NICE draft recommendations on medicinal cannabis

United KingdomScotland

On 8 August 2019, the National Institute for Health & Care Excellence (NICE) published draft guidance on prescribing cannabis-based medicinal products for consultation (Guidance). The Guidance will replace interim clinical guidance issued by specialist medical societies and makes recommendations regarding prescribing cannabis-based medicines for people with intractable nausea and vomiting, chronic pain, spasticity, and severe treatment-resistant epilepsy. The Guidance covers both licensed and unlicensed cannabis-based medicinal products, including “cannabis-based products for medicinal use” (CBPMs).

CBPMs were rescheduled as Schedule 2 drugs under the Misuse of Drugs Regulations 2001 in November 2018, which theoretically made them more available as “specials” within the UK medicines framework. However, recent reports suggest that there are few NHS prescriptions for CBPMs since their rescheduling. It appears that specialist clinicians that are able to prescribe CBPMs are reluctant to do so in the absence of better evidence on their long-term safety and effectiveness and clear clinical guidance specifying that such products may be appropriate in certain circumstances. The Guidance has adopted a fairly restrictive approach to prescribing CBPMs and other cannabis-based medicinal products, so may do little to improve the prospect of doctors obtaining approval from their NHS trust to prescribe such products.

The Guidance does not recommend any cannabis-based medicinal products, including CBPMs, for patients with intractable nausea and vomiting, chronic pain, spasticity, or severe treatment-resistant epilepsy, other than nabilone (a synthetic cannabinoid with a licensing authorisation) for adults with intractable nausea and vomiting. Rather the Guidance makes recommendations for priority research into the clinical (and cost) effectiveness of:

  • cannabis-based medicinal products for (i) spasticity and (ii) intractable pain in children and young people, as an add-on treatment;
  • cannabidiol (CBD) in combination with delta-9-tetrahydrocannabinol (THC) for epileptic disorders; and
  • CBD for (i) epileptic disorders and (ii) fibromyalgia or persistent treatment-resistant neuropathic pain in adults, as an add-on treatment.

Notwithstanding the above, the Guidance does make recommendations concerning who can prescribe cannabis-based medicinal products that may make access more straightforward where these products are considered to be appropriate in a given case. In particular, the Guidance provides that, whilst initial prescriptions of these products must be made by a specialist doctor, subsequent prescriptions may be issued by another prescriber as part of a “shared care” arrangement.

The Guidance is open for public consultation until 5 September 2019. Although the guidance will not be legally binding, health professionals and NHS bodies will need to consider the recommendations when offering treatments involving CBPMs. In the meantime, NICE is also developing technology appraisal guidance on CBD for treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two forms of severe epilepsy. These technology appraisal recommendations are expected to be published by the end of 2019.