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UK: Parents contest NICE Cannabis Guidelines at Court Natalie Drew Lexology Wednesday 16 Sep 2020 A family is seeking judicial review of NICE guidelines in the hope that doctors are more likely to prescribe cannabis-based medicines. The outcome could have significant consequences for the healthcare sector. Nearly two years ago, in November 2018, medical cannabis was legalised in the United Kingdom. Many welcomed this change, heralding it a progressive move towards helping patients who had failed to benefit from more 'traditional' medicines. However, the reality seems to be a little different. A simple online search will quickly reveal the number of disappointed patients (or parents of patients), struggling to get an NHS prescription. In fact, to date, only a handful of NHS prescriptions for cannabis-based medicine have been written by doctors. But why? Prescribing Problems Well, first we need to differentiate between the public and the private health sectors. Whilst NHS prescriptions for cannabis-based medicine seem hard to come by, private prescribing seems to be thriving. Grow Biotech, for example, which handles about three quarters of all medical cannabis imported into the United Kingdom said that, as at July, it had received more than 100 requests for private prescriptions. The NHS, on the other hand, tells a very different story; the reason for this seems to be the guidance produced by the National Institute for Health and Care Excellence ("NICE") for the NHS. NICE's role is to consider the benefits derived from a treatment and balance that against the cost to the public purse. Its guidelines states that there is not enough evidence to recommend cannabis-based medicines for severe, treatment-resistant epilepsy. Whilst the guidelines do not prohibit prescribing the drug, the lack of a 'positive' recommendation means that many NHS doctors do not feel confident to do so – for fear of criticism, complaints, and perhaps even legal claims. It is understood that some NHS trusts (which undoubtedly have the cost question in mind) have effectively blocked clinicians' attempts to prescribe the drugs. Judicial Review And this was the exact situation in which the parents of Charlie Hughes (aged 3) found themselves. As reported in the media, Charlie suffers from a rare form of treatment resistant epilepsy, called West syndrome. Under the care of the NHS, he was given six different anti-epileptic drugs but saw no improvement in his condition. His father, Matt Hughes, felt that they were 'all out of options' after trying traditional medication, and so turned to medical cannabis. After obtaining a prescription privately (clinicians at two NHS Trusts refused to prescribe), the family reported that Charlie's seizures reduced (from 120 a day, to 20) and his development started to improve. Brain scans also showed a significant reduction in 'chaotic brain activity' associated with seizures, his father said. However, the treatment has come at a significant cost to the Hughes family, who have been paying between £1,000 and £3,000 a month for oil made from the whole cannabis plant (including both CBD and THC). Given this, the family made an application for a judicial review of the NICE guidelines. On 30 July 2020, Mr Justice Holman granted permission for a judicial review on the basis of: 'Alleged inadequate consultation'; and 'Alleged failure to take into account relevant considerations'. NICE contends that evidence for the effectiveness of cannabis-based medicines is so far relatively weak and the evidence regarding its safety is limited. The family, on the other hand will argue that current evidence (despite much of it being anecdotal and low quality) should be enough at least to support modest recommendations for doctors to consider cannabis oil for severe cases of treatment resistant epilepsy. As cannabis is not a single molecule medicine, it is more difficult to assess in randomised control trials – accordingly, a more flexible and pragmatic approach to assessment of its efficacy may need to be deployed. The lawyer acting for the family in the judicial review proceedings said that although NICE left the option open to clinicians, its guidance was 'so cautious that the effect is children aren’t getting medical cannabis'. Where are we heading? The likely outcome of the Judicial Review remains very finely balanced. Whilst the hearing offers a glimmer of hope for those patients seeking NHS prescriptions of cannabis-based medicines, even if the Judicial Review is successful, it is unclear what any redrafted guidelines might look like – and they will only ever be guidelines. In the event they do become more 'supportive', we would expect to see a change in the landscape, with perhaps: Doctors and clinicians feeling more comfortable in recommending these types of medicines; Thereby increasing NHS prescriptions of cannabis-based drugs; Creating more data, to assist in understanding efficacy and benefit; And perhaps generating a new, more flexible, approach to medicine and 'non-traditional' drugs. Harry Sumnall, Professor of Substance Use at Liverpool John Moores University said: "NICE has argued that the guidance is clear and that there is nothing stopping the NHS from currently prescribing cannabis-based products. Perhaps a successful outcome for the claimant will lead to clarity over this or generate momentum for prescribing in the claimant’s particular case". The hearing may be listed before the end of the year – and whilst it is unclear what the outcome might be – it is certainly one to keep an eye on. The consequences for patients, clinicians, and the healthcare sector, as a whole, could be extremely wide reaching. https://www.lexology.com/library/detail.aspx?g=cf0d491c-f781-484c-ac88-7c69cd6f7fe4
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