Medicinal Cannabis – approved for NHS use

Two cannabis based medicines have now been approved for use by the NHS in England following new guidelines from NICE.

Background

In November 2018, the law governing medicinal cannabis underwent an overhaul; for the first time in the UK's history it was legalised (albeit in very specific circumstances).

Whilst this change in the law was celebrated by many, in the year that has since passed, only a handful of patients have actually benefitted. Our February blog considered some of the reasons behind this, including: prescribing issues; cost; and availability.

Where are we now?

Just this month, two cannabis based medicines, Epidyolex (for epilepsy), and Sativex (for multiple sclerosis), have been approved for use by the NHS in England, following new guidelines from NICE. Doctors will now be authorised to prescribe these drugs to patients - albeit, again, in certain situations and for specific conditions.

Epidyolex

For children with Lennox Gastaut syndrome and Dravet syndrome (two types of severe epilepsy), a prescription for Epidyolex may now be accessible.  

Clinical trials have shown that the oral solution, which contains CBD (cannabidiol), could reduce the number of seizures in some children by up to 40%.  Given the number of people said to be suffering with these syndromes (5,000 and 3,000 respectively), this drug may offer much needed relief to a significant number of children.

Epidyolex has been approved for use in Europe since September but, in its draft guidance, NICE concluded that it did not offer 'value for money' (it costs between £5,000 and £10,000 per patient, per year). Now, however, the manufacturer, GW Pharmaceuticals, has agreed a discounted price with the NHS.

Sativex

Unlike Epidyolex (which contains only CBD), Sativex combines CBD and THC (Tetrahydrocannabinol – the main psychoactive component in cannabis), and has been approved for treating muscle stiffness and spasms in adults in multiple sclerosis. Doctors will not be able to prescribe it to treat pain.

Sativex was the first cannabis based medicine to be licensed in the UK after clinical trials, and has been available on the NHS in Wales for over five years. At that time, regulators in England said that it was not cost effective; that decision has now been reversed.  

Public Response

Many are delighted with this announcement. Professor Helen Cross, a consultant in paediatric neurology at Great Ormond Street Hospital, who led UK trials of Epidyolex said it was "great news". She explained that the syndromes are "both complex difficult epilepsies with limited effective treatment options and this gives patients another option… that could make a difference to care."

There have been some responses, however, expressing concerns. Many parents are paying substantial sums for medicines containing both CBD and THC, which are being imported from Europe and Canada, and are disappointed that NICE not has not approved any cannabis based medicines for childhood epilepsy that contain both components. Mille Hinton, spokesperson for campaign group End Our Pain has said: "This restrictive guidance is condemning many patients to having to pay for life-transforming medicine privately, to go without or to consider accessing illegal and unregulated sources."

What Next?

Legal developments a year ago promised change. It is clear that advancements in this (controversial) area are slow and incremental in nature; whilst the legalisation of medicinal cannabis is undoubtedly a positive step for UK medicine and law, it is likely to be some time until the benefits are felt by the majority of patients.

And what next? It is hoped that with ongoing clinical trials, increased data, and perhaps, further public pressure, opportunities to use UK cannabis based medicine will make further strides forward. How long that might take is an entirely different question.

In November 2018, the law governing medicinal cannabis underwent an overhaul; for the first time in the UK's history it was legalised (albeit in very specific circumstances).

Whilst this change in the law was celebrated by many, in the year that has since passed, only a handful of patients have actually benefitted. Our February blog considered some of the reasons behind this, including: prescribing issues; cost; and availability.