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NICE backs first cannabis-based drugs, both from GW Pharma

Approved to treat patients with epilepsy and multiple sclerosis

Sativex

Two cannabis-based medicines have been approved for use on the NHS in England for the first time, and will be used to treat patients with epilepsy and multiple sclerosis.

Updated guidelines from cost-effectiveness watchdog NICE back the use of GW Pharma’s Epidyolex (cannabidiol) for the treatment of seizures in patients with Lennox Gastaut syndrome (LGS) or Dravet syndrome – two rare, severe forms of childhood-onset epilepsy – as well as its Sativex (nabiximols) product for spasticity due to MS.

It marks the first time any plant-derived cannabis-based medicine has been recommended by NICE for use on the NHS in England, although Sativex has been available in Wales since 2014. NICE turned down Epidyolex in draft guidance, but has changed its stance after a price reduction from the manufacturer.

Oral liquid Epidyolex was approved in Europe for severe epilepsy in September, becoming the first drug to be approved without tetrahydrocannabidiol or THC – the main psychoactive component of cannabis. Oral spray Sativex – which does contain THC – was first registered in the UK in 2010.

There has long been huge demand for CBD products among the parents of children with severe epilepsy, who have had to rely on using unlicensed cannabis-based products in many countries although some have started to allow regulated access.

The UK ruled last year that unlicensed medicinal cannabis products could legally be prescribed by a registered hospital doctor for certain indications which don’t respond to other therapies, including severe epilepsy and MS, but access is reported to be patchy and inconsistent.

Epidyolex and Sativex are now available as licensed options for these two indications that can be routinely prescribed, and Sativex has been added to the current prescribing framework introduced in 2018.

NICE’s decision is a development that GW’s chief operating officer Chris Tovey said is “a momentous occasion for UK patients and families who have waited for so many years for rigorously tested, evidenced and regulatory approved cannabis-based medicines to be reimbursed by the NHS”.

There is still no legal route to obtain CBD products to treat chronic pain however, and pressure group End Our Pain tweeted that the guidelines “don’t go far enough to help the patients with…greatest need, for whom whole plant medical cannabis containing THC has life-transforming effects”.

The advice also means that patients with other forms of epilepsy are also excluded from access to cannabis-based products for the time being, and the MS Society said “disappointingly NICE didn’t recommend any cannabis-based treatments for pain” associated with the disease.

GW says it has been working with the relevant bodies in the UK, Germany, Spain, France and Italy to secure reimbursement ahead of the anticipated launch of Epidyolex in these countries.

Wales and Northern Ireland typically also follow NICE guidance, while the agency’s counterpart in Scotland – the Scottish Medicine Consortium (SMC) – is due to make a decision on Epidyolex next year. It says GW hasn’t made a submission for Sativex in MS-related spasticity.

Article by
Phil Taylor

11th November 2019

From: Regulatory

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