Digital endpoints are increasingly being used to evaluate new medical products. Our field has focused extensively on regulatory acceptance of digital endpoints in support of drug approval, with draft regulatory guidance now available. But let’s think ahead to solving the next big challenge: reimbursement.

Three stakeholder groups are critical to ensuring that evidence from digital endpoints is acceptable for reimbursement decisions:

1. Pharmaceutical companies developing new drugs and other medical products evaluated using data derived from digital endpoints.
2. Payer organizations making reimbursement decisions about new drugs demonstrating their efficacy using data derived from digital endpoints.
3. Patients and patient groups who are instrumental to establishing the value of evidence derived from digital endpoints.

Another important stakeholder group is vendors that develop digital clinical measures for use as digital endpoints in trials of new drugs and other medical products. Our toolkit of resources support those developing and deploying digital endpoints as part of an evidence generation strategy supporting value and reimbursement discussions, or those assessing such evidence.