The pharmaceutical industry is making progress to incorporate digital endpoints into clinical trials as the industry shifts to decentralized clinical trials and as digital evidence plays a bigger role in drug development.
To prepare for the first drug labels and approvals based on data from digital endpoints, the nonprofit Digital Medicine Society partnered with Anthem and major pharmaceutical companies to develop a toolkit to support reimbursement for new drugs developed using digital endpoints.
Digital endpoints are assessed using sensor-generated data often collected outside of a clinical setting during activities of daily living. As an example, a smartphone’s microphone might be used to diagnose or predict mild cognitive impairment due to Alzheimer’s disease or an accelerometer in a smartwatch can be used to capture motion data.
Since the fall of 2019, the Digital Medicine Society (DiMe) has seen the number of unique endpoints in its open access Library of Digital Endpoints grow by 790% since October 2019, with 91 different sponsor organizations relying on these measures to answer questions about new medical products.
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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 In March 2022, the FDA issued draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, furthering the widespread speculation that regulatory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, according to DiMe executives.
The organization partnered with Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer and Savvy Co-op to develop a toolkit of resources created to facilitate the inclusion of digital endpoints as evidence for payers in reimbursement decisions for new drugs.
DiMe has planned a public meeting on April 7 to detail the recommendations and resources.
“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 in a statement. “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.”
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The open-access 3Ps (pharma, payers and patients) 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 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, according to the organization.
These efforts will help ensure the industry avoids future delays in making effective new treatments available to patients following regulatory acceptance, DiMe executives said.
“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 in a statement. “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”
The Digital Medicine Society also has worked with Big Pharma players such as Biogen, Eisai, Eli Lilly and Merck plan to establish digital standards for Alzheimer's disease studies.
“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 in a statement. “The 3Ps are a crucial step in developing evidence for payers to incorporate digital endpoints in reimbursement and pricing decisions for new drugs."