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Decoding the NICE Guidelines: What They Actually Mean for Patients

Two cannabis-based drugs, Epidyolex and Sativex, have been approved by the National Institute for Health and Care Excellence (NICEfor use by the NHS.

However, while this move by the institute may outwardly seem like a step in the right direction for medical cannabis prescription, the public consensus on the move is mixed at best, with many being outraged by the body’s latest decision. This is mainly because NICE has recommended that whole-plant products will not be available for use on the NHS. The body has prompted additional consternation from the public as the guidelines state that patients with chronic pain will not be able to access cannabis-based drugs as ‘the potential benefits offered were small compared with the high and ongoing costs’.

In fact, upon closer inspection, the cannabis-based medicines now available on the NHS appear to be accessible only by those suffering from a limited number of medical conditions. In the updates published by the body, Epidyolex, a substance containing cannabidiol (CBD), is recommended for use only by those specifically suffering from Dravet and Lennox-Gastaut syndromes – very rare forms of childhood-onset epilepsy. The other medicine, Sativex, a spray containing equal amounts of CBD and THC, is recommended only for those suffering from spasticity related to multiple sclerosis.

With multiple conditions that could potentially be treated using medical cannabis, like chronic pain, fibromyalgia and more common epilepsy disorders, being overlooked, it’s easy to see why NICE’s guidelines have been met with dismay from many who hoped their conditions could be treated more affordably on the NHS. These guidelines instead appear to suggest only minor updates to the existing regulation, for the treatment of a very limited number of clinical indications.

Why do we need whole-plant medicines?

While cannabis-based medicines like Epidyolex and Sativex have proved their medical efficacy for those suffering from treatment-resistant conditions to an extent, arguably whole-plant medicines are more effective for the management of multiple conditions due to their theorised ‘entourage effect’.

The ‘entourage effect’ is a theory that suggests that when the various compounds of the cannabis plant are used together they elicit more therapeutic effects than when the compounds are used in isolation. This type of whole-plant medicine is therefore considered very useful when patients become gradually more tolerant to their formerly successful forms of treatment.

In many cases, a higher concentration of THC is required over time for patients to be able to cope with their symptoms in the same way as they formerly did (prior to becoming tolerant to their medicines). Therefore, NICE’s decision to make only two cannabis-based medicines available on the NHS will no doubt come as a blow to many who require more THC-rich products to cope with their debilitating conditions.

The fine print

Severe treatment-resistant epilepsy

Although NICE noted that they were made aware of cases where patients reported less seizures as a result of taking cannabis-based medicines other than Epidyolex, they stated that current research in this area was ‘limited and of low quality’, which made it difficult to assess the effectiveness of these different medicines.

As such, only Dravet syndrome and Lennox Gastaut syndrome will now be treated through the use of Epidyolex on the NHS. This comes following GW Pharmaceuticals’ decision to go ahead with a discounted price of the drug for NHS use after draft guidelines in September initially considered the product poor value for money.

Multiple Sclerosis spasticity

Whilst the NICE committee agreed that Sativex spray had benefits that made the use of the medicine on the NHS permissible, with ‘the longer-term benefits of THC:CBD spray [being] likely to outweigh any potential harms’, they made sure to stress that much of the evidence gathered on these reductions in spasticity was ‘low quality’ with it not being clear ‘how benefits related to improvements in quality of life’.

It should also be noted that NICE only recommends Sativex use in an initial 4-week trial when all other pharmacological treatments for spasticity have proved ineffective. After this 4-week trial period, the use of THC:CBD spray should only be continued if a 20% reduction in symptoms is observed.

Overall, it was deemed by the committee that the cost-effectiveness and safety of other medical cannabis products was more limited than with Sativex, hence the decision to allow the prescription of this medicine alone.

Chronic Pain

NICE made their decision not to allow the use of medical cannabis for the treatment of this condition due to evidence suggesting that although CBD reduced chronic pain, ‘the treatment effect was modest’. Additionally, the advisory body noted that they did not observe a reduction in opioid use in people prescribed medical cannabis products.

As with their assessments for other conditions, NICE created an economic model to compare the potential costs of products with possible therapeutic benefits. In the case of chronic pain, the benefits of treatment were deemed too minor when compared to the cost of the products, meaning they were ‘not an effective use of NHS resources’.

Looking forward

Although the NICE guidelines may have outwardly seemed promising, it is clear that much more needs to be done on this front. With the promise to deliver significant therapeutic benefits for patients suffering from debilitating conditions, cannabis-based medicines should be considered more broadly as treatment options for a wide range of conditions from more general epilepsy conditions to chronic pain, to a variety of mental health conditions.

Additionally, whole-plant cannabis products should be considered more thoroughly for the management of resistant conditions, particularly those where tolerances to previous CBD or CBD: THC combined treatments have developed.

What do you think about these updated NICE guidelines? Do you think they’ll make enough of a difference for patients? Let us know in our comments below this post. We’d love to hear from you.

For more information on cannabis use for the treatment of chronic pain access our chronic pain course.

The rest of our comprehensive resources on medical cannabis are available on our website. We urge anyone considering the use of medical cannabis products to consult with a trained medical professional prior to beginning use.

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