The host of new digital health products on the market has led to questions of how to effectively integrate evidence-based tool into clinical practice and pay for them.

Leading pharmacy benefits manager Express Scripts is charting a path forward with a new stand-alone digital health formulary it intends to offer starting in 2020. The company is now a part of Cigna after its $54 billion acquisition last year.

Building and maintaining a formulary of pharmaceuticals is among the standard functions played by a PBM. The company’s new solution takes that role into the 21st century by offering payers a curated list of technology and software-enabled applications and devices that have been vetted for safety, effectiveness and usability.

“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,” Express Scripts Vice President of Innovation and Member Experience Mark Bini, 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. This formulary will help ensure developers do right by payers and consumers, while increasing patient access to technology that can help improve their health.”

Express Scripts said it will use a comprehensive review process that includes physicians, pharmacists, user experience experts and health researchers to review data and make decisions on formulary makeup. Solutions will be judged on therapeutic value, effective usability, security and privacy standards and cost effectiveness. Payers will have still have ultimate control on which technologies will be provided and covered.

Outside of ensuring clinical effectiveness, Express Scripts said the formulary is intended to reduce the administrative burden for plan sponsors associated with contracting with digital health companies, improve affordability using the economies of scale that Express Scripts can provide and create a pathway to cover prescription-only digital therapeutics that are coming to market.

“Express Scripts has had such an outsize role in managing pharmaceutical benefits, their establishment of a digital health formulary is a very important development for digital therapeutics,” said David Lee, a partner with consulting firm Simon-Kucher & Partners.

“I expect this will accelerate market access and adoption of leading digital therapeutics, and create barriers to entry for therapeutics that are later to market.”

The initial focus of the Express Scripts formulary will be technologies that address diabetes, cardiovascular, behavioral health and pulmonary conditions, which will be expanded to other chronic and complex conditions.

“In addition to helping payers manage currently available digital health solutions, our digital health formulary lays the groundwork to manage new solutions and tools that have yet to be invented,” Bini said.

“We want to create a level playing field for inventors and entrepreneurs to encourage continued innovation in this space, and to ensure a pathway to deliver those innovations to patients with assured safety, accuracy and affordability.”

Increasingly, digital therapeutics companies like Akili Interactive and Pear Therapeutics have been partnering with big pharma as a pathway toward commercialization.

Lee pointed to similar trends internationally bringing software-based health technologies and drugs closer together, including plans by the German Ministry of Health to establish a reimbursement pipeline for digital therapeutics parallel to that of pharmaceuticals.

Picture: metamorworks, Getty Images

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