As expected the National Institute for Health and Clinical Excellence has published draft guidance on the treatment of Alzheimer's disease lifting previous restrictions on using drugs to treat patients with mild forms of the disease.

In guidelines unveiled this morning, the cost regulator for treatments funded by the National Health Service in England and Wales confirmed its new position that Eisai/Pfizer's Aricept (donepezil), Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine) are cost-effective options for the treatment of mild to moderate forms of Alzheimer's disease, extensively expanding patient access to these drugs. 

In addition, NICE has also endorsed the use of Lundbeck's Ebixa (memantine) for severe disease and for some patients with moderate forms of the condition.  

The recommendations represent a major U-turn in NICE's position; the Institute previously barred the use of Aricept, Reminyl and Exelon in patients with mild forms of the disease and limited Ebixa to clinical trials for patients with moderate to severe symptoms, triggering a stream of campaigns and even High Court battles from those adamant that it had drastically underestimated costs of care and had overlooked carer benefits when drawing up its cost-effectiveness model. 

Explaining the cost watchdog's change of heart, its chief executive Chief Executive Sir Andrew Dillon said that since 2007 "clinical trials have continued to show the positive effects of these drugs and, in the case of memantine, have reduced the uncertainty about its clinical effectiveness". Furthermore, he said more information about the costs of living with and treating the disease through its stages has become available, paving the way for the drugs' use on the NHS.

“This is great news for people with Alzheimer’s disease and their families," said Professor Roy Jones from The Research Institute for the Care of Older People, Royal United Hospital, Bath, UK. "Patients with mild disease will at last be able to get access to early, cost-effective treatment at the point of diagnosis – treatment that can potentially help to relieve the symptoms in these patients”, he added.

Shift in treatment strategy?

The new recommendations will likely cause a significant shift in treatment strategies in the UK. Results of a survey by Eisai and Pfizer has revealed that 70% of GPs believe their management of Alzheimer’s will change as a result of the new recommendations, while 64% believe their detection and diagnosis of mild forms of the condition will improve as a result of the expected new NICE guidance. Moreover, 58% of said that they would recall patients with mild Alzheimer’s who had previously been denied access to treatment for a reassessment.

Novartis was also quick to welcome the new guidelines, which should boost the use of its new patch form of its AD drug Exelon. "The Exelon Patch is the first and only transdermal patch licensed for the symptomatic treatment of mild to moderately severe Alzheimer's dementia [and] is an important treatment option as it reduces the patient pill burden, provides visual reassurance of compliance for the carer and has a preferable side effect profile compared with oral Exelon capsules", the firm said.

The draft guidance is now open to consultation, and final guidelines are expected in March 2011.