David King, Senior Researcher
The draft NICE guidelines for the use of Cannabis-based medicinal products (CBMPs), which were published last week, contained no recommendations for the use of CBMPs except nabilone as an add-on treatment for adults suffering from intractable nausea and vomiting. Thus, for now, prescriptions of CBMPs on the NHS are likely to remain effectively unavailable. That these guidelines were highly restrictive and risk-averse came as no surprise to most, but nonetheless a huge disappointment for many.
Cost-effectiveness was calculated by use of a novel economic model, which the CDPRG have not yet critically examined. We strongly encourage third party evaluation of this model, on which NICE are accepting feedback until September 5th. The CDPRG will be submitting evidence in due course.
NICE recommended that CBMPs should not be offered for the treatment of chronic pain and spasticity, but made no recommendations for prescribing or not prescribing CBMPs for severe treatment-resistant epilepsy, pending separate guidance to be published in December.
However, NICE do recommend the use of shared care agreements to allow non-specialist prescribers, including GPs, to issue subsequent prescriptions of CBMPs once an initial prescription has been issued by a clinician on the GMC’s Specialist Register with a special interest in the conditions being treated.
Multiple recommendations for further research were outlined, including the use of CBMPs to treat:
· Fibromyalgia or persistent treatment-resistant neuropathic pain in adults;
· Chronic pain in children and young people;
· CBD and CBD-THC combinations for severe treatment-resistant epilepsy;
· Chemotherapy-induced intractable nausea and vomiting in adults; and in babies, children and young people;
· Intractable nausea and vomiting not caused by chemotherapy.
The current situation in the UK is a mess. The United Patient Alliance have estimated that more than a million people in the UK are using cannabis for medicinal purposes, but the only way of accessing CBMPs lawfully is through expensive private prescriptions that price out much of the patient population. Those who can afford these prescriptions can legally access cannabis flowers, while poorer patients growing, buying or using cannabis unlawfully risk criminal penalties for doing so. Home Office rules do not permit UK citizens to bring in cannabis products prescribed overseas, but those habitually resident in jurisdictions overseas can bring cannabis products prescribed in their home countries into the UK legally.
To the bitter disappointment of many, access of CBMPs through the NHS is going to stay severely restricted for years to come. The available evidence is of insufficient strength and quantity to convince regulators to recommend wider prescribing, thanks a multi-decade long Dark Age throughout which draconian drug control laws hindered scientific research. Unfortunately, randomized controlled trials (RCTs) make for uneasy bedfellows with CBMPs, but the CDPRG will be publishing a review at the end of the year on clinical trials designs that may better address these methodological issues.
Yet, the regulators themselves are simply doing their job, and I find it difficult to criticise NICE for not recommending wider access, much as I wish they had. To permit a class of medicines to be widely prescribed without going through the ordinary routes of evidence collection, assessment and licensing might set a dangerous precedent for pharmaceutical companies to exploit in the future. Medicines regulations are there to protect patients and the high standards of evidence required are well deserved.
So, what can be done? The immediate answer seems obvious. While access to CBMPs through medical routes remains limited, we need to guarantee that those who are taking their health into their own hands and treating their conditions successfully with cannabis products are not treated like criminals for doing so. We need urgent assurance that individuals will not be prosecuted for accessing cannabis medicines.
Since some of the conditions for which cannabis is used by these patient populations are inherently subjective, like pain, it could be sensible to decriminalise personal possession of cannabis for the entire public. There is no convincing evidence that criminal penalties deter either the supply or the use of cannabis, nor any evidence that decriminalisation would lead to a significant increase in use. Nor is there public support for the prosecution of those self-treating medical conditions unlawfully with cannabis – CDPRG’s recent survey found only 17% of the public support prosecution in such cases.
To deny patients access to a medicine that they know from experience works for them is bad enough, but to criminalise them for doing so is beyond the pale. In the absence of rapid developments in NHS prescribing, we need to seriously consider decriminalisation.