NICE decisions can often prove unpopular. Opposition from doctors, patient groups and drug companies are played out in the press. But as NICE faces a possible judicial review of its decision on Alzheimer’s drugs, the disputes could shift to the courts.
Under its latest technology appraisal, NICE said that only patients with moderate Alzheimer’s disease can be treated with donezepil (Aricept), galantamine (Reminyl) and rivastigmine (Exelon).
Two drug manufacturers have now asked for a judicial review to examine the procedure NICE used to reach its decision (GP, 24 November).
The Alzheimer’s Society is also considering whether it has a case for judicial review against the NICE technology appraisal.
A spokeswoman for the charity said: ‘We support the fact that NICE is being taken to court about this. There were a number of flaws in its assessment and judgment on the drugs.
‘We have been exploring issues on a judicial review ourselves.’
No independent appeal
NICE allows time for consultation between draft and final guidance being published. But because NICE oversees this process, there are questions as to whether it is fair.
‘The fact that there is no independent appeal means people have no choice but to challenge NICE in this way,’ said the Alzheimer’s Society spokeswoman.
Debate over which patients with Alzheimer’s disease should receive the drugs began in March 2005. NICE published a draft technology appraisal saying acetylcholinesterase (AchE) inhibitors should not be given to newly diagnosed Alzheimer’s patients. Guidance issued in 2001 placed no such restrictions on the drugs.
Further analysis of information from drug manufacturers led to a shift. In January, NICE said patients with a mini-mental state examination (MMSE) score of 10–20 could be treated with AchE.
NICE maintains that the drugs are not cost-effective for patients with mild or severe Alzheimer’s disease when considered at cost per quality-adjusted life year.
Eligibility for AchE inhibitors is strictly by MMSE score in the technology appraisal. But in a NICE clinical guideline on dementia issued the same day, the same rule does not apply. That states that patients with mild Alzheimer’s can receive the drugs if aggression and behavioural symptoms are causing severe distress and other medications are ineffective or unsuitable.
The manufacturers of Aricept, Eisai and Pfizer, want to know how NICE calculated cost-effectiveness for its appraisal. At £68 for a 28-tablet pack, Aricept 5mg costs £2.50 per patient per day.
Eisai and Pfizer say NICE has repeatedly refused to disclose a full-working version of its cost-effectiveness model. This would allow independent evaluation and comment, they argue.
NICE has claimed that because the model was provided ‘by a third party in confidence’ it is exempt from publication under the Freedom of Information Act.
Eisai and Pfizer notified NICE of their intention to take the case to judicial review in mid-November. They asked NICE to postpone publication of the final appraisal. A week later, NICE issued the document.
Chief executive of NICE Andrew Dillon said it intended to respond to the drug companies’ letter and will ‘act appropriately in any court proceedings which may follow’.
Depending on how NICE responds, a High Court decision could soon be made over whether the case should go ahead. If it does, NICE may have to justify its decision in the High Court as early as January or February next year.
Bertie Leigh, a senior partner in solicitors Hempson’s, has specialised in medical law for over 25 years. He said: ‘There’s no reason in theory why NICE should not be subject to judicial review.
‘It is an application that is being watched with considerable interest,’ he added. ‘If this application is successful, I think it is likely that other companies will try it.’
Shire pharmaceuticals, which makes Reminyl, has already offered its support to the other pharmaceutical companies pursuing the case. The Association of the British Pharmaceutical Industry (ABPI) also backs the move and accused NICE of using arbitrary thresholds of cost-effectiveness.
An ABPI spokesman said: ‘The basis for the economic modelling should be known and should be open to peer-review. All parts of the system need to be transparent.’
All eyes will turn to the High Court to see whether NICE is likely to face further challenges.
Jan 2001: NICE publishes first technology appraisal on Alzheimer’s drugs.
March 2005: review concludes that AchE inhibitors no longer cost-effective in newly diagnosed patients.
January 2006: review document modified. Those with an MMSE of 10–20 can receive AchE inhibitors.
November 2006: final appraisal document published. Eisai and Pfizer initiate judicial review process against NICE.