NICE backs use of GW Pharmaceuticals' cannabis-based medicines Epidyolex, Sativex

GW Pharmaceuticals announced that the National Institute for Health and Care Excellence recommended routine reimbursement from NHS England for Epidyolex (cannabidiol) as an adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. NICE also backed use of the company's Sativex (nabiximols) for the treatment of spasticity due to multiple sclerosis, but ruled against the cannabinoid spray to manage chronic pain in adults.

According to GW Pharmaceuticals, the decisions represent "the first-time any plant-derived cannabis-based medicine has been recommended by NICE for use on the NHS," with the latest ruling overturning a preliminary recommendation made for Epidyolex in August. Chief operating officer Chris Tovey said "this is proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous NICE evaluation process to reach patients."

Epidyolex gained EU approval in September for use as adjunctive therapy of seizures associated with LGS or Dravet syndrome, making it the first plant-derived cannabis-based medicine to be authorised in the region. Since gaining clearance, GW Pharmaceuticals has been working with bodies in the UK, Germany, Spain, France and Italy to secure reimbursement ahead of launch.

Studies have shown that when added to other anti-epileptic therapies, the cannabidiol oral solution significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome. NICE originally determined that Epidyolex, which costs between £5000 ($6438) and £10,000 ($12,876) per patient each year was not a cost-effective use of NHS resources, before GW Pharmaceuticals agreed an undisclosed discount on the therapy.

Meanwhile, Sativex was cleared in 2010 in the UK, where it is marketed by Bayer as a treatment for patients with spasticity due to MS with a price tag of around £2000 ($2575) a year per patient. However, in 2014, NICE rejected NHS funding for the therapy, ruling at the time that it provides "only a modest benefit at a significant cost."

Commenting on the latest decision, Genevieve Edwards, director of external affairs at the MS Society, noted "it's brilliant NICE has finally listened," adding "these guidelines are an important first step." However, Edwards said the recommendations "don’t go far enough [as]… No cannabis-based treatments have been recommended to treat pain, a common symptom of MS." Edwards also warned that "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."

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