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New HTA Decisions in England
December 2019
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 Lennox–Gastaut syndrome in people aged 2 years and older.
Decision Detail
Cannabidiol with clobazam is only indicated if: 1) the frequency of drop 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 2 RCTs: GWPCARE3 and 4. These were placebo controlled, with a follow up of 14 weeks and showed that cannabidiol reduces the number of drop and non-drop seizures when compared with usual care. The economic model provided resulted in an ICER of £33,721 per QALY which is slightly above 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: reducing the number of non-drop seizures, or improving the quality of life of the siblings of people with Lennox–Gastaut 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 Lennox–Gastaut syndrome in the NHS.