The rapid pace and sometimes confused manner of introduction of new therapies into the National Health Service, and the associated escalating costs, have become problems of increasing complexity in recent years. The Scottish solution, announced in a White Paper in December, 1997, was to create the Scottish Health Technology Assessment Centre (SHTAC) to provide a single authoritative source of advice on the clinical and cost effectiveness of new health interventions. An implementation group was set up to make recommendations as to how the centre should function and its chairman, Dr Angus Mackay, was the speaker at the March meeting of the Royal Pharmaceutical Society's Scottish Department.
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Dr MacKay: not SHTAC's remit to become involved in health rationing |
The SHTAC was being set up with special health board status to:
Dr MacKay stressed that it was not SHTAC's remit to become involved in rationing - "even by stealth". The centre would give advice on cost effectiveness, not on budgetary priority or affordability. It was for health boards and politicians to make decisions as to the availability of a medicine or procedure within the NHS.
He stated that the measures of efficacy, derived from strictly controlled clinical trials, were not always the best indicators of positive outcomes in practice. Further, the patient population in trials was chosen according to strict inclusion criteria. Interventions were often applied far more widely in clinical circumstances.
Dr MacKay suggested that it was more appropriate to apply measures of "effectiveness" based on reliable, patient-oriented outcome measures.
Dr MacKay said that the SHTAC differed from its English equivalent (the National Institute for Clinical Excellence) in that it was totally independent of Government control. The structure of the new body, its exact name and its personnel had yet to be announced, he said. It was likely to comprise a management board of 12 persons supported by a director working with support staff in a core group and an advisory council dealing with issues associated with methodology. Reference groups would assist in giving advice and stimulating debate, while multidisciplinary topic groups would be convened to deal with specific or specialised advice. The health care professions, the drug industry and representatives from patient groups would be involved in the organisation.
Dr MacKay thought that other existing bodies might join the new organisation to produce a widely ranging resource that could respond more quickly and efficiently to the requirements of the rapidly expanding health industry. Getting the necessary evidence of effectiveness and actual costs would be difficult before the intervention had become established in practice.
Furthermore, self-centred or patient-centred doctors who believed that they alone should be the arbiter of whether an intervention should be used without consideration for the wider implications for resources might be a problem, but Dr MacKay said he was hopeful that this potential barrier could be overcome.
The SHTAC was likely to be up and running by July, 2000.
Dr Norman Lannigan (chief pharmacist, Lothian University Hospitals NHS trust) pointed out that the term "effectiveness" was subjective and could have different meanings for different people. Dr MacKay agreed, but proposed that this would not invalidate the suggestion, providing the terms "effectiveness" and "benefit" were based on as wide an interpretation as possible.
Dr MacKay was asked about the possibility of cross-border inconsistencies between decisions taken by the NICE and the SHTAC. He agreed that it was possible that the two centres could come to different decisions and that this could theoretically influence the availability of medicines in Scotland and England. However, he thought this to be rather unlikely. On the contrary, he expected there to be close co-operation between the two bodies.
The danger of denying medication to a particular patient, with possible dire consequences, because the centre had ruled it poor value for money worried one member of the audience. Dr MacKay agreed that this was a possibility, but said that this was inevitable when the NHS was working with a capped health budget that could not accommodate every single health requirement. It was important to do the best possible for the community as a whole.
The subject of "bench-marking" was mentioned. In Canada, a threshold of a Can$20,000 per quality adjusted life year (QALY) had been set for the acceptance of a new intervention. Dr MacKay was asked if a similar criterion might be set. He did not think, he said, that such an intransigent constraint would be applied in Scotland.