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Alzheimer's disease: physicians do not always practice what NICE preaches

The UK government's drug watchdog NICE has received a lot of publicity recently after publishing guidelines restricting the prescription of certain cognitive enhancers for Alzheimer's disease for reasons of cost. However, a recent survey of 181 neurologists by Datamonitor indicates that the NICE cost-benefit methodology may not reflect how the drug is actually used in the clinical setting.

Cognitive enhancers do not treat the cause of Alzheimer's, rather they seek to prevent the cognitive decline associated with it, and fall into two categories: acetycholinesterase inhibitors (AChEIs) including Aricept (donepezil), Exelon (rivastigmine) and Razadyne (galantamine), or the NMDA antagonist memantine, which is branded as Namenda and Ebixa in the US and Europe respectively.

The National Institute for Clinical Excellence (NICE) published guidelines in the UK in November of 2006, stating that AChEIs are recommended for moderate severity AD only, and that memantine is not recommended for any disease severity. Following the publication of these guidelines, stakeholder groups reacted angrily, and much of the media has condemned the NICE for suggesting that AD suffers should not be prescribed drugs which only cost around GBP2.50 a day.

NICE in practice

However, there is evidence to suggest that the guidelines do not necessarily reflect clinical practice. In the previous NICE guidelines published in 2001, AChEIs were not recommended for severe severity AD patients. Despite this, and a lack of marketing license, Datamonitor's neurologist survey showed that 54% of severe AD patients in the UK currently receive an AChEI (either alone or with memantine) as a first-line therapy. This not only indicates that neurologists are willing to prescribe AChEIs off-label, but that Aricept's recent approval for severe severity AD may not stimulate significant increased sales revenue.

In addition, Datamonitor found that 2.2 times more AD patients receive AChEI + memantine combination therapy than memantine monotherapy in the UK. The survey also indicated that the single most common second-line therapy was Aricept + memantine. NICE evaluated the cost-effectiveness of memantine and AChEI's separately, therefore, Datamonitor believes that the calculations do not always represent how the drugs are actually used in the clinic.

This finding suggests that pharmaceutical companies marketing AD drugs may benefit from further clinical trials investigating the benefit of AChEI + memantine combination therapy. Although this may be a risky strategy, as it is entirely possible that the combination therapy approach may be less cost-effective than monotherapy.

Positive future on horizon

The current treatments for AD are merely symptomatic, enhancing or rescuing some cognitive function. The efficacy of these treatments is modest, with one meta-analysis of AChEI clinical trials indicating that only 9% of patients significantly respond to treatment1. In addition, little scientific evidence exists to indicate that cognitive enhancers prolong life.

The future however, could be brighter for AD patients. Two potentially disease modifying drugs, Neurochem's Alzhemed and Myriad Genetics's Flurizan, are currently in phase III development. Their modes of action are centered on inhibiting the toxic beta-amyloid cascade believed to be responsible for the neuronal cell death found in AD.

Although it is difficult to assess until the current large-scale clinical trials are complete, hopefully these new drugs will prove to be significantly effective at prolonging cognition, and perhaps even prolong life. If that was the case, a much higher cost could be justified by the pharmaceutical companies when challenged by pharmacoeconomic bodies such as the UK's NICE.

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