Advisory Council July 2018 Meeting Presentation: Future Alzheimer's Treatment

07/30/2018

ADVISORY COUNCIL ON ALZHEIMER'S RESEARCH, CARE, AND SERVICES

Friday, July 30, 2018

Printer Friendly Version in PDF Format (9 PDF pages)

 

How Prepared is the U.S. Health Care System for a Future Alzheimer's Treatment?

Jodi Liu, Jakub Hlavka, Richard Hillestad, Soeren Mattke
RAND Health

Why focus on Alzheimer's treatment now?

  • Alzheimer's dementia affects over 5 million Americans today
  • Guarded optimism for Alzheimer's disease-modifying therapies in development
  • Treatment paradigm has shifted to early stage disease
    • Estimated 13.8 million Americans with mild cognitive impairment
  • Objective: Quantify the potential mismatch between supply and demand for the delivery of a future Alzheimer's treatment

Alzheimer's disease progression and clinical pathway

  • No cognitive impairment
    • Screen
  • Mild cognitive impairment (MCI)
    • Evaluate
    • Test
    • Treat
  • Assume treatment reduces the risk of transitioning from MCI to dementia
  • Alzheimer's dementia

Model assumptions and framework

  • Key assumptions:
    • Disease-modifying therapy for early-stage Alzheimer's disease available in 2020
    • Therapy delivered by intravenous infusion every 4 weeks for a year
    • Treatment reduces relative risk of progression from MCI to Alzheimer's dementia by 50%
    • Dementia specialists: neurologists, geriatricians, geriatric psychiatrists
    • Uptake rates based on expert input
Partial flow chart.

Snapshot of potential patients in 2019 (millions)

Pyramid: Age 55+ (88.4); Cognitive screening in primary care setting (70.7); Screening positive for MCI (14.9); Evaluation by specialist (7.5), Constraint 1 dementia specialists; Amyloid testing (6.7), Constraint 2 PET scanners; Amyloid posie (3.0); Treatment indicated (2.4) Constraint 3 infusion centers.

Millions of patients projected to be on waitlists

  • Initial bottleneck for specialist visits with 4.6 million patients
  • With treatment first available in 2020, wait lists expected until 2034
Line chart.

Projected wait times are extensive

  • Average 14-month wait for specialists in 2019
  • Average 11-month wait for testing in 2023 Infusion waits until 2034
  • 2.1 million MCI cases could progress to Alzheimer's dementia while on wait lists
Stacked bar chart.

Specialist shortage is most urgent issue

  • Binding constraint and unlikely to resolve
  • Improve productivity
    • More specific secondary screening test for MCI reduce number of false positives or to prioritize based on risk
    • Task shifting during evaluation process
  • Qualifying providers from other specialties
    • Train physicians in larger specialties (internal medicine, general psychiatry) and potentially mid-level providers in dementia care
    • Use telemedicine to facilitate access to dementia care specialists by primary care providers

Range of diagnostic options could be expanded

  • Expanding capacity for PET scans technically feasible but probably inefficient
    • High fixed and variable cost
    • Insufficient volume for cyclotrons in rural areas
    • Building up capacity to handle prevalent cases when treatment is first approved would lead to idle capacity later
  • Use of CSF assay is a possible solution
    • Samples can be obtained in most clinics and sent to central labs
    • Less expensive per test
  • Blood and retinal tests in development

Access to amyloid PET limited by geographic gaps in cyclotrons that manufacture tracers

United States map.
SOURCE: Society of Nuclear Medicine and Molecular Imaging as of October 6, 2017 (undated); Cardinal Health (2017).
RAND RR2272-3

Home infusions could play an important role

  • Expected prevalent cases imply the need to triple existing infusion chair capacity
    • Increase would likely lead to idle capacity later
  • Home infusion delivery could increase capacity in the short run without fixed infrastructure
    • Covered for patients in traditional Medicare starting 2020
    • Already covered by many Medicare Advantage plans
  • Nature of treatment could allow home infusion
    • Short duration, cognitively intact patients, rare acute reactions

What are the implications for a research agenda?

  • Development of better screening tools to reduce the large number of patients entering care pathway probably has high ROI
    • "rescoring" of MMSE
    • Better tests for primary or secondary screening or risk stratification
    • Non-invasive biomarkers
  • Demonstration projects for scalable delivery models that leverage specialist time better are needed
    • Will also help to address regional access issues
  • Capacity constraints on diagnostic testing and infusion delivery are likely to be addressed with current efforts
    • Assuming adequate reimbursement

Summary

  • Disease-modifying AD therapy would be a breakthrough
  • Simulation suggests that US healthcare system is ill-prepared to deliver a therapy to the large number of prevalent cases
    • As many as 2.1 million patients might develop AD because of delays in access to care under current capacity assumptions
  • Increasing capacity to deliver a potential therapy would involve payment policy, regulatory requirements, workforce considerations, and capacity planning

Thank you

PET scan capacity

  • Versus demand for 6.7 million scans in 2019 (plus geographic gaps)
Line chart.

Dementia specialist workforce capacity

  • Versus demand for 7.5 million evaluation visits and 3 million indication visits in 2019
Line chart.

Infusion capacity

  • Versus demand for 33 million infusions in 2020
Line chart.

MCI progresses to dementia while patients wait, 2020-2040

Stacked bar chart.

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