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"This decision essentially means there are no licensed and effective treatments routinely available for a vulnerable patient population where it is particularly needed. The overall NICE appeal outcome limits choice for all patients.”
Lundbeck, a Danish research-based company that finds new drugs for treatment of CNS disorders, including depression, schizophrenia, and Alzheimer’s disease comments on the NICE Appeal Decision:
Lundbeck is disappointed that the Appeal Committee for the National Institute for Health and Clinical Excellence (NICE) has decided not to recommend obligatory NHS funding for the routine prescription of Ebixa (memantine) in England and Wales for the treatment of moderately severe to severe Alzheimer's disease (AD) 2. However, the Appeal Committee did uphold Lundbeck's Appeal to amend their statement to acknowledge that they had not reviewed the moderate extension to Ebixa's indication 3. NICE guidance therefore does not apply to Ebixa for patients with the moderate stage of the disease, where evidence in clinical trials shows Ebixa delays clinical worsening that would otherwise be the normal course in AD4. Therefore, Ebixa is an NHS treatment option that can be initiated as early as moderate AD.
This guidance conflicts with the views of a large number of specialists who treat Alzheimer's disease. Indeed, the majority of them felt that Ebixa should be routinely available on the NHS, and would wish to continue to prescribe 5. The Alzheimer's Society has been campaigning against this guidance, which it feels cruelly restricts access to Alzheimer's drugs. Individual Trusts can now decide locally if they will routinely fund Ebixa for moderately severe to severe AD. Moderately severe to severe patients already receiving treatment with Ebixa are not affected by this Guidance. Over a million people worldwide have experienced treatment with Ebixa; 7,500 UK patients per month have access to Ebixa on the NHS.
1. Alzheimer's Society.
2. NICE Appeal Announcement.
3. Lundbeck Appeal post NICE FAD, Health Technology Appraisal, Alzhiemer's Disease - donepezil, rivastigmine, galantamine & memantine (review), May 26th 2006.
4. Wilkinson D. Prevention of the Worsening of Clinical Symptoms in Moderate to Severe. Alzheimer's Disease in Patients Treated with Memantine. Presented at the 9t International Geneva/Springfield Symposium on Advances in Alzheimer Therapy, 19th-22nd April 2006, Geneva, Switzerland.
5. Lundbeck survey carried out by TNS in May 2006 using a sample size of 100 dementia specialists.
Recently, the NHS (National Health Service) in the United Kingdom refused to provide an important drug to Alzheimer's Disease sufferers. As a result, there are virtually no medications available to later-stage Alzheimer's patients in the UK. As a result, the Mayfield Clinic for Regenerative Research has decided to conduct a new study targeting Alzheimer's Disease with stem cells in an effort to give new hope to those patients who may have been effected by the NICE Appeal decision.
NICE Appeal Leaves Inequity Of Access To A Licensed NHS Treatment For UK's 309,000 Advanced Alzheimer's Disease Patients
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