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.

Toolkit

All Stakeholders
Pharma Resources
Payer Resources

Using evidence from digital endpoints to demonstrate the value of a new drug: Considerations and recommendations

Opportunities and challenges to using digital clinical measures to inform reimbursement decisions in drug development

Key terms glossary

Quick start guide to drug reimbursement – U.S.

Quick start guide to drug reimbursement – Europe
Recommendations for pharma

Decision tool: Integrating digital endpoint evidence into integrated evidence plans

Recommendations for pharma at-a-glance
Recommendations for payers

Recommendations for payers at-a-glance

Did you miss the 3ps launch event?

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:

Pharmaceutical companies developing new drugs and other medical products evaluated using data derived from digital endpoints.
Payer organizations making reimbursement decisions about new drugs demonstrating their efficacy using data derived from digital endpoints.
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.