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What does the final NICE recommendation on cannabidiol/ CBD (Epidyolex) mean for people with epilepsy?

13 Nov 2019

What's happened?

The National Institute for Health and Care Excellence (NICE) has recommended Epidyolex, a purified cannabidiol (CBD) oral solution, for use in the NHS. The recommendation is for two rare and severe epilepsies, Dravet syndrome and Lennox-Gastaut syndrome.

The NICE recommendation means that more people with these epilepsy syndromes will be able to access Epidyolex if other treatments have not worked. Epidyolex has previously been made available on the NHS to a small number of people with these syndromes through an Early Access Programme (EAP).

This announcement follows an earlier decision by the European Medicines Agency (EMA) to license Epidyolex for use in the European Union (EU). The recommendation from NICE means that there is now a process and funding in place to make Epidyolex available in the NHS.

What has NICE said?

In their report NICE highlighted that clinical trial data shows that Epidyolex reduces the number of convulsive and non-convulsive seizures compared to existing treatment options. The cost of this treatment is high but NICE agree that Epidyolex is an appropriate use of NHS resources.

The recommendation from NICE gives more details about when Epidyolex will be considered for use on the NHS:

  • For Dravet syndrome - The frequency of convulsive seizures being reduced by at least 30% after 6 months of treatment when compared with the 6 months before starting treatment. This would be assessed twice a year to make sure that the 30% reduction in convulsive seizures is maintained.
  • For Lennox-Gastaut syndrome – The frequency of drop seizures being reduced by at least 30% after 6 months of treatment when compared with the 6 months before starting treatment. This would be assessed twice a year to make sure that the 30% reduction in drop seizures is maintained.
  • For both - The manufacturer, GW Pharmaceuticals, continuing to provide Epidyolex according to the terms agreed with the Department of Health and Social Care (DHSC) in their commercial arrangement.

Once prescribed, continued access to these drugs on the NHS will depend on:

  • The frequency of convulsive seizures being reduced by at least 30% every 6 months, compared with the 6 months before starting treatment
  • The manufacturer, GW Pharmaceuticals, continuing to provide Epidyolex according to the terms agreed with the Department of Health and Social Care (DHSC) in their commercial arrangement

What does this mean for people who are already accessing Epidyolex on the NHS?

NICE has made it clear that this recommendation will not impact on people who are currently accessing Epidyolex on the NHS, such as those on the Early Access Programme.

This group will continue to access without changes unless a specialist decides there is a reason to stop the treatment.

What does this mean for people with epilepsy?

This decision only directly impacts people affected by Dravet syndrome and Lennox-Gastaut syndrome but it is an important step forward. The debate around cannabis-based medicines for people with epilepsy has been going on for almost two years. Epidyolex has now become the first cannabis-based medicine that has been licensed and recommended for epilepsy in the NHS.

What does Epilepsy Action think?

In response to the NICE decision, Epilepsy Action deputy chief executive, Simon Wigglesworth said:

"NICEs decision means that Epidyolex is now the first cannabis-based medicine to be licensed and recommended for epilepsy in the NHS. Epilepsy Action are delighted that a new treatment option is now available for people with Dravet syndrome and Lennox-Gastuat syndrome, two severe and treatment-resistant epilepsies.

For people affected by Lennox-Gastaut syndrome and Dravet syndrome, the reality of living with these conditions is often incredibly challenging. These syndromes are often treatment-resistant and can cause tens or even hundreds of seizures every day. Any one of these seizures could be life-threatening.

Epidyolex is not a silver bullet. However there is high-quality clinical evidence that this treatment can reduce the number of seizures caused by these epilepsies. As the name suggests, new treatment options for treatment-resistant epilepsies do not come about very often. The decision by NICE to recommend Epidyolex offers a potential way forward for people affected. It's not an overstatement to say that it could be life changing for some."

What next?

The decision to recommend Epidyolex in the NHS represents an important and welcome step for cannabis-based medicines as a potential treatment option for epilepsy.

There is high-quality clinical evidence that this treatment can reduce seizure frequency in people with these specific epilepsies. There is also potential for this treatment to be used for other treatment-resistant epilepsies.

The manufacturer of the drug, GW Pharmaceuticals, is looking into whether Epidyolex could benefit people with West syndrome and Tuberous Scelerosis Complex (TSC). This research is ongoing and is likely to take some time.

People affected by rare and severe epilepsies often struggle to achieve adequate seizure control with existing treatment options. Any new treatment options that are safe and effective are very welcome and we hope the Epidyolex could be beneficial for people with other epilepsies.

Cannabis-based medicines containing THC

Some people affected by rare and severe epilepsies have turned their attention to cannabis-based medicines that also contain THC. This is the compound in the cannabis plant that is linked to users feeling ‘high'.

The recent NICE guidelines on cannabis-based medicines do not make a recommendation about when, where and how drugs containing THC could be made available on the NHS. Instead the guidelines have made a number of research recommendations.

There is a lack of high-quality clinical evidence around medicines containing THC as a treatment for epilepsy. It's clear that more research is needed. There also needs to be a route for people to access these treatments where there is a clear need and where other options, including Epidyolex, haven't worked.

Comments: read the 2 comments or add yours

Comments

These Nice guidelines are in my opinion deliberately narrow to exclude many people with LGS from being prescribed cannabis. My daughter has LGS - at the moment, she is having 282 seizures a month. She has one or two atonic drops a month; the rest are mainly focal seizures followed by tonics and tonic clinics. If she has a focal seizure standing up, she will fall with a risk of head, neck, back and other injuries. She has been to MIUs and A & E countless times for status epilepticus and injuries from falling.

A 30% reduction in atomic drops would be difficult to quantify in her; but a reduction in focal seizures would lead to a massive improvement in the quality of her life and the cost of her residential care of £174,000 pa funded by the NHS CHC, plus the trips to A & E - she has 1:1 care all her waking hours in a specialist epilepsy centre with an on-site medical Centre 24/7, as recommended for epilepsy as severe as hers. She is on three expensive aeds which are already causing osteopenia in her 20s - and we suspect she will have osteoporosis in her 40s!

However, these guidelines will preclude people like her from ever being able to try cannabis!

Submitted by Susan Lyons on

I agree with Susan Lyons: it appears unfair that the somewhat arbitrary threshold of a 30% reduction in atonic ('drop-attack') seizures over a 6-month period may preclude some people with LGS from accessing Epidyolex. Moreover, who is to monitor the frequency of these seizures ? Additionally, is it always possible to distinguish an 'atonic' from a 'tonic-clonic' seizure ? An atonic seizure is usually obvious, it normally happens when a person with LGS is awake and stiffens/falls to the ground. However, many people with LGS also have frequent nocturnal tonic-clonic seizures during sleep - if these seizures happened whilst the person was awake, might we not re-classify them as atonic seizures ? Furthermore, will the arbitrary target not encourage some carers of people with LGS to massage the reporting of seizures in order to qualify for Epidyolex ? Are you really going to disqualify if the figure is say 28% ?

Ken

Submitted by Ken Mullen on
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