The National Institute for Health and Clinical Excellence has updated its guidance on the use of four drugs to treat Alzheimer's disease, significantly extending the treatment criteria by allowing patients access to therapy at a much earlier stage of their disease than before.

The guidelines now recommend that Eisai/Pfizer's Aricept (donepezil), Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine) are also used to treat National Health Service patients with mild as well as moderate forms of Alzheimer’s disease, marking a huge victory for patients, patient groups and drugmakers who have long battled for this change in guidance.

In another change, the cost watchdog also backed the use of Lundbeck's Ebixa (memantine) for the treatment of severe disease and for some patients with moderate disease.

The recommendations mark a major U-turn since the use of Aricept, Reminyl and Exelon was previously barred in patients with mild forms of the disease, while Ebixa was limited to use in clinical trials for patients with moderate to severe symptoms, triggering a stream of campaigns and court battles from those adamant that the guidelines drastically underestimated costs of care and overlooked carer benefits. 

Positive effects

Commenting on the new guidelines, NICE chief executive Andrew Dillon said the Institute is pleased to be able to extend its recommendations made back in 2007, given that "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". 

In addition, he said the availability of more data on the costs of living with and treating the disease as it moves through the mild, moderate and severe stages also helped to convince NICE that using these drugs earlier on in the pathway is indeed a cost-effective use of NHS resources.

“This is a milestone for people with Alzheimer’s disease, their families, carers and society as the new ruling means that crucial treatment can be given earlier thereby helping to reduce the impact of the disease at a much earlier stage”, commented Craig Ritchie from Department of Psychological Medicine, Imperial College London, Honorary Consultant and R&D Director, West London Mental Health Trust.

Vidaza in for MDS

Meanwhile, in another NICE u-turn, patients with myelodysplastic syndromes in England and Wales will be able to get treatment with Celgene's Vidaza on the NHS.

Initially the drug had been turned down on grounds that it is too expensive, but following the offer of a revised (confidential) patient access scheme by Celgene, the incremental cost dropped to £47,200 per QALY gained, and so below the Institute's ceiling value.

"[Vidaza] is an expensive drug, and this discount enabled us to recommend it as a cost effective use of resources on the NHS,” said Carole Longson, Health Technology Evaluation Centre Director at NICE.

While Vidaza does not offer a cure for MDS, it has the potential to extend patients’ lives by an average of nine months, potentially making a big difference to both patients and their families.