NICE to work with GW Pharma on cannabidiol evaluation

Bayer's Vitrakvi ® (larotrectinib) receives first tumour-agnostic licence in EU

NICE has announced its intention to work with 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.

NICE’s draft guidance, also published today, does not recommend cannabidiol (also called Epidyolex and made by GW Pharma) with clobazam for treating Dravet and Lennox-Gastaut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.

The committee noted that the clinical trial evidence shows that cannabidiol with clobazam reduces 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 are for them. However, because the duration of the clinical trials was only 14 weeks, the longer-term effectiveness of cannabidiol with clobazam is uncertain.

The committee also had concerns about the validity of the economic models provided by the company. For example, the committee was not convinced that the models adequately reflect the underlying conditions, nor did the company explore scenarios that allow for the effectiveness of cannabidiol to diminish over time, which is seen with other antiepileptic drugs.

Importantly, the committee concluded that the models may not capture all aspects of severe treatment-resistant epilepsy that are 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 are modelled, and not the effects of reducing other types of seizures.

“Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, 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. Patients, carers and their families deserve no less.”

Cannabidiol is taken orally as a 100 mg/ml solution. It is not yet licensed for use in the UK but based on the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use last month, we expect the marketing authorisation to be granted imminently.

Consultees, including the company, healthcare professionals and members of the public can comment on the draft recommendations via the NICE website until 16 September. All comments received during this consultation will be considered by the committee. The next committee discussion is currently scheduled for 26 September with final guidance expected to be published in November.