Update November 2019: The final recommendations have now been published. The following information is about the draft recommendations.
What has happened?
The National Institute for Health and Care Excellence (NICE) have made an initial decision not to recommend prescribing cannabidiol/ CBD (Epidyolex) for people with Lennox-Gastaut or Dravet syndrome.
This is a draft recommendation and not final NICE guidance. This draft recommendation will now go out to consultation before a final decision is made. More information about how you can respond to this consultation is included at the bottom of this page. This final guidance is expected later in the year.
If the draft recommendation does not change, going forward specialist doctors will not routinely prescribe cannabidiol as an add-on treatment for seizures associated with these epilepsy syndromes.
Why have NICE decided not to recommend this medicine?
The committee that has been tasked with evaluating this medicine for NICE highlighted a number of concerns with the evidence that was submitted to them by the manufacturer of the drug, GW Pharmaceuticals.
For instance, the committee acknowledged some high-quality clinical evidence showing that cannabidiol is safe and effective over a short period of time but they did not believe there was enough evidence to show it was effective over a longer period of time.
There were also concerns raised about the accuracy of some evidence provided to the committee by GW Pharmaceuticals and around the cost-effectiveness of the treatment.
What about people who are currently accessing this medicine on the NHS?
NICE have made clear that this draft recommendation is not intended to affect people who have been accessing cannabidiol on the NHS before this guidance was published.
When a final decision has been made, people who are currently accessing cannabidiol on the NHS for severe and treatment-resistant epilepsies should discuss what this means for them with their healthcare professional.
What does Epilepsy Action think?
Simon Wigglesworth, Deputy Chief Executive of Epilepsy Action, said:
“The initial decision of the NICE technology appraisal committee not to recommend cannabidiol/ CBD (Epidyolex) as an add-on treatment for seizures associated with Lennox-Gastaut and Dravet syndromes will come as a major blow to families affected by these severe and debilitating conditions.
“It is particularly disappointing that, despite some high-quality clinical research demonstrating its safety and effectiveness, a number of concerns with the evidence GW Pharmaceuticals put forward in their submission to NICE are preventing it from being routinely available on the NHS.
“These epilepsy syndromes are almost always resistant to the treatments currently available on the NHS. While we recognise the need for rigorous and robust assessments of safety, effectiveness and cost, for many this draft recommendation will be bitterly disappointing.
“It is hard not to look at this decision alongside the recent NICE draft guidelines on cannabis-based medicines. Today’s announcement, coupled with the draft recommendation from NICE not to approve the prescribing of cannabis-based medicines for severe and treatment resistant epilepsies, is leading to a two-tier system for accessing these medicines in the UK.
“Those with the financial means to access these medicines privately will be able to do so. However, many people who can’t afford the high prices of private healthcare will likely have to continue going to drastic lengths to raise funds or ultimately be unable to access cannabis-based medicines. This situation is wholly unacceptable in a country that prides itself on universal free at the point of use healthcare.”
Epilepsy Action will be doing all we can to encourage NICE, NHS England and GW Pharmaceuticals to work together to address the concerns raised with some of the company’s evidence.
NICE have made a statement setting out their commitment to working with GW Pharmaceuticals to address the issues identified with their submission. You can read the statement from NICE in full here.
GW Pharmaceuticals have also provided a statement on this issue:
“We are encouraged that NICE recognises the significant unmet need of patients with Lennox-Gastaut syndrome and Dravet syndrome, and the benefit the cannabidiol oral solution can bring to patients battling these diseases.
“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 decision not to recommend cannabidiol for these epilepsy syndromes is currently open for consultation. This means you can have your say about this decision. You can read the full decision find out how to share your comments on the NICE website. For Lennox-Gastaut syndrome click here and for Dravet syndrome here.
Epilepsy Action will be responding to this consultation and engaging with key stakeholders in the coming weeks.
It is vital for people affected by these epilepsy syndromes that an accurate and detailed assessment of the potential of cannabidiol as an add-on treatment can take place.
Find out more about the recent NICE draft guidelines for other cannabis-based medicines here.