How will the UK’s relaxed cannabis regulations impact clinical practice?

The UK Home Secretary announced that as of 1 November, specialist doctors will be given the option to legally prescribe patients cannabis-based products if their patients would benefit from the treatment. This will stop regulations from limiting the disease indications that cannabis-based medicines can be prescribed for, and physicians will no longer need to seek approval from an expert panel for patients to access these medicines.

While this important policy change will undoubtedly impact the medicinal use of cannabis-based products, it still remains unclear how quickly, and to what extent, it will influence actual clinical practice.

With the National Institute for Health and Care Excellence set to release guidelines for clinicians in October 2019, some uncertainty exists surrounding how cannabis-based products will be prescribed in the near future. Furthermore, both the British Pediatric Neurology Association and the Royal College of Physicians will be responsible for providing clinical advice to physicians. Due to the fact that cannabis is a controlled substance, these products can only be prescribed by specialists, not by general practitioners.

GlobalData believes that it is highly likely that cannabis-based products will be moved to Schedule 4 of the Misuse of Drug Regulations 2001, similar to Bayer’s cannabidiol molecule Sativex (nabiximols), which is approved for muscle spasticity. Schedule 4 drugs can be obtained in the UK with no restriction on supply, but can only be lawfully possessed under prescription.

The drug that brought about the policy change was GW Pharmaceuticals’ Epidiolex (cannabidiol), which is approved for epilepsy. It is also currently in Phase III development for infantile spasm and tuberous sclerosis. If Epidolex proves to have strong efficacy and boast a good safety profile in the indications mentioned above, GW Pharmaceuticals will have more of an incentive to apply for approval in the UK. The new policy change will help to increase sales if physicians can prescribe the drug without expert panel opinions. This will help the company compete with Bayer’s Sativex and possibly become a major player in the UK cannabinoid market.

Furthermore, there are two other companies with cannabis-based products at Phase II stage in Europe: Kalytera Therapeutics and Axim Biotechnologies, which are indicated for graft versus host disease and irritable bowel syndrome (IBS), respectively. In April 2017, Axim Biotechnologies’ CanChew (cannabidiol) completed its Phase II trial and there were no significant adverse effects.

All patients who participated in the study saw a decrease in levels of pain caused by IBS with a trend curve showing that patients had 50% higher pain reduction when administered CanChew compared with placebo. If Axim can boast promising Phase III results, it has the potential to be the third company in the UK with an approved cannabis-based product.

The new policy change could see more companies conducting clinical research for cannabis-based products in the UK. Although there are still some uncertainties as to how clinicians will administer the product, the new policy change suggests that the UK is warming to the idea of medicinal cannabis.