NICE recommends cannabis based drugs for epilepsy and multiple sclerosisBMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6453 (Published 11 November 2019) Cite this as: BMJ 2019;367:l6453
In final appraisal documents the UK National Institute for Health and Care Excellence has recommended the use of cannabidiol with clobazam for treating seizures associated with two rare and severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.12
The decision comes after NICE initially rejected the use of cannabidiol in draft appraisal documents released in August because of concerns over a lack of data on the drug’s long term effectiveness.3
However, in its latest documents NICE has recommended the drug for people aged 2 or over, reporting that clinical trials had shown that, in comparison with usual care, cannabidiol reduced the number of drop and non-drop seizures and the number of convulsive and non-convulsive seizures.
GW Pharmaceuticals, which markets cannabidiol as Epidyolex, has agreed an unknown discount price for the NHS. England has an estimated 3000 people with Dravet syndrome and 5000 with Lennox-Gastaut syndrome.
NICE recommends that cannabidiol be used as long as the frequency of drop seizures (in patients with Lennox-Gastaut syndrome) or convulsive seizures (Dravet syndrome) is checked every six months and that it be stopped if the frequency has not fallen by at least 30% when compared with the six months before treatment started.
The final appraisal documents are out for consultation until 27 November, and final approval is expected on 18 December.
The documents were released alongside NICE’s final guideline on cannabis based medicinal products.4 In this, NICE also recommends the use of nabiximols for patients with multiple sclerosis. Marketed by GW Pharmaceuticals as Sativex, nabiximols is a mouth spray containing a mix of tetrahydrocannabinol and cannabidiol intended to treat spasticity and spasms in multiple sclerosis.
NICE initially rejected nabiximols in draft guidelines, as it was not a “cost-effective treatment at its list price.”5 However, since then GW Pharmaceuticals has agreed to provide the drug to the NHS through a “pay for responders” scheme, meaning that the company will fund the first three 10 ml vials of nabiximols for each patient and that the NHS will continue funding treatment for patients who experience “at least a 20% reduction in spasticity-related symptoms on a 0 to10 patient-reported numeric rating scale after four weeks of treatment.”
The new guidance advises doctors to offer a four week trial of nabiximols to treat moderate to severe spasticity in adults with multiple sclerosis if other treatments have not been effective. After four weeks the treatment should be continued if the patient has had at least a 20% reduction in spasticity related symptoms (on a 0 to 10 patient reported rating scale).
The treatment should be “initiated and supervised by a physician with specialist expertise in treating spasticity due to multiple sclerosis,” the guideline says.