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Aspects of implementing a policy of 'managed entry' for new drugs
The Department of Health has implemented, with varying degrees of success, several cost-containment, or control, measures acting on, both the supply and demand for, drugs prescribed by NHS doctors. In 1994, the NHS Executive introduced the concept of 'managing the entry' of new drugs when it advised Health Authorities in EL(94)72 to 'develop an authority-wide policy for the managed entry of new drugs into the NHS'. The documents offered no further guidance regarding exactly what it meant by 'managed entry' or how the concept was to be operationalised. Managed entry has never been defined clearly or evaluated explicitly but there is an implied acceptance that it is worthwhile. The aim of this study is to describe how decision-makers interpreted the 'managed entry' of new drugs in England and Wales at Health Authority and NHS Trust level. A national postal survey was sent (in June 1998) to decision-makers based in Health Authorities (pharmaceutical advisers n=120) and NHS Trusts (chief pharmacists n=272) involved in the introduction of drugs into practice. They were asked 'How would you define the concept of managing the entry of a new drug into the NHS?' The key themes in the responses to this open question were identified and coded. All coding was checked for consistency by a second researcher (inter-coder reliability). The response rate for Health Authorities was 47% (n=56) and for NHS Trusts 57% (n=155). The majority of respondents were able to describe their interpretation of the concept of managed entry but 14% of Health Authority and 7% of NHS Trust respondents, did not. Key components were characterised in respondents' interpretations:
However, there was no common approach to the implementation of managed entry and the processes involved in selecting, evaluating and introducing new drugs were highly variable. This national survey suggested that individual approaches to managed entry have been developed. The implementation of managed entry by local decision-makers can not be graded as 'good' or 'bad' because there was no 'gold standard' with which to compare. However, two key observations can be made i) the term 'managed entry' was a misnomer. It was more appropriate, using the study respondents' interpretations of the concept, to describe the policy, in the manner it has been implemented, as 'managed exit' from practice i.e. non-adoption. ii) one implicit aim of 'managed entry' was to achieve 'cost-minimisation' and reduce expenditure on drugs. The focus, in some cases, was on the acquisition costs of drugs rather than considering the wider service implications of a new therapy. We suggest that, before decision-makers embark on a 'managed entry' policy, they must identify the objectives they hope to achieve and how they intend to operationalise the concept. Presented at the HSRPP Conference 2001, Nottingham
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