NHS aims to remove medical cannabis barriers – while NICE dithers

NHS England and NHS Improvement issued a report this week setting out a series of measures to help remove barriers to the appropriate prescription of medical cannabis on the NHS.

The report, commissioned by the government in March, comes amid a farcical situation in the UK in which medical cannabis containing THC has been legalised for certain conditions since November 2018; yet reportedly, just two children have been given NHS prescriptions since.

The measures published yesterday aim to tackle the current stasis both by helping doctors gain a better understanding of cannabis medicine and speeding up the generation of vital research linking cannabis with various conditions and symptoms.

The report calls for the creation of a UK-wide paediatric specialist clinical network to provide clinical expertise, support discussion of complex cases, provide support to clinicians and to assist in evidence generation.

Also, the National Medical Director and Chief Pharmaceutical Officer for England will write to doctors and pharmacists clarifying the procedure for prescribing and supplying cannabis-based products for medicinal use.

Doctors will also be made aware of how they can access the Health Education England (HEE) cannabis education package, commissioned by NHS England.

Crucially, steps will be put in place to develop clearer information for patients and patient groups on the prescribing of cannabis-based products for medicinal use.

It also urges the government and the Medicines and Healthcare products Regulatory Agency (MHRA) to provide access to information on the manufacturing standard and with consistency of products containing CBD and THC.

Responding to the report, Prof Mike Barnes, leading medical cannabis expert and chair of the Medical Cannabis Clinicians Society, said: “This is a positive review that recognises the need for accepting different but valid evidence for the efficacy of cannabis as a medicine.”

Yesterday was somewhat confusing for the many families desperate to access medicinal cannabis on the NHS, however.

Just as the progressive NHS report was published, the National Institute for Health and Care Excellence (NICE) released its own rather contradictory paper.

It issued draft guidelines on the use of cannabis-based medicine for people with MS, in chronic pain, undergoing chemotherapy and with severe treatment-resistant epilepsy.

The report states that: “The committee were unable to make a recommendation about the use of cannabis-based medicines for severe treatment-resistant epilepsy because there was a lack of clear evidence that these treatments provide any benefits.”

Hannah Deacon, whose son Alfie was the first patient in the UK to receive a permanent cannabis licence and is now only one of two patients with an NHS prescription, said: “I’m extremely disappointed. There are hundreds of thousands of people using cannabis-based medicines across the world and it’s having an enormously positive impact on their health. Many countries have legalised medical cannabis industries – America, Canada and other G7 countries – they see the evidence is good enough. The UK is insisting on reinventing the wheel for no reason – and the people who are suffering are patients.

“In the UK, I’m supporting 20 families who are trying to secure prescriptions for their children and over half have now had private prescriptions – what’s the provision for them? They can’t afford to continue paying over £1000 a month or travelling to Europe to illegally access this medicine. There is no empathy at all in these guidelines – they will force people to criminalise themselves and it’s making vulnerable people more vulnerable.”

The Medical Cannabis Clinicians Society, meanwhile, criticised NICE for its failure to understand the fundamentals of how medical cannabis works.

It said: “It is a pity the committee does not understand the nature of the family of medical cannabis medicines and failed to take into account alternative, valid sources of evidence. It relies solely on the pharmaceutical model of the randomised controlled trials which is not an appropriate methodology for the assessment of cannabis efficacy.”

NICE recommended the synthetic cannabinoid nabilone as an add-on treatment for adults with chemotherapy-induced nausea and vomiting which hasn’t responded to conventional licensed medicines.

But Sativex is not recommended for treating spasticity in people with MS because it was found to be not cost-effective at its current list price in relation to the benefits it provides. NICE also said that other cannabis-based medicinal products should not be offered to treat spasticity unless as part of a clinical trial.

Genevieve Edwards, spokesperson for the MS Society , said the charity was “bitterly disappointed” by the guidelines.

“NICE’s refusal to recommend cannabis for pain and muscles spasms, or to fund Sativex on the NHS, means thousands of people with MS will continue to be denied an effective treatment,” she said.

The draft guidance also says that, other than CBD used on its own in the context of a clinical trial, no cannabis-based medicinal products should be used for treating chronic pain.

“Again, this is because the benefits they offer are very small compared with their high costs and so they can’t be considered a cost-effective use of NHS resources,” NICE said.

The campaign group End Our Pain responded on Twitter: “The guidelines appear restrictive and could entrench the interim guidelines currently in place that have meant that since medical cannabis was rescheduled last year we are not aware of a single NHS prescription for any patient in the UK.

“As a registered stakeholder End Our Pain is committed to ensuring the NICE guidelines show compassion and common sense. There is evidence from around the world of the efficacy of cannabis-based medicine, as well as anecdotal evidence from UK patients accessing medical cannabis now.”

Dani Gordon, a Canadian doctor now specialising in cannabis medicine in the UK said:“These guidelines are very disappointing as they do not reflect what we see clinically treating patients with chronic pain conditions. It also fails to recognise that this is a quality of life medication, hugely beneficial for helping improve people’s level of functioning who are dealing with chronic serious medical conditions which have no cure and even best drug therapy often fails to improve quality of life in any measurable way.

“The guidelines are also unnecessarily restrictive in terms of the types of conditions where medical cannabis might be prescribed such as for complex symptom clusters including pain and anxiety.  These complex symptom clusters and use of cannabis-based medicines in the real-world practice of medicine and their efficacy cannot be adequately measured in a randomised controlled trial environment.

“They fly in the face of the incredible results I have seen in symptom management and quality of life using cannabis based medicinal products to treat thousands of patients in my Canadian physician-referral medical practice and do a real disservice to patient-centred care.”

With NICE repeatedly blaming a perceived lack of evidence for its restrictive approach, it was at least encouraging yesterday to hear NHS recommendations to accelerate medical cannabis studies.

Research was a dominant theme in the NHS England/improvement report, which called for the National Institute for Health Research (NIHR) to support research into the five priority research areas identified by NICE.

It suggested that, for severe treatment-resistant paediatric epilepsy, evidence generation should include one or more randomised control trials (RCTs) using a standardised approach with several comparative treatment arms.

But it also said: “NHS England and NHS Improvement and NIHR in conjunction with the specialist network will work together to determine an appropriate alternative study design that will enable evidence generation for those patients who cannot be enrolled into a standard RCT. This scope of study should include those children and young adults who are currently in receipt of a CBPM.

“These should commence as soon as possible, pending ethical review, and if necessary the alternative study should commence in advance of the RCT.”

Other recommendations include the NHS working with industry and academia to develop a national UK patient registry to collect a uniform data set, across all indications, for patients prescribed a cannabis-based product for medicinal use.

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