NICE refuses GW Pharma’s cannabis-based Epidyolex for treatment-resistant epilepsy
UK-based GW Pharma has suffered a setback in its home country after drug watchdog NICE chose not to recommend NHS reimbursement of Epidyolex (cannabidiol/CBD) in combination with clobazam for people with Dravet or Lennox-Gastaut syndrome (LGS), two forms of treatment-resistant epilepsy.
Despite concluding that the combo therapy effectively reduced the total number of the most prominent seizure types associated with these conditions compared to standard of care, the institute pointed to the lack of definitive long-term efficacy data, given that trial data submitted covered just 14 weeks.
It also voiced scepticism in the reliability of economic models provided by the manufacturer on the drug combo’s cost-effectiveness, arguing that they failed to adequately account for all key aspects that would affect those with treatment-resistant epilepsy and their caregivers and families.
“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,” commented Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE. “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.”
A spokesperson for GW Pharma responded: “We are committed to working with NICE to address the technical questions it has raised, with the aim of ensuring patients can access the medicine on the NHS as soon as possible following regulatory approval. We remain hopeful that NICE will recommend cannabidiol oral solution at the end of its appraisal process.”
The therapy was approved by the FDA in June last year under the slightly different moniker Epidiolex, while EU approval is expected by October this year following a positive CHMP recommendation in July.
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