Disappointment for campaigners and investors as NICE pours cold water on cannabis

Ever since then-Home Office minister Sajid Javid ordered a change in the law to allow cannabis-based medicinal products (CBMPs) to be prescribed by specialist clinicians, campaigners have waited…and waited…for things to change.

Almost two years later, there’s little to get excited about. Prescriptions are few and far between.  Parents still have to travel abroad – and pay an arm and a leg – for treatments that can dramatically improve their children’s condition. And they continue to run the gauntlet of a capricious Border Control which sometimes allows the drugs to pass unmolested, and sometimes doesn’t.

It’s in this context we should assess the draft guidelines published this month by NICE. While there are grounds for optimism there’s no disguising the fact that far from helping to develop the market as some hoped it would, it’s placed further obstacles in the way. These draft guidelines are a considerable disappointment for those invested in medicinal cannabis – whether for health or financial reasons.

Should we be surprised though? NICE is charged with assessing the efficacy of a new medicinal treatment – that is to say, how efficiently does it combat a nominated condition, and what is the cost benefit analysis? Its committees are influenced by clinical research and economic calculation. The more widespread and consistent the data, the better.

Yet the cannabis plant – while used by many around the world to enhance health for hundreds of years – is relatively new as a modern pharmaceutical phenomenon. While observational and anecdotal evidence abounds, ‘proper’ clinical research is conspicuous in its absence (a message to industry reiterated throughout the document).

Neither does the cannabis plant lend itself naturally to NICE analysis. Unlike, say, the poppy flower which fuels the global opioid industry there are hundreds of compounds in cannabis with perceived medicinal properties. This makes it hard to isolate individual cannabinoids and terpenes for analysis and synthesis which is partly why Big Pharma has so far kept its distance.

With this background in mind, here is a brief summary of the consultation’s key points. NICE are inviting comments on the draft guideline until 5 September – you can register as a stakeholder here.

CBMPs are typically seen currently in the UK as a treatment for epilepsy, MS, easing nausea and vomiting symptoms or in treating chronic pain. The NICE guidelines examines each of these use cases in turn.

Intractable nausea and vomiting

While there is some research around the use of CBMPs nabilone and dronabinol to treat chemo- and radiotherapy-induced nausea and vomiting, NICE was sceptical of the studies’ quality. The committee did, however, agree that nabilone ‘…may play a role in treating intractable chemotherapy-induced nausea and vomiting’ in some circumstances.

Chronic pain

NICE pointed to evidence showing that CBMPs does reduce chronic pain but cautioned that the benefit was modest (an average improvement of 0.4 out of 10). Neither is there evidence of cannabis reducing opioid use. In any case, the potential benefits are outweighed by the ‘high and ongoing costs’ and cannot therefore be considered an effective use of NHS money.

The committee did point to the potential for CBMPs to help people with fibromyalgia and those with neuropathic or intractable cancer-related pain. Specifically, cannabis can negate the effects of nausea, drowsiness and mood disturbance caused by other painkillers – and might allow people to receive care in an outpatient setting rather than in hospital.

Multiple Sclerosis

There was qualified approval of the benefits of THC:CBD spray Sativex for treating spasticity. The committee does not consider it a cost-effective treatment however. They suggest the acquisition cost would need to come down from £375 to £188 per pack to stack equally against the quality of life gains it provides.

Epilepsy

NICE criticised current research into the efficacy of CBMPs but did point to anecdotal reports of patients having fewer seizures as a result of taking them. It decided not to recommend against their use, recognising there are people currently benefiting from including CBMPs in their treatment, and to encourage further research in this area.

The Memery Crystal view

NICE is right in that there is limited clinical data proving the efficacy of CBMPs. As a Governmental body, their hands are tied until sufficiently robust clinical research emerges to support claims made in respect of CBMPs.

However, there is also a body of observational data which we would hope drives specialists clinicians to take their own informed view as to the effectiveness of CBMPs. The NICE guidelines are just one piece in the puzzle.

NICE could and should consider the global clinical data which is available as well as just UK produced data as we are many years behind places like Canada and Israel.

We urge all those involved in the research, development and distribution of medicinal cannabis to heed NICE’s call to invest in the kind of clinical trials needed to open up the NHS and to influence the wider medical community.

In the meantime, we understand the need to prove CBMP efficacy in a clinical setting; however in the interim politicians and regulators must do all they can to facilitate the promises made in November 2018.