Treatment Algorithms: Alzheimer's Disease – Off-label prescribing driven by dearth of treatment options

Published by: Datamonitor

Published: Mar. 1, 2012 - 76 Pages


Table of Contents

Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
COUNTRY TREATMENT TREES
Introduction to treatment trees
Seven major markets
US
Japan
France
Germany
Italy
Spain
UK
DISEASE DEFINITION AND DIAGNOSIS
Disease definition
Etiology
Beta-amyloid cascade thought to drive downstream tau pathology and neuron loss
Age is the major risk factor for onset of Alzheimer’s disease
Symptoms
Cognitive, functional, behavioral, and neurologic symptoms progress with disease severity
Presentation and diagnosis
Less than one third of prevalent Alzheimer’s disease cases are diagnosed
Literature estimates for Alzheimer’s disease diagnosis rates vary between 19% and 42%
There can often be a significant delay between onset of symptoms, presentation, and disease diagnosis
Treatment rates
The pharmacological treatment rate increases with disease severity up to moderate Alzheimer’s disease
However, drug treatment is markedly lower among severe Alzheimer’s disease patients
Legacy of NICE recommendations contributes to low treatment rates in the UK
Influences on diagnosis and treatment rates
Even among symptomatic Alzheimer’s disease patients, presentation and diagnosis rates remain low
Increased awareness, better diagnostic tools, and disease-modifying drugs can drive an increase in presentation and diagnosis rates
Referral patterns
Despite the intentions of guidelines, many Alzheimer’s disease patients remain in primary care
PATIENT SEGMENTATION
Severity
The majority of neurologists’ diagnosed patients have mild or moderate Alzheimer’s disease
Considerable off-label prescribing to MCI patients was revealed by survey results
Line of therapy
A lack of treatment options means that most patients remain at first line
CURRENT TREATMENT OPTIONS
Overview of the available drug classes
Acetylcholinesterase inhibitors
NMDA receptor antagonists
Prescribing trends
Class trends
Combination therapy trends
Generic prescribing trends in the US
Changes in therapy
Mild cognitive impairment due to Alzheimer’s disease
Mild Alzheimer’s disease
Moderate Alzheimer’s disease
Severe Alzheimer’s disease
Regional variations
Treatment outcomes
Progression through lines of therapy
Compliance
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX A
Physician research methodology
Physician sample breakdown
The survey questionnaire
Screener
Alzheimer’s disease regimens
Treated disease stages
Treatment flow – mild cognitive impairment due to Alzheimer’s disease
Treatment flow – mild Alzheimer’s disease
Treatment flow – moderate Alzheimer’s disease
Treatment flow – severe Alzheimer’s disease
Compliance
Diagnosis techniques currently in use for Alzheimer’s disease
APPENDIX B
PharmaVitae Explorer database
Contributing experts
Conferences attended
Report methodology

Abstract

Introduction

In the absence of new therapies, treatment guidelines appear to be only loosely followed as physicians struggle with a limited number of rational treatment options. However, with the late-stage pipeline for new Alzheimer’s disease drugs holding promise, Datamonitor has quantified important patient subpopulations and identified opportunities in the current standard of care.

Features and benefits
  • Quantify the prevalent, diagnosed, and treated Alzheimer’s disease patient populations in each of the seven major markets.
  • Analyze physician prescribing habits by disease severity and line of therapy.
  • Understand how treatment and compliance rates vary according to disease severity.
  • Identify opportunities for increasing market share through effective product positioning.
Highlights

Datamonitor’s survey found that the pharmacological treatment rate increases with disease severity up to moderate Alzheimer’s disease. However, drug treatment is markedly lower among severe Alzheimer’s disease patients. This reflects the diminishing benefit of pharmacological treatment of severe patients and fewer approved drugs in this indication.More than 80% of patients receive a cholinesterase inhibitor at every therapeutic setting. This widespread use is unsurprising, considering the dearth of other pharmacological treatment options. The broad therapeutic role of cholinesterase inhibitors for Alzheimer’s disease is affirmed by commonly followed treatment guidelines.The use of combination therapy increases at second line and in more severe patients. In the US, combination therapy is apparent even at first-line treatment of moderate and severe Alzheimer’s disease, indicating that neurologists are willing to initiate therapy of an advanced patient with a cholinesterase inhibitor and memantine.

Your key questions answered
  • How does each drug’s patient share vary by disease severity and line of therapy?
  • What can be done to influence the patient pathway to increase market share?
  • What is the realistic patient population that a new market entrant can target?
  • How has generic donepezil affected prescribing behaviors in the US?


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