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New HTA Decisions in England
June 2020
Drug name
EPIDYOLEX® (cannabidiol)
Company
GW Pharma
Decision date
11/11/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Epilepsy
Decision
Recommended with restrictions
Indication
Cannabidiol with clobazam is indicated as an option for treating seizures associated with Dravet syndrome in people aged 2 years and older
Decision Detail
Cannabidiol with clobazam is only indicated if: 1) the frequency of convulsive seizures is checked every 6 months, and cannabidiol is stopped if the frequency has not fallen by at least 30% compared with the 6 months before starting treatment; 2) the company provides cannabidiol according to the commercial arrangement. There is a simple discount patient access scheme for cannabidiol.
Summary
Key trials were GWPCARE1 and 2 which were placebo controlled RCTs, both with a follow up of 14 weeks. These clinical trials show that cannabidiol reduces the number of convulsive and non-convulsive seizures when compared with usual care. The economic model provided in the submission resulted in an ICER of £32,471 per QALY which is slightly aboce the NICE threshold for cost effectiveness. However, the cost-effectiveness estimates are uncertain for cannabidiol because of some of the assumptions in the company's model. The cost-effectiveness estimates do not include the benefits of: 1) reducing the number of non-convulsive seizures 2) reducing the duration of convulsive seizures 3) improving the quality of life of the siblings of people with Dravet syndrome. When taking both the uncertainties and the uncaptured benefits into account, cannabidiol is considered an appropriate use of NHS resources, and is recommended as an option for treating Dravet syndrome in the NHS