April 4, 2022
Digital Medicine Society, Evidation, and Industry Partners Launch Toolkit to Support Reimbursement for New Drugs Developed Using Digital Endpoints
New essential resources ensure that patients will benefit without delay following regulatory acceptance of digital endpoints
Boston, MA, April 4, 2022 – Today, the Digital Medicine Society (DiMe), in partnership with Evidation, Anthem, Biogen, Eli Lilly, Janssen, Merck, Pfizer, and Savvy Co-op, announced the public launch of the 3Ps of Digital Endpoint Value (3Ps), a toolkit of resources created to facilitate the inclusion of digital endpoints as evidence for payers in reimbursement decisions for new drugs. A public meeting for industry leaders will detail the recommendations and resources on April 7, 2022.
DiMe maintains an open access library of digital endpoints being used in industry sponsored trials of new medical products. Since the library’s launch in October 2019, the number of unique digital endpoints being used to answer questions about new therapies has grown by 790%. Today, 91 different sponsor organizations are relying on these measures to answer questions about new medical products.
As digital endpoints are used more frequently in the evaluation of new medical products, the field has focused extensively on regulatory acceptance in support of drug approval. In March 2022, the FDA issued a draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, furthering the widespread speculation that regulatory acceptance is not far ahead.
“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,” says Jennifer Goldsack, CEO of DiMe. “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.”
The open-access 3Ps toolkit recognizes that pharma and payers must work together to define the evidence needed to support the value of new, digitally generated data to patients’ lives. The 3Ps resources were developed following a series of workshops convening global regulators, health technology assessment (HTA) bodies, public and private payers, industry sponsors, health economists, and clinical and patient experts.
“Following a series of discussions with payers from the U.S. and Europe, it is clear that pharmaceutical organizations using digital endpoints in drug development must pursue integrated evidence plans that generate data to inform regulatory, reimbursement, and pricing decisions,” says Katrine Christensen, global value and access strategy lead at Biogen Digital Health. “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”
“Great progress has been made on patient-centric digital evidence for registration of new medicines,” says Mariah Leach, patient expert and member of Savvy Co-op. “The 3Ps toolkit of resources defines the path for multiple stakeholders to cooperate and continue that momentum to ensure that new drugs that address the most important symptoms to patients make it quickly to market following regulatory approval.”
“We know that digital endpoints can provide a more complete picture of a patient’s lived experience, helping researchers and clinicians better measure and manage changes in symptoms, improve early detection of disease, and lower the burden of assessment through permissioned, passive data collection,” says Bray Patrick-Lake, senior director of strategic partnerships at Evidation. “The 3Ps are a crucial step in developing evidence for payers to incorporate digital endpoints in reimbursement and pricing decisions for new drugs."
About the Digital Medicine Society: 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. At DiMe, our commitment to fully integrating experts from all of the disciplines comprising digital medicine is unwavering. From regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists, we are proud to welcome all experts committed to ensuring that digital medicine realizes its full potential to improve human health. Join us!