Established in 1999, the National Institute for Health and Clinical Excellence reviews newly approved drugs and decides whether they will be available on the NHS based on their cost-effectiveness. On this basis, the watchdog said only Alzheimer’s sufferers in the moderate and severe stages of the disease, not mild cases, should have access to acetylcholine esterase inhibitors. The Alzheimer’s Society and drug makers Eisai and Pfizer said this was unfair and campaigned against the decision. This was the first time NICE had faced legal action.
The claimants alleged that NICE’s cost-effectiveness analysis of Eisai’s Alzheimer’s drug Aricept, costing GBP2.50 per day per patient, was flawed as it underestimated the cost of long-term care and failed to recognize the impact on the quality of life of carers. Furthermore, the claimants asserted that, as these drugs can delay the need for long-term stay in care homes, they should be available to patients with a mild, and not only moderate, form of the disease.
While the High Court has upheld the drugs’ restriction, NICE has been ordered to change its guidance so that those with learning difficulties and non-English speakers can be assessed equally to determine whether they have an early or moderate form of the disease.
“It was always our intention that people with learning disabilities or people whose first language is not English should have equal access to the drugs in the moderate stage of Alzheimer’s disease. We will reissue our guidance to the NHS to make this crystal clear,” NICE said in a statement.
Chief executive of the Alzheimer’s Society, Neil Hunt, commented: “This is not satisfactory and the Society is considering whether to pursue an appeal.”