The Digital Medicine Society (DiMe) teamed up with a slew of pharma giants and payers to launch a digital endpoints toolkit for stakeholders.

The open-access toolkit, which came from a partnership between DiMe, Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer and Savvy Co-op, gives payers a road map for including digital endpoints in reimbursement for new drugs. Dubbed the 3Ps toolkit, it has specific recommendations for pharma and payers, as well as information for patients and patient groups. 

"An endpoint more traditionally is a very clearly defined and pre-specified performance metric that you expect to see as a result of a clinical trial in order to say that the trial was successful," Jennifer Goldsack, CEO of DiMe, told MobiHealthNews.

Goldsack gave the example of a heart failure patients, where the measure may be hospitalizations or time to death. There are many types of endpoints, she said, including blood tests, self-reported data and imaging.

"And then, obviously in the digital era, we've got all of these sensor-generated measures that are able to measure things that we've never been able to measure before. They're able to measure existing outcomes of interest with much lower burden, with much higher resolution.

"There's no doubt that digital endpoints offer extraordinary opportunities to more efficiently develop therapies that actually matter to patients," Goldsack said. 

Digital endpoints include sensor-generated information, which can come from a range of sources that include smartwatches, phones, bed mats, connected scales and even smart contact lenses.

This new toolkit also includes a glossary of terms, a quick-start guide to drug reimbursement in the U.S. and Europe, and information about opportunities and challenges in implementing the technologies.

"It really was a sort of high-powered, multidisciplinary group of very thoughtful experts at the leading edge of this field saying we believe in the use of digital endpoints. We need to make sure that if we are using them, we aren't going to risk any delays or any inefficiencies in bringing new therapies developed using digital endpoints to market," Goldsack said. 

WHY IT MATTERS 

The use of digital endpoints in research is growing quickly. In fact, last month the FDA issued a draft guidance on using digital health data in clinical trials. This new initiative is focused on propelling the conversation on adoption. 

"We thought a lot, as an industry, about the use of these sorts of digital-measurement products, these digital sensors, digital endpoints for drug development. We spent years as an industry thinking about regulatory acceptance of these new measures of the data and the evidence they generate," Goldsack said. "To date, we've thought very little about payer and health-technology-assessment organization acceptance."

THE LARGER TREND

This isn't the first time that DiMe has dipped into the digital-endpoints game. In November, the company announced that it is teaming up with pharma giants AbbVie, Janssen Research and Development, Novartis, Pfizer and UCB to make nocturnal scratch an endpoint for atopic dermatitis. 

ON THE RECORD 

"By launching these new recommendations and resources, we are the first to recognize and address the need to ensure that evidence from digital endpoints is developed in a way that is acceptable to payers as well as regulators," Goldsack said in a statement.

"We applaud the forward-looking vision of our partners in this project and are proud to make these resources available in advance of any delays in making effective new treatments available to the patients who need them."