Requires registration
The Court of Appeal says ‘yes’ where NICE said ‘no’
by Susanna Twidale
Pharmaceutical companies manufacturing treatments for Alzheimer’s and the families of those affected have received a boost from the Court of Appeal, which has overturned a decision to deny Alzheimer’s sufferers vital treatment on the NHS.
In 2005 the National Institute for Health and Clinical Excellence (NICE) ruled that four licensed Alzheimer’s treatments should not be given on the NHS even though it conceded the drugs had a positive effect. Aricept, produced by Pfizer and Eisai, and Shire’s Reminyl where among those named, along with Novartis’s Elexon and H.Lundbeck’s Ebixa. Unsurprisingly there was widespread consternation about the decision and Nice changed its position, saying people in moderate stages of the disease could continue with treatments, but maintained the £2.50 cost per day was too expensive for patients in the early stages of the disease.
Pfizer and Eisai fought this decision, which has led to the court ruling that Nice’s process was ‘procedurally unfair’. Nice will now have to provide access to the model it has used to decide who should be given the treatment, which has wider implications for the whole UK pharma sector. The industry has long been calling for the institute’s workings to be made more transparent, but Nice could still appeal against this decision in the House of Lords – it argues that changes the industry wants could lead to longer drug appraisals and a lengthier process for deciding which drugs would be given on the NHS. ‘Releasing the executable model will have an impact on increasing our timelines because we will need to consult more,’ it says.
However, the pharma companies believe change is necessary. ‘The court decided that Nice’s failure to disclose the fully executable version of the model put consultees, including Shire, at a significant disadvantage in challenging the reliability of the model,’ Reminyl maker Shire said in a statement. ‘In that respect it limits their ability to make an intelligent response on something that is central to the appraisal process.’ Separately the House of Commons Select committee has said it will conduct an inquiry into how Nice works and that how the treatments benefit carers should be better reflected in Nice’s decisions.