BMJ  2007;335:11 (7 July), doi:10.1136/bmj.39265.593796.4E

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Lawyers claim "concession" over drug prescribing for Alzheimer's disease

BMJ

NHS doctors have the discretion to prescribe dementia drugs for patients whose cognitive function scores indicate mild Alzheimer's disease, despite guidance apparently restricting their use to patients with moderate disease, a lawyer for the National Institute for Health and Clinical Excellence (NICE) told the High Court last week.

Lawyers for the Alzheimer's Society, which is fighting NICE guidance that limits the use of acetylcholinesterase inhibitors to patients with moderate disease, hailed the statement as a "dramatic concession."

But NICE said it was not a concession, but simply an explanation of how its guidance works.

"Healthcare professionals are expected to take NICE guidance fully into account when exercising their clinical judgment, but our guidance does not override their individual responsibility to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient or guardian or carer," said a spokesman.

The clarification emerged during a High Court challenge to the guidance by Eisai, the Japanese company that makes Aricept (donepezil). The Alzheimer's Society, which represents patients and their carers, joined Eisai in challenging the guidance as an interested party.

The guidance says that patients should be tested using the mini mental state examination and that drugs be prescribed for patients whose scores show the moderate stage of the disease.

But Nigel Giffin QC for NICE said that there were circumstances in which, provided they took the NICE guidance into account, doctors could exercise their own clinical judgment and decide that an individual patient whose score indicated mild disease was entitled to the drugs.

He said that doctors "must accept the general approach of the guidance" but could determine, "because there are particular circumstances of the individual patient," that it was "nevertheless clinically appropriate to prescribe the drug."

He gave as examples patients with language and learning difficulties at one end of the scale and those with a high IQ at the other, where the test results might be distorted.

He said that clinicians could not ignore the guidance. However, if they exercised their discretion after taking account of the guidance, the treatment would fall within the guidance, and the NHS would normally have to fund it.

David Pannick QC, appearing for Eisai, said that it had taken questioning by the judge to show the true scope of the NICE guidance. This showed how difficult it is for doctors to make sense of it.

But Mr Giffin had clarified the guidance "only up to a certain point." He called on the judge, Mrs Justice Dobbs, to give a judgment spelling out the position more fully so that doctors and NHS funding authorities knew where they stood. She said she expected to give judgment within a couple of months.

John Halford, solicitor for the Alzheimer's Society, said that NICE's "concession" was not limited to patients who would have failed the cognitive test for reasons that had nothing to do with the stage the disease had reached. "On the face of things, responsible doctors can use their professional judgement to override the guidance in cases where they believe patients will benefit, even though NICE takes a different view. According to NICE, treatment must be funded when this happens."

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