DiMe partners with big pharma, insurers on new toolkit for digital endpoints

The Digital Medicine Society (DiMe) partnered with a slew of pharmaceutical giants and payers to launch digital endpoints stakeholder toolkit.

The open-access toolkit, which emerged from a collaboration between DiMe, Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer and Savvy Co-op, gives payers a roadmap for including digital endpoints in the reimbursement of new drugs . Called the 3Ps Toolkit, it contains specific recommendations for pharmaceuticals and payers, as well as information for patients and patient groups.

“A more traditional endpoint is a very clearly defined and pre-specified measure of performance that you expect to see as a result of a clinical trial to say the trial was successful,” Jennifer Goldsack, CEO of DiMe, said: MobiHealthNews

Goldsack gave the example of a patient with heart failure, where the measure could 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 age, we’ve got all these sensor-generated measurements that can measure things that we’ve never been able to measure before. They’re able to measure existing results of interest at a much lower load, at a much higher resolution.

“There is no doubt that digital endpoints offer extraordinary opportunities to develop more efficient therapies that really matter to patients,” Goldsack said.

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

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

“It was really kind of a powerful, multi-disciplinary group of very thoughtful experts on the edge of this field who said we believe in using digital endpoints. We need to make sure that if we use them, we don’t risk delays or inefficiencies.” risk in marketing new therapies developed using digital endpoints,” Goldsack said.

WHY IT MATTER

The use of digital endpoints in research is growing rapidly. In fact, last month the FDA has released a draft guideline on the use of digital health data in clinical trials. This new initiative aims to start the conversation about adoption.

“We as an industry have thought a lot about using these types of digital measurement products, these digital sensors, digital endpoints for drug development. We as an industry have spent years thinking about the legal acceptance of these new measurements of the data and the evidence that they “To date, we’ve thought very little about payer adoption and health technology assessment organizations.”

THE BIGGER TREND

This isn’t the first time DiMe has plunged into the digital endpoint game. In November, the company announced that it collaborate with pharma giants AbbVie, Janssen Research and Development, Novartis, Pfizer and UCB to make nighttime scratching an endpoint for atopic dermatitis.

ON THE REGISTRATION

“By launching these new recommendations and resources, we are the first to recognize and address the need to ensure evidence of digital endpoints is developed in a way that is acceptable to both payers and 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 before any delays in making effective new treatments available to the patients who need them.”