Article Abstract

Article Abstract

Online ISSN: 1099-176X Print ISSN: 1091-4358
The Journal of Mental Health Policy and Economics
Volume 18, Issue 2, 2015. Pages: 63-73
Published Online: 1 June 2015

Cost-Effectiveness of Florbetapir-PET in Alzheimer's Disease: A Spanish Societal Perspective

John Hornberger,¹* Steven Michalopoulos,² Minghan Dai,³ Paula Andrade,⁴ Tatiana Dilla,⁴ Michael Happich⁵

¹Adjunct Clinical Professor, Stanford University, Stanford, CA, USA and CEO/President, Cedar Associates, Menlo Park, CA, USA
²Sr. Research Analyst, Cedar Associates, Menlo Park, CA, USA
³Research Analyst, Cedar Associates, Menlo Park, CA, USA
⁴Health Outcomes Scientist, Eli Lilly & Co, Spain
⁵Sr. Research Scientist, Lilly Deutschland GmbH, Bad Homburg, Germany

* Correspondence to: John Hornberger, MD MS FACP, 3715 Haven Avenue, Suite 100, Menlo Park, CA 94025, USA.
Tel.: +1-650-257 3315
Fax: +1-650-257 3328
E-mail: ujch@stanford.edu

Source of Funding: The project was funded by a research contract with Eli Lilly and Company. MH, TD, and PA are employees of Eli Lilly and Company. JH, SM, and MD had complete editorial independence in the conduct of this research and in the reporting herein.

Abstract

Management of Alzheimer’s disease (AD) is complicated by disease-specific features which make it difficult to diagnose accurately during milder stages. Florbetapir F18 positron emission tomography (florbetapir-PET) is an imaging tool used to capture b-amyloid neuritic plaque density in cognitively impaired adults, which can help clinicians identify patients with AD early when treatments are most effective. A decision analysis with a ten-year time horizon was developed to evaluate long-term outcomes of adopting florbetapir-PET. The target population included patients undergoing initial assessment for cognitive impairment. Influences of AD diagnosis and treatment were based on relevant clinical studies and published literature. Adjunctive florbetapir-PETincreased quality-adjusted life years by 0.008 years and increased costs by €36 compared to standard care alone (incremental cost-effectiveness ratio, €4769). The addition of florbetapir-PET to practice is expected to improve the accuracy of AD diagnoses and is cost-effective due to decreased healthcare costs and caregiver burden.

Background: The rising prevalence of Alzheimer's disease (AD), and other diseases associated with dementia, imposes significant burden to various stakeholders who care for the elderly. Management of AD is complicated by multiple factors including disease-specific features which make it difficult to diagnose accurately during milder stages. Florbetapir F18 positron emission tomography (florbetapir-PET) is an approved imaging tool used to capture \beta-amyloid neuritic plaque density in brains of cognitively impaired adults undergoing evaluation for AD and other causes of cognitive impairment. It has the potential to help improve healthcare outcomes as it may help clinicians identify patients with AD early so that treatments are initiated when most effective.

Aims of the Study: Evaluate the potential long-term clinical and economic outcomes of adopting florbetapir-PET -- adjunctive to standard clinical evaluation (SCE) -- versus SCE alone in the diagnostic assessment of cognitively impaired patients with suspected AD.

Methods: A decision analysis with a ten-year time horizon was developed in compliance with Good Research Practices and CHEERS guidelines. The target population was comprised of Spanish patients who were undergoing initial assessment for cognitive impairment (Mini-Mental State Examination [MMSE] score = 20). Diagnostic accuracy, rate of cognitive decline, effect of drugs on cognition and dwelling status, economic burden (direct and indirect costs), and quality of life (QoL) were based on relevant clinical studies and published literature. Scenario analysis was applied to explore outcomes under different conditions, which included: (i) use of florbetapir-PET earlier in disease progression (MMSE score = 22); and (ii) the addition of fluorodeoxyglucose (FDG)-PET to SCE.

Results: Adjunctive florbetapir-PET increased quality-adjusted life years (QALYs) by 0.008 years and increased costs by 36 compared to SCE alone (incremental cost-effectiveness ratio [ICER], 4,769). Use of florbetapir-PET was dominant in alternate scenarios. Sensitivity analyses indicated rates of institutionalization (by MMSE) and MMSE score upon initiation of acetylcholinesterase inhibitor (AChEI) treatment most influenced the primary outcome (ICER) in the base case scenario. Over 82% of probabilistic simulations were cost-effective using the Spanish threshold (30,000/QALY).

Discussion: The addition of florbetapir-PET to SCE is expected to improve the accuracy of AD diagnoses for patients experiencing cognitive impairment; it is cost-effective due to decreased healthcare costs and caregiver burden. Prospective studies of the clinical utility of florbetapir-PET are necessary to evaluate the long-term implications of adopting florbetapir-PET on clinical outcomes and costs in real-world settings.

Implications for Health Care Provision and Use: Florbetapir-PET is expected to improve decision-making regarding appropriate and sufficient care for cognitively impaired patients with suspected AD, while cost-effective.

Implications for Health Policies: Earlier and more accurate diagnosis of AD may help to improve patient's health status and reduce treatment costs by effectively allocating healthcare resources and maximizing the benefit of treatments and supportive services.

Implications for Further Research: Use of florbetapir-PET may help accurately identify patients with AD. The development of novel therapeutics for use with companion diagnostics may provide additional benefits by slowing or halting progressive cognitive decline with AD, increase QoL and prolong survival.

Received 21 October 2014; accepted 14 May 2015.