Analysis: The NICE Guidelines

The National Institute for Health and Care Excellence (NICE) has released its guidelines for prescribing cannabis-based medical products (CBMPs) in the UK. The release is significant because it is these guidelines - rather than politically-imposed regulations - that will effectively determine the extent of medical cannabis access on the NHS.

A summary of the NICE guidelines (which have been updated from the consultation version previously released ) is given below.

Prescribing recommendations:

The recommendations have disappointed those who hoped that the NICE guidelines would significantly increase patient access to CBMPs - instead, the report largely echoes the limited recommendations in place since medical cannabis was legalised last year. In particular, the recommendation against CBMPs for the treatment of chronic pain is a bitter blow for the 13 percent of the UK adult population with the condition, many of whom may benefit from medical cannabis in some form. And while it is positive that the proposed guidelines allow epilepsy specialists to make CBMP prescribing decisions on a case-by-case basis, rather than recommending outright against their use, it is disappointing that such flexibility is not extended to additional conditions.

One notable and positive departure from previous advice is the recommendation to trial Sativex for adults with MS spasticity. Sativex treatment for MS patients was previously recommended against on the grounds that it was not cost-effective, and NICE’s revised position reflects the fact that the drug’s list price has since been reduced from £375 to £300 per pack.

Despite this, the prescribing recommendations confirm a frustrating reality - that until either sufficient clinical data on cannabis’ efficacy is produced, or the UK adopts an alternative framework for CBMP access - medical cannabis will remain largely an option only for those who can afford up to £800 a month for a private prescription. 

Shared-care arrangements

NICE acknowledges that the requirement to see a specialist doctor for each CBMP prescription places an unfair burden on patients and carers. In response, they now allow for repeat prescriptions to be issued by a non-specialist prescriber (such as a GP) as part of a shared care agreement. 

That NICE recognises the ‘clear need’ to streamline CBMP access is a good step in the right direction. Allowing greater involvement by non-specialist healthcare providers should reduce tertiary healthcare costs, increase the healthcare profession’s exposure and comfort with medical cannabis, and hopefully pave the way towards regulation granting greater autonomy (such as dose adjustment) for non-specialist healthcare providers as the scheme develops.

Research recommendations

Throughout the proposed guidelines, NICE is clear when a lack of good evidence limits the strength of their recommendations or prevents them from making one at all. NICE have therefore issued key research recommendations in five areas, including CBD as a treatment for persistent neuropathic pain, CBMPs for people with spasticity, and the effect of THC/CBD combination treatment on seizures. Research recommendations regarding intractable nausea and vomiting are also given, with research sought into both the cost-effectiveness of CBMPs as well as their clinical efficacy.

These recommendations are welcome and will help direct UK clinical trials and research where (in terms of expanding UK CBMP access) it is needed the most. By issuing several ‘priority’ recommendations NICE also signals a commitment to the rapid progression of such research, and facilitates the fast-tracking of project funding by the National Institute for Health Research (NIHR), the UK’s largest supporter of healthcare research.

Hanway’s analysis

Although disappointing, NICE’s largely limited recommendations are not unexpected and show that the major institutional hurdles to medical cannabis prescription are twofold. The first issue is a lack of clinical evidence, thanks to the decades-long restrictions on medical cannabis research. NICE’s research recommendations are a positive move, but given the high costs and long lead time for the RCTs typically demanded by the body (and the potential for patients to source cannabis illegally when lacking an affordable legal alternative) there are strong arguments for accepting an alternative burden of proof or prescription framework for CBMPs. Such avenues have been proposed by groups including Transform and the Centre for Medical Cannabis, and alternative study designs are even recommended by NHS England in the case of paediatric epilepsy. NICE does support NHS England’s proposal for a national patient registry to record standardised data on patients prescribed CBMPs. However, the value of any such data collection is limited unless it can be used to inform future prescribing guidelines.

The second important takeaway is that the high cost of medical cannabis reduces the likelihood of NHS access. NICE’s recommendations are driven by the cost-effectiveness of treatment rather than efficacy alone, and most CBMPs fail to meet NICE’s affordability threshold at their current prices. For example, CBMPs would need to become either ten times cheaper or ten times more effective (or some combination of both) in order to be considered a cost-effective treatment for chronic pain.

Affordability is an issue which industry must actively work to address. Participants should set out how they intend to lower their costs, and explain any legal or regulatory barriers which prevent them from doing this effectively. That NICE have removed a longstanding recommendation against the use of Sativex as a direct result of its reduced cost shows that industry has a significant and important role to play in lowering prices and expanding patient access.

Regardless of content, the NICE guidelines are valuable for the clarity which they provide to doctors, prospective patients, and the wider industry. Hanway Associates offered stakeholder feedback on the draft guidelines released in August, and are committed to working with regulators and politicians as well as industry to help build a sustainable and equitable medical cannabis framework for the UK.

For more insights and advice on cannabis policy developments in the UK, please get in touch at info@hanwayassociates.com.