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Stakeholder Insight: Alzheimer's Disease - Prescribing trends indicate that neurologists are not adhering to guidelinesPublished by: Datamonitor Published: Dec. 20, 2006 - 179 Pages Table of ContentsCHAPTER 1 EXECUTIVE SUMMARY Scope of the analysis Datamonitor insight into the Alzheimer’s disease market CHAPTER 2 INTRODUCTION AND SCOPE Coverage of the Stakeholder Insight Survey Disease definition & epidemiology Diagnosis Key prescribing influences CHAPTER 3 COUNTRY TREATMENT TREES Country treatment trees CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION Definition of Alzheimer’s disease Etiology Beta-amyloid hypothesis Tau neurofibrillary tangles Neuronal death caused by beta-amyloid deposition and neurofibrillary tangles Prevalence of Alzheimer’s disease and other dementias Literature-reported Alzheimer’s prevalence rates US AD population EU5 and Japan AD populations Comparison with other reported AD prevalence rates Datamonitor survey reported Alzheimer’s disease prevalence rates Factors influencing prevalence Age and gender Patients most frequently presented for the first time in the 70-79 age group Genetics Prevalence rates of Mild Cognitive Impairment and other dementias Neurologists reported similar prevalence rates of Mild Cognitive Impairment and Alzheimer’s disease Mild cognitive impairment (MCI) may be a precursor to AD Off-label prescribing for MCI constitutes approximately 6% of acetyl cholinesterase inhibitors sales in the seven major markets Progression of MCI to Alzheimer’s disease Segmentation of Alzheimer’s disease Clinical features of Alzheimer’s disease severity subtypes Mild AD affects memory, language and reasoning Moderate AD demonstrates more pronounced symptoms Severe AD leaves patients completely dependent Prescribers may not regard the segmentation of AD into severities as clinically significant Patients are generally categorized as suffering from moderate AD for the longest period of the disease progression Clinical definition and features of each AD severity Prevalence of Alzheimer’s disease severity subtypes Co-morbidities A large proportion of the AD population suffer from co-morbidities Treating depression improves quality of life and behavior Treatment of agitation, aggression and psychotic symptoms is limited by side effects Anxiety is treated using antidepressants and benzodiazepines Treatment of sleep disturbances is a difficult balance of sedation Broad symptomatology provides commercial opportunity CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS Presentation and diagnosis Diagnosis techniques - many hopes on the horizon, but current practices have not developed much in the last 100 years Diagnostic guidelines for AD are provided by multiple sources Severity of AD is often assessed using symptomatic subscales An holistic view of AD progression is lacking 56 Time to presentation Time to presentation may seem long, but KOLs were unconcerned It is in pharmaceutical companies’ interests to decrease this time by increasing awareness Significant reduction in time to presentation only possible following development of more advanced diagnostic tools The future - biomarkers Time to correct diagnosis Treatment options Non-pharmacological treatment is still a commonly used option for AD therapy Pharmacological treatment Acetylcholinesterase inhibitors NMDA receptor antagonist: Memantine (Namenda/Ebixa/Axura) Non-pharmacological treatment Treatment guidelines UK - National Institute of Clinical Excellence (NICE) guidelines NICE guidelines for AD NICE guidelines are for the UK NHS only, but may have further reaching implications How could NICE guidelines directly impact AD drug sales in the UK? Treatment of cognitive symptoms with AChEIs only recommended for moderate severity AD patients It is still advised that mild and severe severity AD patients with non-cognitive symptoms receive AChEIs Choice of AChEIs If cost-benefit analysis had been conducted on the actual cost paid by PCTs, the AChEIs could be cost-effective NICE only considers the direct cost to the NHS, if costs to individuals and social services had been appreciated, the cost-benefit balance may have been different Memantine not recommended for AD treatment of any severity An evaluation of AChEI/memantine combination therapy would more closely reflect treatment regimes NICE recommend continuation of therapy for patients currently receiving treatment Datamonitor’s view on the direct effect of these NICE guidelines on sales revenue Can an estimate of future prescribing trends post-NICE recommendations be made from past prescribing? Germany - Institute for Quality and Efficiency (IQWiG) American Academy of Neurology guidelines Other guidelines in the seven major market Referral patterns CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS Prescribing trends Prescribing trends caveats Role of pharmacological treatment in the management of AD Progression from first- to second-line therapy consistent across disease severity Higher percentage of pharmacological treatment for severe AD patients than mild AD patients would seem contradictory to clinical benefit Pharmacological treatment of severe AD patients particularly high in relation to mild AD patients in the UK Pharmacological treatment of moderate AD patients higher in the US than the EU5 Companies marketing AD drugs should concentrate resources on the treatment of mild AD patients in the six major markets outside of the US Seven major market overview of prescribing trends for AD Overview of treatment paradigms for AD patients Eisai’s and Pfizer’s donepezil (Aricept) is the clear market leader in AD treatment What is first- and second-line AD treatment? Memantine is used more frequently in combination with an AChEI than as a monotherapy in moderate and severe AD patients Use of combination therapy as a first-line treatment increases through the disease progression First- to second-line progression Approximately one-quarter of pharmacologically treated patients move to second-line treatment when first-line treatment has failed Second-line therapy consists of either adding memantine to the treatment regime, or switching patients to another AChEI Increased use of AChEI + memantine combination treatment in second-line therapy Neurologists not prescribing combination therapy first-line for mild severity AD patients, prescribe it as a second-line therapy More mild severity AD patients treated by neurologists that do not prescribe AChEI and memantine combination therapy move to second-line therapy Neurologists that do not prescribe mild severity AD patients combination therapy first-line, do prescribe this treatment regime for moderate and severe patients Lundbeck/Forest should attempt to stimulate prescribing of memantine first-line, especially in mild AD patients Off-label prescribing in the AD market Neurologists reported that off-label prescribing of the AChEIs and memantine represents approximately one-fifth of total prescribing Beyond other unlicensed disease severities, what are AChEIs and memantine used for off-label? Factors influencing physician decision making Neurologists report efficacy based factors are the primary considerations when prescribing AD drugs Symptomatic improvement is still a high priority Neurologists would welcome a new non-disease modifying drug if it was differentiated from the AChEIs Neurologists regard the introduction of a disease modifying drug as critical in the longer term Side-effect profile is the most important non-efficacy related factor considered by neurologists when prescribing AD drugs Reimbursement status, formulary inclusion and cost effectiveness are the least considered factors by neurologists when prescribing AD drugs Scenarios for future AD treatment paradigms, patient prognosis and the AChEI market Datamonitor believe that the introduction of disease modifying drugs will not threaten AChEI sales Diagram A - Untreated AD patient Diagram B - AD patient prescribed an AChEI (and/or memantine) Diagram C - AD patient prescribed ideal disease slowing drug Diagram D - AD patient prescribed efficacious disease slowing drug Diagram E - AD patient prescribed ideal disease slowing drug and cognitive enhancer (e.g. AChEI) Diagram F - AD patient prescribed efficacious disease modifying drug and cognitive enhancer Diagram G - AD patient prescribed ideal disease slowing/disease modifying drug diagnosed before cognitive decline with a biomarker Diagram H - AD patient prescribed ideal disease modifying drug Late-stage disease modifying drugs aim to attenuate the production of ‘toxic’ beta-amyloid Alzhemed Clinical trials investigating the efficacy of Alzhemed Flurizan Phase III trials investigating Flurizan currently underway Phase II studies Neurologists perception of marketed and pipeline drugs Datamonitor has used a brand map to show the significance of neurologists’ perception of the marketed and pipeline drugs Interpreting Datamonitor’s AD brand map Datamonitor’s brand map shows a clear differentiation between the three classes of AD drug Symptomatic improvement characteristic defines the AChEI class of drug Memantine’s side-effect profile differentiates it from other classes of AD drugs Neurologists believe that the beta-amyloid modifying pipeline drugs will prove to be disease modifying by slowing disease progression Indication expansion Donepezil (Aricept) for severe Alzheimer’s patients Due to off-label prescribing, the severe severity AD market may already be saturated Donepezil’s (Aricept) number one position in the AD market will be secured following this license Reformulation strategies Launch of liquid donepezil (Aricept) Generic incursion Neurologists’ perceptions of generic uptake Reduced cost, increased use? CHAPTER 7 IMPROVING TREATMENT OUTCOMES Treatment outcomes Patient response to current treatment is modest Reason for discontinuing therapy Lack of efficacy and intolerable side effects are the leading reasons for treatment discontinuation Unmet needs Overview of neurologist weighted unmet needs Improved efficacy of treatment remains the most important clinical unmet need Improved side effect profile of treatments is imperative given the overall health of the many AD patients Cost is an issue because of a general move towards pharmacoeconomic evaluations and the potential arrival of new treatments BIBLIOGRAPHY Journals Websites Datamonitor reports APPENDIX A Physician research methodology Physician sample breakdown Contributing experts APPENDIX B THE SURVEY QUESTIONNAIRE Epidemiology, presentation and diagnosis of Alzheimer’s disease Treatment of Alzheimer’s disease Treatment of mild Alzheimer's disease Treatment of moderate Alzheimer's disease Treatment of severe Alzheimer's disease Current and future treatment of Alzheimer's disease Key prescribing factors Unmet Needs Disclaimer AbstractIntroductionA lack of prescriber adherence to both marketing licenses and pharmacoeconomic guidelines represents both a challenge and opportunity for pharmaceutical companies marketing current Alzheimer's disease drugs. Indication expansion between disease severities may not be a viable commercial option; conversely, stricter guidelines by bodies such as the UK's NICE will not necessarily threaten the market. Scope
Datamonitor's survey shows that symptomatic improvement is still a high priority, indicating that neurologists would welcome a new non-disease modifying drug if it was differentiated from the current cognitive enhancers on efficacy or side effects. In order to achieve this in the minds of neurologists, an alternative mode of action is required. Datamonitor forecasts that the introduction of disease modifying drugs (e.g. Alzhemed, Flurizan) will not necessarily threaten the acetylcholine esterase inhibitor market, in fact, treatment with such drugs will extend the therapeutic window for symptomatic drugs, resulting in an opportunity for key players in this market. Datamonitor believes that the recently published NICE guidelines will only have a modest impact on Alzheimer's disease drug sales in the UK. From looking at survey reported current prescribing trends and relating this to adherence with previous NICE Alzheimer's disease drug guidelines, prescribers do not appear to guideline-prescribe. Reasons to Purchase
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