NICE process and methods
2 Evidence summaries: new medicines
2.1 Aims
The aim of 'Evidence summaries: new medicines' (ESNMs) is to inform local planning around the managed use of medicines within a local health system. For the purposes of this process statement, the term 'new medicines' encompasses these areas:
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a medicine recently granted a marketing authorisation in the UK (normally within the past 6 months)
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a medicine with an existing UK marketing authorisation that has been recently licensed for a new indication (normally within the past 6 months)
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a new formulation of an existing licensed medicine (normally within the past 6 months).
2.2 Key audiences
ESNMs are produced for:
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local decision-making groups involved in commissioning and funding services related to medicines (for example, Area Prescribing Committees)
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local medicines management and horizon scanning services
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clinicians[1], involved in local commissioning decisions for planning purposes, for example within a Clinical Commissioning Group (CCG) or NHS Trust.
2.3 Key activities
The key activities involved in the production of each ESNM are:
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identifying, prioritising and selecting the topic
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summarising the key published evidence
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critically reviewing the strengths and weaknesses of the evidence
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placing the new evidence in the context of the wider evidence base for the licensed indication(s) or anticipated licensed indication(s), particularly NICE guidance, if available
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highlighting any potential implications for local decision-making or clinical practice
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identifying any new evidence relevant to published ESNMs through horizon scanning, reviewing and, if necessary, updating or withdrawing an ESNM.
[1] There are restrictions on the promotion of new medicines to clinicians before receipt of a marketing authorisation. Information on yet-to-be-licensed medicines may be provided to clinicians only for use for planning purposes in their role as commissioners.