Judicial review ruling could slow NICE appraisals Drug appraisals by the National Institute for Health and Clinical Excellence, which govern prescribing guidance in England and Wales, may take longer in the future following what is being seen as a landmark Court of Appeal ruling.
The Court last week decided that NICE was wrong to refuse to publish
the full health economic model that supported its decision over the availability
of Alzheimer’s disease drugs.
Lord Justice Richards, one of three judges sitting in the Court of Appeal,
said: “Procedural fairness does require release of the fully executable
version of the model.”
In the judicial review ruling he said: “It is true that there is
already a remarkable degree of disclosure and of transparency in the
consultation process; but that cuts both ways, because it also serves
to underline the nature and importance of the exercise being carried
out.
“The refusal to release the fully executable version of the model
stands out as the one exception to the principle of openness and transparency
that NICE has acknowledged as appropriate in this context.”
Failure to release the model, he said, puts pharmaceutical companies
at a significant disadvantage if they want to challenge the reliability
of the model.
The judges rejected the reasons given by NICE for not publishing the
model as unsound and of insufficient weight to justify NICE’s position.
NICE had argued that the model should only be available as a read-only
document — which in practice would prevent any drug company adapting
the model for its own analytical purpose — because the information
is confidential and subject to intellectual property rights.
Andrew Dillon: decision will increase complexity of drug appraisals |
After the
ruling, NICE chief executive Andrew Dillon said the decision will “increase
the complexity of our drug appraisals in some cases and they may take
longer as a result”.
He pointed out, however, that NICE’s decision about the availability
of drugs to treat Alzheimer’s disease — that donepezil, galantamine
and rivastigmine should only be available on the NHS for people with
moderate disease — remains.
He said: “The judgment concerns
a small but important step in our process and method for making decisions
on the best way to use new treatments in the NHS.”
Responding to the judgment, Richard Baker, director general of the Association
of the British Pharmaceutical Industry, which supported the appeal lodged
by drug manufacturer Eisai Ltd, said: “Companies will in future
be able to use the same system to judge whether, for example, treating
different groups of patients with a particular medicine might result
in it being more cost effective.”
The judicial review was brought by Eisai Ltd, manufacturer of Aricept
(donepezil). The company was appealing against an earlier High Court
ruling that NICE was right not to release a working economic model that
supported its decision only to recommend donepezil, galantamine and rivastigmine
for people with moderate Alzheimer’s disease.
Nick Burgin, managing director of Eisai Ltd, said: “As soon as
we have reviewed [NICE’s] cost-effectiveness calculations we will
submit any new findings to NICE. We hope that this action will ultimately
restore access to anti-dementia medicines for those patients at the mild
stages of Alzheimer’s disease.”
John Young, managing director of Pfizer Ltd, which supported Eisai's
appeal, said: “The failure of NICE to disclose these fundamentally
important calculations has impaired the ability of stakeholders to engage
fully in the appraisal process in order to provide final guidance that
truly helps budget holders and clinicians make the best quality decision
possible for individual patients.” |
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