Alzheimer's Disease

Alzheimer’s Disease Interception: Methods for Evaluating a New Generation of Therapies

Building on a 2013 GPC guidance document, this initiative will provide updated guidance on methods for evaluating the efficacy of therapies to treat Alzheimer's disease.

The field of Alzheimer’s therapeutics has rapidly progressed over the past few years to focus increasingly on earlier stages of disease and on disease interception. This new focus raises issues regarding the types of evidence needed by health plan decision-makers to cover these new therapies. How can study designers assure that patients are correctly identified as candidates for therapy? How long should patients be followed to demonstrate benefit?

This initiative involves a broad, multi-stakeholder group of participants. Representatives from the following organizations are participating:

  • Pfizer Innovative Health
  • Alzheimer’s Drug Discovery Foundation
  • Center for Alzheimer's Care, The University of Utah
  • FDA
  • High Lantern Group
  • Aetna
  • Faegre Baker Daniels Consulting
  • University of Utah Health Care
  • Johns Hopkins School of Medicine
  • United Healthcare
  • Alzheimer Disease Research Center, Icahn School of Medicine at Mt. Sinai
  • Keck School of Medicine, University of Southern California
  • Alzheimer's Foundation of America
  • Beating Alzheimer's by Embracing Science
  • UsAgainstAlzheimer's
  • GNS Healthcare, Inc.

Developing Recommendation

  • Fall 2016: Participant and Sponsor Recruitment
  • January 2017: Kickoff Webinar, in which researchers and scientific experts will present the most recent advances in drug development, highlighting contemporary issues in diagnosing and treating Alzheimer's disease and evaluating the efficacy of therapies.
  • Spring 2017: Develop draft recommendations
  • Summer 2017: Multi-stakeholder meeting in Baltimore, MD to review draft recommendations.
  • Late 2017/Early 2018: Release final recommendations

Improved Understanding of Evidence Needs for Better Decision-making

  • To foster a shared understanding between industry, health plans, and other key stakeholders of current scientific innovation in drug development for Alzheimer’s disease and the challenges it raises for demonstration of patient benefit and value for health plans.
  • To develop a consensus set of recommendations for evaluating new Alzheimer’s drugs in a way that can reasonably convince health plans of their value.