The National Institute for Health and Clinical Excellence has modified its guidance on Alzheimer's disease drugs in line with the outcome of the judicial review published on August 10.
While the High Court ruled in August that Eisai/Pfizer's Aricept (donepezil), Novartis' Exelon (rivastigmine) and Shire's Reminyl (galantamine) will continue to be recommended only for people with moderate Alzheimer's disease, it found that NICE had breached its duties under the Disability Discrimination Act and Race Relations Act by not offering specific advice regarding people with learning difficulties and people for whom English is not their first language.
NICE has, therefore, included new text in its guidance to advise that when using the Mini Mental State Examination (MMSE) to assess the severity of Alzheimer's disease, healthcare professionals should make sure that people from different ethnic or cultural backgrounds with disabilities have equal access. It further notes that in some cases healthcare professionals should not rely on the MMSE, or not rely on it alone, if it will not fairly reflect the severity of the disease. Such cases may include people who have learning disabilities or other disabilities such as deafness or blindness; or have difficulty speaking, such as after a stroke, or other difficulties with communicating; or are not fluent enough in a language in which the MMSE test can be given. For these people, NICE advises healthcare professionals to use a different measure to judge whether the person has moderate Alzheimer's disease when deciding about starting or stopping treatment.
The amended guidance came into force with effect from September 7. In accordance with the High Court ruling, NICE consulted Eisai, the claimant in the judicial review, and the two interested parties – the Alzheimer's Society and Shire - on details of the amendment.
Rest of guidance unchanged
The grounds on which the judicial review was sought related to three areas: NICE's guidance on Alzheimer's disease drugs issued in November 2006 was challenged by Eisai/Pfizer as irrational, on four different but limited grounds; the decision was claimed to be procedurally unfair in one specific respect (by providing a "read only" version of the economic model); and it was considered indirectly discriminatory against certain groups. Apart from the latter issue, the High Court judge rejected the other challenges made against NICE. Jeanette Marchant