The
Pharmaceutical Journal Vol 266 No 7134 p196-197
Drug utilisation research groupPrescribing in the consumer age
The United Kingdom Drug Utilisation Research Group held its 12th annual meeting at the Royal Society of Medicine, London, on December 15, 2000. Speakers reviewed the issues surrounding prescribing for patients in a consumer age |
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The NICE |
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The impact of a new medicine on an individual’s health must not be undervalued, said Mr MICHAEL BAILEY (immediate past president, Association of the British Pharmaceutical Industry). The targets set in the National Health Service plan relied heavily on modern medicines and such drugs brought great benefits to the quality of life of patients. Mr Bailey pointed out that the cost of NHS medicines made up only 12 per cent of NHS costs with 60 per cent of medicines costing less than the current prescription charge. But, for a new medicine, the cost to the pharmaceutical industry might be £350m and 12 years of research and development. The increasing pace of science had led to increased competition. Now, when a new product came on to the market, there could be second and third followers in only one to two years. And these subsequent entries would be marketed at lower prices. In the United Kingdom, generic prescribing accounted for over 60 per cent of prescribing. Generic usage was the highest and generic pricing the lowest in Europe, so, on the whole, the NHS got a good deal, said Mr Bailey. The branded medicines bill was going down and with the generic pricing rises being addressed, the medicines bill would again represent good value for money. With the European Community encouraging free movement of goods, parallel trade was increasing. Price controls in the pharmaceutical industry were incompatible with such free movement and meant sales and investment would be driven from the UK. A legal solution to the problems created by parallel imports was needed, he said. Commenting on the issue of patient information, Mr Bailey said that the pharmaceutical industry wanted the opportunity to put out factual, balanced information to patients about the treatments they received but that current regulation restricted this. The NICE
The objectives of the National Institute for Clinical Excellence (NICE), such as faster access to modern treatments, were supported by the pharmaceutical industry, but the current NICE process could not deliver these objectives. The selection process was neither transparent nor inclusive and there was a problem with confidentiality. Having the evaluation process in the public domain was not helpful and the early release of NICE proposals had had an impact on the perception of products. This was especially problematic if the decision changed. "Bad news lasts longer than good news," Mr Bailey said. He also pointed out that negative decisions were
implemented quickly but that positive decisions still faced problems because
of cost implications. Balancing costs
Professor MIKE DRUMMOND (director, centre for health economics, University of York) said there was now a formal role for economic evaluation in health care. Worldwide, the pharmaceutical industry was increasingly required to provide economic submissions when its products, which governments would be paying for, were evaluated. There were practical difficulties in deciding what constituted good value for money. When looking at costs and benefits, from whose point of view did one look? Costs borne by the family or employer were not the NICE’s primary consideration and a case had to be made for them. And, should economic studies be based on clinical trials, which were often not realistic, or on models for which assumptions had to be made? Being cost effective was not always enough and overall affordability was usually taken into account. Separating value for money and the size of the patient population was difficult, so expensive therapies were more likely to be thought of as reasonable if the patient population was small. A survey of decision makers in the NHS had highlighted barriers to the use of economic evaluation. Difficulties in moving resources from secondary to primary care and tight budgets meant money could not be freed easily. There was a feeling that the Department of Health was only interested in cost containment rather than cost effectiveness. Taking a long-term view when it was this year’s budget that was important was also difficult. Some of the results of the survey had been worrying. As expected, most NHS decision makers looked at acquisition costs when considering the value for money of a particular therapy. However, only about half those questioned would consider purchasing a more expensive drug if savings could be made outside of the hospital or even in other areas of the hospital. Professor Drummond pointed out that the UK was wealthy
enough to pay for new health technologies. "It is not a question
of can we pay but do we want to pay." Informed patientsGiving the patient’s perspective on prescribing, Mr PETER CARDY (chief executive, Multiple Sclerosis Society) said that the Medicines Control Agency and the European Medicines Evaluation Agency had little room in their evaluations for patients’ views. The process of licensing new medicines involved impressive research into safety and efficacy but questions about whether a product really mattered to patients or whether the consequences of its use were regarded as insupportable by patients were not asked during this process. However, the idea that it did not matter what patients thought about drugs was changing. Very few prescriptions were now dispensed without a patient information leaflet and the MCA’s website now included some details of licensing decisions. Until recently, patients and the public had not been able to find out anything about the licensing process for new medicines. Such secrecy, which could be argued to be beneficial, was probably only of benefit to organisations, not to patients. Lack of education in science meant that, even if information was available, the public would find it hard to interpret. In addition, the patient’s perspective was often ignored when considering the design of clinical trials. It was the exception rather than the rule that companies asked patients what their priorities were. "The danger is, of course, that companies might find out that patients do not actually want their product," he said. Interpreting results from randomised, controlled trials (RCTs) which were often held under artificial conditions was difficult. Evaluations of new drugs were usually based on results from trial data not on real clinical experience and a "modest benefit" shown in an RCT might represent a huge change in real life. Mr Cardy pointed out that little reference was made to patients’ experiences in medical journals. The Drug and Therapeutics Bulletin routinely made no reference at all to patients and was, paradoxically, produced by the Consumers’ Association. Patients’ opinions were often described as anecdotal and although they did not constitute an RCT they could be collected and evaluated. Did it matter what patients thought? They were not true consumers in the NHS as they did not have the ultimate choice about what was prescribed or purchased on their behalf. But to ignore what patients had to say was to ignore vital information, he said. It was important to find appropriate and systematic ways to understand the views and priorities of patients and the public to improve planning, appraisal and licensing as well as compliance/concordance. Reflecting contemporary opinion about the role of the patient in the management of health and disease was also necessary. The supply of information to patients and to the
public was increasing. The pharmaceutical industry recognised the power
of informed patients and was finding new ways to educate them. Mr Cardy
accepted that public opinion would be open to distortion but welcomed
the contribution of the pharmaceutical industry to the education of patients.
The NHS had to sort out its thinking as it wanted the pharmaceutical industry’s
money and information but was very distrustful of its motives, he said. Judicial reviewGovernance could give a more uniform expectation of the NHS, said Mr CHRISTOPHER NEWDICK (barrister and reader in health law, University of Reading). In the past, the public had accepted a fragmented service. Organisations, such as the NICE and the Commission for Health Improvement, and national service frameworks were all seeking to reduce variations in service and to improve the knowledge base. The duty of promoting a comprehensive health service lay with the Secretary of State but this function was delegated to local health authorities. It was not only the control of budgets that was delegated but also power which allowed health authorities to make priority decisions. Something had changed in the willingness of law courts to make health decisions and even when a judicial review was successful the ultimate power still remained with the local health authority. There was no right to resources; there was just the right to have the decision looked at again. In primary care, treating a patient on the basis of clinical need was a general practitioner’s duty. There was a dual duty in terms of the general population but in the GP’s terms of service only a duty to the individual was specified. Political pressure to keep this duty to the individual in place existed but it highlighted the limitations of those at the top to dictate to those at the bottom. When Frank Dobson (former Secretary of State for Health) issued a letter to health authorities and GPs to tell them not to prescribe Viagra (sildenafil), the manufacturer, Pfizer, asked whether this was lawful. Telling GPs not to prescribe the drug was telling them not to prescribe on the basis of need. Mr Newdick pointed out that the concerns of the Secretary of State had been reasonable but what he had done was unlawful. How did the NICE fit into the structure? The NICE
was empowered to give guidance but this was not direction, said Mr Newdick.
Health authorities and primary care trusts had a duty not to exceed budgets
and although guidance had to be taken into account when making decisions,
health authorities were not obliged to follow the guidance. The Government perspective
Mr ANDY McKEON (head of medicines, pharmacy and industry division, Department of Health) told audience members that guidance issued by the NICE should be treated with great respect. If guidance was departed from then there had to be good reason, and health authorities would have to justify their policies. Commenting on the issues of fairness and value for money, Mr McKeon said that policies needed to be fair to both individuals and to society as a whole. The national press concentrated on the issue of postcode prescribing but the real challenge was "postcode treatment" and standards of quality of care. The NICE’s guidance programme would have more impact on quality of care than on postcode prescribing, he said. In terms of accessibility of treatments, prescribing routes had been steadily widened through patient group directions and nurse prescribing, said Mr McKeon. An excellent network of community pharmacies was in place but was access good enough out of hours? The introduction of e-pharmacy and electronic transfer of prescriptions would help to improve access to treatments. The least studied area of prescribing practice was
probably patient satisfaction and outcome. The Government would be putting
substantial effort into the medicines management initiative to improve
compliance and concordance. The act of prescribing was only the start
of the story, not the end of it, and there was a need to ask patients
what they wanted from a drug. Discussion
In the discussion that followed, the speakers were asked to comment on the problems associated with media attention surrounding the introduction of a new drug which could result in "everyone wanting it!". Mr BAILEY said that it was important that patients
had choices and that they were informed about their choices. Mr NEWDICK
commented on the difficulty in disentangling values from facts and said
that the NICE would do this. Mr McKEON pointed out that as a consequence
of NICE guidance, allocations to health authorities had gone up as had
expenditure on new medicines. This was a "funny sort of rationing",
he said. |