NICE drug reviews overhauled to speed up access

NICE will begin publishing assessments of medicines that are not yet available in the UK later this month, in order to help inform commissioners' planning decisions.

Medicines will be assessed by NICE before launch to help commissioners

The move forms part of the institute’s efforts to accelerate patient access to medicines and will be the first time drugs have been assessed before being launched in the UK.

Last year, GP revealed that many PCTs maintain a policy that all newly licensed drugs are added to blacklists until they have been appraised by NICE.

NICE’s evidence summaries for new medicines (ESNMs) for October will include the long-acting insulin analogue degludec. In January NICE will publish an evidence summary about the once-daily glucagon-like peptide-1 receptor agonist lixisenatide. Neither degludec nor lixisenatide has yet been launched in the UK.

NICE has also issued its first recommendations this week as part of its review on the use of unlicensed and off-label medicines. The first topic covered as part of these reviews is the use of tranexamic acid for significant haemorrhage following trauma.

A NICE spokesman said ESNMs summarised evidence on new medicines considered to be of significance to the NHS and would be a useful resource for commissioners.

‘Topics for ESNM will be considered either at the point of product launch, or up to 12 months in advance of launch,’ he said. ‘The strengths and weaknesses of the relevant evidence will be critically reviewed within this summary.’

He stressed that ESNMs would not constitute formal NICE guidance and this would be clearly stated on each publication.

‘There are restrictions on the promotion of new medicines to clinicians before receipt of a marketing authorisation,’ he said. ‘The information in our ESNMs on drugs that are still awaiting UK marketing authorisation is provided to clinicians for use for planning purposes in their role as commissioners.’

A spokesman for Sanofi, which manufatures lixisenatide, said the company was 'content' to work with NICE's medicines and prescribing centre (MPC) on the evidence summaries.

'We have worked with National Prescribing Centre (predecessor to MPC) for many years on this type of early product summary,' he said.

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