“(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 … ” (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.” (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.”
“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.”
“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”
“the SHTAC (AHEAD) model is crude, flawed, uses inadequate data and does not provide an accurate assessment of the costs and utilities associated with AD. In conclusion, the SHTAC (AHEAD) model is not a robust basis for the Appraisal Committee to base their decision.”
“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.”
“there is a difference between the role that we have as ultimately owner of the guidance, and the consultees, who quite properly need to be able to understand why it is we are proposing what we are proposing. The difference is I think important in considering whether or not it is essential, as opposed to desirable, for consultees to have an executable version of the economic models”
“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”
“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.”
“In considering the comments from consultation that suggested an individualised approach to the use of cognition scores for the initiation of AChE inhibitors, the Committee accepted that for specific groups of people with Alzheimer’s disease, such as those with learning disabilities or with marked language problems MMSE scores are difficult to interpret. However, the Committee concluded that these groups were not disadvantaged by the treatment entry level of MMSE. The discontinuation level of MMSE is set by the lowest limit that the Committee considered would normally be interpreted as moderate Alzheimer’s disease; it also reflects the evidence base for the use of AChE inhibitors. The Committee considered that the interests of learning disability patients were best served by including initiation of treatment by learning disability specialists in the guidance. The Committee felt that learning disability specialists were best placed to judge entry and continuation criteria for people with learning disabilities that could be considered equivalent to the general Alzheimer’s population.”
“1.6.2.2 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 FAD has failed to have regard to the Secretary of State’s Directions to ‘attach particular importance to equal opportunities issues both as employer and in relation to guidance it issues.’ The upper treatment threshold disadvantages people with high levels of language skills and education, and the lower limit threshold disadvantages those with learning disabilities, poorer language skills, a first language other than English, a different cultural background and lower educational attainment levels.”
“I would like to come back to my question. I was not clear how you answered Andrew (Stevens). For people who have a score of less than 10, is it possible that you can have a score of less than 10 and still have moderate disease? What you answered earlier was that you didn’t consider people less than 10, because they have severe disease”
“Whether it is helpful for to then write a whole series of additional paragraphs on plausible exceptions, I do not think so, because that would then cross with the problem of how accessible is what we write when we start to have great length on sub clauses”. (247) The question was repeated in a different form. “Just turning to non-first language English speakers, I mean there is clearly a significant population group here who would be disadvantaged by using MMSE. Has the committee had any kind of discussion about how that group might be affected by the guidance, about the effect?”
“This will be a much more universal problem, I recognise with the dysphasia issue and the possible association that would have that is not relevant with dementia, but that is a specific issue. As regards language and the ubiquity of language instruments throughout medical care, we would then be making that kind of exception and making either a recommendation that there was Punjabi or whatever version of the instrument down, but we do not do that or feel the need to do that. That is up for others to use their common sense and to create those alternatives.” (248) The Chairman pointed out that it was a bigger point than just translation: “is it not around how that particular score is validated in a particular population who thinks in a particular way”
“Would the patient continue to deteriorate more slowly than someone not taking the drug, or indeed continue to improve his position. Or would he, at that stage, deteriorate at the same rate, but in the treated patient’s case from a higher base than someone who had started off originally at the same point but had never been treated?”
“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 4.3.2.1 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 …”
“The FAD does not explain the Appraisal Committee’s unqualified acceptance of the data from the controversial AD2000 study”
“did the Appraisal Committee accept the AD2000 study without qualification?”
“ 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.”