Experts Support The Continual Prescribing Of Ebixa (memantine) F
9/11/2008 ·
The National Institute for Health and Clinical Excellence (NICE) has today jointly published its guidance on the use of drugs to treat Alzheimer's disease (AD) and the clinical guideline on the management of all types of dementia, including AD, jointly with the Social Care Institute for Excellence. Lundbeck is disappointed by today's guidance on the use of drugs to treat AD where NICE has recommended Ebixa (memantine) only "as part of clinical studies for people with moderately-severe to severe AD(2)" in England and Wales. This means that Ebixa will not receive obligatory NHS funding for its routine prescription and will leave inequity of access to a licensed NHS treatment for UK's 309,000(3) advanced AD patients. NICE guidance didn't take account of the recent indication for the use of Ebixa in moderate patients, therefore it is still freely available to be initiated as an NHS treatment for moderate Alzheimer's disease.
This guidance conflicts with the views of a large number of specialists who treat AD. In its recent joint position statement, the Royal College of Psychiatrists and the British Geriatrics Society argue that there are compelling reasons why doctors should continue to be allowed to prescribe Ebixa(1). The reasons included that Ebixa improve outcomes for people with AD, reduces caregiver time, lead to more legitimate prescribing, reduce the costs of alternative medication, and reduce the need for specialist and continuing care(1).
Professor Roy Jones, Director of the Research Institute for the Care of the Elderly in Bath, said, "Ebixa has shown significant benefits in moderate to severe Alzheimer's disease. For example, one study has shown that Ebixa saves carers on average one and a half hours per day with benefits for the patients who are better able to feed themselves and are less agitated."
The British Association for Psychopharmacology (BAP) guidelines(13) and the European Federation of Neurological Societies (EFNS) guidelines(14) reinforces the efficacy of Ebixa in the treatment of moderate to severe AD either on its own or when added to a cholinesterase inhibitor (4,5).
Ebixa remains available in the UK on the NHS drug list for prescribing by clinicians in the UK. Individual Trusts can now decide locally if they will routinely fund Ebixa for new patients diagnosed with moderately severe to severe AD. Moderately severe to severe patients already receiving treatment with Ebixa are not affected by this guidance.
The clinical evidence for Ebixa:
Ebixa is approved in the UK for the treatment of patients with moderate to severe AD(6) and is the only anti-dementia drug with a licence for severe dementia. NICE did not recommended Ebixa in their guidance on the basis that the evidence provided showed that the drug did not make enough of a difference for AD patients. However, its efficacy has been established in all three main symptom categories of AD: cognition, function and behaviour. Large scale clinical trials have also demonstrated that Ebixa is effective in reducing some of the core and more distressing symptoms of AD. Ebixa treated patients experienced significant benefits in memory, language and the ability to perform daily activities(7-11).
In a six month trial, Ebixa has proven effective in delaying the emergence of, and significantly reducing levels of agitation/aggression in patients with AD, a benefit considered valuable amongst AD treatments(12,13,14).
Lundbeck's continued research will further support the comprehensive data set already presented to NICE and has the support of the expert community, many of whom feel that there is an inequity in the way that Ebixa has been evaluated(14).
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