Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer and Savvy Co-op have partnered with a non-profit organization to develop a toolkit to support reimbursement for new drugs developed using digital terminals .
According to an April 4 press release, the nonprofit Digital Medicine Society, alongside pharmaceutical companies, has developed a toolkit of resources to facilitate the inclusion of digital endpoints as evidence for payers in drug decisions. reimbursement of new drugs.
Numerical parameters are assessed using sensor-generated data, often collected outside of a clinical setting during activities of daily living.
The use of digital endpoints has not yet been accepted to support new drug approvals, but in January 2022 the FDA released draft guidance providing its recommendations on the use of data acquisition digital health systems in clinical investigations, bolstering widespread speculation that regulatory acceptance is not far off, according to the press release.
“In launching these new guidelines and resources, we are the first to recognize and respond to the need to ensure that evidence from digital devices is developed in a manner acceptable to payers as well as regulators,” said said Jennifer Goldsack, CEO of DiMe.
The toolkit resources were developed following a series of workshops bringing together global regulators, health technology assessment bodies, public and private payers, industry sponsors, health economists and clinical and patient experts.
The group plans to hold a meeting on April 7 on the hardware.