NICE authority hangs in the balance ahead of court ruling
pharmafile | January 22, 2007 | News story | |Â Â Â
A High Court judge is poised to decide whether the first ever legal challenge to NICE guidance can go ahead – with the future authority of the institute hanging in the balance.
The potential judicial review of NICE's guidance on Alzheimer's drugs is the latest development in a bitter two-year battle over access to Eisai and Pfizer's Aricept, Shire's Reminyl, and Novartis' Exelon for some sufferers of the disease.
The High Court will shortly decide if there are sufficient grounds for a judicial review of NICE's decision, which Eisai and Pfizer say was fundamentally flawed.
If the court accepts there is enough evidence for the review to proceed, the judge will then consider whether or not NICE's decision-making was rational and sufficiently transparent.
If the judge were to find against NICE, it could be forced to start its process again from scratch and undertake an entirely new appraisal.
Ahead of the decision, the institute's chief executive, Andrew Dillon, condemned Eisai's challenge.
In unusually tough talk, he declared: "We are disappointed that Eisai has taken this step.
"We consider the claim without foundation and it will require us to divert energy and funding from the work we do to support patients and health professionals and get the most out of the resources available to the NHS."
Dillon will be hoping that the judicial review is never heard, bearing in mind that NICE's authority has already been undermined by long-running protests and sometimes ambiguous support from the government.
Meanwhile, the Alzheimer's Society has added its name to the legal action and says it will continue fighting for access to the drugs while awaiting the legal decision.
Despite uncertainty about who should receive the drugs, the Alzheimer's Society says it has not received any reports of patients being denied the medication so far.
Spokeswoman Hannah Clack said: "We believe experienced and confident clinicians, familiar with the drugs, appear to be continuing to prescribe them despite NICE. It's the younger, newer physicians that we are really worried about. They may not be familiar with the drugs and will err on the side of caution, toe the line and go along with NICE guidance."
However, she explained that actual figures of how many clinicians were continuing to supply the drugs on the NHS would not be known until the end of the financial year in March, when sales figures were published.
At present, these drugs are only indicated for treatment on the NHS for moderate forms of the disease.
A fourth drug, Lundbeck's Ebixa, which is indicated for late-onset Alzheimer's has been barred from the NHS altogether.
The showdown between pharma and NICE came to a head earlier this month after Eisai gave the institute two weeks to revoke its decision.
When NICE refused, Eisai immediately carried out its threat to pursue the institute through the courts.
An Eisai spokesman said: "This action is being taken because we believe it is necessary to challenge the lack of transparency in the process by which NICE made a decision that we believe to be flawed, in order to ensure patients newly diagnosed with mild Alzheimer's disease receive the best care possible."
Campaigners against NICE claim the institute used inaccurate methodology when weighing up care costs for early Alzheimer's patients against the cost of drug provision.
Hannah Clack said: "Alzheimer's drugs are proven to reduce the need for full-time institutional care. NICE took this into account, but used a figure of £355 per week in its model; far below the average cost of care, which is £520 per week.
Neil Hunt, the Alzheimer's Society's chief executive, said: "More than 10,000 people will develop dementia this year; yet NICE has completely ignored the shattering effect that this decision will have not just on them, but their carers too."
He added; "This is a fatally flawed decision and we are left with no choice but to challenge it in court. We are determined to get justice for thousands of people across the country."
NICE has flatly denied these claims. Andrew Dillon stated: "Our consultation, decision-making and appeals processes are transparent and fair.
"We share our methodology and enable our stakeholders to see the basis on which our experts arrive at their decisions."
He said the reality was that Alzheimer's drugs were only part of the care that needed to be offered. "Non-drug interventions have an important part to play and the evidence indicates that drugs are simply not effective for some patients," he commented.
Because no legal challenge has ever been mounted against NICE guidance before, all sides are in uncharted territory, with even the procedure difficult to predict.
But, even if the High Court decides that there is sufficient evidence to grant Eisai a judicial review, it could take months before a hearing is convened.
Jonathan Brain, a lawyer in clinical negligence and a member of the Law Society explained that even if Eisai won its case, NICE would have the right to appeal against the judgment. That procedure would, most likely, take months, he said.
Despite this uncertainty, Eisai has vowed not to throw in the towel even if the court refuses the request for a judicial review
A spokesman for Eisai said: "In this instance, there would most probably be an appeal. Certainly, there would be a number of high-level strategy board meetings to decide the next move."
