NICE and NHS England, in two separate documents published on Thursday, have flagged the lack of evidence to support the use of medicinal cannabis.
Draft guidance from the NICE, open for public consultation until 5 September, makes eight separate recommendations for further research across all the indications and cannabis-based medicinal products (CBMP) covered in the document.
The guidance, which follows the re-classification of these products last year, notes the overall lack of clinical and cost-effectiveness evidence for the products.
NICE said it is unable to make a recommendation about the use of CBMPs for severe treatment-resistant epilepsy and chronic pain. The watchdog cited lack of clear evidence and high costs respectively for the decision.
It permitted cannabidiol, a pure, plant-derived cannabinoid, used on its own in the context of a clinical trial for chronic pain.
The guidance also refrained from recommending Sativex for treating spasticity in people with multiple sclerosis as it was found to be not cost-effective. It added that other CBMPs should not be offered to treat spasticity unless as part of a clinical trial.
The draft guidance recommended nabilone as an add-on treatment for adults with chemotherapy-induced nausea and vomiting which hasn’t responded to conventional licensed medicines.
NHS England has published a review aimed at assessing the barriers to prescribing cannabis-based medicinal products where it is safe and clinically appropriate.
The review noted that prescribing decisions on CBMPs have been heavily affected by the lack of evidence about the long term safety and effectiveness of the products.
The review, developed by listening to families and the specialist clinicians responsible for care, recommended two clinical trials for severe treatment-resistant paediatric epilepsy.
Clinicians need the best information and support available to make decisions to prescribe medicinal cannabis for children with severe epilepsy, it said.
The review asked the National Medical Director and Chief Pharmaceutical Officer for England to write to doctors and pharmacists to clarify the procedure for prescribing and supplying CBMPs.
“This may be viewed as progress, but perhaps also as frustrating for the UK medicinal cannabis sector and families of patients who have campaigned for it to be authorised to treat severe epilepsy,” commented Sarah Ellson, a partner and life sciences regulatory expert at law firm Fieldfisher.
“It seems that the cannabis sector and patients will have to wait until the outcome of the NICE consultation and the NHS review for further clarity.”
NICE noted that the guidance would be a disappointment for certain stakeholders, but said the decision should not be surprising given the lack of evidence base for these products.
“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,” said Paul Chrisp, director of the centre for guidelines at NICE.
Dr Keith Ridge, chief pharmaceutical officer at NHS England, added: “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.”