By Sarah Ellson
The National Institute for Health and Care Excellence (NICE) on 8 August published its draft Guideline for prescribing cannabis-based medicinal products – kicking off a consultation period designed to allow feedback from medical practitioners, manufacturers and health organisations on the future of medical cannabis in the UK.
A change to the law in November 2018 made it possible to prescribe medicinal cannabis in the UK in certain circumstances, but the regulations only permit specialists on the GMC register, such as consultants in neurology or paediatrics, to issue such prescriptions.
A Health Select Committee report in July this year suggested fewer than 20 prescriptions may have actually been issued, and recent NHS data indicated that there have been fewer than 10 NHS and five private cannabis prescriptions since the law was amended.
Because such products are largely classified as “specials” – unlicensed medicines manufactured or procured specifically to meet the special clinical needs of individual patients – prescribers have to be able to justify any decisions and be clear that the patient’s need can, and can only, be met by a cannabis-based medicinal product.
NICE’s Guideline should help prescribers and commissioners gain confidence about the clinical and cost-effectiveness of such drugs. The draft Guideline, which is expected to be finalised in November, will permit prescribers to consider using the synthetic cannabinoid nabilone as an add-on treatment for adults with chemotherapy-induced nausea and vomiting.
Nabilone already has a marketing authorisation for this and can be prescribed by non-specialists.
NICE held back from a more positive recommendation in its draft Guideline, however, because it considered many of the clinical studies were low quality and outdated.
All other prescribing possibilities received an even more negative recommendation. Unless as part of a clinical trial, NICE did not recommend:
- nabilone, dronabinol, tetrahydrocannabinol (THC) or cannabidiol (CBD) with THC for chronic pain; or
- THC or Sativex (which has marketing authorisation) for spasticity for multiple sclerosis (MS), because it is not cost-effective at its list price.
NICE said it was unable to make any recommendation for cannabis products for treatment-resistant epilepsy because of a lack of evidence, and because the use of CBD to treat seizures is being considered under a separate appraisal.
It did make a number of recommendations for further research in the areas of fibromyalgia, persistent treatment-resistant pain in adults, chronic pain in children, treatment-resistant epilepsy and spasticity.
NICE modelled cannabis use in chronic pain, recognising that the number of people who might benefit was large, but that the potential benefits were likely to be small compared with high ongoing costs.
It concluded that the evidence did not show a reduction in opioid use in people prescribed medicinal cannabis, a point disputed by advocates for cannabis being made available for pain relief.
The draft Guideline was also concerned that the use of these products in children could have unknown effects on brain and cognition development.
Organisations and individuals can respond to the consultation until 5 September 2019 and can review the evidence and economic modelling via the NICE website.
The final Guideline is expected to be published on 4 November 2019. It seems unlikely that the recommendations will change, although sometimes commercial price agreements can alter recommendations, which is possible in relation to Sativex, manufactured by GW Pharmaceuticals.
Campaigners argue that progress will be slow if prescribing is limited to clinical trials.
Some advocate a Danish-style approach, which involves a four-year medicinal cannabis pilot programme that provides guidance to doctors based on global literature and evaluations, and enables “diligent and conscientious” prescribing for MS and spinal cord damage spasms and neuropathic pain.
Others point to the increasing potential of health informatics data that has been gathered globally in relation to cannabis treatments and suggest greater reliance on a ‘Learning Health System’ and ‘Real-World Evidence’, rather than insisting on the formality of clinical trials.
Published on the same day as NICE’s draft Guideline was NHS England’s Review of barriers to accessing cannabis-based products for medicinal use on NHS prescription. This review acknowledges public pressure to provide wider access to medicinal cannabis.
Since November 2018, NHS England has issued two sets of guidance to clinicians and a set of FAQs on medicinal cannabis.
This latest report makes a commitment to develop supply by improving information for clinicians and pharmacists relating to GMP-approved products, prescribing procedures, establishing a national patient registry and a network of paediatric specialist clinicians.
The UK patient registry is intended to collect uniform data across all indications with cooperation from NHS England, NHS Improvement, the Department of Health and Social Care and devolved administrations.
Overall, there seems to be disappointment among campaigners about what many feel is an overly cautious approach to building the required evidence base for wider prescriptions of cannabis products.
But medicines regulation exists for good reason and anecdotal evidence, including from illicit use, would be a highly problematic basis on which to proceed.
Given the global pace of change and the substantial investment already being made in medicinal cannabis, the UK may accelerate its approach to this sector.
Used in the right way, international expertise and experience can provide sufficient evidence to reassure regulators and commissioners about the grounds on which to take forward these potentially revolutionary medicines.
Sarah Ellson is a life sciences specialist at the law firm, Fieldfisher.
This article also appears in the September issue of Pharmacy Business.