Thousands of patients with Alzheimer's disease will have to wait months to find out whether they will be given access to drugs that have so far been denied to them, following a landmark ruling by the Court of Appeal yesterday.
The court said that the government watchdog that determines whether treatments are clinically and cost effective had been procedurally unfair in refusing to give anti-dementia medicines, costing about £2.50 a day, to those with early or mild forms of the disease. But the current guidance, restricting NHS prescriptions to those at the moderate stage of the disease, will remain in place in England and Wales, pending the release of the watchdog's economic reasoning.
The Alzheimer's Society said the verdict was "a damning indictment" of a flawed process which discriminated against vulnerable people. Eisai and Pfizer, the companies behind the drug Aricept, said the court ruling was a "victory for common sense" and that they were committed to working with the National Institute for Health and Clinical Excellence (Nice) to ensure all patients had access to the drugs.
Nice said it would provide Eisai with a fuller version of the economic model it had used in reaching its guidance, but was still considering whether to appeal against the decision. Andrew Dillon, its chief executive, said: "We will be considering very carefully the findings and the implications for the time it takes us to provide advice to patients and the NHS on the use of new treatments. The ruling will increase the complexity of our drug appraisals in some cases and they may take longer as a result."
He added that Nice had not been told to amend or withdraw its current guidance. Nice decisions take on average 12 to 18 months, a timescale criticised by patients' groups, drug companies and MPs.
The organisation's defeat arising from the first judicial review of any decision, albeit on a technical and procedural point, is a severe blow to its claims to operate transparently in its difficult role of ensuring value for money for the NHS.
Lord Justice Richards, giving the ruling, said Nice's refusal to give Eisai full details of the economic model used put drug companies "at a significant disadvantage" in challenging its reliability.
Nice announced in 2006 it would not support NHS prescriptions for newly-diagnosed patients, prompting fierce campaigns and legal action. Patients already using the medicines were not affected.
The Alzheimer's Society estimates around 60% of patients benefit from the drugs. Neil Hunt, its chief executive, said: "Time and quality of life has been snatched away from thousands of vulnerable people who learned they have this devastating disease this year. This decision must be ... urgently revisited to ensure everyone with Alzheimer's disease is given access to these treatments on the NHS."
Nick Burgin, managing director of Eisai, said: "As soon as we have reviewed their cost-effectiveness calculations we will submit any new findings to Nice."
FAQ Alzheimer's drugs
Which drugs are affected by this decision?
Aricept, Reminyl and Exelon. They belong to a class called acetylcholinesterase inhibitors, which prevent an enzyme breaking down a chemical in the brain that nerve cells use to communicate and thus temporarily improve or stabilise symptoms.
How many people in Britain have Alzheimer's disease?
An estimated 415,000, of which there are about 230,000 in its early, mild stage and 133,000 in the moderate stages.
Why does Nice only sanction their use in those with moderate Alzheimer's?
It does not believe the drugs are cost-effective in the early stages.
How many are prescribed them?
About 60,000 people at present.
How many people are newly diagnosed with Alzheimer's each year?
About 60,000.
What does the court decision mean?
The Nice guidance will not change in the short term, but it will have to provide Aricept's makers with full access to the technical model on which they based their decision. The Alzheimer's Society believes that might mean further challenges to the Nice position.
