Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has undertaken recent research on the use of medical cannabis for the treatment of (a) Dravet and (b) Lennox-Gastaut syndrome.

The National Institute for Health and Care Excellence (NICE) has published technology appraisals recommending Epidyolex, a licensed form of cannabidiol extracted from cannabis, for the treatment of seizures associated with two rare forms of epilepsies, specifically Dravet syndrome and Lennox-Gastaut syndrome, and tuberous sclerosis complex.

Deciding whether to prescribe an unlicensed cannabis-based medicine, a medicine that has not been assessed or approved by the medicines regulator, is a clinical decision, and the funding of medicines within the National Health Service is governed by well-established processes and evidence-based guidelines produced by the NICE. The NICE found that there is insufficient evidence of safety and effectiveness to support a population-wide recommendation in relation to unlicensed cannabis-based medicines for severe treatment-resistant epilepsy. The NICE also calls for further research.

Following the publication of the NICE’s guidance, NHS England and The National Institute for Health and Care Research (NIHR) has agreed funding for two trials relating to the use of cannabis-based medicines for the treatment of difficult-to-treat epilepsies. These will be world-first trials and will be crucial in informing future NHS funding decisions. Due to commercial confidentiality, further information on the trials cannot be released at this time.

Where a treatment is not currently routinely funded by the NHS in England, an NHS clinician can, on behalf of their patient, make an application for funding in exceptional clinical circumstances. This is known as an Individual Funding Request (IFR). In making an application for an IFR, clinicians must demonstrate that the patient in question is clinically exceptional compared to the wider group of patients with the same condition, and is likely to derive greater benefit from the treatment. Each case is assessed on an individual basis, and is not a process the Government can seek to influence.

Until the evidence base improves, prescribers will remain reticent in prescribing, and no decision can be made by the NHS on routine funding. That is why the Government is committed to research and catalysing the generation of evidence to support use of these products.

Like any other area of medicine, manufacturers of these products must invest in research and clinical trials to ensure that cannabis-based medicines are proven both safe and effective before they can be considered for routine funding by the NHS. The NIHR remains open to receiving good quality proposals for research in this area as a priority, and stands ready to support researchers and manufacturers to develop applications.