Cannabis-based medicinal products: clarification of guidance - March 2021
Status of this clarification
1.1 This clarification should be read together with the NICE guideline on cannabis-based medicinal products, first published on 11 November 2019 (“the guideline”). Both the guideline, and this clarification, must be taken into account by healthcare professionals when making clinical judgements, and by NHS bodies.
2.1 This clarification relates to the interpretation of the aspect of the guideline concerned with the use of cannabis-based medicinal products to treat severe treatment-resistant epilepsy in children. (NICE has published separate technology appraisal guidance on cannabidiol with clobazam for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome).
2.2 In every case, healthcare professionals must properly interpret the guideline when making clinical judgements about the use of cannabis-based medicinal products.
Interpretation of the guideline
3.1 The guideline made recommendations for research for the use of unlicensed cannabis-based medicinal products for severe treatment-resistant epilepsy. The committee took the view, based on the evidence available at the time, that there was insufficient evidence of safety and effectiveness to support a population-wide practice recommendation (that is, a recommendation relating to the whole population of people with severe treatment-resistant epilepsy).
3.2 The fact that NICE made no such population-wide recommendation should not however be interpreted by healthcare professionals as meaning that they are prevented from considering the use of unlicensed cannabis-based medicinal products where that is clinically appropriate in an individual case. Patients in this population can be prescribed cannabis-based medicinal products if a tertiary paediatric epilepsy specialist considers that that would be appropriate on a balance of benefit and risk, and in consultation with the patient, and their families and carers or guardian.
3.3 There is no recommendation against the use of cannabis-based medicinal products. For more information about why the committee decided not to recommend against use of these products, see the rationale section of the guideline.
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