The activities of the National Institute for Clinical Excellence were discussed at a meeting in London on January 12 organised by the Pharmaceutical Times
The National Institute for Clinical Excellence should eliminate the "postcode prescribing" of new, expensive treatments that has occurred with some products recently (eg, donepezel), the institute's chairman, Professor Sir MICHAEL RAWLINS, told the meeting.
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Michael Rawlins: the NICE will eliminate "postcode" prescribing |
He stressed that the NICE could not commit the Government to spend money; it could only offer guidance. It weighed the cost-effectiveness and clinical-effectiveness of various health technologies. If the advice it offered could lead to a considerable increase in NHS expenditure, funding for this had to be a political decision.
The NICE expected that its guidance would form the second most important element in determining what hospitals had to spend their money on. (The most important category was salaries and related costs.)
The uncertainty and strategic options for industry were outlined by Professor TONY CULYER (head, department of economics and related studies, University of York, and deputy chairman, NICE). He stressed that there was no hidden agenda to which the institute was operating. From its first days, it had attempted to be open and transparent in its activities, as witnessed by its detailed website (www.nice.org.uk), which even published provisional minutes of board meetings, and the comprehensive membership of its partners council. He stressed that developing the institute's operations represented an opportunity for partnership and participation, especially as its staff did not have all the answers - yet!
Outlining what cost-effectiveness meant, Professor Culyer emphasised that it was not the same as "safe", which was for others (eg, regulatory authorities) to determine. "Effectiveness" was a measure of the ability of the technology to work under normal practice conditions, and was distinct from "efficacy", which was the use of the technology under controlled conditions.
"Cost-effectiveness" answered the question: "At what cost does the technology achieve its outcomes relative to plausible substitutes?" The appraisal process was multidisciplinary (including economics, epidemiology, and statistics), and it was already a major part of the NHS research and development programme. It was vital that companies became acquainted with the basis of technology appraisal and health economics and had staff who were well versed in both.
However, there was an overall shortage of people with the appropriate epidemiological and economic skills. As a result, the institute would be contracting with university researchers to conduct its appraisals. Some companies would elect to have in-house teams of people with the requisite skills; other would rely on contracts with external organisations. It was not sufficient just to have the staff and to set them to work on the evaluations. There needed to be managerial capacity to exercise quality assurance, and to engage in effective contracting and performance monitoring and evaluation of those contracted to do the work.
Discussing the training implications for industry, Professor Culyer said that a culture change would be required in many companies (eg, including economists among clinical researchers). The types of training required could include: senior management training in strategic development of company-NICE relations; training for senior management in strategic management of the research groups carrying out cost-effectiveness analyses; middle management training for recruitment and day-to-day management of research groups; and clinical and economic training for technical staff.
Industry could make an important contribution to shaping the methodology of appraisals and clinical guidelines. Industry experts would be included in the various ad hoc seminars being arranged by the institute for development of its methodologies. Equally, industry experts should engage in discussions with academic professionals in relevant technical and academic journals. Industry could also form strategic alliances with selected academic groups having developmental skills.
The possible conflict of interest that could arise between clinicians conducting the appraisal and those evaluating the appraisal was raised. It was stressed that the same people could not participate in both activities.
The objective of meeting the NICE's requirements by health economics evaluation was reviewed by Dr PETER WEST (York Health Economics Consortium). He indicated that the United Kingdom had only about 350 health economists, of whom most were in the NHS and universities. The number in the pharmaceutical industry was growing, and a small group of specialist consultants also existed.
One of the most important types of health economic evaluation was cost-impact assessment. This involved determining: the cost of the new technology to the NHS, the patient and the community; the savings that would be made in resources (including money, time and facilities); and the real changes in resources that would be derived at the sharp end of practice. One way of obtaining these data was the cost-utility study - a measure of the cost per unit health gain. However, welfare improvement was a more all-encompassing term than health gain, relative to the cost.
The NICE required four types of data: the NHS cost impact; the NHS/patient/social cost impact; cost-effectiveness; and cost utility. The studies required to generate this data had different time-scales for their completion and varied in their breadth and complexity. Ideally, the data should be collected at the same time as the clinical trial data. In reality, the clinical trial might have been completed without the economic data, and the trial might give an unrepresentative picture of resource use. The key components of the data were: recognised quality of life measure; estimate of resource use, unit costs, and what had to be done to release the resource; incremental and marginal costs and benefits; cost-effectiveness ratios; discounting of future gains and costs; and sensitivity/uncertainty analysis.
Dr West added that, despite concerns expressed by industry, health economics support was available and something could be achieved with even only limited data.