High Court rejects claims NICE acted irrationally and unfairly
Eisai’s legal challenge is the first time NICE guidance has
been tested in court |
Claims of unfairness and irrationality in the development of national guidance on Alzheimer's disease have been rejected by the High Court.
The pharmaceutical company Eisai, supported by the Alzheimer’s
Society and Shire Pharmaceuticals, challenged
a National Institute for Health and Clinical Excellence appeal panel
decision and subsequent guidance
issued by NICE in November 2006 (PJ, 13 January, p42). The guidance recommended
that patients with moderate Alzheimer’s disease, but not those
with mild disease, should receive donepezil, galantamine or rivastigmine.
Of the six grounds for the claims (see Panel), five relating to procedural
unfairness and irrationality were rejected by the court. Eisai, which
holds the UK marketing authorisation for donepezil, said it would appeal
against the High Court’s decision on these claims. “The guidance
NICE has issued is morally reprehensible,” the company said. “NICE
has got it wrong and it has got it wrong under a shroud of secrecy.”
Eisai’s claims and the High Court decisions
Eisai said that NICE had been procedurally
unfair when it refused to disclose a fully executable version
of the economic model
used in NICE’s assessment. Mrs Justice Dobbs said NICE had not
acted unfairly. Eisai had, she said, “more than sufficient
information to make intelligent response and to give proper advice” and
had made comments to NICE that “could not have been made
without a good understanding of how the model worked”.
Eisai claimed that NICE’s decision was irrational on four
grounds:
• it assumed that patients would derive no additional
benefit after six months of treatment with an acetylcholine inhibitor
• it relied
on the findings of one study (the AD2000 study)
• it failed to capture
benefits to carers
• it failed to capture reductions in costs
of care
In terms of NICE’s assumption on benefits after
six months, Mrs Justice Dobbs said that NICE had argued cogently
and
logically in reaching its conclusions and that the conclusions
were not perverse. The court ruled that there was not unqualified
acceptance
of the AD2000 study — “its drawbacks were acknowledged;
and in the overall scheme, the study was given reduced weight,” it
said. And NICE’s approach to the issue of carer benefits
was, the court said, “within the range of acceptable approaches” and
its decision on this was not irrational.
Eisai claimed that NICE had acted unreasonably, and created a discriminatory
effect in its guidance, by its rigid adherence to mini mental state
examination scores as an exclusive test of defining severity of
Alzheimer’s
disease. It was on this ground only that the High Court decided
that the Eisai claim succeeded. |
However,
the court accepted the claim that NICE’s rigid adherence
to mini mental state examination scores as an exclusive test of defining
disease severity was discriminatory against those with problems with
English and learning disabilities. Mrs Justice Dobbs said that NICE had
failed to give proper consideration to its duties to promote equal opportunities
and eliminate discrimination. The court has asked NICE to amend the guidance
to comply with its duties under anti-discrimination legislation.
Commenting on the ruling, NICE chief executive Andrew Dillon said: “Our
guidance stands and the drugs continue to be recommended only for people
with moderate Alzheimer’s disease, but the court has asked us to
clarify our guidance when it is used for certain groups.” He said
it had always been NICE’s intention for people with learning disabilities
or whose first language is not English to have equal access to treatment.
This is the first time a NICE recommendation has faced a legal challenge.
At a media briefing following the High Court’s judgment, Sir Michael
Rawlins, chairman of NICE, said it was “gratifying” to know
that NICE’s procedures met the standards of the High Court.
He
added: “When NICE was first set up my friends told me that we would
be legally challenged within the first 12 months and we’ve gone
eight and a half years before a judicial review. But it may well happen
again. Patient organisations, professional organisations, pharmaceutical
companies, devices manufacturers are all entitled to challenge us; they
have a legal right to do so.”
National dementia
strategy Plans
for the first national
dementia strategy have been unveiled by the
Department of Health. Ministers will publish
the strategy next summer following a 12-month work programme that aims
to increase awareness of dementia in society, ensure early and accurate
diagnosis and improve services so that people with dementia receive
high quality treatment and support. |
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