ISPOR Issues Report on New Approaches for Accurately Valuing Future Alzheimer’s Therapies

– Chris Leibman, Senior Vice President, Value and Access, Biogen

 

The scientific journey to finding treatments for Alzheimer’s has been a long and intensive process, but advancements in research and technology offer hope for patients and families impacted by the disease. With 1 in 10 Americans aged 65 and over living with Alzheimer’s – a number that is rapidly growing1 – Biogen believes that Alzheimer’s and other neurological diseases are a source of both urgent unmet need, and also believes that it is an area of great promise for medical breakthroughs. Whether or not those living with Alzheimer’s and their families have access to those breakthroughs, however, will be determined, in part, by whether health insurers and the broader healthcare system properly account for the unique challenges of Alzheimer’s when assessing the value of future therapies.

Over the past several months, Biogen and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) have collaborated to bring together leading experts from academia, industry, and patient associations to examine new long-term and holistic approaches to value assessments that can fairly capture a path forward for potential treatments for individuals, caregivers, and society.

In 2020 ISPOR and Biogen jointly hosted three webinars on valuing future Alzheimer’s therapies to account for a greater focus on equity, evidence needs, and the appropriate definitions of cost effectiveness. As a result, the organizations have issued a new report that identifies the need for a holistic approach to valuing Alzheimer’s treatments, spotlighting key takeaways and broadening the reach of these critically important discussions.

This report, “Valuing Future Alzheimer’s Disease Treatments: The Need for a Holistic Approach,” features perspectives from thought-leaders from across the healthcare sector, including:

  • Anirban Basu, University of Washington
  • Paola Barbarino, Alzheimer’s Disease International
  • Matthew Baumgart, Alzheimer’s Association
  • Lou Garrison, University of Washington
  • Joseph Gaugler, University of Minnesota
  • Anders Gustavsson, Quantify Research
  • Youssef H. El-Hayek, Shift Health Toronto
  • Drew Holzapfel, Global CEO Initiative on Alzheimer’s Disease
  • Eric Jutkowitz, Providence Veterans Affairs Medical Center
  • Nancy Lynn, BrightFocus Foundation
  • Peter J. Neumann, Tufts University MA
  • Susan Peschin, Alliance for Aging Research
  • Jason Resendez, UsAgainstAlzheimer’s Center for Brain Health Equity

The report examines how to define the value of an Alzheimer’s disease therapy, the role of value assessment in addressing the global dementia crisis and issues around equity, and the need to integrate real-world evidence into long-term value assessments.

For example, the report highlights how in recent years there has been significant concern about whether the Cost Per Quality Life Year (QALY) model is appropriately suited to certain disease areas, including Alzheimer’s. Garrison and others propose that funders should draw on the “value flower” framework, which expands considerations to give weight to the burden on the caregiver, lost productivity, and other dynamic opportunity costs that are not represented in traditional QALY models.

In 2018, an ISPOR task force group reviewed a number of alternative frameworks and synthesized an overarching approach, often referred to as the value flower.3 The value flower ‘broadens the view of what constitutes value in healthcare’ with 10 elements that extend beyond traditional cost per QALY analysis. Several of these elements of value are especially relevant to Alzheimer’s disease.

— Louis P. Garrison, Jr, PhD, Department of Pharmacy, University of Washington, Seattle, WA, USA; Matthew Baumgart, Vice President, Health Policy, Alzheimer’s Association, Chicago, IL, USA; Youssef H. El-Hayek, PhD, MBA, Senior Consultant, Shift Health, Toronto, Ontario Canada; Drew Holzapfel, MBA, Executive Director, The Global CEO Initiative on Alzheimer’s Disease, Washington, DC, USA; Chris Leibman, PharmD, MS, Senior Vice President, Value and Access, Biogen, Cambridge, MA, USA

In addition, authors Basu and Peschin describe how traditional value frameworks rely on a cost-per-QALY approach, which puts a dollar value on a year of human life and reduces that value for people who are not in perfect health. In practice, this method places a greater value on the impact a medication has on a healthy person than that of someone with a chronic illness. Alzheimer’s disease also disproportionately impacts women and racial and ethnic minorities.

Gustavsson notes that traditional value frameworks do not appropriately account for the long-term benefits of a treatment and argues that therapies should be considered for the real-world benefits they may provide over time. This idea is particularly relevant for Alzheimer’s, given how critical early detection and diagnosis will be once a drug that can reduce the decline of disease progression is available.

As we struggle with the rapidly growing challenge of Alzheimer’s disease and dementia, there is an urgent need for robust and sustained responses in countries around the world. These ongoing discussions and decisions about value frameworks for new and emerging therapies are an important part of solving the challenges faced by patients living with Alzheimer’s. ISPOR’s latest report provides a thoughtful starting point for those conversations.

— - Paola Barbarino, Chief Executive Officer, Alzheimer’s Disease International, London, England, UK

In addition to the considerations above, determining the value of future Alzheimer’s therapies must evolve to reflect the latest science on Alzheimer’s. In the past two decades, researchers, the medical community, and the private sector have achieved important strides to better understand Alzheimer’s disease with the aim of developing new interventions. This is a journey of progress, enabling the scientific community to possess a deeper understanding of Alzheimer’s, how to identify and target the disease in its earliest stages, and how to account for its heterogeneity. With a record 29 drug candidates in Phase 3 clinical development—59% of which are potential disease-modifying therapies—the future now looks brighter than ever.2

 
 
 
https://www.alz.org/alzheimers-dementia/facts-figures#
2Cummings J, Lee G, Ritter A, Sabbagh M, Zhong K. Alzheimer’s disease drug development pipeline: 2020. Alzheimers Dement (NY). 2020;6(1):e12050.