More research is needed on cannabis-based medicinal products before they can be widely prescribed, says the National Institute for Health and Care Excellence (NICE). Medicinal cannabis products were re-classified last year to allow specialist doctors to prescribe them where the needs of patients could not be met by licensed medicines. The decision followed the high profile cases of two children with epilepsy whose parents were unable to legally access cannabis oil-based medicines to prevent their seizures (DDN, July /August 2018, page 5).
NICE has issued draft guidance for public consultation on the use of cannabis-based products for use by people with severe treatment-resistant epilepsy, chronic pain, spasticity and intractable nausea and vomiting as a result of chemotherapy. The guidance makes a range of recommendations for further research based on the ‘overall lack of clinical and cost-effectiveness evidence’ for the products.
The guidance states that, other than pure cannabidiol (CBD) used ‘on its own in the context of a clinical trial’, no cannabis-based products should be used for treating chronic pain, while Sativex should not be used for treating spasticity in people with multiple sclerosis as it was not found to be cost-effective in relation to its benefits.
NHS England has also published a review of the barriers to prescribing the products, which states that the lack of evidence regarding their long-term safety and effectiveness has ‘weighed heavily on prescribing decisions’ and recommends that two major clinical trials be set up. It also states that ‘consistency is key’ when making decisions about the use of medicinal cannabis for children with severe epilepsy, as without sufficient clinical trial evidence clinicians were ‘very reluctant’ to prescribe.
‘We heard loud and clear the concerns and frustration the children’s families are feeling, but these recommendations aim to help us develop the evidence base to understand how safe these products are, and ensure education and expert advice is available to support clinicians across the UK,’ said chief pharmaceutical officer at NHS England, Dr Keith Ridge.
‘We recognise that some people will be disappointed that we have not been able to recommend the wider use of cannabis-based medicinal products,’ added director of NICE’s centre for guidelines, Paul Chrisp. ‘However, we were concerned when we began developing this guidance that a robust evidence base for these mostly unlicensed products was probably lacking. Having now considered all the available evidence it’s therefore not surprising that the committee has not been able to make many positive recommendations about their use.’
Director of external affairs for the MS Society, Genevieve Edwards, said her organisation was ‘bitterly disappointed’ by the guidelines. ‘NICE’s refusal to recommend cannabis for pain and muscles spasms, or to fund Sativex on the NHS, means thousands of people with MS will continue to be denied an effective treatment,’ she said.
‘MS is relentless and painful, yet not a single person with MS has benefited from medicinal cannabis being legalised nine months ago.’
Read the draft guidance here
Read the NHS review here