NICE process and methods
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:
-
a medicine recently granted a marketing authorisation in the UK (normally within the last 6 months)
-
a medicine with an existing UK marketing authorisation which has been recently licensed for a new indication (normally within the last 6 months)
-
a new formulation of an existing medicine.
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 CCG or NHS trust.
2.3 Key activities
The key activities involved in the production of ESNMs are:
-
identifying and selecting the relevant and most important new medicines
-
summarising the published evidence for selected new medicines
-
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 or anticipated licensed indication(s), particularly NICE guidance, where 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 ESNMs.
[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 can only be provided to clinician for use for planning purposes in their role as commissioners.