Epidyolex approved by NICE for reimbursement in UK

The National Institute for Health and Care Excellence in the UK (NICE) has recommended the CBD-based medication Epidyolex for use on the NHS in the UK in Lennox-Gastaut syndrome and Dravet syndrome, two rare, severe forms of epilepsy. Epidyolex received marketing approval for use in the EU in September.

NICE recommends that Epidyolex can be prescribed as an add on treatment with clobazam in patients over two years old and where two or more anti-epileptic drugs (AEDs) have failed to control seizures.

The decision by NICE overrules their initial draft guidance earlier this year, which questioned the cost-effectiveness of recommending the drug for reimbursement by the NHS and also questioned the long-term impact on the use of CBD-based medication. According to BBC reporting, the NHS has agreed a lower discounted price with manufacturers GW Pharmaceuticals. Once prescribed, continued access the drug will depend on the frequency of seizures being reduced by at least 30% every 6 months, compared with the 6 months before starting treatment.

It is important to note that as part of their revised decision, NICE have again pointed to the need for continued research on the long-term impact of CBD based medications. The NICE guidance also only relates to one specific CBD drug which has been through extensive clinical trials and does not change the UK’s position on THC-containing products.

More details on NICE’s decision can be found here.

With regard to the availability of Epidyolex in Ireland, the drug recently received marketing approval by the EU commission. The drug’s manufacturers, GW Pharmaceuticals have - as of this writing - not yet submitted an application for consideration by the National Centre for Pharmacoeconomics (NCPE) in Ireland having previously stated that they would initially focus the launch of the drug in the 5 largest European countries.

We will provide updates on the plans for Epidyolex in Ireland as we receive them.