On November 12, two cannabis-based medicinal products (CBMPs) received a positive recommendation from the National Institute for Health and Care Excellence (NICE). This marks the first time that any plant-derived CBMP has received a recommendation from NICE for use on the National Health Service. However critics and campaign groups will undoubtedly state that these measures do not go far enough.
What are the medicines?
The first of two medications to be recommended is Epidyolex, which is an oral solution which contains highly purified cannabidiol (CBD). The medicine will be used for the treatment of seizures for patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. The drug does not include THC, the main psychoactive constituent of cannabis.
When used in conjunction with other anti-epileptic treatments, Epidyolex is said to significantly reduce the frequency of seizures affecting patients with LGS and Dravet syndrome. CBD, the active ingredient in the medicine, is thought to reduce or prevent seizures by targeting the movement of calcium in certain nerve cells, which can cause excessive electrical activity in the brain. NICE has previously turned down Epidyolex on the basis of cost (£5,000 to £10,000 per patient per year). The change in stance is understood to have been a result of a price reduction by the manufacturer, GW Pharmaceuticals, plc (GW), in the cost of the medicine.
LGS and Dravet syndrome are rare and severe forms of childhood-onset epilepsy, whose symptoms include seizures, abnormal electrical activity in the brain, learning disability and behavioural problems. An important factor in the recommendation of Epidyolex by NICE was the drug’s targeted reduction of drop seizure frequencies in patients – a symptom which current treatments often do not control.
Sativex (nabiximols), the other of GW’s CBMPs to be approved for NHS use, is a mouth spray which contains a mixture of THC and CBD. The drug is already approved for use in over 25 countries worldwide and is used for the treatment of multiple sclerosis (MS) related spasticity for those who have not responded adequately to other medication.
Why is it important?
Epidyolex and Sativex are now available as licensed drugs which can be prescribed to NHS patients with LGS and Dravet syndrome.
GW’s Chief operating officer Chris Tovey hailed the NICE announcement, saying: “This is a momentous occasion for U.K. patients and families who have waited so many years for rigorously tested, evidenced and regulatory approved CBMPs to be reimbursed by the NHS.”
What fell outside of the recommendations
Often, it is what is left out, which is equally as interesting as what is included. Whilst the published guidelines are welcomed for certain patients, others may feel aggrieved by the recommendations.
NICE’s report explicitly states that CBMPs should not be used to treat patients suffering from chronic pain. The reasoning behind the recommendation was that the reduction in pain was modest, showing an average improvement of about 0.4 on a scale ranging from 0 to 10.
Furthermore, the data available to the committee suggested that there was no reduction in opioid use in people prescribed medicinal cannabis. The committee considered the outcomes overall to be less important compared with mean pain intensity, which could not be differentiated between THC:CBD and placebo.
However, whether or not CBMPs can have an opioid-sparing effect remains to be seen as further evidence comes to light. Given the known risks and public health crisis which many countries face with prescribing opioids to patients, query whether CBMPs might be an alternative in the first place to chronic pain management.
Ultimately, it stated that the relatively “small” benefits offered compared to the high costs as “not an effective use of NHS resources.” Until CBMPs are able to be offered on a more-cost effective basis, it is therefore unlikely that such recommendations will change. Nonetheless, it is a welcomed step in improving patient access to alternative medicines.
The NICE recommendations at a glance:
Condition: Intractable nausea and vomiting
- Nabilone (a synthetic drug which replicates cannabinoids) to be offered as an “add-on” treatment for adults with chemotherapy-induced nausea
Condition: Chronic Pain
- Recommendation against offering nabilone, THC or THC/CBD combination drugs
- CBD only to be offered as part of a clinical trial
- Adults who started CBMPs to manage chronic pain in the NHS before this guidance was published can continue treatment until they and their NHS clinician think it appropriate to stop
Condition: Treatment-resistant epilepsy
- NICE has not made a practice recommendation, nor has it made a recommendation against CBMPs. Instead, it has made recommendations for further research in light of its view that more evidence is needed on clinical effectiveness in severe treatment-resistant epilepsy.
- It remains open for epilepsy specialists to continue making their own treatment decisions.
- For adults with MS and moderate to severe spasticity, a 4-week trial of Sativex can be offered if other treatments prove ineffective
- Treatment to be extended if patient reports at least 20% reduction in spasticity related symptoms
With thanks to Rahool Sarjua and Daniel-Yaw Miller for their assistance, both of DLA Piper