Doctors free to overrule NICE decisions, claims charity
pharmafile | July 17, 2007 | News story | |Â Â Â
A patient group is urging doctors to exercise their clinical judgement to overrule NICE guidance which restricts access to Alzheimer's drugs.
The Alzheimer's Society says remarks made by NICE's lawyer suggest doctors are free to go against they guidance if they consider it clinically appropriate to prescribe the drugs.
The remarks made during the judicial review into NICE's decision-making process has cast a new light on the status of the body's guidance
NHS trusts and clinicians are obliged to take NICE guidance into consideration, but this has been widely interpreted as been definitive.
But NICE's barrister, Nigel Giffin QC, said the disclaimer at the beginning of all NICE guidance, which says it does not override the individual responsibility of healthcare professionals, means clinicians still have the final say.
Giffin said that although doctors must accept the general approach of the guidance, they still had the power to decide when it was clinically appropriate to prescribe the drug.
The Alzheimer's Society's solicitor, John Halford, said the slight change in emphasis could transform the reality of Alzheimer's care.
"It is completely against the grain of what everyone has historically understood the position to be," Halford told Pharmafocus. He said the disclairmer gives NICE a Get Out Of Jail Free card against accusations of discrimination, but it also allows doctors to trump guidance by exercising their clinical freedom.
He added: "NICE says the PCT has to fund the treatment that the doctor has decided is appropriate for that patient and so the guidance is trumped by the doctor's decision."
The Alzheimer's Society is now writing to all of its branches explaining how patients can use this concession to receive treatment from their doctors in appropriate cases.
Head of Policy and Communications at the charity Andrew Chidgey said: "It seems to offer up the hope of better access to treatment and more flexibility, because the nub of it is whether the NHS has a duty to fund particular types of treatment."
Responding to the new tack taken by the Alzheimer's Society, a spokesman for NICE commented: "The statement referred to is not a concession, it is simply an explanation of our guidance."
In court
The new line of attack has emerged from the judicial review, an unprecedented legal probe of NICE's decision-making process.
Pharma company Eisai launched the court case earlier this year in response to guidance restricting access to Aricept, which it co-markets with Pfizer, Novartis Exelon and Shire's Reminyl. A third drug, Lundbeck's Ebixa, was blocked altogether.
Eisai's barrister David Pannick said: "We are asking the court to conclude that NICE and its appeal panel failed properly to assess the issues and so the matter must go back for consideration."
The judicial review is the latest episode in a bitter two-year battle over access to drugs for patients with early and late-stage Alzheimer's disease.
The Alzheimer's Society argued in its evidence to court that NICE guidance was discriminatory in its use of a standard assessment test for the disease, which it says fails to pick up false results in certain groups, such as people with learning difficulties. It argues that this then prevents these patients from receiving drug treatment, even if they have the moderate form of the disease.
Asked to predict an outcome, the Alzheimer's Society's solicitor, John Halford, said: "It's quite complicated, but if the judicial review succeeds, the most likely outcome is that the guidance will be quashed so that the 2001 guidance will take its place while NICE re-considers its position and possibly the consultation process starts again."
Andrew Dillon, NICE's chief executive, has always maintained that the decision to restrict access to the drug was sound and based on clinical evidence.
In November, he said: "We have to be honest and say the evidence [suggests] these drugs do not make enough of a difference for us to recommend their use for treating all stages of the disease."
NICE's guidance said only patients with moderate Alzheimer's disease, the middle stage of the progressive disease, should receive the drugs on the NHS.
NAO report
A further boost to the campaign for greater access came with the publication of a National Audit Office's report, published the week after the hearing.
The in-depth review of Alzheimers services does not comment directly on whether or not NICE's decision is correct, but says the UK is lagging behind much of Europe in providing for patients with the condition.
"Discussion concerning the cost-effectiveness of the available drugs notwithstanding, these data provide evidence that the UK is functioning relatively poorly in terms of the diagnosis and treatment of dementia," the report noted.
The publicly-funded watchdog said too few people with dementia are being diagnosed, or being diagnosed soon enough, and early interventions known to be cost-effective are not being made widely available to patients.
The UK is in the bottom third of countries in Europe in terms of the percentage of dementia patients receiving anti-dementia drugs (less than 20%) and the average time taken to diagnose patients in the UK is up to twice as long as in some other countries.
