Drugs watchdog faces legal review- NICE's approach is irrational and flawed
A decision by the government's drugs watchdog to restrict the use by the NHS of Alzheimer's medication is to be challenged in court. Two drug companies plan to apply for a judicial review of the way the National Institute for Health and Clinical Excellence reached its conclusion. NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.
Eisai and Pfizer claim the process leading to this guidance was unfair.They claim many of NICE's conclusions on the Alzheimer's treatments - which include donepezil, rivastigmine and galantamine - cannot be supported legally or are "irrational".
They want NICE to withdraw the recommendations and postpone issuing its final guidance, which is due on 22 November.
Eisai and Pfizer, who produce donepezil (also known as Aricept) are also asking the institute to disclose a "fully transparent working version of the calculations used in the cost effectiveness model for independent evaluation and comment".
They would like NICE to develop a new guidance using "both a more accurate cost effectiveness model and data".
Dr Paul Hooper, managing director of Eisai Limited, said: "We are deeply concerned about the way that NICE's decision on treatment recommendations for early Alzheimer's disease was reached.
"A judicial review is now the only option remaining to us to ensure that NICE reconsiders how it arrived at such flawed conclusions."
If the judicial review goes ahead it would be the first time a NICE decision has been contested at this level.
NICE, whose guidelines cover England and Wales, has 14 days to formally respond to Eisai's written proposals, after which Eisai may apply to the High Court for permission to proceed to judicial review.
Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.
Neil Hunt, chief executive of the Alzheimer's Society, said: "It's great news that NICE will be challenged in court. NICE holds the fate of thousands of people's lives in its hands and it is only right that it is brought to account."
The society is co-ordinating a number of protest marches across the country calling for doctors to have greater flexibility in prescribing Alzheimer's treatments.
Last month, NICE rejected their appeal saying studies showed the drugs "did not make enough of a difference."
More on this story can be found at:
http://news.bbc.co.uk/1/hi/health/6154668.stm
Health Direct has seen that time after time NICE (the National Institute for Curbing Expenditure) restricts small priced drugs because many thousands of voters would hope to use the drugs.
On 11 Oct 06 Health Direct carried this origional ruling in - National Institute for Curbing Expenditure (NICE) blights thousands of Alzheimer sufferer when NICE was renamed by NHS doctors as the National Institute for Curbing Expenditure after it's latest edict to ban the funding of Alzheimers drugs costing only £2.50 a day- which will effect hunderds of thousands of sufferers. "This blatant cost-cutting will rob people of priceless time" said Neil Hunt of the Alzheimer's Society.
Neil Hunt, chief executive of the Alzheimer's Society, added: "This blatant cost-cutting will rob people of priceless time early in the disease and later clinicians will have no choice but to use dangerous sedatives that increase the risk of heart disease and stroke."
He said there had been "fundamental flaws" in NICE's appraisal process, and called on the government to step in.
Jonathan Ellis, senior policy manager at the charity, added: "It cannot be right to allow the health of thousands of older people to deteriorate on the altar of cost.
"On the one hand, the government says it is committed to improving care for older people, while on the other NICE is blocking access to treatment which would help them retain their independence and dignity. This is botched policy making at its worst."
Eisai and Pfizer claim the process leading to this guidance was unfair.They claim many of NICE's conclusions on the Alzheimer's treatments - which include donepezil, rivastigmine and galantamine - cannot be supported legally or are "irrational".
They want NICE to withdraw the recommendations and postpone issuing its final guidance, which is due on 22 November.
Eisai and Pfizer, who produce donepezil (also known as Aricept) are also asking the institute to disclose a "fully transparent working version of the calculations used in the cost effectiveness model for independent evaluation and comment".
They would like NICE to develop a new guidance using "both a more accurate cost effectiveness model and data".
Dr Paul Hooper, managing director of Eisai Limited, said: "We are deeply concerned about the way that NICE's decision on treatment recommendations for early Alzheimer's disease was reached.
"A judicial review is now the only option remaining to us to ensure that NICE reconsiders how it arrived at such flawed conclusions."
If the judicial review goes ahead it would be the first time a NICE decision has been contested at this level.
NICE, whose guidelines cover England and Wales, has 14 days to formally respond to Eisai's written proposals, after which Eisai may apply to the High Court for permission to proceed to judicial review.
Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.
Neil Hunt, chief executive of the Alzheimer's Society, said: "It's great news that NICE will be challenged in court. NICE holds the fate of thousands of people's lives in its hands and it is only right that it is brought to account."
The society is co-ordinating a number of protest marches across the country calling for doctors to have greater flexibility in prescribing Alzheimer's treatments.
Last month, NICE rejected their appeal saying studies showed the drugs "did not make enough of a difference."
More on this story can be found at:
http://news.bbc.co.uk/1/hi/health/6154668.stm
Health Direct has seen that time after time NICE (the National Institute for Curbing Expenditure) restricts small priced drugs because many thousands of voters would hope to use the drugs.
On 11 Oct 06 Health Direct carried this origional ruling in - National Institute for Curbing Expenditure (NICE) blights thousands of Alzheimer sufferer when NICE was renamed by NHS doctors as the National Institute for Curbing Expenditure after it's latest edict to ban the funding of Alzheimers drugs costing only £2.50 a day- which will effect hunderds of thousands of sufferers. "This blatant cost-cutting will rob people of priceless time" said Neil Hunt of the Alzheimer's Society.
Neil Hunt, chief executive of the Alzheimer's Society, added: "This blatant cost-cutting will rob people of priceless time early in the disease and later clinicians will have no choice but to use dangerous sedatives that increase the risk of heart disease and stroke."
He said there had been "fundamental flaws" in NICE's appraisal process, and called on the government to step in.
Jonathan Ellis, senior policy manager at the charity, added: "It cannot be right to allow the health of thousands of older people to deteriorate on the altar of cost.
"On the one hand, the government says it is committed to improving care for older people, while on the other NICE is blocking access to treatment which would help them retain their independence and dignity. This is botched policy making at its worst."
posted by Dr Search- Principal Consultant at the Search Clinic at
2:11 PM
1 Comments:
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Skillipedia, at 2:34 PM
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