2 Evidence summaries: new medicines
2.1 Aims
The aim of ESNMs is to inform local planning around the managed use of medicines within a local health system. For the purposes of this interim 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 last 6 months)
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a medicine with an existing UK marketing authorisation which has been recently licensed for a new indication (normally within the last 6 months)
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a new formulation of an existing medicine.
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, involved in local commissioning decisions for planning purposes, for example within a CCG or NHS trust.
Note: there are restrictions on the promotion of new medicines to clinicians before receipt of a marketing authorisation. Information on yet to be licensed medicines can only be provided to clinician for use for planning purposes in their role as commissioners.
2.3 Key activities
The key activities involved in the production of ESNMs are:
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identifying and selecting the relevant and most important new medicines
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summarising the published evidence for selected new medicines
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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 or anticipated licensed indication(s), particularly NICE guidance, where 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 ESNMs.