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

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.