics market allows both app developers and their patient support partner to take advantage of push notifications, email, and in-app alerts to reach patients for everything from self-reported outcomes to subscription renewal payments.

That means adherence support will look a little different. "On the nursing side, a lot of the support is set up to help onboard," notes Dale Hanna, Product Director at Lash Group. "There's a level of engagement to get them started, and then tracking and supporting the patient through different modules of treatment. It's different in the sense that it's more troubleshooting for the technology, if you will, but it's also helping keep patients on track as they use the digital therapeutic so that meaningful outcomes are captured. This ultimately benefits both the patient and the developer."

Also, remember that upgrades are akin to advances in therapy in the digital space. "If you think about it from a regulatory approval perspective, the FDA approves the core algorithms for some digital interventions," says Reinhardt. "Since tech companies are designing these therapeutics, they'll continue to release upgrades and versions of the initial algorithm they produced, which means patient users will need to upgrade and they may need help. The new release may need to be monitored or rolled out, not unlike a new drug."

The biggest difference? The pace of innovation. "Technology evolves much more quickly than any other aspect of healthcare," Reinhardt adds. "As patient support partners, we're working with a client who has an 18- to 24-month evolution mindset, not someone who's taken years to bring a drug to market. Our capabilities have to evolve just as rapidly."

DON'T ignore the data
Partnering with a qualified patient support provider around your data strategy will be crucial to successfully commercializing a digital therapeutic. How will you extract data from the app while being mindful of patient privacy rights? Who will interpret that data — and how? What actions will you take based on those insights?

The most skilled patient support teams have nurses on program teams who look at data and advise on changes to intervention schedules based on how patients are using the therapy (i.e., "stickiness," or adherence, data).
"One of the benefits that's always highlighted with digital therapeutics is rapid patient-generated data and health outcomes," says Alex Kilgore, Research Fellow at Xcenda. "But understanding and utilizing that data seems to be a bit of a hurdle."

DO leverage automation
Patient support solutions for any digital therapy should be structured to support and deliver automation. Look for partners that invest in application programming interfaces (APIs) and technologies that enable interoperability. The integration between patient services and the patient-facing app should feel seamless. Back-end technology and engagement solutions should complement the high-tech way in which the patient is accessing their therapy.

“We wouldn't want or expect the patient journey of a digital therapeutic to mimic that of traditional pharmacotherapy,” explains Jack McGuire, Vice President of Pharmacy Services at Lash Group. “There are multiple steps to get a patient on a covered drug product, due to determination of benefit type, prior authorization requirements, cost-sharing responsibilities, non-primary health coverage, coding and claim submission guidelines, and drug distribution. As digital therapeutics become more well-defined and commonly prescribed, a benefit determination may be required but the coverage process will more than likely be more streamlined, which once completed can result in triage and digital download. By leveraging automation and keeping the digital therapeutic within that data mesh of interoperability, each step in the process, whether it be benefit determination or transfer to a digital pharmacy can happen in 'tech time.'”

DON'T underestimate digital therapies' staying power
Our final don't is more of a cautionary tip than anything else. Simply put, these innovative products are here for the long term. Three Lash Group experts tell us why.

"The market trends right now show that the compound annual growth in this space is going to be huge," says Cummins. "What we'll see is an increase in adoption by providers and patients because the newness and uncomfortableness will wear off and people will start asking if there are alternatives to traditional therapies. I see that as being a driver towards better adoption on the payer side, too. Demand on one side is going to influence the other side."

Reinhardt adds: "I think there is a desire to try different therapeutic approaches, especially in young adults and children, where digital therapies may be as effective or more effective without potential side effects."

"We're watching as some of our clients get their contracting in place, and it will be interesting to see how that continues to shake out from a value standpoint," notes Hanna. "If it doesn't, then how do digital therapeutics position themselves as companion products, partnered with other treatments specific to more symptom and condition management? Or are they paired with a biosimilar for lower-cost treatments with a digital component to refine what the patient outcome might look like? The possibilities for these products are promising."