Eisai Ltd v NICE (Interested Party The Alzheimers Society) [2007] EWHC 1941 (Admin)

This was a challenge to NICE guidance which restricted the availability of new Alzheimer’s drugs to those with moderate (but not mild) Alzheimer’s disease.  NICE issues guidance to the NHS which contains “recommendations” as to the circumstances in which a particular treatment should be given or the particular patient group for whom it should be prescribed.  The Secretary of State for Health has directed that the NHS make the necessary funding available for all treatments recommended by NICE.  Therefore if a drug treatment is not recommended by NICE its availability becomes severely restricted.  NICE has adopted a detailed process known as Appraisal for developing its recommendations to the NHS.  It involves a series of reports, consultations on those reports and deliberations by NICE committees.  The final stage is an Appeal stage and involves a reconsideration of a proposal to which consultees, identified by NICE, may objected.  In this case, the claimants (E) a drug company and the Alzheimers Society, were both consultees. 

NICE have a concept for putting a value on the improvement in patient quality brought about by a particular technology or treatment.  This concept is known as the ‘cost per quality life adjusted year’ or QALY.  E had developed drugs known as inhibitors for the treatment of mild to moderate Alzheimer’s Disease.  The High Court stated that the effect of the drugs, though not a cure, did alleviate or postpone symptoms for a limited period for some sufferers.  For those patients for whom the drug did work it was a “god-send”. 

The conclusion of the Assessment report by NICE was that the cost per QALY was well above the fundable range of treatments.  The report was sent out to consultees to comment together with a partly executable version of the model used to arrive at the cost per QALY.  In light of comments received, the cost per QALY was reduced.   However, in its Appraisal Consultation Document, NICE recommended that due to the high cost of the drug it would not be recommended for any patient group.  In its response to this document, E requested a fully executable version of the model used by NICE to appraise the inhibitors.  NICE refused to comply with this request.  A further suggestion from a patient consultee group was that if the treatments were only targeted at the relatively small number of patients who did respond to treatment then the drug could be more cost-effective.  Further adjustments were made by NICE and it was decided that the drug would be made available to patients with moderately-severe (as opposed to mild) Alzheimer’s Disease.  This remained the position in NICE’s final determination.  A number of consultees appealed against that determination but all were rejected and the decision became that basis for guidance to the NHS.  

E claimed judicial review of NICE’s decision and the Alzheimer’s Society appeared as an interested party. 

The High Court held that it was not necessary for E to be in possession of the fully executable model used by NICE in order to tender helpful advice during the consultation exercise.  The consultation had been carried out fairly and E had every opportunity of putting forward suggestions and concerns in light of what it was able to observe. 

E had also argued that the NICE guidance was flawed since it relied exclusively on the Mini Metal State Examination (MMSE) for determining whether a person’s Alzheimer’s was moderate.  The test was language-based and thus argued E, constructed in a way that disadvantaged persons with learning disabilities and those with limited English language skills.  E also pointed out that in earlier NICE guidance, it had acknowledged that a blanket application of MMSE tests could lead to inaccurate diagnoses.  The test might be inaccurate if used with Alzheimer sufferers with “functional disability” or “social handicap” whose first language was not English.  Such cautions were absent from the 2006 guidance. 

E claimed that NICE had

(1)  Failed to comply with s71 Race Relations Act 1976 to have “due regard” in carrying out its functions to the need to “promote equality of opportunity” between persons of different racial groups and
(2)  Failed to comply with its duty under s49A of the Disability Discrimination Act 1995 to have due regard, in carrying out its functions, to the need to promote equality of opportunity between disabled persons and other persons “the need to take steps to take account of disabled persons disabilities”. 

The High Court found that there was no discussion by NICE about its legal duties under equalities legislation despite matters having been drawn to its attention by consultees.  This reluctance stemmed from the misguided belief that it would make the Guidance too complicated and that diagnostic difficulties amongst atypical groups could be left to the common sense of practitioners.  As a result NICE failed to comply with its duties under the relevant legislation.
Comment

NICE have since reconsidered its Guidance in light of this decision which can be found at  http://guidance.nice.org.uk/cg42/?c=91523

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