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Pink Sheet – Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s

Pink Sheet – Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s

UsAgainstAlzheimer’s wants to replicate the successful multi-stakeholder COVID-19 Evidence Accelerator led by the Reagan-Udall Foundation of the US Food and Drug Administration and Friends of Cancer Research with a similar effort focused on treating Alzheimer’s disease.

The patient advocacy group released a request for information on developing an Alzheimer’s Disease Evidence Accelerator on 10 May and hopes to announce progress on further developing and funding the accelerator project in the coming months. Responses to the RFI are requested by 17 June.

As part of the COVID evidence accelerator project, researchers from major data organizations, government, academia and industry engaged in regular meetings to present and critically discuss findings from different real world data sources. Former FDA principal deputy commissioner and acting chief information officer Amy Abernethy was instrumental in launching that initiative.  (Also see “US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data” – Pink Sheet, 23 Mar, 2021.)

Abernethy is now president of clinical research platforms at life sciences research organization Verily. UsAgainstAlzheimer’s envisions companies like VerilyOptumRx Inc. and IQVIA Holdings Inc. as among the potential data sharing partners in the Alzheimer’s evidence accelerator.

According to the RFI, the new accelerator’s two main functions would be to:

  1. Convene and support a “precompetitive, collaborative forum in which experts and stakeholders can share ideas on how best to generate meaningful evidence,” and
  2. Support the development of real-world data infrastructure to enable the efficient generation and sharing of the evidence.”

The data infrastructure would “collect, curate and analyze valid, reliable actionable RWD to support decisions on the diagnosis and management of patients,” including the “benefits and risks and comparative effectiveness of new Alzheimer’s disease therapies as they move into the clinic,” the group explained.

This “broad range of study designs” would include those that emerge to address the research questions and study requirements described in the Centers for Medicare and Medicaid Services’ recently-issued national coverage determination on monoclonal antibodies directed against amyloid for the treatment, the RFI points out.  (Also see “Medicare Registry-Based Studies For Alzheimer’s Drugs Still ‘Challenging’ Prospect – Former CMS Official” – Pink Sheet, 8 Apr, 2022.)

The idea for the evidence accelerator preceded the controversial approval of Biogen, Inc.’s Aduhelm for Alzheimer’s but the Medicare NCD for Aduhelm and similar drugs has added a sense of urgency to the project. USAgainstAlzheimer’s has been a vocal opponent of the NCD and its coverage with evidence development requirements.  (Also see “Medicare Alzheimer’s Drug Study Criteria Would Be Out Of Reach In Many States – Analysis” – Pink Sheet, 29 Mar, 2022.)

Accelerator Will Focus Initially On Early-Stage Alzheimer’s Patients

The initial focus of the accelerator will be on patients with early-stage Alzheimer’s, “reflecting the target population for current and emerging disease modifying therapies,” the organization says. Future applications of the infrastructure could promote evidence generation on all aspects of the diagnosis and management of patients, including the ability to assess new diagnostic tools, biomarkers, care pathways and quality of care.

The system would facilitate generation of key questions for “priority review” and enable aggregated analysis of data contributed through a variety of sources, including from drug sponsors, clinical registries, health data companies, health plans, payers, and direct from patients. Through a centralized, coordinated system, the infrastructure will be designed to support observational studies, prospective comparative studies, and streamlined clinical trials, including large scale pragmatic clinical trials.

Data could also be drawn from patient registries, including Biogen’s ICARE-AD initiative for Aduhelm, the Brain Health Registry, which is supported by Alzheimer’s advocacy groups and private foundations, and a new registry to be formed by UsAgainstAlzheimer’s. The Alzheimer’s Association has also announced plans to launch the Alzheimer’s National Registry for Treatment and Diagnostics to evaluate the long-term outcomes of people treated with any novel FDA-approved Alzheimer’s drug in real-world settings to inform clinical practice.

However, the accelerator project would aim to supplement registry data recorded by clinics and clinicians in traditional and often burdensome ways with passively and more easily collected data drawn from sources such as digital and wearable technologies.

The project is an ambitious one and UsAgainstAlzheimer’s consulted with a number of health policy and data experts in developing the RFI. “We think this is the right thing to build knowledge for patients, for their doctors, for the people who love the patients, as well as for payers, regulators” and researchers, chief operating officer Russ Paulsen told the Pink Sheet.

“It’s hard to imagine a more important platform play in Alzheimer’s disease than gathering real world evidence from wherever it is into one place so it can be analyzed. It’s important for all stakeholders and we really want to get it off the ground.”