The first direct legal challenge of guidance from the National Institute for Health and Clinical Excellence (NICE) has been heard in the High Court.

NICE advised against funding dementia drugs for those with mild Alzheimer’s disease. It said that the drugs should be reserved for those at the moderate stage. The drugs in question do not cure the disease but are recognised to be the only licensed products that delay its progression. NICE contended that the drugs form only a part of the care that should be offered to Alzheimer’s sufferers.

Lawyers for one of the drugmakers argued that this guidance was “procedurally flawed and irrational”. They claimed that the government watchdog did not make a proper assessment of the issues surrounding the use of dementia drugs when it recommended that NHS funding be withdrawn. The drugmakers argued a failure by NICE to behave in a transparent way throughout the consultation process.

The Alzheimer’s Society joined the two drugmakers in the judicial review challenge, representing the views of people with dementia and their carers. The Society argued that NICE had:

  • failed to take into account, when evaluating costeffectiveness, the benefits treatment brought to carers
  • failed to reflect the true costs of long term care in its calculations and
  • breached duties under the Disability Discrimination Act and the Race Relations Act.

The judicial review challenge proved largely unsuccessful, with the Court upholding NICE’s decision that the drugs are not cost-effective in the early stages of the disease. However, NICE was told to rewrite its guidance on how the disease is assessed as tests were held to discriminate against certain groups of Alzheimer’s sufferers. The drugmakers and the Alzheimer’s Society have indicated an intention to appeal the decision.

Despite the outcome, this remains a landmark case, as it is the first time that NICE has come under the scrutiny of the judicial review process.