NICE announces Alzheimer's disease drug appeal outcome and NHS guideline to support patients and carers

Source: NICE: National Institute for Clinical Excellence

The National Institute for Clinical Excellence has announced that the appeals lodged by stakeholders against draft guidance on the use of drugs to treat Alzheimer’s Disease have not been upheld.

NICE will recommend to the NHS in England and Wales in November, that donepezil, galantamine and rivastigmine should only be considered as options in the treatment of people with moderate Alzheimer’s disease. Memantine is only recommended as part of clinical studies for people with moderately-severe to severe Alzheimer’s disease.

NICE, in their Final Appraisal Determination had made the following recommendations:
• The three acetylcholinesterase inhibitors donepezil, galantamine and rivastigmine are recommended as options in the management of people with Alzheimer’s disease of moderate severity only (that is, those with a Mini Mental State Examination [MMSE] score of between 10 and 20 points), and under the following conditions:
? Only specialists in the care of people with dementia (that is, psychiatrists including those specialising in learning disability, neurologists, and physicians specialising in the care of the elderly) should initiate treatment. Carers’ views on the patient’s condition at baseline should be sought.
? Patients who continue on the drug should be reviewed every 6 months by MMSE score and global, functional and behavioural assessment. Carers’ views on the patient’s condition at follow-up should be sought. The drug should only be continued while the patient’s MMSE score remains at or above 10 points and their global, functional and behavioural condition remains at a level where the drug is considered to be having a worthwhile effect. Any review involving MMSE assessment should be undertaken by an appropriate specialist team, unless there are locally agreed protocols for shared care.
• When the decision has been made to prescribe an acetylcholinesterase inhibitor, it is recommended that therapy should be initiated with a drug with the lowest acquisition cost (taking into account required daily dose and the price per dose once shared care has started). However, an alternative acetylcholinesterase inhibitor could be prescribed where it is considered appropriate having regard to adverse event profile, expectations around concordance, medical co-morbidity, possibility of drug interactions, and dosing profiles.
• Memantine is not recommended as a treatment option for people with Alzheimer’s disease except as part of well designed clinical studies.
• People with mild Alzheimer’s disease who are currently receiving donepezil, galantamine or rivastigmine, and people with Alzheimer’s disease currently receiving memantine, whether as routine therapy or as part of a clinical trial, may be continued on therapy (including after the conclusion of a clinical trial) until they, their carers and/or specialist consider it appropriate to stop.