Drug for treating epilepsies not approved

Author: Adrian O'Dowd

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Drugs watchdog the National Institute for Health and Care Excellence (NICE) is to seek more assurances from a drug firm before it approves use of cannabidiol for treating difficult to control epilepsies on the NHS.

NICE said it would work with drug company GW Pharma to address the issues highlighted by its independent appraisal committee in its evaluation of cannabidiol for treating two types of severe treatment-resistant epilepsy.

In draft guidance published at the weekend, NICE does not recommend the drug (also called Epidyolex and made by GW Pharma), used with clobazam, for treating Dravet and Lennox-Gastaut syndromes, types of epilepsy which begin in early childhood and which are lifelong and difficult to control.

In England it is estimated there are around 600 people with Dravet syndrome and around 4,000 people with Lennox-Gastaut syndrome.

The appraisal committee noted that the clinical trial evidence showed that cannabidiol with clobazam reduced the number of the main types of seizures associated with these conditions compared with usual care with anti-epileptic drugs, and heard from patients and their carers how important these benefits were for them.

However, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of cannabidiol with clobazam was uncertain, said NICE.

In addition, the committee had had concerns about the economic models provided by the company.

Committee members concluded that the models may not capture all aspects of severe treatment-resistant epilepsy that were important to people with these conditions, and to their carers and families.

For example, only the effects on health-related quality of life of reducing the number of main types of seizure were modelled, and not the effects of reducing other types of seizures.

Meindert Boysen, director of NICE’s Centre for Health Technology Evaluation, said: “The often distressing and life-limiting nature of these very difficult to control epilepsies mean that we should all welcome new treatment options. Cannabidiol is a promising treatment for people with these types of epilepsies.

“Even though the committee accepted that the evidence shows that cannabidiol with clobazam reduces seizure frequency, its long-term efficacy is unknown, and the committee was not convinced about the way the company had modelled the effect on people living longer or having a better quality of life.

“Based on the evidence presented to it, the committee could not recommend cannabidiol with clobazam as an effective use of NHS resources.

“However, we are committed to working with the company to resolve the economic modelling issues identified by the committee, and to help them understand what they may need to do to mitigate the cost of cannabidiol to the NHS.”

Responses to the draft guidance can be made via the NICE website until 16 September.

The next committee discussion is scheduled for 26 September with final guidance expected to be published in November.

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