Battle for Alzheimer’s drugs finally over
pharmafile | October 8, 2010 | News story | Sales and Marketing | Alzheimer's, Aricept, NICE
NICE is to allow wider access to Alzheimer’s disease treatments, ending an epic five year battle for access to the drugs.
The draft guidance extends NICE’s recommendation for the use of Pfizer/Eisai’s Aricept, Shire’s Reminyl and Novartis’ Exelon to include mild, as well as moderate disease.
It also recommends the use of Lundbeck’s Ebixa for severe disease and for some patients with moderate disease.
This new appraisal saw NICE use a different model to assess cost-effectiveness of the drugs, and had further clinical trials data to examine; however its overall verdict on the new data was that it was ‘disappointing’. Nevertheless, NICE’s committee found that the three cholinesterase inhibitors generally delayed the need for patients to go into a nursing home or institution, and therefore concluded the treatments represented value for money.
The decision brings to an end one of the longest running controversies in the history of NICE, with campaigners fighting to reverse restrictions first imposed in 2006. These were amended in 2007, meaning that patients in the ‘mild’ stage of the disease were denied the drugs on the NHS. A protracted legal battle ended in 2009 with NICE sticking to its decision, but yet another review of the evidence has now produced an end to the restrictions.
Chief executive, Sir Andrew Dillon, said: “Since we published our guidance in September 2007 clinical trials have continued to show the positive effects of these drugs and, in the case of memantine [Ebixa], have reduced the uncertainty about its clinical effectiveness.
“In addition, we now have more information about the costs of living with and treating this very distressing disease, as it progresses through its mild, moderate and severe stages.”
The Alzheimer’s Society’s interim chief executive Ruth Sutherland said: “The drugs aren’t a miracle cure but they can make important differences to people’s lives.
“For the price of a cup of coffee they can mean the difference between recognising your loved ones and playing with your grandchildren.
“It is critical that this draft decision becomes a reality and that all people with Alzheimer’s are given the opportunity to benefit from these treatments.”
Alzheimer’s has yet to set a major treatment breakthrough and the therapy area remains one of unmet medical need.
Hundreds of thousands of people with Alzheimer’s disease who have been denied medical treatment could soon be given access to life-changing drugs on the NHS.
Ruth Sutherland added: “This is a momentous day for thousands of people with Alzheimer’s and their carers. These drugs can help people have a better quality of life at all stages of the condition. While they don’t work for everyone, small but important benefits can enable many people to recognise their loved ones for longer, play with their grandchildren or make vital plans for the future. Alzheimer’s Society welcomes the draft decision and will now be campaigning for more people to have access to the treatments from today.”
Professor Clive Ballard, Alzheimer’s Society’s director of research and leading old aged psychiatrist said: “If this guidance is issued, doctors will no longer have to watch people deteriorate without being able to treat them. Being able to prescribe in the best interest of their patient will also be a strong incentive for GPs to diagnose Alzheimer’s disease earlier and for doctors to go to their doctor if they are worried about their memory. “Early diagnosis and intervention means better choice and control in the support and care available.”
Growing burden of disease
There are 465,000 people with Alzheimer’s in the UK and 62,000 people develop the disease every year. In compiling its latest guidance, NICE used a different model to assess the cost-effectiveness of the drugs and concluded they can now be shown to offer value for money.
Nick Burgin, managing director UK, Eisai said: “We are delighted by NICE’s decision to again recommend Alzheimer’s treatments such as Aricept in the early stages of the disease.
“This was the right decision for patients in 2000 when these medicines were originally reviewed by NICE and it is the right decision today. While we welcome this decision, it will always remain a huge disappointment that NICE changed their original guidance in 2006, thereby preventing patients with early stage Alzheimer’s disease from benefiting from early treatment. After a five year battle, today’s recommendation will once again allow patients to get the treatment they need, when they need it most.”
A second meeting of the Appraisal Committee will take place on 25 November, after which the decision is expected to progress towards a final approval.
Alzheimer’s drugs timeline
Jan 2000: NICE recommends Aricept, Reminyl and Exelon.
March 2005: NICE conducts routine re-examination of data, and decides that Aricept, Reminyl and Exelon should no longer be available to NHS patients because they are not cost-effective. It also recommends that Ebixa should not be prescribed, except in clinical trials. Patient, carer and professional groups condemn decision, led by Alzheimer’s Society.
June 2006: NICE recommends that Aricept, Reminyl and Exelon should only be available to people in the moderate stages of Alzheimer’s disease, and Ebixa should only be available as part of a clinical trial.Five separate appeals were refused in November 2006.
Jan 2007: Eisai wins right to challenge decision via a judicial review. The High Court rules that NICE’s core guidance was justified.
May 2008: Eisai challenges decision in Court of Appeal and wins, forcing NICE to divulge the formerly secret health economic model used to make its decision.
June 2009: Stakeholders comment on methodolgy, but NICE still concludes that drugs are not cost- effective. However NICE accepts its guidance should be reviewed because new evidence has emerged in the meantime.
October 2010: NICE published new draft guidance recommending full access to the drugs.
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