Outrage over NICE verdict on Alzheimer’s drugs
pharmafile | June 1, 2006 | News story | Sales and Marketing |Â Â Â
Hundreds of thousands of patients with early or late-onset Alzheimer's disease (AD) are to be denied access to four drugs on the NHS because they are not clinically or cost effective in the long-term.
NICE has declared that three acetylcholinesterase (AChE) inhibitors, Eisai/Pfizer's Aricept, Novartis' Exelon and Shire's Reminyl should only be available on the NHS for patients with moderate Alzheimer's because the drugs are not clinically or cost effective to prescribe to patients in the early or late stages of the disease.
It has also ruled that Lundbeck's Ebixa, the only treatment for the distressing behavioural symptoms of late dementia, should not be used on the NHS, with similar shortcomings found in its clinical and cost effectiveness data.
Neil Hunt, spokesman for the pressure group Action on Alzheimer's Drugs Alliance, which represents more than 30 charitable and professional organisations, said: "This decision by NICE is outrageous. It will rob families of precious time in the early stages of dementia and deprive people of comfort and dignity in the final stages of their lives."
He claimed: "NICE has rejected the views of experts, clinicians and, most importantly, people with dementia and their carers, all for a saving of just two pounds fifty per person a day."
And he added: "Where is the clinical excellence in a decision that puts cost-cutting and flawed calculations ahead of care and quality of life? NICE is victimising the vulnerable in society and we will do everything in our power to make sure this unethical and unworkable guidance is overturned."
NICE's updated guidelines recommend that the three cholinesterase inhibitors should only be considered as options to treat Alzheimer's disease of moderate severity; ie: those with a mini-mental state examination (MMSE) score of between 10 and 20 points (with those patients achieving lower scores having a higher level of dementia).
Furthermore, Ebixa is not recommended as a treatment option for people with moderately-severe, to severe AD, except as part of clinical studies.
Cholinesterase inhibitors are now only recommended for patients with an MMSE score of between 10 and 20 points under the following conditions:
* Only specialists in the care of people with dementia (ie: psychiatrists, including those specialising in learning disability, neurologists and physicians specialising in the care of the elderly) should initiate treatment.
* Patients who continue on these drugs should be reviewed every six months by MMSE score and global, functional and behavioural assessment.
* The drug should only be continued while the patient's MMSE score remains at, or above, 10 points and the patient's condition remains at a level where the drug is considered to be having a worthwhile effect.
NICE says when the decision has been made to prescribe one of the drugs, the one with the lowest cost should be used, taking into account required daily dose and the price per dose once shared-care has started.
Dr Ian Howe, medical director of Shire Pharmaceuticals in the UK, said: "Withdrawing drug treatments on the NHS for people diagnosed with mild AD is a grave error as clinical trials demonstrate that mild AD patients benefit significantly with measurable improvements in cognition and the ability to continue to participate in activities of daily living."
NICE is expecting many appeals against its ruling to be lodged by the deadline of 15 June, with final guidelines expected to be issued in July.
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