The National Institute of Health and Clinical Excellence's decision to lift restrictions of use on three Alzheimer's disease drugs has been greeted enthusiastically by doctors, patients and the pharmaceutical industry.
In a new draft guidance, the cost-effectiveness watchdog is now recommending that three acetylcholinesterase inhibitors - Eisai/Pfizer's Aricept (donepezil), Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine) - can now be prescribed on the National Health Service to treat mild, as well as moderate Alzheimer's disease. This represents a major U-turn on NICE's part which published a guidance in September 2007 to restrict the use of the aforementioned drugs to patients with moderate forms of the disease. That stance led to concerted campaigns against NICE and High Court battles.
Now, NICE chief executive Andrew Dillon, notes that since the earlier guidance was published, "clinical trials have continued to show the positive effects of these drugs". He added that 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".
Sir Andrew concluded by saying that "our increased confidence in the benefits and costs associated with the use of the three drugs for treating mild and moderate stages of the disease has enabled us to make a positive recommendation for their use in mild disease". NICE has also recommended the use of a fourth drug - Lundbeck's Ebixa (memantine) - for severe disease and for some patients with moderate disease.
The policy turnaround has gone down very well. Ruth Sutherland, interim chief executive of the Alzheimer’s Society, said "this decision stands to benefit hundreds of thousands of people. The drugs aren’t a miracle cure but they can make important differences to people’s lives".
She went on to say that "for the price of a cup of coffee [the drugs cost around £2.80 per day] they can mean the difference between recognising your loved ones and playing with your grandchildren". Ms Sutherland claimed "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". She concluded by saying "it will be important to ensure any new guidance is monitored closely to end postcode prescribing and ensure these drugs are available across the country".
Drugmakers are pretty happy too and Nick Burgin, managing director of Eisai UK, said "this was the right decision for patients in 2000 when these medicines were originally reviewed by NICE and it is the right decision today". He noted, however, that "it will always remain a huge disappointment" that the agency changed its original guidance in 2006, "thereby preventing patients with early-stage Alzheimer’s disease from benefiting from early treatment".
The draft NICE recommendations on Alzheimer’s will now go into consultation, with final guidance expected in early 2011. There are currently around 820,000 people living with the disease and other dementias in the UK, but only about one in ten receive any medication.