The Digital Medicine Society (DiMe), in partnership with Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer, and Savvy Co-op, announced the public launch of the 3Ps of Digital Endpoint Value (3Ps) toolkit. The objective of the 3Ps toolkit is to support those developing and deploying digital endpoints as value-based evidence in reimbursement decisions. By implementing these resources now, the digital health industry will be ready for success when the first digital endpoints are accepted to support new drug approvals, according to the DiMe website. DiMe has reportedly seen a 665% increase in the number of unique digital endpoints used in clinical programs over the past two years, pointing to a surge of interest in mHealth devices, including wearables, that can collect biometric data outside the healthcare setting.
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. We applaud the forward-looking vision of our partners in this project and are proud to make these resources available in advance of any delays in making effective new treatments available to the patients who need them.
Jennifer Goldsack, CEO of DiMe
3Ps of Digital Endpoint Value – The Digital Medicine Society
As digital endpoints are used more frequently in evaluating new medical products, the field has focused extensively on regulatory acceptance in support of drug approval. In March 2022, the FDA issued draft guidance guiding digital health data acquisition in clinical investigations, furthering the widespread speculation that regulatory acceptance is not far ahead.
The Digital Medicine Society, or DiMe, maintains an open-access library of digital endpoints used in industry-sponsored trials of new medical products. Since the library’s launch in October 2019, the number of unique digital endpoints used to answer questions about new therapies has grown by 790%. Today, 91 different sponsor organizations rely on these measures to answer questions about new medical products.
Similar to all other DiMe resources, the 3Ps of Digital Endpoint Value tools are action-oriented and intended to help organizations in everyday work. According to the announcement, the 3Ps toolkit acknowledges that pharma and payers must work together and define the evidence needed to support the value of new, digitally generated data to patients’ lives. The development of the 3Ps resources follows a series of workshops assembling health economists, global regulators, health technology assessment (HTA) bodies, public and private payers, industry sponsors, and clinical and patient experts.
3Ps Project Toolkit
According to the Digital Medicine Society, three stakeholder groups are critical to ensuring that evidence from digital endpoints is acceptable for reimbursement decisions:
- Pharmaceutical companies are developing new drugs and other medical products 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 in establishing the value of evidence derived from digital endpoints
DiMe also highlights that another essential stakeholder group is vendors that develop digital clinical measures as digital endpoints in trials of new drugs and other medical products. Below are the open-access resources DiMe has curated alongside leaders from pharma, health tech, payer organizations, and patient groups.
Digital Medicine Society Project Toolkit
Toolkit for All Stakeholders (click to expand)
- The Integrated Evidence Plan –Â Using evidence from digital endpoints to demonstrate the value of a new drug: Considerations and recommendations
- The Value of Digital Endpoints for Reimbursement Decisions –Â Opportunities and challenges to using digital clinical measures to inform reimbursement decisions in drug development
- Quickstart guide: Reimbursement in the U.S. –Â Quickstart Guide
- Quickstart guide: Reimbursement in Europe –Â Quickstart Guide
- 3Ps of Digital Endpoint Value –Â Key terms glossary
Pharma Toolkit (click to expand)
- Recommendations for Pharma –Â Advancing the Acceptability of Evidence Derived from Digital Endpoints for Payers
- Digital Endpoints Value-Add Best Practices –Â Decision tool for integrating digital endpoint evidence into your Integrated Evidence Plan
- At-A-Glance –Â Recommendations for Pharma
Payer Toolkit (click to expand)
- At-A-Glance –Â Recommendations for Payers
An industry leader’s public meeting (webinar) will detail the recommendations and resources on April 7, 2022.Â
Following a series of discussions with payers from the U.S. and Europe, it is clear that pharmaceuticaU.S.ganizations using digital endpoints in drug development must pursue integrated evidence plans that generate data to inform regulatory, reimbursement, and pricing decisions. The 3Ps toolkit will advance the dialogue between manufacturers, patients, payers, and regulators on what patient-centric evidence should look like. Hopefully this will help further broaden acceptance of the new improved endpoints.
Katrine Christensen, Global Value and Access Strategy Lead at Biogen Digital Health
The Continued Adoption of Digital Solutions
Digital tools that facilitate innovative methods and modalities to improve health care, enable lifestyle change, and create efficiencies are progressing quickly. In the last decade, we have changed the model of care by virtualizing the practice of medicine where it makes clinical and economic sense. Simplifying processes is just a start. Digital patient access has significantly evolved throughout the pandemic, and consumer decisions have developed along with it. As healthcare organizations move toward offering more personalized care solutions, they will increasingly need to rely on software and hardware solutions to support these initiatives. The view of digital health solutions is that they are long-term investments that, if implemented correctly, will net great returns.
DiMe 3Ps Project Partners
About the Digital Medicine Society (DiMe)
The Digital Medicine Society (DiMe) is the professional society serving the digital medicine community, driving scientific progress and broad acceptance of digital medicine to enhance public health. DiMe is committed to fully integrating experts from all disciplines comprising digital medicine is unwavering. From regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists, DiMe is proud to welcome all experts committed to ensuring that digital medicine realizes its full potential to improve human health.
