2 Evidence summaries: new medicines

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:

  • a medicine recently granted a marketing authorisation in the UK (normally within the past 6 months)

  • a medicine with an existing UK marketing authorisation that has been recently licensed for a new indication (normally within the past 6 months)

  • a new formulation of an existing licensed medicine (normally within the past 6 months).

2.2 Key audiences

ESNMs are produced for:

  • local decision-making groups involved in commissioning and funding services related to medicines (for example, Area Prescribing Committees)

  • local medicines management and horizon scanning services

  • 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:

  • identifying, prioritising and selecting the topic

  • summarising the key published evidence

  • critically reviewing the strengths and weaknesses of the evidence

  • 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

  • highlighting any potential implications for local decision-making or clinical practice

  • 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.