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England and Wales High Court (Administrative Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Eisai Ltd. v The National Institute for Health and Clinical Excellence (Nice)  EWHC 1941 (Admin) (10 August 2007)
Cite as:  EWHC 1941 (Admin)
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QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
|- and -
|THE NATIONAL INSTITUTE FOR HEALTH
AND CLINICAL EXCELLENCE
|- and -
|THE ALZHEIMER'S SOCIETY
|1st Interested Party
|- and –
Mr Nigel Giffin QC and Mr Daniel Stilitz (instructed by Beachcroft LLP) for the Defendant
Mr Michael Fordham QC, Mr Tim Ward and Mr Gerry Facenna (instructed by Bindman & Partners) for the 1st Interested Party
Mr Brian Kennelly (instructed by Ashursts) for the 2nd Interested Party
Hearing dates: 25th June to 29th June 2007
Crown Copyright ©
Mrs Justice Dobbs :
The role of NICE
"(1) the Secretary of State directs the Institute to exercise the following functions in connection with the promotion of clinical excellence and the effective use of available resources in the health service:
(a) to appraise the clinical benefits and the costs of such health care interventions as may be notified by the Secretary of State and to make recommendations;
(b) to develop guidelines providing advice on good practice in the management of such diseases and conditions as may be notified by the Secretary of State … "
"(4) In exercising the functions described in paragraphs (1)(a)-(d) and (3) above the Institute shall have regard to the following factors-
(a) the broad balance of clinical benefits and costs;
(b) the degree of clinical need of patients with the condition or disease under consideration;
(c) any guidance issued to the NHS by the Secretary of State that is specifically drawn to the attention of the Institute by the Secretary of State and any guidance issued by the Secretary of State;
(d) the potential for long term benefits to the NHS of innovation."
The status and effect of NICE Guidance and Guidelines
NICE's system of technology appraisals
"If money is spent on donepezil for patients with mild Alzheimer's disease, then that money is not available to spend elsewhere on the treatment of other patients. The role of NICE's appraisal committees is therefore to judge whether the clinical and cost effectiveness of a technology being appraised is such as to justify spending the NHS's money on that technology, rather than on one of the many other technologies competing for the finite resources available."
The Chronology of the appraisal under challenge
THE GROUNDS OF CHALLENGE
1. Procedural Unfairness
"It has to be remembered that consultation is not litigation: the consulting authority is not required to publicise every submission it receives or (absent some statutory obligation) to disclose all its advice. Its obligation is to let those who have a potential interest in the subject matter know in clear terms what the proposal is and exactly why it is under positive consideration, telling them enough (which may be a good deal) to enable them to make an intelligent response. The obligation, although it may be quite onerous, goes no further than this."
and R v Secretary of State for Social Services, ex.p. Association of Metropolitan Authorities  1 WLR 1 per Webster J @4G-H [11a/4/116]:
"In any context the essence of consultation is the communication of a genuine invitation to give advice and a genuine receipt of that advice. In my view it goes without saying that to achieve consultation sufficient information must be supplied by the consulting to the consulted party to enable it to tender helpful advice…By helpful advice, in this context, I mean sufficiently informed and considered information or advice about aspects of the form or substance of the proposals, or their implications for the consulted party, being aspects material to the implementation of the proposal as to which the Secretary of State might not be fully informed or advised as to which the party consulted might have relevant information or advice to offer."
"For the avoidance of doubt, it was correct for you to allow the Institute's appeal before initiating any judicial challenge, and NICE will take no point on delay arising before October 2006"
Given that the decision not to disclose the fully-executable model was one which the Appeal Panel had jurisdiction to hear, it seems to me that it was not unreasonable for the Claimant to take the route of appeal envisaged by the regulations. It is an unattractive argument that the Defendant now advances in light of the concession made in the letter. Moreover, I am not persuaded that the Guidance and the issue of the Model were separate and discrete issues, or that substantial sums of money may have been expended unnecessarily as a result of the challenge not being taken earlier. NICE needed to take into account and respond to the substantial contributions made to the consultation by others even without further representations from Eisai about the Model.
i) the problem was one common to "commercial in confidence" material, where a balance had to be struck: see p.90 line 4 to15; ii) NICE had to respect the IPR concerns of those supplying materials: p.90 line 16 to 22; iii) in making that judgment NICE had to decide whether the conduct of the appraisal is likely to be substantially frustrated by not being able to put material into the public domain: see p.90 line 23 to p.91 line 7; iv) in the case of Models those producing them have indicated they do not wish such to be available outside NICE: p.91 lines 8 to 18. He went on:
"So what we have done is to make a judgment about the extent to which that leaves consultees in the position of being able to understand the nature of the information that the appraisal committee is seeing. It is worth pointing out at this point that typically only perhaps two members of the appraisal committee will see an executable version of the model. In fact the appraisal committee generally does not examine the spreadsheets themselves in any detail. They are briefed on the content and implications of the models by officers inside the Institute…… I quite understand why those consultees who wish to see a copy of the model would like to be able to have an executable version and to run it with different assumptions, to test it in the way that Eisai have described in their document. If there were no restrictions placed by those who produce these models on the way in which we can use them, we would have no objection to models being made available in that form to consultees. But we are not in that position, and we have to deal with the reality of restrictions being placed on them by those who supply them to us."
i) the Claimant was aware at the outset of the consultation of the policy to supply "read- only" models on request. No objection to the principle was raised at the time (See: Guide to the Technology Appraisal Process para 4.4.19 [2/1/18]; see also observations in paragraph 63);
ii) there is no requirement that consultees see every document seen by the decision-maker: Coughlan supra. (This proposition is accepted by the Claimant);
iii) although two members of the Appraisal Committee had had access to the fully-executable version, the Committee's decisions were taken without use of the full model by the 30-strong committee. The evidence reveals that the Appraisal Committee rarely examines the spreadsheets, relying on briefing as to the contents and implications of the Model. [Dillon 7a/33/176/92] In other words, the Claimant was in a position similar to that of the members of the Appraisal Committee;
iv) the nature of the assumptions were at the heart of the Model and these were disclosed to the Claimant;
v) the information disclosed allowed for trenchant criticism of the Model, its approach and system. The Claimant has drawn the attention of the Appraisal Committee to its concerns about the robustness of the system, the sensitivity analyses, the accuracy and reliability of data, etc. As can be seen from paragraphs 50-54 above, the Claimant could and did challenge the validity of the use of a QALY-based model, did criticize its assumptions, features and techniques, and did comment on the overall quality of the Model;
vi) the Claimant had and took the opportunity to suggest alternative assumptions, and gave advice as to what should be done as an alternative approach. The Claimant has also submitted its own model with different assumptions. The opportunity to compare the results of inputs from its own submitted models when used on the SHTAC model was afforded;
vii) at the appeal hearing the Claimant submitted a 13-page document [7a/31/145-157] entitled "Limitations of the SHTAC economic model". Only at one very brief point in the document is there a comment that it is not possible to see precisely how a particular set of adjustments have been made(@163). The rest of the document sets out the limitations of the model and cautions the decision-maker against placing too much reliance on the estimates of cost-effectiveness. The submissions set out why it was not possible to understand the model [115/160] but then set out in great detail, with reasons, why reliance on the Model is perverse. [7a/31/123-5]. These submissions to NICE during the Appraisal and subsequently to the Appeal Panel could not have been made without a good understanding of how the Model worked;
viii) no other body alleged unfairness in relation to the "read-only" version, in particular no other manufacturer, either in the original consultation or at the appeal hearing;
ix) no other consultee has asked for a fully-executable version of an economic model, or complained to NICE during consultation that withholding of the fully-executable Model is unfair.
2) Rigidity of the Guidance and its unlawful discriminatory impact
"It is unclear how the limitations in application and interpretation of MMSE scores have been taken into account by the Appraisal Committee in determining the threshold at which treatment with AChEIs should commence and be discontinued".
The second ground was that "the use by NICE of thresholds for commencement and discontinuation of treatment with AChEIs based on MMSE scores breaches Article 14 of the ECHR".
"2.5 Measurement of outcomes in AD is often subject to interpretation, error and uncertainty, as patients' moods and abilities can vary from day to day, the measuring tools are imprecise, and in some cases the scores rely to a large extent on clinical impression. For cognitive outcome, MMSE (Mini Mental State Examination) scored out of 30 (best) is used. …
2.6 Mild AD is usually associated with an MMSE or 21 to 26. Moderate AD is usually associated with an MMSE of 10 to 20. Severe AD is usually associated with an MMSE of less than 10. The clinical definition of AD severity must also take account of functional disability and social handicaps.
4.3 … The MMSE score is not without problems and reliance on this assessment is difficult in people whose AD is complicated by dysphasia and whose first language is other than English."
"This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgment. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer."
"188.8.131.52 Although it is recommended that acetylcholinesterase inhibitors should be prescribed only to people with Alzheimer's disease of moderate severity, healthcare professionals should not rely on the MMSE score in certain circumstances. These are:
- in those with a MMSE score greater than 20, who have moderate dementia as judged by significant impairments in functional ability and personal and social function compared with premorbid ability
- in those with an MMSE score less than 10 because of a low premorbid attainment or ability or linguistic difficulties, who have moderate dementia as judged by an assessment tool sensitive to their level of competence
- in people with learning disabilities
- in people who are not fluent in spoken English or in the language in which the MMSE is applied."
The need for the extensive quotes above will become apparent in the decision below.
i) whilst accepting that clinicians would read both the Guidance and the Guidelines, and that they were issued on the same day, they are two distinct documents with two very different purposes. The former imposes a duty on the PCTs to fund the drugs for sufferers of moderate AD, the latter does not so bind them. This is an important distinction;
ii) if the two documents were intended to be read together for the purposes of funding requirements, then there would need to be specific cross-reference in the text rather than merely a reference at the back of the Guidance to related guidance;
iii) Professor Stevens would have raised this connection during the appeal hearing if this were the case. Moreover, NICE, in its written submissions to the Appeal Panel, would also have referred to the Guidelines;
iv) that the Guidance and Guidelines should be read together for the purpose of funding is inconsistent with the concern expressed by the authors of the Guidelines about the lack of clarity in the Guidance;
v) separate consultations took place for each document and there is no evidence that there was a physical meeting or a meeting of minds between the two committees. To the contrary, as already indicated, Professor Jones, during the hearing, flagged up the Guidelines Group's disagreement with the Guidance [7b/33/198].
a) "No cumulative benefit"
b) Irrational reliance on flawed AD2000 study
2.33. The Panel was satisfied that the Committee had in fact been very cautious in considering the data from the AD2000 study, and had given it correspondingly reduced weight. The reference in paragraph 4.3.11 of the FAD served to demonstrate that not all the evidence pointed in the same direction, and the AD2000 trial was used as an example". [CB/3/60-1]
Discussion and decision
a) No cumulative effect
"An appeal is not an opportunity to reopen arguments and issues upon which the Appraisal Committee has reached a determination. The Appeal Panel will not substitute its own judgment for that of the Appraisal Committee or look afresh at the evidence submitted to the Appraisal Committee, and will almost certainly not accept new evidence. The Appeal Panel has the restricted role of hearing appeals that fall within one or more of the three strictly limited grounds upon which interested parties may appeal. An appeal on any other ground will not be considered. It is not possible to appeal against the FAD simply because the appellant does not agree with it.
The grounds of appeal are as follows.
1. The Institute has failed to act fairly and in accordance with its published procedures as set out in the Institute's Guide to the Technology Appraisal Process.
2. The Institute has prepared a FAD that is perverse in the light of the evidence submitted.
3. The Institute has exceeded its powers."
"Perversity" is defined at paragraph 184.108.40.206 of the Guide in the following terms:
"To be 'perverse' means to be obviously and unarguably wrong, to be in defiance of logic or so absurd that no reasonable Appraisal Committee could have reached such conclusions. The Appeal Panel will not substitute its own judgment for that of the Appraisal Committee …"
As Dr Lawrence, Chair of the Appeal Panel, remarked in the course of the hearing during a heated debate between experts, "I recognise that there is disagreement in this room but we are not here to resolve that" [7b/33/700217].
b) Reliance on AD2000
Discussion and decision
c) Carer benefits; d) Carer costs
Discussion and decision
c) carer benefits
d) The cost of care
" 3.42 The Appeal Panel questioned why the figure of UK£355/week had been used, and heard that this was the average (NHS/PSS) cost estimate for full time institutional care. In response to comments from the Alzheimer's Society and others following the Assessment Group Report, the figure of UK£520/week was inserted into the model, but this made no difference to outcome in the sensitivity analysis. The Committee had not merely accepted the Assessment Group's costs, but had moved the cost of full time care up and pre full time care down to assess the outcome cost: there was no difference. The base case remained the best case, leading to the recommendation to treat the moderate group. If the base case were adjusted, the incremental cost effectiveness reduced in the mild group, but not sufficiently to bring it within the bounds of acceptable cost-effectiveness.
3.43 The Panel concluded that, in taking the average costs, the figure used in the model was reasonable. Furthermore, if a higher figure was used, there was no difference in outcome, and the recommendations in the FAD would have stayed the same."
Summary of Conclusions