The Digital Medicine Society (DiMe) has announced the public introduction of the 3Ps of Digital Endpoint Value (3Ps), a toolkit of resources designed to facilitate the inclusion of digital endpoints as evidence for payers to use in reimbursement decisions for new drugs. The toolkit was created in partnership with Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer, and Savvy Co-op.
Jennifer Goldsack, CEO of DiMe, told Outsourcing-Pharma that the project featured contributions from top minds in the field on digital clinical measures.
“Those teams recognize that we’ve achieved broad acceptance of digital endpoints – there are currently 302 digital endpoints in DiMe’s library and FDA issued draft guidance on the use of DHTs for data acquisition in clinical investigations in December – and need to prepare for the first drug labels and approvals based on data from digital endpoints,” Goldsack said. “This collaboration was a strong group representing pharma, payers, and patients. The ‘3Ps’ needed to define and demonstrate the value of digital endpoints in medical product development.”
According to DiMe, the group maintains an open-access library (launched in October 2019) of digital endpoints for use in industry-sponsored trials of new medical products. This collection of unique digital endpoints reportedly has expanded by 790%, with 91 different sponsor organizations turning to these measures to answer questions about new medical products.
Goldsack said that while industry members have long spent a great deal of effort on best practices that help regulators accept evidence from digital endpoints, there has been relatively little consideration of how payers might consider such data in reimbursement and pricing decisions.
“To do this effectively, we recognized that we needed to bring together stakeholders from pharma, payers, and patients (as well as global regulators, health technology assessment bodies, health economists, and clinical and patient experts through the workshop series that informed this resource toolkit) to define what evidence is needed to support the value of new, digitally generated data to patients’ lives,” she commented. “DiMe is founded on the premise that to thrive as a field, digital medicine requires an unprecedented level of interdisciplinary collaboration. The ‘3Ps’ project and new resource toolkit is a terrific example of how this principle is successfully applied to solve some of the most important challenges in the rapidly advancing field.”
While digital endpoints are being used more frequently to evaluate new products, the industry has honed in on regulatory acceptance in support of drug approval. Last month, the US Food and Drug Administration (FDA) the FDA issued a draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations.
“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,” Goldsack remarked. “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.”
By launching the open-access 3Ps toolkit, the industry players recognize that pharma and payers must work together to define the evidence required to support the value of new, digitally generated data to patients’ lives. The resources came out of a series of workshops bringing together regulators, health technology assessment bodies, public and private payers, industry sponsors, health economists, and clinical and patient experts.
Katrine Christensen, global value and access strategy lead at Biogen Digital Health, said after a series of talks from payers from the US and Europe, it is apparent pharma organizations using digital endpoints in their drug development efforts “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,” Christensen said. “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,” said 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,” said 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."