New PBM programs offer road to validity, adoption for digital therapeutics

Vetting digital health products for distribution and reimbursement is another step forward for novel digital treatments hoping to stand alongside traditional biologics.
By Dave Muoio
02:32 pm
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In many respects, the pharma industry’s operations are still in the early stages of technological  revolution, and there’s no better example of this than its gradual adoption of digital health and digital therapeutics.

On one hand, more and more groups are regularly striking new partnerships that supplement existing drug treatments with digital tools, while Novartis continues its work with Pear Therapeutics to develop and commercially launch the first wave of prescription digital therapeutics. Conversely, many pharmas, clinicians and other healthcare stakeholders remain hesitant to adopt these tools into practice due to the difficulty of vetting the wide range of digital products being introduced with each passing day.

Fortunately, the past few months have seen entities toeing the line between pharma and payer taking steps to validate and support specific digital health products, thereby paving the way to reimbursement and widespread adoption.

First, in May, pharmacy benefit manager Express Scripts announced it will be releasing a stand-alone digital health formulary next year, which it will use to highlight digital health tools of quality for its customers. To be included, a digital health device or software tool will be reviewed by physicians, pharmacists and other experts who will gauge the product’s clinical outcomes, therapeutic value, effective usability, security and privacy standards, and cost effectiveness.

In addition to reduced contracting burden and costs, Express Scripts said that it hopes this groundwork will eventually lead to the establishment of a new pathway for prescription-only digital therapeutics looking to enter the market.

“We are in an exciting age when technology is giving people even greater control of their own health and well-being. However, much of this technology is still emerging, and there are many digital health solutions that require clinical review and validation,” Mark Bini, VP of innovation and member experience at Express Scripts, said in a statement. “We see a need to put mechanisms in place to help carefully manage these innovations, and are proud to lead again by being the first health services organization to establish a formulary of this nature.

A month later, CVS Health took a similar step with the rollout of Vendor Benefit Management, a service that will help CVS Caremark PBM clients roll out and manage third-party health products.

It’s designed to help PBM clients access negotiated pricing, real-time and standardized member eligibility verification, easy billing and payment processing, and standardized result reports for vendors and products — but what makes the open platform noteworthy is that it also supports digital health and wellness products. As such, CBT app maker Big Health was announced as the first vendor that will be participating in the service.

“The challenge is not just in developing [digital] products — we now have very effective products — but how do we distribute and gain reimbursements for those products in a very, very scalable way, in a way that allows not just the really early adopters to buy and then offer to their populations?” Big Health CEO Peter Hames asked MobiHealthNews at the time. “What this partnership with CVS offers, specifically in the context of digital therapeutics, is a new pathway to facilitate that mainstream adoption of a digital therapeutic.”

Hames stressed that his company’s product was supported by CVS Health due to its substantial body of evidence supporting its effectiveness that the Big Health has generated over the years. If other digital health products are to receive similar support, he said, they’ll have to follow suit by spending increased time and effort validating their products for payer and pharma partners alike.

“If we are serious as an industry about really fulfilling our potential to offer a real mainstream modality of healthcare, we have to be held and hold ourselves accountable to exactly the same high bar that any other domain of therapeutic would be held to,” he said.

These ideas were echoed by Megan Coder, executive director of the Digital Therapeutics Alliance. For her, these types of programs from major decision makers are “incredibly encouraging” due to their capacity to increase access to digital therapies, while also ensuring that the products that reach patients are delivering the outcomes they are promising. She said that these kinds of programs can also motivate digital health companies to generate their data in both a pre- and post-market environment — an increasing area of focus for pharmas, payers and even regulators thanks to the ease with which software and devices can now collect and transmit data.

But the onus is not on digital health and digital therapeutics companies alone, she continued. Much of the digital industry has already come together to devise definitions and guidelines targeting many of the same goals PBMs would seek through their own validation process. She warned that if each stakeholder ignores established frameworks when constructing their respective programs, the industry will face a cacophony of incongruous rules and requirements that will only serve to hamstring adoption of these novel therapies.

“I hope that when groups like Express Scripts and CVS move forward that they do look at what the industry has already put together,” Coder told MobiHealthNews. “We have a really broad group of companies that came together to help define this space and define some best practices. And also important to note is that our membership is international in scope, so we’re really trying to ensure that we have international perspective, recognizing that the products should be of the same level of quality and rigor regardless of where they are developed or used by patients.”