According to an April 4 press release, the nonprofit Digital Medicine Society, alongside the pharmaceutical companies, developed a toolkit of resources to facilitate the inclusion of digital endpoints as evidence for payers in reimbursement decisions for new drugs.
Digital endpoints are assessed using sensor-generated data often collected outside of a clinical setting during activities of daily living.
The use of digital endpoints has yet to be accepted in support of new drug approvals, but in January 2022, the FDA issued draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, furthering the widespread speculation that regulatory acceptance is not far off, according to the press release.
“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,” Jennifer Goldsack, CEO of DiMe said.
The resources for the toolkit were developed following a series of workshops convening global regulators, health technology assessment bodies, public and private payers, industry sponsors, health economists, and clinical and patient experts.
The group is planning to host a meeting April 7 on the material.
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