Two Cannabis-based Medicines Approved in the UK
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Two cannabis-based medicines have been approved for use by the National Health Service (NHS) in England, after the issuance of new guidelines from the drugs advisory body the National Institute for Health and Care Excellence (NICE).
The medicines, both produced by the British company GW Pharmaceuticals, are designed to treat spasticity in people with multiple sclerosis (MS) and seizures in two rare forms of epilepsy.
The decision by NICE to recommend the two medicines for NHS funding will come as a surprise to many, after an August report from NICE concluded that evidence supporting medical cannabis as a treatment for epilepsy was “limited and of low quality,” and that cannabis for MS-related spasticity was “not a cost-effective treatment.”
Epidiolex finally recommended after initial rejection
Epidiolex is an oral solution of purified cannabidiol (CBD) that is believed to have good anti-epileptic effects. It was initially rejected by NICE for approval in August, though the rejection was just a draft decision.
Following further negotiations and the drug receiving approval from the European Commission in September, NICE has now recommended that Epidiolex be funded for NHS funding as a treatment for Lennox-Gastaut Syndrome and Dravet Syndrome – two rare forms of epilepsy.
The drug received approval from the US Food and Drug Administration for use in America in June 2018 – also for the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome – following several randomized, double-blind, placebo-controlled clinical trials covering over 500 patients that found Epidiolex to be effective in managing seizures and improving patients’ overall quality of life.
However, recently the effectiveness of Epidiolex has been called into question, after questions were raised over whether the anti-epileptic effects observed in the clinical trials were actually caused by other medications. Authors of a new study believe that the reduction in seizure frequency should be attributed to clobazam, a common anti-epileptic drug that was also administered to a number of patients in the trials.
“I'm not saying that I know for a fact that cannabidiol does not have any anti-epileptic effects,” Geert Jan Groeneveld, the lead author of the new study, told Analytical Cannabis. “What I am saying is, I can explain the effects that [the clinical trials] observed through elevated blood levels of clobazam.”
Despite the questions over the drug’s true efficacy, many have welcomed the new NICE guidelines on Epidiolex.
“Many families come to us asking about the potential of cannabis-based medicines, particularly cannabidiol, and we are thrilled that one is now available on the NHS,” Galia Wilson, chairwoman of Dravet Syndrome UK, told BBC News.
Sativex also recommended for funding
Regulators have approved Sativex since 2010, but the drug was excluded from previous funding guidelines as it wasn’t considered cost-effective.
NICE have now included the drug – which is 1:1 blend of CBD and tetrahydrocannabinol (THC) administered as an oromucosal spray – in their new funding guidelines and in a guideline on cannabis-based medicinal products, recommending it for use in treating spasticity in people with MS.
Like Epidiolex, Sativex has been proved effective in numerous clinical trials. In these trials, Sativex was administered in conjunction with patients’ existing medications and was seen to significantly improve patients’ numeric rating scale, spasticity score, and spasm frequency over and above the effect seen with the patients’ existing treatments.
Sativex was developed by GW Pharmaceuticals and marketed in the UK by Bayer, and following both companies working with NICE, they say they were able to demonstrate the value of the drug to the advisory body.
The drug was previously approved by the All Wales Medicines Strategy Group (AWMSG) and has been available on the NHS in Wales since 2014.
What has been the reaction?
Overall, the news of the two cannabis-based medicines securing NHS funding has been warmly welcomed.
Professor Helen Cross, a consultant in pediatric neurology at Great Ormond Street Hospital, who led UK trials of Epidiolex, told the BBC that the new guidelines were “great news.”
"Dravet and Lennox-Gastaut syndromes are both complex difficult epilepsies with limited effective treatment options and this gives patients another option … that could make a difference to care," she said.
Despite their praise of the guidelines, for many medical cannabis campaigners and medical charities groups, the new guidelines do not go far enough.
Millie Hinton, of the medical cannabis campaign group End Our Pain, told the Guardian that the new guidelines were “a massive missed opportunity” to provide medical cannabis for a wider range of conditions.
“It is particularly devastating that there is no positive recommendation that the NHS should allow prescribing of whole-plant medical cannabis containing both CBD and THC in appropriate cases of intractable childhood epilepsy,” she said.
“It is this kind of whole plant extract that has been shown to be life-transforming for a significant number of children, including these involved in the high-profile cases of last year which led to medical cannabis being legalized,” she added, in reference to the campaigns led by the families of children Billy Caldwell and Alfie Dingley.
The families of both children led prominent campaigns to legalize medical cannabis in the UK and were instrumental in the government’s eventual decision to legalize medical cannabis.
Genevieve Edwards, director of external affairs at the MS Society, echoed this sentiment, saying that the approval was “brilliant” but didn't go far enough.
“No cannabis-based treatments have been recommended to treat pain, a common symptom of MS,” she said. “Additionally, because Sativex will be funded by local bodies – who might not have the resource they need to prescribe it – even more people could miss out.”