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3Ps of Digital Endpoint Value

Reimbursement for New Drugs Developed using Digital Drug Development Tools

DiMe and our partners on the 3Ps of Digital Endpoint Value project have developed a toolkit of resources to support those developing and deploying digital endpoints as value evidence in reimbursement decisions. By implementing these resources now, our field will be ready for success when the first digital endpoints are accepted in support of new drug approvals.

Did you miss the 3ps launch event?

Project Partners

We are proud to have partnered with leaders from pharma, health tech, payer organizations, and patient groups to develop these open-access resources.

Project Background

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. 

Our project in the news!

The 3Ps in Action: tell us how you are using these resources

As for all DiMe resources, the 3Ps of Digital Endpoint Value tools are action-oriented and intended to help you in your everyday work! We would love to hear from you, so please use this form to tell us about how the 3Ps resources have helped you bring digital evidence into value and reimbursement discussions.

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DiMe’s projects are seeded by our member community, where experts share the greatest barriers to advancing the field of digital medicine. When the most complex and significant roadblocks can be addressed with a cross-ecosystem, pre-competitive approach, that’s where we come in: DiMe convenes multi-stakeholder teams to quickly dive deep into issues and rapidly produce high-quality resources that meaningfully enable progress.

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