Alzheimer’s companies hope renewed by House of Lords
pharmafile | October 30, 2008 | News story | Sales and Marketing |Â Â Alzheimer's, NICEÂ
The companies behind Alzheimer's drug Aricept have won the right to see the economic model NICE used to assess the drug and others in its class.
The House of Lords has ordered NICE to hand over the model to Eisai and Pfizer and backed an earlier legal decision which ruled that its Alzheimer's drug appraisal had been 'procedurally unfair'.
The decision is a major victory for the companies, who have been fighting a legal battle for nearly two years.
The companies hope that they can find flaws in NICE's economic modelling, and ultimately reverse its guidance which bars the use of Alzheimer's drugs in patients in the mild stage of the progressive disease.
Nick Burgin, managing director of Eisai, said: "We are obviously pleased on behalf of patients by today's news. It finally brings to an end a long and arduous process and means that we now have an opportunity to review NICE's cost-effectiveness calculations.
"Most importantly, however, it means that the patients and carers affected by mild Alzheimer's disease are potentially one step nearer to receiving proven and effective treatments."
"We are delighted that the highest court in the land has agreed that NICE did not follow a fully fair and transparent process," said John Young, managing director of Pfizer, adding that stakeholders needed to be fully engaged in appraisals to maintain confidence in the process.
The ruling by the appeal committee of the House of Lords means NICE must disclose a fully functioning version of the model to the companies which will allow them to check the 'robustness and reliability of the assumptions' within 14 days.
NICE must also give the companies and other interested parties 42 days in which to make representations following disclosure of the model.
Eisai and Pfizer have confirmed they will make an announcement after they have conducted a 'rigorous review' of the economic model.
NICE must also pay Eisai's costs of the appeal as well as 60% of the costs of the original hearing.
Neil Hunt, chief executive of patient group the Alzheimer's Society, which joined the legal battle against NICE, welcomed the ruling.
"Today is a small victory in the battle to see justice for thousands of people with Alzheimer's disease and their families. Having access to NICE's model will allow us to scrutinise NICE's calculation and to try and make sense of this unfathomable decision.
"We strongly believe that NICE's decision to deny people in the early stages of Alzheimer's disease access to drugs is fundamentally flawed. For the price of a cup of coffee, drug treatments can give people hope, dignity and time when it is the most precious."
He concluded: "If NICE has got it wrong, the decision must be scrapped and people should be given back their right to have treatment."
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