Drugs: Licensing

(asked on 19th November 2015) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what discussions he has had with clinical commissioning groups on commissioning of off-patent drugs for use in new indications.


Answered by
George Freeman Portrait
George Freeman
This question was answered on 24th November 2015

NHS England supports the national commissioning system in England, including the provision of guidance to the service, where appropriate.


The National Institute for Health and Care Excellence (NICE) does not routinely appraise drugs outside their licensed indications. Where drugs are not appraised by NICE, it is the responsibility of clinical commissioning groups (CCGs) to decide how drugs should be funded locally, in line with any guidance from NHS England. The Department has produced no guidance and had no discussions with CCGs on off-label drug use.


Many thousands of patients benefit from the use of off-patent drugs, off-label, every day in the National Health Service. NICE publishes Evidence Summaries on unlicensed and off-label medicines. These provide a summary of the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, usually when there is no licensed medicine for the condition requiring treatment or no licensed medicines are appropriate for a significant proportion of people requiring treatment.








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